The Management of Pressure Ulcers in Primary and Secondary Care PDF

Royal College of Nursing
20 Cavendish Square London W1G ORN
The management of pressure ulcers in

primary and secondary care
A Clinical Practice Guideline
22 September 2005
This guideline has been developed by the Royal College of

Nursing
The management of pressure ulcers in primary and secondary care

Final Version June 2005
This work was undertaken by the Royal College of Nursing (RCN) Quality Improvement
Programme (QIP), and the Guideline Development Group (GDG) convened to develop the
Guideline. Funding for the health economics analysis of this Guideline was received from the
National Institute for Health and Clinical Excellence (NICE), and this work was undertaken by
the Centre for Health Economics (CHE) at the University of York. The RCN is host to the
National Collaborating Centre for Nursing and Supportive Care (NCC-NSC) which receives
partnership support from the: Centre for Evidence-Based Nursing; Centre for Statistics in
Medicine; Clinical Effectiveness Forum for Allied Health Professionals; College of Health;
Health Care Libraries (University of Oxford); Health Economics Research Centre; and UK
Cochrane Centre.
This Guideline should be read in conjunction with the NICE guideline for risk assessment and
prevention of pressure ulcers (beds, mattresses and support surfaces) (NICE, 2003) and is a
further addition to clinical guidelines forming the Wound Care Suite.
Other relevant guidelines and documents:
Nutritional support in adults: oral supplements, enteral and parental feeding.Currently

out for public consultation and can be found at the following link:
http://www.nice.org.uk/page.aspx?o=33921
National Service Framework for children, young people and maternity services (2004)
DH.
http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/ChildrenServic
es/ChildrenServicesInformation/ChildrenServicesInformationArticle/fs/en?CONTENT_
ID=4089111&chk=U8Ecln
National Service Framework for older people (2001) DH.

http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGu
idance/PublicationsPAmpGBrowsableDocument/fs/en?CONTENT_ID=4096710&chk
=yLadyI
Royal College of Nursing and National Institute for Health and Clinical Excellence
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Disclaimer
Clinical guidelines have been defined as systematically developed statements that
are designed to assist clinicians, patients and carers in making decisions about
appropriate treatments for specific conditions and aspects of care.
As with all clinical guidelines, recommendations may not be appropriate for use in all
circumstances. Decisions to adopt any particular recommendations must be made by
the practitioners in the light of:
available resources
local services, policies and protocols
the patients circumstances and wishes
available personnel and support surfaces
clinical experience of the practitioner, and
knowledge of more recent research findings.
When implementing evidence-based guidance it is important that all health care

professionals understand the local context in which they work and existing quality
improvement structures.
Where the term carer is used in the Guideline, this refers to unpaid carers as
opposed to paid carers such as care workers.
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Guideline Development Group membership

and acknowledgements
Guideline Development Group
Mrs Sarah Bazin
Mr Malcolm Blanch
Ms Jane Hampton
Chartered Society of Physiotherapy

Patient Representative, Carers UK
Professional Development Nurse, Westminster Primary
Care Trust
Mr Hugh Henderson
Royal College of Surgeons
Dr Jacqueline Morris
British Geriatric Society
Mr Mark OBrien
Paediatric Tissue Viability Nurse, Great Ormond Street
NHS Trust. Tissue Viability Nurses Association.
Dr Alison Porter-Armstrong College of Occupational Therapists
Julie Stevens
Consultant Tissue Viability Nurse, Hounslow Primary
Care Trust and West Middlesex University Hospital
NHS Trust. Tissue Viability Nurses Forum.
Adam Thomas
Patient Representative, Royal Association of Disability
and Rehabilitation
Dr Steve Thomas
Royal Pharmaceutical Society
Mrs Tracy Vernon
Tissue Viability Lead Nurse, Doncaster and Bassetlaw
NHS Trust
Dr Paul Yerrell (GDG Lead) Senior Research Fellow, Oxford Brookes University
Dr Ian Bullock
Prof Debra Bick
Mr Will Gray
Miss Helen Weatherly
Mrs Kate Misso
Mr Rayhan Rashid
Acting Director, National Collaborating Centre Nursing

and Supporting Care (NCC-NSC) and Senior Research
and Development Fellow, Quality Improvement
Programme, RCN Institute
Professor and Chair Midwifery and Womens Health,
Thames Valley University; formerly Senior Research
and Development Fellow, Quality Improvement
Research and Development Fellow, Quality
Improvement Programme, RCN Institute (Project Lead)
Health Economist, University of York
Information Scientist, University of York
Guidelines Administrator, Quality Improvement
Acknowledgements
Additional support was received from:
Jo Rycroft-Malone (RCN Institute) especially on consensus methods development.
Lisa Askie (UK Cochrane) who assisted with updating systematic reviews. Special
thanks to the Cochrane Wounds group at the University of York for providing advice
and support in conducting the updates of the systematic reviews, in particular Sally
Bell-Syer, Nicky Cullum and Andrea Nelson. We also thank Julie Glanville for
conducting the update searches for this Guideline.
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Stakeholder organisations
The following stakeholders are registered with NICE. All were invited to comment on
all drafts of these guidelines.
Cochrane Wounds Group
Acute Care Collaborating Centre
Chronic Conditions Collaborating Centre
Mental Health Collaborating Centre 1
Mental Health Collaborating Centre 2
NCC for Cancer
Nursing & Supportive Care Collaborating Centre
Primary Care Collaborating Centre
Women's & Children's Collaborating Centre
3M Health Care Limited
Aguettant Limited
Association of British Health-Care Industries
Association of the British Pharmaceuticals Industry (ABPI)
BES Rehab Ltd
Coloplast Limited
ConvaTec
Forest Laboratories UK Limited
Huntleigh Healthcare Ltd
Independent Healthcare Association
Johnson & Johnson Medical
Kaymed
KCI Medical Ltd
Maersk Medical
Medical Support Systems Limited
Molnlycke Health Care
Nutricia Ltd (UK)
Park House Healthcare Limited
Pegasus Limited
Smith & Nephew Healthcare
SSL International plc
Surgical Dressing Manufacturers Association
Surgical Materials Testing Laboratory (SMTL)
Talley Group Ltd
Tempur-Med
Tyco Healthcare
Vernon Carus Limited
Westmeria Healthcare Ltd
Addenbrooke's NHS Trust
Anglesey Local Health Board
Ashford and St Peters Hospitals NHS Trust
Barnet PCT
Buckinghamshire Hospitals NHS Trust
Cambridgeshire & Peterborough Mental Health Partnership NHS Trust
Craven, Harrogate & Rural District PCT
Croydon Primary Care Trust
Gloucestershire Hospitals NHS Trust
Guys & St Thomas NHS Trust
Herefordshire Primary Care Trust
Kingston Primary Care Trust
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Knowsley Primary Care Trust

Leeds Teaching Hospitals NHS Trust
Luton and Dunstable Hospital NHS Trust
Mid Staffordshire General Hospitals NHS Trust
National Nurses Nutrition Group
North Middlesex University Hospital NHS Trust
Northumberland Care Trust
Nottingham City PCT
Nuffield Orthopaedic Centre NHS Trust
Princess Alexandra Hospital NHS Trust
Rotherham Primary Care Trust
Royal Liverpool Children's NHS Trust
Royal National Orthopaedic Hospital NHS Trust
Sheffield Teaching Hospitals NHS Trust
South Birmingham Primary Care Trust
South Devon Healthcare Trust
South Essex Partnership NHS Trust
South West Kent PCT
Surrey & Sussex NHS Trust
Tameside and Glossop Acute Services NHS Trust
The Dudley Group of Hospitals NHS Trust
The Medway NHS Trust
The Royal West Sussex Trust
Trafford Primary Care Trusts
University College London Hospitals NHS Trust
Vale of Aylesbury PCT
West Norfolk PCT
West of Cornwall Primary Care Trust
African & Caribbean Diabetes Association
Help the Aged
Help the Hospices
L'Arche UK
Limbless Association
Marie Curie Cancer Care
National Council for Disabled People, Black, Minority and Ethnic Community (Equalities)
Relatives and Residents Association
Sue Ryder Care
All Wales Senior Nurses Advisory Group (Mental Health)
Association of Surgeons of Great Britain and Ireland
British Association for Parenteral & Enteral Nutrition (BAPEN)
British Association of Dermatologists, The
British Dietetic Association
British Geriatrics Society
British Healthcare Trades Association
British Psychological Society, The
British Society for Antimicrobial Chemotherapy
British Society of Rehabilitation Medicine
Chartered Society of Physiotherapy
College of Occupational Therapists
Community District Nurses Association
Faculty of Public Health
Health Protection Agency
Hospital Infection Society
National Association of Theatre Nurses
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Nightingale Care Beds Ltd

Nuffield Hospitals Acute Care
Royal Association of Disability and Rehabilitation
Royal College of General Practitioners
Royal College of General Practitioners, Wales
Royal College of Nursing (RCN)
Royal College of Paediatrics and Child Health
Royal College of Physicians of London
Royal College of Surgeons of England
Royal Pharmaceutical Society of Great Britain
Skin Care Campaign
Society of Chiropodists & Podiatrists
Southern Alliance of Tissue Viability Nurses
Spinal Injuries Association
Stoke Mandeville NHS Trust
The National Association of Assistants in Surgical Practice
The Royal Society of Medicine
Tissue Viability Nurses Association
Tissue Viability Nurses Forum (South)
Tissue Viability Society (UK)
Wound Care Society
British National Formulary (BNF)
Department of Health
Healthcare Commission
Medicines and Healthcare Products Regulatory Agency (MHRA)
National Patient Safety Agency
National Public Health Service Wales
NHS Modernisation Agency, The
NHS Quality Improvement Scotland
Scottish Intercollegiate Guidelines Network (SIGN)
Welsh Assembly Government (formerly National Assembly for Wales)
Peer reviewers
Mark Collier (Lincolnshire)
Lynfa Edwards (Ealing PCT)
Jed Rowe (Birmingham)
Jackie Fletcher (University of Herts)
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Abbreviations
Technical terms
ARR
ARr
BMI
CI
DH
GDG
GRP
HTA
NNT
OR
QALY
RCT
RR
RD
SEM
PU
absolute relative risk

absolute risk reduction
body mass index
confidence intervals
Guideline Review Panel
health technology assessment
number needed to treat
odds ratio
quality-adjusted life year
randomised controlled trial
relative risk (risk ratio)
risk difference
standard error of the mean
pressure ulcer
Organisations
CHE
CRD
CWG
DH
GIN
JBI
MHRA
NCC-NSC
NICE
RCN
SIGN
UKC
Centre for Health Economics, University of York

Centre for Reviews and Disseminations, University of York
Cochrane Wounds Group
Guidelines International Network
Joanna Briggs Institute
Medicines and Healthcare Products Regulatory Agency
National Collaborating Centre for Nursing and Supportive Care
National Institute for Health and Clinical Excellence
Scottish Intercollegiate Guidelines Network
UK Cochrane
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General glossary
Absolute risk reduction
The difference between the observed event rates

(proportions of individuals with the outcome of interest) in the
two groups.
Basic dressings
Dressings that may cover a wound but do not create an

optimum healing environment e.g. gauze, paraffin gauze
and simple dressing pads.
Bias
Influences on a study that can lead to invalid conclusions

about a treatment or intervention. This may result from flaws
in the design of a study or in the analysis of results, and may
result in either an underestimate or an overestimate of the
effect. Bias can occur at different stages in the research
process for example in the collection, analysis,
interpretation, publication or review of the research.
Case-control study
A study in which the effects of an exposure in a group of

patients (cases) who have a particular condition is compared
with the effects of the exposure in a similar group of people
who do not have the clinical condition (the latter is called the
control group).
Case report
Detailed report on one patient (case), usually covering the

course of that persons disease and response to treatment.
Case series
Description of several cases of a given disease or condition,

usually covering the course of that disease and response to
treatment. There is no comparison (control) group of
patients.
Carer
An individual who provides unpaid care as opposed to paid

carers for example care workers.
Cohort
A group of people sharing some common characteristics

e.g. patients with the same disease or condition followed
up in a research study for a specified period of time.
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Clinical effectiveness
The extent to which an intervention for example a support

surface or treatment produces health benefits, that is more
good than harm.
Cochrane collaboration
An international organisation in which people retrieve,

appraise and review available evidence of the effect of
interventions in health care. The Cochrane Database of
Systematic Reviews contains regularly updated reviews on a
variety of issues. The Cochrane library contains the Central
Register of Controlled Trials (CENTRAL), and a number of
other databases which are regularly updated, and is
available as a CD-Rom or on the internet
(www.cochranelibrary.com).
Cohort study
An observations study that takes a group (cohort) of patients

and follows their progress over time to measure outcomes,
such as disease or mortality rates, and make comparisons
according to the treatments or interventions that patients
receive. Thus, within the study group, subgroups of patients
are identified and these groups are compared with respect to
outcome for example comparing mortality between groups
that did or did not receive treatment. Cohorts can be
assembled in the present and followed into the future (a
concurrent or prospective cohort study) or identified from
past record and followed forward from that time up to the
present (a historical or retrospective cohort study). Patients
are not randomly allocated to subgroups; these may be quite
different in their characteristics and therefore adjustments
must be made when analysing the results to ensure that the
comparison between groups is as fair as possible.
Co-interventions
Interventions or treatments other than the treatment under

study that are applied differently to the treatment and control
groups.
Co-morbidity
Co-existence of a disease or diseases in a study population

in addition to the condition that is the subject of study.
Concordance
A consultation process between a health care professional

and a patient where the focus is on the consultation process
rather than specific patient behaviour. There is an underlying
ethos of a shared approach to decision-making.
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Confidence intervals
A way of expressing certainty about the findings from a study

or group of studies using statistical techniques. A confidence
interval (CI) describes a range of possible effects (of a
treatment or intervention) that is consistent with the results of
a study or group of studies. A wide confidence interval
indicates a lack of certainty or precision about the true size of
the clinical effect and is seen in studies with too few patients.
Where it is narrow this indicates precision and is found in
studies with larger patient samples. It is usual to interpret a
95% CI as the range of effects within which we are 95%
confident that the true effect lies.
Cost-benefit analysis
A type of economic evaluation where both costs and benefits

of health care treatments are measured in the same
monetary units. If benefits exceed cost, the evaluation would
recommend the treatment.
Cost-effectiveness
A type of economic evaluation that assesses the additional

costs and benefits of doing something. In cost-effectiveness
analysis, the cost and benefit of different treatments are
compared. When a new treatment is compared with the
current care, its additional costs divided by its additional
benefit is called the cost-effectiveness ratio. Benefits are
measured in natural units for example cost per additional
pressure ulcer healed or prevented.
Cost-utility analysis
A special form of cost-effectiveness analysis where benefit is

measured in quality-adjusted life years. A treatment is
assessed in terms of its ability to extend or improve quality of
life.
Cost impact
The total cost to the person, the NHS or to society.
Discounting
The process of converting future pounds and future health

outcomes to their present value.
Debridement
The removal of dead (devitalised) tissue, cell debris or

foreign material from a wound.
Dead tissue
Dead tissue can present in a variety of forms. Dead

(necrotic) tissue varies in appearance according to moisture
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content. When dry it presents as black eschar (hard leatherlike material). If moisture content rises the eschar becomes
brown, then yellow, before breaking down to slough
(yellow/grey fibrous tissue with a gelatinous surface attached
to the wound bed).
Double-blind study
A study in which neither the subject (patient) nor the

observer (investigator or clinician) is aware of which
treatment or intervention the subject is receiving. The
purpose of blinding is to protect against bias.
Economic evaluation
Comparative analysis of alternative courses of action in

terms of both their costs and consequences.
Effectiveness
The extent to which interventions achieve health

improvements in real practice settings.
Efficacy
The extent to which medical interventions achieve health

improvements under ideal circumstances.
Epidemiological study
A study which looks at how a disease or clinical condition is

distributed across geographical areas.
Eschar
Brown or black necrotic, devitalised tissue; can be loose or

firmly adhered, hard, soft or soggy.
Evidence-based
The process of systematically finding, appraising and using

research findings as the basis for clinical decisions.
Evidence-based clinical
practice
Evidence-based clinical practice involves making decisions

about the care of individual patients based on the best
available research evidence rather than on personal opinion
or common practice (which may not always be evidencebased). Evidence-based clinical practice involves integrating
individual clinical expertise and patient preferences with the
best available evidence from research.
Evidence table
A table with information extracted from research papers

usually summarising the results of a collection of studies.
Together this information represents the supporting evidence
for a recommendation in a guideline.
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Experimental study
A research study designed to test whether a treatment or

intervention has an effect on the course or outcome of a
condition or disease, where the conditions of testing are to
some extent under the control of the investigator. Controlled
trials and randomised controlled trials are examples of
experimental studies.
Extrinsic
Factors which are external to the individual.
Follow-up
Observation over a period of time of an individual, group or

population whose relevant characteristics have been
assessed in order to observe changes in health status or
health-related variables.
Gold standard
A method, procedure or measurement that is widely

accepted as being the best available.
Health professional
Includes nurses, allied health professionals and doctors.
Health economics
A field of economics that examines the benefits of health

care interventions for example medicines compared with
their financial costs.
Health
technology assessment
The process by which evidence on the clinical effectiveness

and the costs and benefits of using a technology in clinical
practice is systematically evaluated.
Heterogeneity
Or lack of homogeneity. The term is used in meta-analysis

and systematic review when the results or estimates of
effects of treatment from separate studies seem to be very
different, in terms of size of treatment effects and adverse
treatment effects. Such results may occur as a result of
differences between studies in terms of the patient
population, outcome measures, definitions of variables or
duration of follow up.
Homogeneity
This means that the results of the studies in a systematic

review or meta-analysis are similar and there is no evidence
of heterogeneity. Results are usually regarded as
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homogenous when the differences between studies are

those which can reasonably be expected between studies.
Incidence
The number of new cases of illness commencing, or of

persons falling ill, during a specified time period in a given
population.
Intervention
Health care action intended to benefit the patient for

example drug treatment, dressings, physiological therapy.
Intrinsic
Factors which present within the individual.
Logistic regression model
A data analysis technique to derive an equation to predict the

probability of an event given one or more predictor variables.
This model assumes that the natural logarithm of the odds
for the event (the logit) is a linear sum of weighted values of
the predictor variable. The weights are derived from data
using the method of maximum likelihood.
Meta-analysis
A statistical method of summarising the results from a group

of similar studies.
Modern dressings
Dressings that aim to create the optimum wound healing

environment e.g. hydrocolloids, hydrogels, foams, films,
alginates and soft silicones.
Number needed to treat
The number of patients who need to be treated to prevent

one event.
Odds ratio
Odds in favour of being exposed in subjects with the target

disorder divided by the odds in favour of being exposed in
control subjects (without the target disorder).
Predictive validity
A risk assessment tool would have high predictive validity if

the predictions it makes of pressure ulcer development in a
sample became true i.e. it has both high sensitivity and
specificity.
Prevalence
The proportion of persons with a particular disease within a

given population at a given time.
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Quality-adjusted
Life expectancy using quality-adjusted life years rather than
life expectancy
nominal life years.
Quality-adjusted life years
A measure of health outcome which assigns to each time

period a weight, ranging from 01, corresponding to the
health-related quality of life during that period, where a
weight of 1 corresponds to optimal health, and a weight of 0
corresponds to a health state judged as equivalent to death.
These are then aggregated across time periods.
Randomised controlled
A clinical trial in which the treatments are randomly assigned
trial
to subjects. The random allocation eliminates bias in the

assignment of treatment to patients and establishes the basis
for the statistical analysis.
Relative risk
An estimate of the magnitude of an association between

exposure and disease, which also indicates the likelihood of
developing the disease among persons who are exposed
relative to those who are not. It is defined as the ratio of
incidence of disease in the exposed group divided by the
corresponding incidence in the non-exposed group.
Retrospective cohort study
A study in which a defined group of persons with an

exposure, and an appropriate comparison group who are not
exposed, are identified retrospectively and followed from the
time of exposure to the present, and in which the incidence
(or mortality) rates for the exposed and unexposed are
assessed.
Sensitivity
In diagnostic testing, this refers to the chance of having a

positive test result given that you have the disease or
condition. A 100% sensitivity means that all those with the
disease will test positive, but this is not the same the other
way round. A patient could have a positive test result but not
have the disease or condition this is called a false positive.
The sensitivity of a test is also related to its negative
predictive value (true negatives) a test with a sensitivity of
100% means that all those who get a negative test result do
not have the disease. To fully judge the accuracy of a test, its
specificity must also be considered.
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Specificity
In diagnostic testing, this refers to the chance of having a

negative test result given that you do not have the disease. A
100% specificity means that those without the disease will
test negative but this is not the same the other way round. A
patient could have a negative test result but still have the
disease or condition this is called a false negative. The
specificity of a test is also related to its positive predictive
value (true positives) a test with a specificity of 100%
means that all those who get a positive test result definitely
have the disease or condition. To fully judge the accuracy of
a test, its sensitivity must also be considered.
Statistical power
The ability of a study to demonstrate an association or causal

relationship between two variables, given that an association
exists for example, 80% power in a clinical trial means that
the study has 80% chance of ending up with a p value of less
than 5% in a statistical test (statistically significant).
Systematic review
A way of finding, assessing and using evidence from studies

(usually randomised, controlled trials) to obtain a reliable
overview.
User
Any one using the guideline.
Validity
The extent to which a variable or intervention measures what

it is supposed to measure or accomplish. The internal validity
of a study refers to the integrity of the design. The external
validity of a study refers to the appropriateness by which its
results can be applied to non-study patients or populations.
Wound bed preparation
Management of the wound to promote endogenous healing

or to facilitate the effectiveness of therapeutic interventions.
This glossay is partially based on Clinical epidemiology glossary by the Evidence Based Medicine Working Group,
www.ed.ualberta.ca/ebm; Information for National Collaborating Centres and Guideline Development Groups (NICE,
2001) and the glossary from the Patient Involvement Unit at NICE.
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Contents
Disclaimer.......................................................................................................3
Terminology ...................................................................................................3
Abbreviations and general glossary8
1
EXECUTIVE SUMMARY ....................................................................19
PRINCIPLESOF PRACTICE & SUMMARY OF RECOMMENDATIONS
2.1
2.2
2.3
2.4
Person-centred care............................................................................21
A collaborative inter-disciplinary approach to care ..............................21
Organisational issues ..........................................................................21
Recommendation statements.22
BACKGROUND TO THE CURRENT GUIDELINE .............................24
3.1
3.2
3.3
3.4
Clinical need for the guideline .............................................................24

What are pressure ulcers? ..................................................................26
Groups at risk ......................................................................................27
What are the main interventions? (for example pressure-relieving
support surfaces)?...............................................................................27
AIMS OF THE GUIDELINE.................................................................27
4.1
4.2
4.3
4.4
4.5
4.6
4.7
Who the guideline is for.......................................................................28

Groups covered by the guideline.........................................................28
Groups not covered.............................................................................28
Healthcare setting ...............................................................................28
Interventions covered ..........................................................................29
Interventions not covered ....................................................................29
Guideline development group..............................................................31
METHODS USED TO DEVELOP THE GUIDELINE...........................33
5.1
5.2
5.3
5.4
5.5
5.6
5.7
Summary of development process ......................................................33

Clinical effectiveness review methods.................................................36
Cost-effectiveness review methods.....................................................41
Submission of evidence process .........................................................50
Evidence synthesis and grading..........................................................51
Results of clinical effectiveness evidence retrieval and appraisal .......52
Formulating and grading recommendations ........................................52
GUIDELINE RECOMMENDATIONS WITH SUPPORTING EVIDENCE

REVIEWS............................................................................................57
6.1
6.2
6.3
6.3.1
Holistic assessment..55
Ulcer assessment65.
Support surfaces for the treatment of pressure ulcers76
Cost-effectiveness of support surfaces... 88
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6.4
6.4.2
6.5
6.6
6.7
6.8
6.9
Dressings and topical agents in thetreatment of pressure ulcers..100

Cost-effectiveness of dressings and topical agents121
Antimicrobial agents for the treatment of pressure ulcers..145
Mobility and positioning154
Nutrition in the treatment of pressure ulcers.159
Surgery in the treatment of presssure ulcers
170
Topical negative pressure, Electrotherapy, electromagnetic therapy.
and therapeutic ultrasound in the treatment of pressure ulcers179
6.9.1 Cost effectivness
198
RECOMMENDATIONS FOR RESEARCH .......................................206
ALGORITHM...202
AUDIT CRITERIA...203
DISSEMINATION OF GUIDELINES .................................................212
10
VALIDATION ....................................................................................213
11
Review
12
REFERENCES206
212
Appendix A:
Clinical effectiveness evidence table .234
Appendix B:
Search strategies..370
Appendix C:
Quality assessment tools A - I ....467
Appendix D:
Table of excluded studies..495
Appendix E:
Quality checklists/data extraction forms..504
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EXECUTIVE SUMMARY
The Royal College of Nursing (RCN) and National Institute for Health and Clinical
Excellence (NICE or the Institute) collaborated to develop a clinical guideline on the
management of pressure ulcers in primary and secondary care. Identification of the
topic emerged from a consultation process with RCN members and referral of the
topic by the Department of Health and Welsh Assembly Government. This document
describes the methods used for developing the guidelines and presents the resulting
recommendations. It is the source document for the NICE (abbreviated version for
health professionals) and Information for the public (patient and carer) versions of the
guidelines, which will be published by NICE. The Guideline was produced by a
multidisciplinary Guideline Development Group (GDG) and the development process
was wholly undertaken by the RCN.
The main areas examined by the Guideline are:
holistic assessment for the risk of delayed healing or complications of having

a pressure ulcer
the ulcer assessment
pressure-relieving support surfaces for the treatment of pressure ulcers
mobility, positioning and re-positioning for the treatment of pressure ulcers
dressings and topical agents for the treatment of pressure ulcers
debridement for the treatment of pressure ulcers
nutritional support
surgery for the treatment of pressure ulcers
therapeutic ultrasound for the treatment of pressure ulcers
electrotherapy and electromagnetic therapy for the treatment of pressure

ulcers, and
topical negative pressure for the treatment of pressure ulcers.
Recommendations for good practice based on the best available evidence of clinical
and cost-effectiveness are presented. Literature searching details, including cut-off
dates, are reported in the methods section for each topic area. Update searches were
performed for each area not less than six months prior to submission of the first
consultation draft. Recommendations contained in this document are those
considered to be central to the management of pressure ulcers. This is a guide to that
management not a textbook of care.
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Health care professionals should use their clinical judgement and consult with
patients when applying the recommendations, which aim at reducing the negative
personal, physical, social and financial impact of pressure ulcers.
On completion of the process NICE will publish the versions for health professionals
(Quick reference guide) and for patients and carers (Information for the public), which
combine and replace the guideline for risk assessment and prevention of pressure
ulcers (beds, mattresses and support surfaces (NICE, 2003).
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PRINCIPLES OF PRACTICE AND SUMMARY OF

GUIDELINE RECOMMENDATIONS
2.1
Principles of practice
The principles outlined below describe the ideal context in which to implement the
recommendations in this Guideline. They reflect original research and development
work previously produced by the RCN, and enable clinicians using evidence-based
guidance to contextualise and understand the importance of preparation and planning
before using this evidence-based tool.
2.1.1 Person-centred care
Patients and carers should be made aware of the Guideline and its
recommendations, and be referred to the version Information for the public.
Patients and carers should be involved in shared decision-making about the

management of pressure ulcers.
Health professionals are advised to respect and incorporate the knowledge

and experience of people who have had, or have, a pressure ulcer.
Patients and carers should be informed about any potential risks, and/or
complications, of having a pressure ulcer.
2.2
A collaborative interdisciplinary approach to care
All members of the interdisciplinary team should be aware of the Guideline

and all care should be documented in the patient's health care records.
The approach to care should be interdisciplinary, involving all those needed

in the management of pressure ulcers.
2.3
Organisational issues
There should be an integrated approach to the management of pressure

ulcers with a clear strategy and policy supported by management.
Care should be delivered in a context of continuous quality improvement

where improvements to care following Guideline implementation are the
subject of regular feedback and audit.
Commitment to, and availability of, education and training are needed to
ensure that all staff, regardless of profession, are given the opportunity to
update their knowledge and are able to implement the Guideline
recommendations.
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The health care team should have undergone appropriate training and have
demonstrated competence in pressure ulcer management.
Staffing levels and skill mix should reflect the needs of patients, and are
paramount to providing high-quality services for individuals with pressure
ulcers.
Priority should be given to the provision and allocation of resources in the

management of patients with a pressure ulcer/s.
2.4
Summary of Guideline recommendations
Key recommendations
The following recommendations have been identified as priorities for implementation.
Record the pressure ulcer grade using the European Pressure Ulcer
Advisory Panel Classification System. [D]
All pressure ulcers graded 2 and above should be documented as a local

clinical incident. D[GPP]
Patients with pressure ulcers should receive an initial and ongoing pressure
ulcer assessment. Where a cause is identified strategies should be
implemented to remove/reduce these. Ulcer assessment should include: [D]
o
cause of ulcer
site/location
dimensions of ulcer
stage or grade
exudate amount and type
local signs of infection
pain
wound appearance
surrounding skin
undermining/tracking (sinus or fistula)
odour, and
involvement of clinical experts e.g. tissue viability nurse.
This should be supported by tracings and or photography (calibrated with a

ruler).
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Patients with pressure ulcers should have access to pressure-relieving

support surfaces and strategies for example, mattresses and cushions
24 hours a day, and this applies to all support surfaces. [D]
All individuals assessed as having a grade 1-2 pressure ulcer should, as a

minimum provision, be placed on a high-specification foam mattress or
cushion with pressure-reducing properties combined with very close
observation of skin changes, and a documented positioning and
repositioning regime. [D]
If there is any perceived or actual deterioration of affected areas or further

pressure ulcer development, an alternating pressure (AP) (replacement or
overlay) or sophisticated continuous low pressure (CLP) system for
example low air loss, air fluidised, air flotation, viscous fluid should be
used. [D] (NB: For individuals requiring bed rails, alternating pressure (AP)
overlay mattresses should be placed on a reduced-depth foam mattress to
maintain their safety.)
Depending on the location of ulcer, individuals assessed as having grade 3-4

pressure ulcers including intact eschar where depth, and therefore grade,
cannot be assessed should, as a minimum provision, be placed on an
alternating pressure mattress (replacement or overlay) or sophisticated
continuous low pressure system for example low air loss, air fluidised,
viscous fluid). [D]
If alternating pressure equipment is required, the first choice should be an

overlay system, unless other circumstances such as patient weight or patient
safety indicate the need for a replacement system. [D]
Create the optimum wound healing environment by using modern dressings

for example hydrocolloids, hydrogels, hydrofibres, foams, films, alginates,
soft silicones in preference to basic dressing types for example gauze,
paraffin gauze and simple dressing pads. [D]
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BACKGROUND TO THE CURRENT GUIDELINES
Background to commissioning the Guideline

NICE (or the Institute) worked collaboratively with the RCN Quality Improvement
Programme to develop this Guideline on the management of pressure ulcers in
primary and secondary care for use in the NHS in England and Wales. This follows
referral of the topic by the Department of Health and the Welsh Assembly
Government and the identification of pressure ulcer treatment as a priority topic for
nurses by RCN members. The RCN Institute, through its Quality Improvement
Programme, has a long-standing and well-respected reputation for national guideline
development and implementation work. It has established strong links with key
organisations in the field of evidence-based information, both nationally (SIGN) and
internationally (GIN and JBI).
The Guideline will provide recommendations for good practice based on the best
available evidence to the Guideline Development Group of clinical and costeffectiveness. This Guideline follows on from the recently published NICE guideline
Risk assessment and prevention of pressure ulcers (NICE, 2001) and a guideline on
the use of pressure-relieving support surfaces (beds, mattresses and overlays) for the
prevention of pressure ulcers in primary and secondary care completed in October
2003. It is anticipated that these inter-related topics will provide a compilation of NICE
guidance on pressure ulcer care and will form part of the Wound Care Suite of related
guidance.
The Institutes clinical guidelines will support the implementation of National Service
Frameworks (NSFs) in those aspects of care where a framework has been published.
The statements in each NSF reflect the evidence that was used at the time the
framework was prepared. The clinical guidelines and technology appraisals published
by the Institute after an NSF has been issued will have the effect of updating the
framework.
Clinical guidelines have been defined as systematically developed statements that
assist clinicians, patients and carers in making decisions about appropriate
treatments for specific conditions and aspects of care.
3.1
Clinical need for the guideline

The presence of a pressure ulcer creates a number of significant difficulties
psychologically, physically and clinically to patients, carers and their families.
Clinicians working in a variety of clinical and non-clinical settings, including primary
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care and acute trusts, also face challenges when providing holistic, person-centred
services for the assessment and treatment of pressure ulcers. These challenges
include clinical decisions on methods of assessment and treatments to be used for
individuals with an existing pressure ulcer.
Pressure ulcers are more likely to occur in those who: are seriously ill; are
neurologically compromised (i.e. individuals with spinal cord injuries); have impaired
mobility (Allman, 1997; Berlowitz and Wilking, 1990; Berlowitz et al., 1997; Bianchetti
et al., 1993) or who are immobile (including those wearing a prostheses, body brace
or plaster cast); suffer from impaired nutrition (Ek et al., 1990, 1991; Casey, 1997;
Banks, 1998; Casey, 1998a,b), obesity (Gallagher, 1997), poor posture, or use
equipment such as seating or beds which do not provide appropriate pressure relief.
Pressure ulcers affect sub-groups in society, including those with spinal cord injury
(Krause, 1997; Elliot, 1999; Vesmarovich et al., 1999; Kirsch, 2001), the elderly
(Hefley and Radcliffe, 1990; Waltman et al., 1991; Krainski, 1992; Orlando, 1998;
Pase and Hoffman, 1998; Spoelhof, 2000; Thomas, 2001; Ronda and Falce, 2002)
and pregnant mothers (Prior, 2002). Pressure ulcers have been associated with an
increased incidence of infection including osteomyelitis (Darouiche et al., 1994).
Research indicates that pressure ulcers represent a major burden of sickness and
reduced quality of life for patients, their carers (Hagelstein and Banks, 1995; Franks
et al., 1999; Franks et al., 2002) and their families (Benbow, 1996; Elliott et al., 1999).
Often patients require prolonged and frequent contact with the health care system,
and suffer much pain (Emflorgo, 1999; Freeman, 2001; Flock, 2003; Healy, 2003;
Manfredi et al., 2003), discomfort and inconvenience (Franks et al., 1999).
The presence of pressure ulcers has been associated with a two- to four-fold increase
of risk of death in older people in intensive care units (Thomas et al., 1996; Clough,
1994; Bo et al., 2003).
Estimates on pressure ulcer incidence and prevalence from hospital-based studies
vary widely according to the definition and grade of ulcer, the patient population and
care setting. Based on data that are available, new pressure ulcers are estimated to
occur in 410% of patients admitted to acute hospitals in the UK (Clark and Watts,
1994), the precise rates depending on case mix. In the community, new pressure
ulcers affect an unknown proportion of people as reliable data is not available.
The financial costs to the NHS are considered to be substantial (Bennett et al., 2004).
In 1993, the estimated cost of preventing and treating pressure ulcers in a 600-bed
general hospital was between 600,000 and 3 million a year (Touch Ross, 1993).
The cost of treating a grade 4 pressure ulcer was calculated in 1999 to be 40,000 a
year (Collier, 1999). More recent cost data suggest that treating ulcers varies from
1,064 for a grade 1 ulcer to 10,551 for a grade 4 ulcer with total costs in the UK
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estimated as being 1.42.1 billion annually, equivalent to 4% of the total NHS

expenditure (Bennett et al., 2004).
3.2
What are pressure ulcers?

Pressure ulcers, commonly referred to as pressure sores, bed sores, pressure
damage, pressure injuries and decubitus ulcers, are areas of localised damage to the
skin, which can extend to underlying structures such as muscle and bone (Allman,
1995, 1997). Damage is believed to be caused by a combination of factors including
pressure, shear forces, friction and moisture (Allman, 1997). Pressure ulcers can
develop in any area of the body (Rycroft-Malone and McInnes, 2000). In adults
damage usually occurs over bony prominences, such as the sacrum. Presentation in
infants and children is more likely to occur, for example, on the occipital area or ears
(Willock et al., 1999; Murdock, 2002; Jones et al., 2001).
Definitions and classifications

Definition and classification of pressure ulcers were agreed with the Guideline
Development Group at the second group meeting, and will serve to update definitions
and classifications used in related published NICE and RCN guidance, Pressure ulcer
prevention: pressure ulcer risk assessment and prevention, including the use of
pressure-relieving support surfaces (beds, mattresses and overlays) for the
prevention of pressure ulcers in primary and secondary care (NICE, 2003), available
at www.nice.org.uk and www.rcn.org.uk .
A pressure ulcer is defined as:
an area of localised damage to the skin and underlying tissue caused by pressure,
shear, friction and/or a combination of these. EPUAP(2003) European Pressure Ulcer
Advisory Panel www.epuap.org.uk .
Classification of pressure ulcer severity
Grade 1: non-blanchable erythema of intact skin. Discolouration of the skin, warmth,
oedema, induration or hardness may also be used as indicators, particularly on
individuals with darker skin.
Grade 2: partial thickness skin loss involving epidermis, dermis, or both. The ulcer is
superficial and presents clinically as an abrasion or blister.
Grade 3: full thickness skin loss involving damage to or necrosis of subcutaneous
tissue that may extend down to, but not through, underlying fascia.
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Grade 4: extensive destruction, tissue necrosis, or damage to muscle, bone, or

supporting structures with or without full thickness skin loss.
3.3
EPUAP (2003) classification system. www.epuap.org.uk
Groups at risk
Those who are seriously ill, neurologically compromised, i.e. individuals with spinal
cord injuries, have impaired mobility or who are immobile (including those wearing a
prosthesis, body brace or plaster cast), or who suffer from impaired nutrition, obesity,
poor posture, or use equipment such as seating or beds which do not provide
appropriate pressure relief.
3.4
Older people and pregnant women are also at risk.
Interventions under consideration

The guideline will consider interventions such as:
pressure-relieving support surfaces and supports, including specialised seating and
postural support; dressings; removal of devitalised or contaminated tissue
(debridement); surgery; nutritional support; electrotherapy; therapeutic ultrasound;
low-level laser therapy; topical negative pressure (TPN); and topical antimicrobials.
A range of classification systems are used throughout the literature. The one described above is generally
accepted.
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AIMS OF THE GUIDELINE
The aims of the Guideline are to:
evaluate and summarise the clinical and cost-effectiveness evidence for the
management of pressure ulcers in primary and secondary care
highlight gaps in the research evidence
formulate evidence-based and, where possible, cost-effective clinical practice

recommendations for the management of pressure ulcers based on the best
evidence available to the GDG.
4.1
Who the guideline is for

This Guideline is intended to support decision-making in health professionals who
have direct contact with and take decisions on the treatment of patients with pressure
ulcers. It is also written for people with pressure ulcers and their carers. An
Information for the public version of this Guideline will be produced containing all the
key information from the recommendations.
4.2
Groups covered by the guideline

The Guideline recommendations will apply to all patient groups (adults, older people,
infants, children and young people) in primary and secondary care.
4.3
Groups not covered
There are no restrictions.
4.4
Health care setting

This Guideline will make recommendations for care given by health professionals who
have direct contact with and make decisions about the treatment of patients with
pressure ulcers, including those with multiple pathologies, and those suffering from
chronic and acute disease, and terminal illness. Recommendations will apply equally
across the primary and secondary care interface, including specialist units. The
Guideline will also help to guide and inform patients and carers about the
Whilst there are no restriction in terms of inclusion/ exclusion criteria it is clear that the research evidence in some
areas and for some groups , e.g. infants, children and pregnant women, is very limited.
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management of pressure ulcers by increasing awareness of strategies to both assess

and treat individuals with pressure ulcers and prevent re-occurrence.
This is an NHS guideline. Although it will address the interface with other services,
such as those provided by social services, the independent sector, secure settings
and the voluntary sector, it will not include services exclusive to these sectors.
4.5
Interventions covered
This Guideline will make clinical and cost-effective recommendations on pressure
ulcer treatment, based on the best evidence available to the GDG. The
recommendations will cover treatments such as:
pressure-relieving support surfaces and supports, including specialised

seating and postural support
4.6
dressings
removal of devitalised or contaminated tissue (debridement)
surgery
nutritional support
electrotherapy
therapeutic ultrasound
low-level laser therapy
topical negative pressure, and
topical antimicrobials.
Interventions not covered

The Guideline will be relevant to, but will not cover, other aspects of pressure ulcerrisk assessment and prevention (such as identifying patients at risk of developing a
pressure ulcer, the use of risk-assessment scales, risk factors for the development of
pressure ulcers, general skin inspection, and staff education and training).
Recommendations for these areas are included in other guidance produced by the
Institute (see Section 6). This Guideline should be used in conjunction with NICE
guidance on related topics.
Wound healing
The process by which tissue repair takes place is termed wound healing. It comprises
a continuous sequence of inflammation and repair, in which epithelial, endothelial,
inflammatory cells, platelets and fibroblasts briefly come together outside their normal
Due to the size of the scope, timelines and resources to complete the guideline it has not been possible to include
all interventions indicated in the treatment of pressure ulcers. The topic areas included are those prioritised and
agreed through the formal NICE consultation process.
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domains, interact to restore a semblance of their usual discipline and, having done
so, resume their normal function.
The process of wound repair differs little from one kind of tissue to another and is to
some extent independent of the form of injury. Although the different elements of the
wound healing process occur in a continuous, integrated manner, the overall process
can be divided into three overlapping phases.
STAGES OF WOUND HEALING
Fig. 1 Stages of wound healing. Wound healing can be arbitrarily divided into three
phases: inflammation, proliferation and maturation
Inflammatory
Proliferate
Maturation and remodelling
Some wounds will heal with routine wound care for example wounds with even
edges that come together spontaneously (minor cuts) or can be brought together.
Wounds with rough edges and tissue deficit (a crater) may take longer to heal. When
there is a crater and the edges of a wound are not brought together (left open
intentionally), bumpy granulation tissue grows from the exposed tissue. The
granulation tissue is eventually covered by skin that grows over the wound from the
cut edges to the center. When healing is complete, the granulation tissue develops
into tough scar tissue. Wounds heal in three stages.
Inflammatory stage
This stage occurs during the first few days. The wounded area attempts to restore its
normal state (homeostasis) by constricting blood vessels to control bleeding. Platelets
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and thromboplastin make a clot. Inflammation (redness, heat, swelling) also occurs
and is a visible indicator of the immune response. White blood cells clean the wound
of debris and bacteria.
Proliferate stage
After the inflammatory stage, the proliferate stage lasts about three weeks (or longer,
depending on the severity of the wound). Granulation occurs, which means that
special cells called fibroblasts make collagen to fill in the wound. New blood vessels
form. The wound gradually contracts and is covered by a layer of skin.
Maturation and remodelling stage

This stage may last up to two years. New collagen forms, changing the shape of the
wound and increasing strength of tissue in the area. Scar tissue, however, is only
about 80% as strong as the original tissue. The body's ability to heal during this stage
is impaired in the elderly.
Normal wound healing in acute wounds is a co-ordinated and rapid process. This
process is impaired in chronic wounds. In chronic wounds the cells become
unresponsive to chemical messengers, such as cytokines and growth factors, and
such wounds have a prolonged inflammatory response (Van de Berg et al., 1995;
Stanley and Osler, 2001).
4.7

The Guideline recommendations were developed by a multidisciplinary and lay
Guideline Development Group (GDG) convened by the RCN and NICE with
membership approved by NICE. Members include representatives from:
patient groups
nursing
medicine
surgery
allied health
researchers, and
staff from the RCN.
The GDG met thirteen times between April 2003 and May 2005. Full details of the
GDG members can be found on the NICE website (www.nice.org.uk) and at the start
of this Guideline.
All members of the GDG were required to make formal declarations of interest at the
outset, which were recorded. GDG members were also asked to declare interest at
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the beginning of each GDG meeting. This information is recorded in the meeting
minutes and kept on file at the RCN.
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METHODS USED TO DEVELOP THE GUIDELINE
5.1
Summary of development process

The methods used to develop this Guideline are based on those published by NICE
Guideline development methods: information for National Collaborating Centres and
guideline developers (NICE, 2004). The structure of the recommendations section
(section 6) i.e. recommendations, evidence statements, evidence narrative and
Guideline Development Group commentary came from McIntosh et al. (2001) and
has been used in recently published guidelines by the NCC-NSC.
The following sources of evidence were used to inform the guideline:
Cullum N, Deeks J, Sheldon, TA, Song F and Fletcher AW (2004) Beds, mattresses
and cushions for pressure sore prevention and treatment (Cochrane Review) in: The
Cochrane Library, Issue 1, Chichester, UK: John Wiley & Sons, Ltd.
Bradley M, Cullum N, Nelson EA, Petticrew M, Sheldon T and Torgerson D (1999b)

Systematic reviews of wound care management: (2) Dressings and topical agents
used in the healing of chronic wounds. Health Technology Assessment,3(17),pt. 2.
Bradley M, Cullum N and Sheldon T (1999a) The debridement of chronic wounds.

Health Technology Assessment,3(17),pt. 1.
Langer G, Schloemer G, Knerr A, Kuss O and Behrens J (2004) Nutritional

interventions for preventing and treating pressure ulcers (Cochrane Review) in: The
Flemming K and Cullum N (2000) Therapeutic ultrasound for pressure sores. The
Cochrane Database of Systematic Reviews, Issue 4.
Flemming K and Cullum N (2001) Electromagnetic therapy for treating pressure

sores. The Cochrane Database of Systematic Reviews, Issue 1.
Evans D and Land L (2001) Topical negative pressure for treating chronic wounds.
The Cochrane Database of Systematic Reviews, Issue 1.
The stages used to develop this guideline were as follows:
develop scope of guideline
convene multidisciplinary GDG
review questions set
identify sources of evidence
retrieve potential evidence
evaluate potential evidence relating to cost/economics, quality of life and

epidemiology for eligibility, quality and relevance
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extract relevant data from studies meeting methodological and clinical

criteria
interpret each paper taking into account the results including, where
reported, the beneficial and adverse effects of the interventions, cost,
comfort and acceptability to patients, level of evidence, quality of studies,
size and precision of effect, and relevance and generalisability of included
studies to the scope of the Guideline
prepare evidence reviews and tables which summarise and grade the body
of evidence
formulate conclusions about the body of available evidence based on the

evidence reviews by taking into account factors above
develop and utilise formal consensus methods to generate a consensus

statement for areas lacking sufficient research evidence
agree final recommendations and apply recommendation gradings
submit first drafts (full version) of guidelines for feedback from NICE
registered stakeholders
consideration by GDG of stakeholders comments
submit final drafts of all Guideline versions (including Information for the
public version, algorithm and audit criteria) to NICE for second stage of
consultation
consideration by GDG of stakeholders comments
final copy submitted to NICE.
The main clinical questions addressed were as follows:

What assessment process(es)/tools should be used to identify modifiable
risk factors/complications for those with pressure ulcers?
Epidemiological systematic review of prospective cohort studies
What are the modifiable risk factors for individuals with existing pressure
ulcers?
Epidemiological systematic review of prospective cohort studies.
What assessment process(es)/tools should be used to assess a
pressure ulcer?
Narrative review of studies assessing wound measurement.
What is the evidence that pressure-relieving support surfaces (beds,
mattresses or overlays and seating cushions) are effective and costeffective in treating pressure ulcers?
Systematic review of effectiveness.
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What is the most effective positioning (sitting and lying) technique for
people with pressure ulcers?
What is the evidence that dressings are effective and cost-effective in
treating pressure ulcers?
What is the evidence that debridement is effective and cost-effective in
treating pressure ulcers?
What is the evidence that nutritional support is effective and costeffective in treating pressure ulcers?
What is the evidence that topical antimicrobials are effective and costeffective in treating pressure ulcers?
What is the evidence that surgical interventions are effective and costeffective in treating pressure ulcers?
Narrative review of case series.
Additional questions addressed by the evidence reviews included:
Are there any differences in comfort and acceptability rating?
Have there been any adverse events or patient complaints/comments for
any of the included interventions?
Is there any information about the ease of use and acceptability of
interventions for patients, carers or nursing staff?
What studies have been done looking at the quality of life implications of
having a pressure ulcer for both patients and carers in a broad sense of
quality of life?
What studies have been done that measure quality of life implications of
pressure ulcers that we can use to compare the implications of having a
pressure ulcer with other health problems?
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Are there any studies looking at the implications of quality of life of

different equipment use?
RCN staff worked with an information specialist from the Centre for Reviews and
Disseminations at the University of York to develop the search strategies for the topic
areas covered in this Guideline. The information scientist ran the searches and all
results were saved and stored in bibliographical software. RCN staff sifted all topic
areas and conducted systematic reviews, either fully in cases where there were no
existing reviews, or updated in cases where there were existing reviews or health
technology appraisals. The RCN graded the evidence and composed successive
drafts of the recommendations and the full guideline documents which includes the
full version of guidelines, NICE Quick reference guide (QRG) and Information for the
public version based on the evidence reviews, and GDG input and deliberations.
The GDG formulated and graded the recommendations.
The methods for each review are reported in section 6. The results are also reported
in section 6.
More details of the individual trials can be found in the evidence tables found in
Appendix A.
The resulting recommendations are in section six for each review area.
5.2
Clinical effectiveness review methods

The search strategies and databases used are presented in Appendix B. All searches
were comprehensive and included a large number of databases (see Appendix B).
All search strategies were adapted for smaller or simpler databases, or for web-based
sources, which did not allow complex strategies or multi-term searching.
A combination of subject heading and free text searches were used for all areas.
Free text terms were checked on the major databases to ensure that they captured
descriptor terms and their exploded terms.
Extensive hand-searching was not undertaken following NICE advice that exhaustive
searching on every guideline review topic is not practical and efficient (Mason et al.,
2002).
Reference lists of articles were checked for articles of potential relevance.
Search strategy
Terminology
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The terms for the search strategies were identified by discussion between an
information officer and the research team, by scanning the background literature, and
by browsing the Medline Thesaurus (MeSH). Once drafted, the initial strategy of
pressure ulcer terms was circulated round the GDG for comment.
Management of references
As several databases were searched, some degree of duplication resulted. To
manage this issue, the titles and abstracts of bibliographic records were downloaded
and imported into bibliographic management software to remove duplicate records.
Further studies were identified by examining the reference lists of all included articles.
Preliminary literature search

An initial search was undertaken by an RCN Research and Development Fellow to:
identify any existing guidelines, systematic reviews and Health Technology

Assessments (HTAs) covering pressure ulcer management to prevent
duplication, and
estimate the potential size of the literature for this topic area.
All databases were searched from inception date, which varies for each database.
The following databases and websites were searched using keyword search terms:
British Nursing Index (OVID) (up to 2002,10)
Cinahl (OVID) (up to 2002, 10)
Cochrane Library Issue 3. 2002 (internet)
The Database of Abstracts and Reviews of Effectiveness (DARE) (up to

2002, 10)
eGuidelines (up to 2002, 10)
Health Technology Assessment database (HTA) (up to 2002, 10)
National Guideline Clearing House (up to 2002, 11)
New Zealand Guidelines Group (up to 2002, 10)
Sign Scottish Intercollegiate Guidelines Network (up to 2002, 10)
Specialist Trials Register of Cochrane Wounds Group (up to 2002, 10) .
Main literature searches

The following databases were searched:
Medline (OVID)
Medline In-Process Citations (OVID)
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Embase (OVID)
Cinahl (OVID)
British Nursing Index (OVID)
Health Management Information Consortium (SilverPlatter)
Database of Abstracts of Reviews of Effectiveness (DARE) (internal CRD

interface)
AMED (OVID)
Cochrane Library (internet)
System for Information of Grey Literature in Europe (SIGLE) (SilverPlatter)
Search dates are reported in the relevant review.

A search of the Cochrane Wounds Group specialist trials register was undertaken for
each of the reviews.
Sifting process
Articles were retrieved and stored in an Endnote library and were subject to the
following sifting process.
1st sift:
2nd sift:
Remove any irrelevant material based on title/abstract.

Identify material that potentially met eligibility criteria based
on title/abstract.
3rd sift:
Order full papers if they appear relevant and eligible, and

where relevance/eligibility was not clear from the abstract or
the abstract was not available but the title was relevant.
4th sift:
Appraise full articles that met eligibility criteria.
Data abstraction
Data from included trials were extracted by one or two reviewers into pre-prepared
data extraction tables. Discrepancies were discussed and resolved.
The following data were extracted from each study:
patient inclusion/exclusion criteria
care setting
key baseline variables by group
description of the interventions and numbers of patients randomised to each

intervention
description of any co-interventions/standard care
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duration and extent of follow up
outcomes, and
acceptability and reliability if reported.
If data were missing from reports, then attempts were made to contact the authors to
complete the information necessary for the critical appraisal. If studies were published
more than once, the most detailed report was used as the basis of the data
extraction.
No statistical analysis of inter-rater reliability of dual data extraction was performed.
Differences were resolved by discussion.
Masked assessment, whereby data extractors are blind to the details of journal and
authors, was not undertaken because there is no evidence to support the claim that
this minimises bias (Cullum et al., 2003).
Once individual papers were retrieved, the articles were checked for methodological
rigour (using quality checklists appropriate for each study design), applicability to the
UK and clinical significance. Assessment of study quality concentrated on dimensions
of internal validity and external validity. Information from each study which met the
quality criteria was summarised and entered into evidence tables.
All data extraction forms are contained in Appendix A.
Appraisal of methodological quality

The methodological quality of each trial in the effectiveness reviews was assessed by
two researchers. The following quality criteria were used:
description of inclusion and exclusion criteria used to derive the sample from
the target population
description of a priori sample size calculation
evidence of allocation concealment at randomisation
description of baseline comparability of treatment groups
outcome assessment stated to be blinded
outcome measurement, and
clear description of main interventions.
Methods of measuring wound healing can be subjective in the studies included in the
reviews of this Guideline but had to incorporate at least one objective assessment
such as change in ulcer size, rate of healing, frequency of complete healing or time to
complete healing to meet the inclusion criteria.
Change in ulcer size is presented as a percentage or absolute change over a period
of time. Objective methods of measuring changes on wound size include tracing the
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ulcer outline followed by counting grids on graph paper, weighing uniform-density

tracing paper, planimetry or computerised image analysis.
A single standard outcome measure for wound healing does not exist. Both objective
and subjective measures are widely used by researchers. However the validity of
many of these measurements remain the subject of ongoing investigation and debate.
Objective measures of healing are usually based on wound area. Planimetry, often
aided by computer analysis, is the most frequently used method of calculating wound
area. Other methods, such as the measurement of wound diameter or weight of a
tracing drawn around the area of the wound, are also used. Measurements of wound
volume are infrequently reported in the literature; these methods are often
cumbersome and their accuracy has not been proven. Computerised image analysis
may prove to be a useful technique in the future for the assessment of wound volume,
as the equipment becomes more affordable and portable.
Even though objective measures reduce or eliminate subjective biases and reduce
random measurement errors, they have certain inherent biases if the patients being
compared have wounds with different baseline size. A change in wound area is often
expressed as the percentage change which, unlike the absolute change in area,
takes into account the initial size of the wound. For two wounds healing at the same
linear rate (as measured by diameter reduction), percentage area calculations will
show a larger change for a small wound than for a big wound. The converse is true
when the absolute change in area is measured, as for any unit reduction in wound
radius, a bigger area reduction will occur for a large wound.
This has important consequences for the validity of trial results where there is poor
comparability in initial wound size at baseline between the treatment groups. In large
trials, randomised allocation should ensure that the mean wound size and variance
in each group is similar. In a small trial random allocation is unlikely to result in an
even distribution of wound sizes. In a trial where there is poor comparability between
groups for wound size at baseline, and the outcome is based on the change in area,
the result can only be considered valid if it is obtained either: against the anticipated
direction of the bias for wound size; or where percentage area change and absolute
area change are in the same direction. If baseline data are not given then it is not
possible to determine the direction of bias and the validity of the result cannot be
determined. Despite the potential for objective outcomes to be biased by differences
in wound size at baseline, they remain the most reliable assessment of wound
healing as, unlike subjective measures, they reduce the biases of the assessor
which cannot be estimated.
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Data synthesis
For each trial, relative risk (RR) was calculated for outcomes such as complete
healing. When sufficient detail allowed their calculation, 95% confidence intervals
(95% CI) were included. NNT were calculated where possible and appropriate. The
results from replicated studies were plotted onto graphs and discussed by narrative
review. Unique comparisons were not plotted and the relative risk is stated in the text.
Individual study details are presented in the evidence tables (Appendix A). Where
there was more than one trial comparing similar interventions using the same
outcome, and in the absence of obvious methodological or clinical heterogeneity,
statistical heterogeneity was tested for by chi-squared test. In the absence of
significant statistical heterogeneity, studies with similar comparisons were pooled
using a fixed effects model (Clarke, 1999). If heterogeneity was observed, both
random and fixed effects models were used to pool the data. All calculations were
made using Revman 4.2.3 software.
5.3
Cost-effectiveness review methods

Aims
The aim of this section is to assess the economic evaluation literature on pressure
ulcer management interventions. While the clinical effectiveness sections
systematically assess the evidence on whether products can and do work, this
section also considers the resource use and cost implications associated with
interventions. To assess cost-effectiveness, alternative treatment options are
compared in terms of their costs and effects. The technique is used to assess
whether an intervention is worth using, compared with other uses to which the same
resources could be put.
Background
Pressure ulcers have a substantial impact on the health-related quality of life of
patients, and in terms of the financial burden on the health service, patients and their
families, and society as a whole. Recent cost estimates suggest that the cost of
treating a pressure ulcer varies from 1,064 for a grade 1 pressure ulcer to 10,551
for a grade 4i pressure ulcer, with higher grade pressure ulcers taking longer to heal
and being associated with a higher incidence of complications (Bennett et al., 2004).
Bennett et al. (2004) estimated that in the UK the annual cost of treating pressure
ulcers is between 1.4 and 2.1 billion (price year 2000), that is about 4% of total
NHS expenditure.
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A plethora of interventions are available for the treatment and management of

pressure ulcers. However, it is not always clear what works best, given the resource
use and cost implications of different pressure ulcer treatments.
Previous systematic reviews, in which pressure ulcer interventions are assessed,
found little evidence available on the cost-effectiveness of different treatment options
(Bradley et al., 1999ab; Cullum et al., 2001; OMeara et al., 2000). The importance of
obtaining economic evidence in this area has been reiterated with calls for additional
research that incorporates economic evaluations in high-quality clinical trials (Cullum
et al., 2001). As has been suggested before: Measures of clinical effectiveness
alone are rarely sufficient to guide health care decision-makers, since small
incremental improvements in clinical effectiveness may not be worth the costs
(OMeara et al., 2000). In recognition of this the RCN, in collaboration with NICE,
have funded this Guideline to include a review of the cost-effectiveness evidence in
this field. The benefits of incorporating health economics within NICE guidelines were
discussed and formalised within the Guideline development methods (Richardson et
al., 2004). As stated: Clinicians already take resources and value for money into
account in clinical decisions, and the incorporation of good-quality health economic
evidence into clinical guidelines can help make this more consistent.
Methods
Search questions
Searches for economic evaluations were undertaken to assess the cost-effectiveness
evidence on ten different questions:
A. What assessment process tools are most cost-effective in identifying modifiable
risk factors/complications associated with treating pressure ulcers?
B. What assessment tools are most cost-effective in assessing pressure ulcers?
C. What is the cost-effectiveness evidence on pressure-relieving support surfaces to
treat pressure ulcers?
D. What is the cost-effectiveness evidence on pressure ulcer dressings to treat
pressure ulcers?
E. What is the cost-effectiveness evidence on pressure ulcer debridement strategies?
F. What is the cost-effectiveness evidence on nutritional support to treat pressure
ulcers?
G. What is the cost-effectiveness evidence on adjunct therapies in the treatment of
pressure ulcers?
H. What is the cost-effectiveness evidence on topical antimicrobials used to treat
pressure ulcers?
I. What is the cost-effectiveness evidence on surgical interventions to treat pressure
ulcers?
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J. What is the cost-effectiveness evidence on mobility and positioning techniques to

treat pressure ulcers?
Databases searched
For each question the following databases were searched from inception date to early
2004 followed by an update search in August-September 2004 (see Appendix B for
full details):
Medline (1966-) (OVID interface)
Medline In-Process Citations (OVID interface)
Embase (1980-) (OVID interface)
Cinahl (1982-) (OVID interface)
British Nursing Index (1985-) (OVID interface)
Health Management Information Consortium (OVID interface)
AMED (1985-) (OVID interface)
PsycInfo (1872-) (SilverPlatter interface)
System for Information of Grey Literature in Europe (SIGLE) (1980-) (SilverPlatter

interface).
Where possible, searches were limited to retrieve literature published in English, and
to omit animal studies and letters, comments and editorial publication types.
As well as searches undertaken to answer specific questions, three specialist
economics databases were searched to retrieve all references to pressure ulcers
from inception date to September 2004:
EconLit (1969-) (SilverPlatter interface)
HEED (CD-rom)
NHS Economic Evaluation Database (NHS EED) (1994-) (CRD administration

database)
This search is referred to in this document as the core search.
Search terms
Given the number of questions and databases searched, all search strategies are
presented in Appendix B. The information officer, in consultation with the health
economist, identified economics terms to use in the strategy. Terms were based on
the NHS EED health economics filter strategy (CRD Report 6 (2nd Edition 2001))
with additional quality of life terms. On assessment the quality of life terms were found
to introduce high numbers of irrelevant records so the records, once loaded into
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Endnote bibliographic management software, were filtered for assessment by

searching on core economic terms:
cost* or economic* or price* or expenditure* or pharmacoeconomic* or budget* or
quality*
The pressure ulcer terms for the search strategies were identified via discussion
between an information officer and the guideline research team, by scanning the
background literature, and by browsing the MEDLINE Thesaurus (MeSH). Once
drafted, the initial strategy of pressure ulcer terms was circulated round the GDG for
comment.
For Question A the search results from the clinical effectiveness results were used, as
they had not been restricted by study design. The results were loaded into Endnote
and searched there using economics terms to identify a subset of references of
potential relevance to the health economist.
Questions B, C and J were searched separately. Questions D, E, F, G, H and I were
combined into a single search strategy to maximise efficient use of searching time.
Selection criteria
For a study to be included in the review the following criteria were applied.
The study assessed interventions to manage and treat pre-existing pressure

ulcers.
The study compared the costs and effects of two or more interventions.
The interventions that were assessed compared A, B, C, D, E, F, G, I or J.
The study had a sample size of two individuals or more.
For a study to be excluded from the review the following criteria were applied.
The study assessed interventions to prevent pressure ulcers.
The study did not report on costs associated with the interventions.
The study did not report on outcomes associated with the interventions.
The study was only available as a conference abstract or conference

presentation.
The study was not written in English and no translation of the data into
English was available.
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Data extraction
Data on the eligible economic evaluations were abstracted (see Appendix A) for
presentation purposes. Study details were provided including the method of economic
evaluation used, the study design, the results and an overview of the conclusions with
brief comments.
Quality assessment
Eligible studies were quality assessed using a quality checklist by Drummond et al.
(1996) (see Appendix C). This checklist asks 35 questions about the study design,
data collection, and analysis and interpretation aspects of the economic evaluation.
Economic evaluation review
The types of economic evaluations reviewed were full economic evaluations: costutility analysis, cost-benefit analysis, cost-effectiveness analysis and costminimisation analysis studies and partial economic evaluations including costconsequence analysis Full economic evaluations combine costs and health effects
whereas, for cost-consequence analysis, costs are reported separately from health
effects.
As implied by the names of the different types of economic evaluations, they differ in
the way that health effects are measured. Health effects for use in cost-utility
analyses measure individual or society-based preferences for a set of health states.
A utility associated with a particular health state may be adjusted by the length of time
spent in that state to calculate a generic outcome such as a Quality-Adjusted Life
Year (QALY).
Like health effects measured in cost-utility analysis, the effects measured in costbenefit analysis are also generic, in the sense that they can be used to compare
effects across interventions. The difference, compared to cost-utility analysis, is that
they are reported in monetary terms. Techniques such as contingent valuation may
be used to obtain peoples willingness to pay for the effects associated with a
particular health state.
The health effects in cost-effectiveness analysis are measured in the most
appropriate natural or physical units such as, in this case, time to complete heal of the
pressure ulcer. If the effects are shown to be equivalent then a cost-minimisation
analysis may be performed, however, in practice this is very rare. Finally, costconsequence analysis involves the use of multiple outcome measures and these are
not combined with cost (Drummond et al., 1997).
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A treatment is deemed cost-effective (a collective term which may be used for all full
economic evaluations) based on the following decision criteria:
If a treatment has lower costs and more health effects than its comparator it
is cost-effective and cost-saving (area (iv) in Figure 2).
If a treatment has higher costs and more health effects than its comparator
(area (ii) in Figure 2) it may be cost-effective, however incremental costeffectiveness analysis is required. The question then becomes whether the
extra costs are worth the extra effects. If so, the treatment is considered to be
cost-effective. If not, the resources used to provide the treatment may
produce higher-valued effects elsewhere.
If a treatment has lower costs and lower health effects than its comparator
(area (iii) in Figure 2) it may be cost-effective, however incremental analysis
is required.
If a treatment has higher costs and lower health effects than its comparator
(area (i) in Figure 2) it is not cost-effective.
Incremental cost-effectiveness or incremental net health benefit (if a monetary

measurement of health effect is used) is calculated by comparing the difference in
cost of treatment 1 to treatment 2 with the difference in outcome of treatment 1 to
treatment 2 (see Figure 2).
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(-) Difference in costs (+)

(i) Intervention
dominated:
treatment 1 less
effective and more
costly than
treatment 2
(ii) Treatment 1 more

effective and more
costly than treatment
2
(iii) Treatment 1 less

effective and less
2
(iv) Treatment 1
dominates:
Treatment 1 more
effective and less
2
(-) Difference in effects (+)

Figure 2: Cost-effectiveness plane
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Findings
Literature search
Search results and management of references

As several databases were searched, some degree of duplication resulted. To manage this
issue, the titles and abstracts of bibliographic records were downloaded and imported into
Endnote bibliographic management software to remove duplicate records. In total, 3,049
abstracts were assessed for eligibility.
The number of unique records loaded into Endnote are shown below:
A. See clinical effectiveness searches + 703
B. 417
C. 487
D, E, F, G, H, I. 989
J. 304
Core. 149
Total. 3,049
The selection criteria were applied to the abstracts stored in Endnote and 185 studies were
ordered. The selection criteria were then applied to each paper and a total of 26 economic
evaluations were included in the review including the following:
Intervention
Numbers of studies reviewed
Assessment tools
Pressure-relieving support surfaces (beds,
mattresses and overlays), mobility and positioning

Dressings and topical agents including debridement
21
Adjunct therapies (topical negative pressure,
therapeutic ultrasound, electrotherapy and

electromagnetic therapy)
Antimicrobials
Nutritional support
Surgical interventions
Table 1: Economic evaluations
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5.4
Submission of evidence process

Stakeholders registered with NICE, listed at the beginning of the document, were
invited to submit a list of evidence for consideration to ensure that relevant material to
inform the evidence base was not missed. The criteria for the evidence included:
systematic reviews
randomised controlled trials (RCTs) that examine clinical or costeffectiveness and/or quality of life, and economic analyses based on these
findings
representative epidemiological observational studies
qualitative studies/surveys that examine patient/carer experiences
studies of any design which have attempted to formally:
assess the cost-effectiveness/utility of pressure ulcer treatment
assess the cost of having a pressure ulcer
assess quality of life or used cost-utilities in relation to pressure

ulcer management.
Information not considered as evidence included:
studies with weak designs when more robust study designs are available
commercial in confidence material
unpublished secondary endpoint trial data, data-on-file and economic

modelling
promotional literature
papers, commentaries or editorials that interpret the results of a published

study
representations or experiences of individuals not collected as part of

properly designed research.
Initial submissions were received from:
British Healthcare Trades Association
Nutricia Ltd
Coloplast
Hill-Rom
College of Occupational Therapists
Pegasus UK
Submissions were followed up to request the full references.
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5.5
Evidence synthesis and grading

For the update of the clinical effectiveness reviews, data from existing trials of
effectiveness were synthesised with new trials. If there were sufficient trials to warrant
the re-analysis of existing meta-analyses, this was done. The data from included
studies pertaining to costs, economic evaluation, epidemiology and quality of life were
also qualitatively synthesised into a narrative format. Information from the reviews on
costs, economic evaluations and epidemiology was used in the economic modelling.
All included studies are summarised in evidence tables (Appendix A) as well as
discussed in the appropriate evidence reviews.
Evidence gradings were assigned to each evidence review using the evidence
hierarchy shown below (Table 2), which is the only hierarchy recommended by NICE
at the time of writing. (It should be noted that the hierarchy strictly applies to
questions of effectiveness.)
Table 2: Levels of evidence
1++
High-quality meta-analyses, systematic reviews of RCTs, or RCTs with very low

risk of bias.
1+
Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with low

risk of bias.
1-
Meta-analyses, systematic reviews of RCTs, or RCTs with high risk of bias*
2++
High-quality systematic reviews of case-control or cohort studies.

High-quality case-control or cohort studies with very low risk of confounding bias
or chance and high probability that relationship is causal.
2+
Well-conducted case-control or cohort studies with low risk of confounding bias

or chance and a moderate probability that relationship is causal.
2-
Case-control or cohort studies with a high risk of confounding bias or chance

and a significant risk that the relationship is not causal*
Non-analytic studies for example case reports, case-series.
Expert opinion, formal consensus.

*Studies with a level of evidence - should not be used as a basis for making a
recommendation.
Reproduced with permission from the Scottish Intercollegiate Guidelines Network
The evidence tables and reviews were distributed to GDG members for comment on
the interpretation of the evidence and grading.
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5.6
Results of clinical effectiveness evidence retrieval and appraisal
Study quality
A summary of the methodological quality of each study of the trials is shown in
Appendix C.
Characteristics of excluded studies are shown in Appendix D.
Comparisons
The comparisons, relevant to this Guideline, able to be made on the basis of the
included studies were:
5.7
Formulating and grading recommendations

For the GDG to formulate a clinically useful recommendation, it was agreed that the
following factors be considered:
The best available evidence with preference given to empirical evidence over
expert judgement, including:
a profile of the cost data
results of economic modelling
effectiveness data taking into account the strength of evidence (the level,
quality, precision) as well as the size of effect and relevance of the evidence
where reported, data on additional outcomes such as comfort, adverse

effects and patient acceptability
a comparison between the outcomes for alternative interventions where

possible.
The feasibility of interventions, including the cost of the intervention, acceptability

to clinicians, patients and carers and appropriateness of the support surface.
The balancing of benefits against risks including, where reported, all patientrelevant endpoints (including adverse effects, comfort and acceptability where
reported) and the results of the economic modelling.
The applicability of the evidence to groups defined in the scope of the Guideline,
having considered the profile of patients recruited to the trials, and data obtained
from our review of the epidemiological data and quality of life literature.
This information was presented to the group in the form of evidence tables and
accompanying summaries which were discussed at GDG meetings. Where the GDG
identified issues which impacted on considerations of the evidence and the ability to
formulate implementable and pragmatic guideline recommendations, these were
summarised in the GDG commentary sections.
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Issues with the available data identified by the GDG included:
Issues with the data, interpretation of the evidence and the wording were discussed
until there was agreement on the wording and grading.
Where the GDG decided that further higher level evidence was essential before any
recommendations could be considered, recommendations for future research were
made (see section 7). The group then ranked these in order of importance so that the
top five could be included in the NICE version.
The grading of the recommendations was agreed at GDG meetings using the scheme
below.
Table 3: Recommendation grading
A
At least one meta-analyses, systematic review, or RCT rated as

1++, and directly applicable to the target population or
A systematic review of RCTs or a body of evidence consisting
principally of studies rated as 1+, directly applicable to the target
population and demonstrating overall consistency of results
Evidence drawn from a NICE technology appraisal
A body of evidence including studies rated as 2++, directly

applicable to the target population and demonstrating overall
consistency of results or
Extrapolated evidence from studies rated as 1++ or 1+
A body of evidence including studies rated as 2+, directly

applicable to the target population and demonstrating overall
consistency of results, or
Extrapolated evidence from studies rated as 2++
Evidence level 3 or 4, or
Extrapolated evidence from studies rated as 2+, or
Formal consensus
D(GPP)
A good practice point (GPP) is a recommendation for best

practice based on the experience of the Guideline Development
Group
Adapted with permission from the Scottish Intercollegiate guidelines Network
The recommendations with accompanying evidence reviews are presented in section

6 and can be found in a summarised version in the quick reference guide for this
guideline.
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Formal consensus methods

Background
Clinicians often need to make decisions even where there is a variable or
undetermined evidence base. Limiting recommendations to where evidence exists
may reduce the scope of guidelines and thus limit their value to clinicians (Eccles et
al., 1996). Woolf (1992) describes three methods of guideline development but also
adds that in reality these are not mutually exclusive and it is possible to draw from
each one.
In evidence-based guideline development recommendations are based on a
systematic review of the literature, and make explicit reference and linkage to the
level of supporting evidence, which should enable clinicians to make decisions about
adhering to them. Grimshaw et al. (1995) argue that in cases where there is a strong
level of supporting evidence clinicians should have a very good reason for choosing
not to comply with them. However, as Woolf (1992) states, while this approach can be
credited with enhancing the scientific rigour of guidelines, in the absence of
acceptable evidence, one is unable to produce recommendations.
Woolf (1992) suggests that the most common method of guideline development is
informal consensus. This method is probably most frequently used at a local level
where committees formulate recommendations without drawing on research evidence
(Grimshaw and Hutchinson, 1995). By definition, this method tends to be based on
poorly defined criteria and lacks the adoption of explicit consensus. Consequently, the
resulting guidelines tend to be subjective and ill-defined in nature.
Formal consensus development methods, such as Delphi or Nominal Group
Technique, provide a structure to the group decision-making process by, for example,
adopting rating methods to represent the extent of agreement about predefined
issues or questions. In reality, given situations such as poor or lacking evidence,
guideline developers have to adopt strategies based on a framework that utilises
facets of more than one guideline development method.
As already described, the evidence base available for this Guideline is variable.
Despite published and updated systematic reviews, which form the main basis of the
Guideline development, there are some areas where systematic searches of the
evidence revealed little good-quality research evidence. Given this, it was decided to
devise and implement a formal consensus process to augment the weaker and more
variable evidence base for areas of the Guideline. The premise for this decision was
that a guideline that contained both evidence-linked and consensus-based
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recommendations would be more useful to practitioners than one confined to the
limited outcomes of available research-based evidence.
Authors, such as Grimshaw and Russell (1993a), Shekelle et al. (1999) and RycroftMalone (2001), have acknowledged the use of consensus opinion to formulate
recommendations in cases where there is an absence of evidence. They stress,
however, that the process adopted has to be explicit and that the source of
recommendations made in the resulting guideline clearly documented. Thus the
process devised and used here is based on current best practice of formal consensus
in guideline development and also that used in the development of the NICE-inherited
guideline for the risk assessment and prevention of pressure ulcers (NICE, 2002,
2003).
GDG members were asked to rate a number of elements of statement and
statements as to the level of importance or to indicate dont know if it was outside of
their expertise or knowledge base. Ratings were aggregated, and mean and
interquartile range was calculated. The results were used to develop
recommendations statements, which would then enter the next phase and formal
voting consensus.
Example:
The following refer to statements for risk factors of delayed healing/complications of having a
pressure ulcer.
Please indicate how you rate the importance of each statement.
1.
A consensus statement about the holistic assessment for those with pressure
ulcers may include:
Extremes of age
Not
1
Important
4
2
5
1
8
2
9
3
Very
Important
Reduced mobility
Not
1
2
Important
7
1
8
1
9
8
Very
Important
*Indicates GDG responses.

A modified nominal group technique was used to finalise the recommendations and
good practice points. A facilitator was used to chair the meeting. The consensus
process was facilitated by computerised voting consoles, which assured anonymity
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and allowed percentages to be quickly calculated. It also allowed the GDG to view the
range of responses in the form of a graph immediately voting had occurred.
Consensus was set at 80% unless a significant group within the GDG all voted
against a recommendation for example if all the allied health professionals, nurses
or physicians voted against a recommendation, even though 80% agreement was
achieved, a consensus agreement was not considered to have been reached.
Before voting on each recommendation and good practice point, discussion took
place and modifications were made as necessary. Recommendations were reworded
if necessary and then displayed on a screen so that GDG members could see the
recommendation or good practice point on which they were voting. If consensus was
achieved the GDG moved on to discuss the next recommendation or good practice
point. However, if consensus was not achieved, the recommendation or good practice
point was discussed a second time, modifications made to reflect the concerns of the
GDG and re-voting took place. After debate on some areas, consensus was achieved
for all recommendations submitted for first-stage consultation.
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6.
EVIDENCE REVIEWS WITH GUIDELINE RECOMMENDATIONS
6.1
The holistic assessment of individuals with pressure ulcers

Background
Pressure ulcer management approaches and techniques are continuously developing
and there remains no overall consensus about them. Over the last thirty years a
number of risk assessment tools and scales have been developed with the primary
aim of identifying those individuals at risk of developing pressure ulcers. Interventions
should then be implemented to help prevent ulceration.
The predictive validity of these assessment tools and scales in predicting which
patients go on to develop pressure ulcers has been evaluated (Bergstrom, 1987;
Deeks, 1996). These clearly identify variation in sensitivity, which means some tools
are more effective in identifying and predicting those who are at elevated risk, and
thus may go on to develop a pressure ulcer.
The importance of using risk assessment tools and scales as an adjunct to, but not a
replacement for, clinical judgement has been stressed (Cullum et al., 1995; Cullum,
2001; Rycroft-Malone and McInnes, 2000). There still remains little evidence that
indicates using a risk tool or scale is better than clinical judgement. The fact that they
should be chosen on the basis of their suitability for a particular care setting or patient
group, as well as the research evidence demonstration of their predictive validity, has
also been highlighted (Cullum, 2001).
Perhaps more interestingly for this review, their effectiveness and validity for use in
those individuals with established pressure ulcers is even more unclear, with
indications that some perform poorly in identifying patients with existing ulcers as at
risk (Williams et al., 2000). Yet these same tools and scales appear to be used widely
in this patient group in both clinical and non-clinical settings in the UK. One
explanation may be that the individual is recovering and is therefore no longer at risk,
however the validity of this is unclear. Also research indicates that those with existing
ulcers are also at elevated risk of developing further ulcers this is not consistent
with indications that some people with pressure ulcers are not found to be at risk
according to some risk assessment tools.
To what extent these individuals are at further risk, not only of developing additional
pressure ulcers but complications such as infections and delayed healing, is also
unclear.
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Reported characteristics of individuals with existing ulcers
Activity, mobility, or functional limitation or immobility.
Incontinent.
Altered level of consciousness.
Sensory impairment.
Impaired nutrition.
Acute illness.
Dehydration.
Chronic illness.
Terminal illness.
Clinical question
What assessment process should be used to identify modifiable risk factors for
people with existing pressure ulcers?
Objectives
The objective was to undertake a systematic review of the evidence of assessment of
people with pressure ulcers to determine:
What are the characteristics of people with pressure ulcers?
What are the risk factors for people with pressure ulcers?
What are the priorities for assessment?
What is the empirical evidence that this process is effective in the

management of pressure ulcers?
Selection criteria
Types of studies
Prospective cohort studies of risk factors and characteristics or complications
associated with having a pressure ulcer(s), and studies of characteristics and
interventions predictive of healing. Prospective cohort studies comparing assessment
processes for individuals with pressure ulcers, and studies evaluating their
effectiveness in individuals with pressure ulcers in the treatment of pressure ulcers.
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Types of participants
All: adults and children, including those in primary and secondary care, residential
homes, nursing homes, secure settings and the home.
Types of outcome
Risk factors linked to healing/delayed healing, healing, complications and predictors
of healing of pressure ulcers and severity.
Search strategy
The databases searched are found in the review methods section 5 . The full search
strategies are listed in Appendix B. Databases were searched in July 2003 and
update searches performed in August 2004.
Criteria for inclusion (methodological quality found in Appendix C) and pre-defined
principles as outlined in Appendix E .
Selection
Eligible participant population with well-defined demographic information.
High percentage of participants equal to or greater than 80% of those approached.
Identification of risk factors, characteristics and effectiveness of assessment process.
Risk factors and characteristics conceptually relevant to subject of interest.
Explicit details of how risk factor and characteristic information are measured.
Clear description of assessment process and measurements with comparison clearly
defined.
Confounding
Statistical adjustment carried out; evidence of sensitivity analysis with method
described.
Outcomes
Clear outcome measurements used.
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Follow up
Participation rates high with explicit details of losses to follow up.
Search results
Results of search strategy
Initial search results
2,871
N screened for relevance following

sift
197
N included
N excluded
11
Research evidence
A total of 197 studies were identified from the sifting process and subsequently full
papers ordered. This number also included those studies referenced with relevant
titles but where the abstract was absent in the citation. After sifting full papers for
relevance and duplicates at this stage, 183 papers were opinion pieces, editorials,
anecdotal reports or fell outside the inclusion criterion for this review. Out of the five
selected studies, 11 were excluded and three included.
Included studies
The gold standard study design to investigate risk factors is the prospective
cohort design. Only three studies were found which met the inclusion criteria.
Generally the studies were medium-quality prospective cohort studies.
Allman et al. (1995)

Allman et al. (1995) carried a prospective inception cohort study to identify specific
demographic, medical, functional status and nutritional characteristics that predict the
development of stage 2 pressure ulcers or greater. A total of 286 patients met the
inclusion criteria: admission within the past three days, age 55 years or more,
expected to be confined to bed or chair for at least five days and/or hip fracture, and
without grade 2 or greater pressure ulcers. The main outcome of the study was inhospital time to develop a grade 2 or greater ulcer.
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Results of multivariate analysis shows that grade 1 pressure ulcer (RR 7.52 CI 1.059.12), lymphopenia (RR 4.86 CI1.70-13.89), immobility (RR 2.36 CI1.14-4.85), dry
skin (RR 2.31 CI 1.02-5.21) and decreased body weight (RR 2.18 CI1.05-4.52) are
independent and significant risk factors for the development of grade 2 pressure
ulcers in hospital patients. In this study only 24 of the original 286 has a diagnosed
grade 1 pressure ulcer at baseline and it is not clear if this subgroup of patients were
analysed separately. The result of this may mean that the results cannot be
generalised to patients with existing pressure ulcers.
Risk factor
Risk ratio
95% CI
Stage 1 pressure ulcer
7.52
1.0-59.12
<0.001
Lymphopenia
4.86
1.70-13.86
<0.001
Immobility
2.36
1.14-4.85
<0.001
Dry skin
2.31
1.02-5.21
<0.001
Decrease body weight
2.18
1.05-4.52
<0.001
Results of multivariate analysis
Reed et al. (2003)

Reed et al. (2003) conducted a longitudinal prospective cohort study involving 2,771
subjects from 47 Veterans Affairs hospitals. The aim was to determine if three risk
factors (low serum albumin, faecal incontinence and confusion) were significant risk
factors for the development of grade 2 or greater pressure ulcers. Multivariate
analysis shows low albumin OR 1.40 and confusion OR 1.45 to be both statistically
significant risk factors of grade 2 ulcer development while faecal incontinence was
not. While this paper shows that the identification of a stage 1 pressure ulcer is a risk
factor for more severe grade 2 and above ulcers or an open wound, it does not tell of
the extent to which the other identified risk factors contribute to delayed healing or
more severe pressure ulcers.
Risk factor
Odds ratio
95% CI
Stage 1 pressure ulcer
3.13
2.41-4.06
<0.001
Malnourished
1.69
1.31-2.19
<0.001
Urinary catheter on
1.55
1.38-1.75
<0.001
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admission
DNR order
1.40
1.22-1.90
<0.001
Multiple regression analysis for development of grade 2 or greater risk factors
Williams et al. (2000)

Williams et al. (2000) undertook a prospective study of 267 subjects of which 12.8%
had a pressure ulcer present on admission to an acute care environment. The studys
aim was to investigate predictors of pressure ulcer presence and severity using the
Braden scale for pressure ulcer risk assessment. Pressure ulcer risk was evaluated
and skin inspection was performed. Demographic, physiological and laboratory data
were obtained as well as medical history and patient acuity. Inter-rater reliability of
data collection was reported as good. Statistical testing was performed using
Statistical Package for Social Sciences (SPSS).
The study found that the mean Braden score for people without ulcers was 19.7 and
15.9 for those with ulcers (P<.05), indicating that the Braden scale either failed to
highlight patients with ulcers at high risk or detected recovery in those patients with
recovering ulcers. It is not possible to deduce which from the study. The study did
however have a cut-off point of 16 to indicate high risk the lower the score, the
higher the risk of pressure ulcer development. Analysis of variance showed that
subjects with pressure ulcers had significantly lower albumin levels, total lymphocyte
count, haematocrit levels and haemoglobin levels. The paper reports this as
indicating poorer nutritional status.
Subjects with pressure ulcers were also significantly older and had longer length of
stay (LOS). Regression showed that albumin level, oxygen saturation and length of
stay were associated with pressure ulcer presence, and that albumin level and length
of stay (P <.001) accounted for 11.2% of the variance in pressure ulcer severity.
Poorer nutritional status and decreased oxygen perfusion were found to be predictors
of pressure ulcers on admission while nutritional status and length of stay were
predictors of ulcer severity. In this study nutritional status was operationalised by
using biochemical markers such as albumin and haematocrit levels as well as the
subscale of the Braden scale and body mass index.
This study does not provide information on the role of co-morbidity and the presence
of pressure ulcers nor on pressure ulcer severity. A high proportion of subjects (n =
141) were on a surgical unit; the effect of this on the presence and severity of
pressure ulcers, if any, is unclear. The study claims to have calculated odds ratios for
significant factors but they are not reported in the paper.
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Reviewers conclusions
The objective of this review was to determine the following:
What are the characteristics of people with pressure ulcers?
What are the risk factors for people with pressure ulcers?
What are the priorities for assessment?
What is the empirical evidence that this process is effective in the

It remains unclear what assessment process should be used to identify modifiable

risk factors in people with established pressure ulcers. There is not one gold standard
assessment available. There is not sufficient evidence to recommend one process or
tool over another. What is clear is that the same risk assessment tools and processes
are used in both populations: those people with established ulcers and those who are
at risk of developing pressure ulcers. Some studies report that the predictive validity
of assessment tools in those with existing ulcers is poor.
There is limited evidence reporting on the characteristics of those with existing ulcers
on admission to a primary or secondary care environment.
What is clear from the available evidence is that the existence of a grade 1 pressure
ulcer is a significant risk factor for the development of a more severe ulcer and
therefore an open wound.
There is limited evidence reporting on other modifiable risk factors and complications
for those with established pressure ulcers. Where characteristics are identified they
are consequently identified as risk factors. Not all risk factors are modifiable and it is
not clear whether it is the individual effects of each risk factor which is significant or
the collective effect. The risk factors in individuals with ulcers are not only the risks of
developing further pressure ulcers but the risks of delayed healing, and the risks of
infection and complications. Further research is required to identify the risk factors of
having a pressure ulcer. Rigorous intervention studies need to be carried out to
determine the significance of risk factors.
The issue of effectiveness in the assessment process was not found to have been
evaluated in the studies.
No economic evaluations assessing tools used to identify modifiable risk factors
and/or complications for those with established pressure ulcers were found.
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Level of
Evidence statement
evidence
The identification of a grade 1 pressure ulcer is a significant risk
2+
factor for the development of a more severe ulcer and therefore

an open wound.
Recommendations: holistic assessment

Patients with pressure ulcers should receive an initial and ongoing holistic
assessment. Both intrinsic and extrinsic factors have been identified as
important factors for assessment. This assessment should include: [D]
health status
- acute, chronic and terminal illness
- co-morbidity e.g. diabeties and malnutrition
mobility status
posture (pelvic obliquity and posterior pelvic tilt)
sensory impairment
level of consciousness
systemic signs of infection
nutritional status
previous pressure damage
pain status
psychological factors
social factors
continence status
medication
cognititive status, and
blood flow.
Assessment of mobility should include all aspects of independent movement

including walking, ability to reposition for example in bed or a chair or
transfer for example from bed to chair. [D]
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Presence of any sensory impairment in an individual with a pressure ulcer

should be recorded. D[GPP]
Level and duration of impaired consciousness should be recorded. D[GPP]
Presence of acute, chronic or terminal illness and its potential impact on ulcer
healing should be recorded. D[GPP]
Previous pressure damage (site/location, stage or grade of previous ulcer and

previous interventions) should be recorded. [D]
Pain assessment should include: whether the individual is experiencing pain;

the causes of pain; level of pain (using an appropriate tool); location and
management interventions. [D]
In the presence of systemic and clinical signs of infection in the patient with a
pressure ulcer, systemic anti-microbial therapy should be considered. D[GPP]
Psychological assessment should include concordance and abilities of the

individual to self-care (mood, motivation and aptitude). [D]
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Assessment of social factors should include the suitability of the home
environment, level of supportive provision and the involvement of local support
services. [D]
Continence assessment should include whether the individual is continent of

urine, faeces and continence interventions, which may affect ulcer healing and
impair the function of pressure-relieving support surfaces for example pads or
bedding. D[GPP]
Holistic assessment is the responsibility of the inter-disciplinary team and

should be carried out by health care professionals. [D]
Guideline Development Group commentary

Intervention
Commentary
The EPUAP is the classification tool of choice as it identifies not only
the skin colour change of grade 1 pressure ulcers but also other
physiological signs resulting from tissue damage that many other
tools ignore namely the changes in skin temperature and skin
texture due to the inflammation process.
Many clinicians identify any redness as a grade 1 pressure ulcer. A
level of redness is normal for example following crossed legs
where the lower leg has a red mark when the upper leg is removed.
This is not the redness of a grade 1 pressure ulcer and it is not hot
to touch etc. The classification system is about what the skin/tissue
looks like and is not related to patient group/environment/context
these items are part of pressure ulcer risk assessment tools.
Research recommendations
Well-designed, large-scale, prospective cohort studies, including those with pressure
ulcers and including relevant identified risk factors, to show how the identified risk
factors lead to more severe ulcers or delayed healing or complications.
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6.2
Ulcer assessment
Background
The assessment of the pressure ulcer together with the holistic assessment is the
basis for initiating, developing, maintaining and evaluating the plan of care for an
individual with a pressure ulcer. The assessment of the pressure ulcer should provide
information or data to facilitate the communication of information about the severity of
the pressure ulcer and the change of the pressure ulcer over time.
The research identifies many subjective methods of assessing both wound
characteristics and wound healing (Cutler et al., 1993; Griffin et al., 1993; Melhuish et
al., 1994; Thomas and Humphreys, 1994 ; Plassmann, 1995 ; Shubert, 1997; BatesJensen, b, 1992, 1993 , 1995; and Houghton and Kincaid, 2000).
However it is a consistently accurate assessment of pressure ulcers which is key to
monitoring changes in pressure ulcer characteristics that will determine treatment
interventions. A number of characteristics are identified in the literature (Bohannon
and Pfaller, 1983; Bulstode et al., 1987; Cooper, 1990; Ayello, 1992; Bates-Jensen,
1992; Emparanza et al., 2000; Gardner, 2001) as important indices to include in the
pressure ulcer assessment. These include: location, size, depth, stage, condition of
wound edges, tunnelling or undermining, signs of infection, necrotic tissue, exposed
bone, granulation tissue presence, epithelialisation, exudates and odour. The
importance and relevance of these indices to ensure the most effective outcomes is
the focus of this review together with a clearer understanding of the consistency and
accuracy of these measurements in pressure ulcer assessment.
To date there is not one method of assessing pressure ulcer status that is used
universally. Yet the importance of a thorough, accurate, consistent and objective
assessment of pressure ulcers is strongly advocated (Verhonick, 1961; Bohannon
and Pfaller, 1983; Bulstode et al., 1987; Gosnell, 1977; Garrigues, 1987; Preston,
1987; Maklebust, 1987; Ayello, 1992; Emparanza et al., 2000; Gardner, 2001). A
number of tools have been developed specifically to assess pressure ulcer status.
However there remain contentious issues about their validity and reliability. It is now
almost ten years since the publication of the Agency for Health Care Research and
Quality (AHRQ, formerly AHCRQ) guidelines on pressure ulcer prevention and
management, in which a classification system for pressure ulcers was recommended
as well as indices to include in the assessment of a pressure ulcer (www.ahcpr.gov/).
Despite these national guidelines there remain problems among health care
professionals in the communication of pressure ulcer status (Garrigues, 1987;
Preston, 1987; Maklebust, 1987; Ayello, 1992; Emparanza et al., 2000; Gardner,
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2001). Assessment of the ulcer together with the holistic assessment is viewed as
fundamental in ensuring the right interventions or treatment modalities are applied
(Bates-Jensen et al., 1992). A number of evidence-based tools have been developed
and are widely used to assess the status of pressure ulcers. They include the
Pressure Sore Status Tool (Bates-Jensen et al., 1992, 1995a, 1995b and 1997), the
Pressure Ulcer Scale for Healing (Thomas et al., 1997), the Sussman Wound Healing
Tool (Sussman and Swanson, 1997), the Sessing Scale (Ferrell et al., 1995) and the
Wound Healing Scale (Krasner, 1997).
To what extent these tools are valid and reliable for implementation and use in
general UK populations is not clear. A recent review (Woodbury et al., 1999) suggests
that generally the validity and reliability of such tools are variable. However Woodbury
et al. (1999) suggest that there is sufficient published evidence for the Pressure Sore
Status Tool and the Sessing Scale to be considered as valid and reliable.
Many of the techniques advocated in the literature are reported to be inappropriate for
routine use in a clinical environment. There are many high and low-tech methods of
assessing pressure ulcers status e.g. size, depth and volume of pressure ulcers
using scaling gauges, dental impression material, sodium chloride, ultrasound,
tracings, photographs, planimeter and video image analysis among others. The
effectiveness of these is not clear from the small studies evaluated. It is also not clear
what benefit they have to patients or how they link to wound healing, ensuring that
pressure ulcers are assessed accurately to inform the clinical decision-making
process.
Clinical question
What assessment process should be used to most accurately assess a pressure
ulcer?
Objectives
The objective was to undertake a systematic review of the evidence of pressure ulcer
assessment to determine:
What are the wound characteristics of pressure ulcers?
What is the significance of these in pressure ulcer assessment?
What are the priorities for pressure ulcer assessment?
What are the existing evidence-based tools/instruments for

assessment/evaluation of pressure ulcers?
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What is the empirical evidence that these processes are effective in the
Selection criteria
Types of studies
Diagnostic studies reporting the reliability, accuracy and impact of pressure ulcer
diagnostic tools/processes; studies comparing methods of pressure ulcer
assessment, and evaluating their effectiveness in individuals with pressure ulcers in
the treatment of pressure ulcers. Studies comparing methods of measurement.
Types of outcome
Staging performance, sensitivity, specificity, reliability, accuracy and impact linked to
healing/delayed healing, healing, complications and pressure ulcers, and severity.
Search strategy
The databases searched are found in the methods section 5) . The full search
strategies are listed in Appendix B. Databases were searched in July 2003 and
update searches performed in August 2004.
Criteria for inclusion (methodological quality is reported in the evidence tables) and
pre-defined principles as outlined in Appendix E.
Selection
Eligible participant population with well-defined demographic information.
High percentage of participants equal to or greater than 80% of those approached.
Identification of effectiveness of assessment process
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Clear description of assessment process and measurements with comparison clearly
defined.
Confounding
Statistical adjustment carried out; evidence of sensitivity analysis with method
described.
Outcomes
Clear outcome measurements used.
Search results
Results of search strategy
1,759
N screened for relevance following

sift
165
N included
N excluded
Research evidence
A total of 165 studies were identified from the sifting process as potentially relevant to
the topic and subsequently full papers ordered. This number also included those
studies referenced with relevant titles but where the abstract was absent in the
citation. After sifting full papers for relevance and duplicates at this stage, 153 papers
were opinion pieces, editorials, anecdotal reports or fell outside the inclusion criterion
for this review. Out of the seven selected studies, two were excluded and five
included.
Included studies
The gold standard systematic review for this type of clinical question is a
systematic review of diagnostic and screening tests. While it was intended to
conduct this type of review, it must be acknowledged that diagnostic reviews
are a newly developing methodology.
The research evidence on this topic area (assessing the diagnostics of

pressure ulcer assessment) is limited.
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Where studies have addressed and assessed issues such as accuracy,

sensitivity and specificity, these tend to be small studies and heterogenic;
they use varied ulcer measurement parameters and it is not clear how
representative these data are. Also raw data are too limited in the appraised
papers to allow any further analysis.
Where a tool or instrument has been evaluated in terms of reliability these

have been included in the evidence tables.
Cutler et al. (1993)

This was a cross-sectional study to evaluate and compare the various methods of
measuring the characteristics of pressure ulcers, namely area. The study included a
population of initially 20 patients with 17 remaining on completion. There was a mix of
male and female patients; few other demographic details are explicit in the study.
Ulcers were judged as at stage 3 or 4 with a size range between 2 and 150cm2.
Patients with signs of infection, exposed bone or cellulitus were excluded from the
study. Numbers excluded were not included in the reporting.
All ulcer assessments were performed by the same research nurse. Initial baseline
assessment was taken with weekly assessments thereafter. Compared
measurements included direct measurement at the bedside of longest length, longest
width and depth at the deepest point of the ulcers. Tracings and photographs were
calibrated with a ruler. All measurements detected a statistically significant change in
wound size and volume at week four assessment. Sub-group analysis showed that in
the <10cm2 group a statistically significant change in wound size was detected earlier
than in the >10cm2 group.
Griffin et al. (1993)
This study aimed to compare test-retest reliability of measurements obtained by the
use of photographic methodology and those obtained by transparency method, and to
compare wound surface area measurements obtained. Twenty patients were included
in the study, 18 male and two female, from a rehabilitation centre in Memphis.
Measurements were made of 22 ulcers identified, all in the pelvic region. The range of
wound size was 688mm +/- 228mm.
Three photographs were taken at each wound assessment and three tracings were
taken of each wound at each assessment. Both sets of tracing were digitalised. Testretest reliability was obtained measuring five ulcers using both methodologies and
repeating assessments after one hour. To compare the two methodologies all 22
ulcers were measured on a single occasion. To compare the two methodologies over
time, 16 ulcers were measured at five-day intervals for 20 days (four occasions).
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Test-retest reliability ICC =.99, comparison on a single occasion PCC =.99 and
comparison over time r=.996 .999 p = .001. No evidence of superiority was found
with the two methodologies.
Houghton (2000)
This study examined the validity and reliability of using photographs of wounds to
accurately assess wound status. Thirteen patients with pressure ulcers and 46 with
leg ulcers were included in the study. Ulcers that had extensive tunnelling or
undermining were too deep and could not be visualised, so were excluded from the
study. Measurements were performed by a trained health care professional. It was a
blinded assessment but details are not explicit.
Six measurement parameters were assessed using the photographic method: wound
edges, necrotic tissue/type and amount, skin colour, granulation tissue type and
epithelialisation. Total scores were assigned by one trained rater viewing 56
photographs of 13 pressure ulcers on two separate occasions ICC +0.96. Intrarater
reliability for scores were assigned on two occasions for 81 photographs of 34 leg
ulcers ICC = 0.86. Wound size estimates from photographs ICC = 0.96. Interrater
reliability for pressure ulcers ICC =0.75. Correlation for the same observer for
individual domain r = 0.75 and with the exception of skin colour r = 0.56. The between
raters correlation for six domains r = 0.75 with the exception of wound edges r= 0.68.
The concurrent validity was assessed for the Pressure Sore Status Tool and PWAT
r+ 0.70 for PSST and r= 0.66 for six domain PWAT. PSST was used as a reference
standard in this research, and the photographic method had good interrater and
intrarater reliability with scores ICC = 0.75. Reliability was found to be higher for
pressure ulcers than leg ulcers in this study. This could be explained by the fact that
the PSST is a pressure ulcer specific assessment tool.
Shubert (1997)
This study evaluated pressure ulcer surface area measurement using four different
methods. The number of patients was not clear. It was set in the Division of Geriatric
Medicine, University Hospital Huddinge, Sweden. Demographic details were limited.
Four measurements were used and included: direct measurement with digital
planimeter, length and width measurement, number of whole squares, and number of
whole and partial squares. Planimeter was used as the reference standard. A total of
373 different pressure ulcers were measured in the study.
Measurement of length and width gave values significantly higher than the reference
value 31%, p = 0.001. Counting the number of whole squares gave a significantly
lower value than the reference standard 13%, p=0.001. Counting the number of
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whole and partial squares inside the boundary line gave values that were much closer
to the reference value +1%. Counting the number of whole and partial squares within
the tracing area gave the best estimate of wound size.
Plassmann and Jones (1998)
This was a controlled trial comparing the performance of the MAVIS instrument
against three traditional methods of wound measurement for area and volume. The
three traditional techniques included: use of ruler, transparency tracing and alginate
for volume measurement. Precision was established on mock wounds made using
plaster cast and each was measured 20 times for each technique. There were fifty
patients, although demographic detail was limited. Among excluded patients were
those with painful ulcers, undermining, and extremely flexible, small and large ulcers.
Measurements were taken by structured light. Area and volume measurements were
taken simultaneously. Results were reported in graphical form without clear axis. It
was reported that MAVIS gave overall more precise results for area and volume than
the other three methods.
Quality of the studies
The quality assessment for each study is reported in the evidence table for each
study. There are not well-established quality criteria for assessing some of the
designs included in this narrative review. Generic assessment tools (Appendix E)
were used to assess each study according to study design. Generally the studies
aims were clear and although the sample sizes were small, with the exception of
Shubert (1997), they were justified. Statistical methods were well described in all the
studies with clear rationale for their use. There was limited reporting in the studies on
excluded patients and those that did not finish the study.
Reviewers conclusion
The original objective was to undertake a diagnostic review of the evidence of
pressure ulcer assessment to determine:
What are the wound characteristics of pressure ulcers?
What are the significance of these in pressure ulcer assessment?
What are the priorities for pressure ulcer assessment?
What are the existing evidence-based tools/instruments for

assessment/evaluation of pressure ulcers?
What is the empirical evidence that these processes are effective in the
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The research evidence in this area is limited and it has not been possible to conduct a
diagnostic review for several reasons: 1. The research evidence in this area is limited.
2. There is a lack of a generally accepted reference standard both for the assessment
of individual parameters for ulcer assessment or a pressure ulcer assessment tool. 3.
The reporting of the research evidence lacks raw data for any further analysis to be
performed.
While a number of tools have been developed, they have not been evaluated fully. A
number of research-based pressure ulcer assessment tools, such as the PSST, have
undergone a systematic process of development and their reliability has been
assessed. However this review did not find evidence for the use of such tools widely
in the UK, nor did it find evidence that these have been tested against an agreed gold
standard. It remains unclear how these tools are linked to outcomes i.e. the healing
of pressure ulcers as this is not reported in the literature.
Wound size, that is surface area and volume, appears to be the specific parameter
that has been assessed in the literature most frequently, and is reported as being a
useful marker of wound change over time. Various methods of determining this
parameter are advocated in the literature; however caution should be taken when
interpreting the authors findings as they are generally from small studies. There is
also considerable heterogeneity both within and between the studies to be able to
combine any of these data.
The inclusion of location, stage, condition of wound edges, tunnelling or undermining,
signs of infection, necrotic tissue, exposed bone, granulation tissue presence,
epithelialisation, exudates and odour in the ulcer assessment is advocated in the
research. However the evidence base in support of their inclusion is limited. It is also
not clear from this evidence whether these parameters are, firstly, suitable to include
in assessment on the basis of their being consistently identifiable by the same
assessor or, secondly, identifiable at a repeated assessment by the same or different
assessor either within the same patient or between patients.
It is also not clear what effect the context has on the wound assessment. Reporting of
this information was limited in the research evidence. In terms of who should carry out
assessments, one study found significantly better assessments carried out by trained
health care professionals compared with students with limited training and
experience. How often an assessment should take place is also not clear from the
evidence.
No economic evaluations assessing tools used to assess a pressure ulcer were
found.
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Recommendations for this area of the Guideline were sought via formal consensus as
outlined in the methods section.
Recommendations: ulcer assessment

The aim of the ulcer assessment is to:
establish the severity of the pressure ulcers
to generate a personal ulcer profile to develop a plan of care from

which treatment interventions will be initiated
to evaluate treatment interventions
to assess for complications, and
to communicate information about the pressure ulcer to those

involved in pressure ulcer management.
Patients with pressure ulcers should receive an initial and ongoing pressure
ulcer assessment. Ulcer assessment should include: [D]
cause of ulcer
site/location
dimensions of ulcer
stage or grade
exudate amount and type
local signs of infection
pain
wound appearance
surrounding skin
undermining/tracking (sinus or fistula), and
odour.
This should be supported by photography and or tracings (calibrated with a

ruler).
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The pressure ulcer grade should be recorded using the European Pressure
Ulcer Advisory Panel Classification System.
Pressure ulcers should not be reverse graded (retrograding). A grade 4
pressure ulcer does not become a grade 3 as it heals. As the ulcer heals it
should be described as a healing grade 4 pressure ulcer.D[GPP]
Those carrying out ulcer assessments should consider the aims and
objectives of the assessment to ensure that maximum benefit to the individual
is gained. D[GPP]
The dimensions of the pressure ulcer should be measured recording the

longest length/longest width as an estimate of surface area (use of tracings);
the deepest part of the wound should also be measured using a sterile probe.
[D]
Initial and ongoing ulcer assessment is the responsibility of the interdisciplinary team and should be carried out by health care professionals. [D]
Reassessment of the ulcer should be performed at least weekly but may be

required more frequently, depending on the condition of the wound and the
result of holistic assessment of the patient. [D]
All pressure ulcers graded 2 and above should be documented as a local

clinical incident. D[GPP]
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Despite the lack of research evidence from which to generate
recommendations the GDG felt that it was important to guide clinicians
as to the most important parameters to include in an ulcer assessment.
Many different variations of tools are used to gather information about
pressure ulcers in a variety of NHS settings. A comprehensive and
accurate assessment of the pressure ulcer was considered to be
paramount to ensuring that the plan of ulcer care reflected ulcer
severity.
Research needs to focus on what methods of measurement, and which
parameters, are of use to clinicians to allow accurate wound evaluation.
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6.3
Support surfaces for pressure ulcer treatment

The methods described in this review were those used to update the following
systematic review:
Cullum N, Deeks J, Sheldon TA, Song F and Fletcher AW (2004) Beds, mattresses
and cushions for pressure sore prevention and treatment (Cochrane Review) in: The
This review was used as the main source to develop recommendations for this area
of the Guideline.
There is much debate in the literature and among experts about the appropriateness
of the term pressure-relieving. The use in this Guideline is consistent with that of
previously published NICE guidance on pressure ulcer prevention. Pressure-relieving
is used as an umbrella term for all pressure-reducing and pressure-redistributing
devices.
Background
A range of interventions are currently used in pressure ulcer management. Pressurerelieving support surfaces aim to reduce the magnitude and/or duration of pressure
between an individual and the support surface, which is referred to as the "interface
pressure. Some support surfaces may also minimise friction and shear, and may
also address micro-climate needs such as temperature and moisture. Such support
surfaces include cushions, mattress overlays, replacement mattresses or whole bed
replacements. The cost of these interventions varies widely; from over 30,000 for
some bed replacement systems to less than 100 for some foam overlays.
Information on the relative clinical and cost-effectiveness of this equipment is clearly
needed to enable clinicians to make evidence-based decisions for their use.
Pressure-relieving surfaces can be divided into two main categories: continuous low
pressure (CLP) and alternating pressure (AP).
Continuous low pressure surfaces aim to mould around the shape of the individual to
redistribute pressure over a greater surface area. Alternating pressure surfaces
mechanically vary the pressure beneath the individual, so reducing the duration of the
applied pressure.
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CLP support surfaces can be grouped according to their construction:
Standard foam
The conformability and resilience of foam products may vary considerably between
manufacturers. Foam may be shaped, convoluted (egg crate foam), of various
densities or of a combination of densities.
Visco-elastic foam
This is specialised foam, available in varying densities, that moulds to body shape in
response to body temperature.
Air flotation
This is an inflated mattress replacement/overlay that manually or automatically

adjusts airflow allowing immersion and redistribution of pressure. It is adjustable to
individual reposition to maintain immersion and redistribution of pressures.
Air fluidised
A constant flow of air is passed into a deep tank containing minute silicone beads
retained by a permeable membrane. The agitated beads take on the properties of a
fluid. Lying on the surface allows significant immersion and therefore redistribution of
pressure.
Low air loss
A constant flow of air inflates a row of permeable fabric cells. Manual or automatic
adjustment of airflow allows significant immersion and therefore redistribution of
pressure.
Gel/fluid
Fluid surfaces e.g. water-filled mattresses which allow significant immersion and
therefore redistribution of pressure. The density/viscosity of the gel/fluid will govern
the degree of immersion and how stable the support surface is in terms of posture.
Combination products
Many CLP surfaces, particularly cushions, use a variety of materials to provide

optimum pressure relief and postural stability.
N.B. The type and construction of cover material may have a significant impact on the
conformability of the surface.
Alternating pressure support surfaces provide pressure relief by inflating and deflating
alternate air-filled cells. The inflated cells support the body while the deflated cells
provide pressure relief. The duration and sequence of alternation varies between
manufacturers. Such support surfaces are available as cushions, mattress overlays,
and single- or multi-layer mattress replacements.
Pressure ulcer treatment strategies usually comprise a combination of pressure relief
(in the form of support surfaces), positioning and repositioning, and wound
management strategies including wound dressings, debridement techniques, physical
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therapies, antibiotics and antiseptics. Pressure ulcer management is therefore
considered to be multi-faceted and this approach to care is strongly advocated in the
research literature.
Objectives
To undertake a systematic review of pressure-relieving beds, mattresses and
cushions in pressure ulcer treatment.
Questions to be answered were:
Do pressure-relieving beds, mattresses and cushions increase the healing

rate of existing pressure ulcers compared to standard support surfaces?
Which types of pressure-relieving surface are most effective in the treatment

of pressure ulcers: a) in different patient groups, and b) settings?
Selection criteria
Types of studies
Randomised controlled trials (RCTs) comparing beds, mattresses and cushions which
measured pressure ulcer healing as an objective measure of outcome.
Patients with existing pressure ulcers (of any grade) in any setting.
Types of interventions
Studies which evaluated the following interventions for pressure ulcer treatment were
included:
alternating pressure mattresses/overlays
standard foam mattresses
specialised foam mattresses/overlays e.g. convoluted foam, cubed foam
gel-filled mattresses/overlays
fibre-filled mattresses/overlays
water-filled mattresses/overlays
air flotation beds
low air loss beds
sheepskins
turning beds/frames
bead beds, and
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wheelchair support surfaces.
Types of outcome measures
Healing rates of existing ulcers: trials were included if they measured healing
by some objective method such as time to complete healing, or rate of
change in the area/volume of the ulcer.
Costs of the support surfaces.
Patient comfort.
Durability of the support surfaces.
Reliability of the support surfaces.
Acceptability of the support surfaces.
Trials which only measured surrogate outcome measures, such as interface pressure,
were excluded on the basis that interface pressure measurements have not been
demonstrated to reliably predict the clinical performance of support surfaces.
Search strategy
The search strategy included all trials identified up to August 2004. Databases were
searched initially in November 2003 and then updated on 24 June 2004.
Main literature search
Searches were not limited by study design but were limited to retrieve literature
published in English, and to omit animal studies and letters, comments and editorial
publication types.
Methods of the review
Full details can be found in the methods section.
References identified from searches were reviewed by two reviewers who jointly
made a decision to include or exclude a study against the eligibility criteria.
References were entered into a bibliographic software package. Details of eligible
studies were extracted by the primary reviewer and summarised using a data
extraction sheet. Data extraction was checked by a second reviewer.
Description of studies
Fifteen eligible randomised trials were identified. Fourteen trials involved patients with
pressure ulcers and assessed the treatment efficacy of pressure-relieving supports
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(Allman, 1987; Caley, 1994; Clark, 1999; Day, 1993; Devine, 1995; Evans, 2000;
Ferrell, 1993; Groen, 1999; Keogh, 2001; Mulder, 1994; Munro, 1989; Russell, 2000;
Russell, 2003; Strauss, 1991). One further trial evaluated surface effects for both
prevention and treatment of pressure ulcers in the same trial (Ewing, 1964).
Two additional trials were identified that also evaluated pressure-relieving support
surfaces for both the prevention and treatment of pressure ulcers (Bennett, 1998;
Lazzara, 1991). However, neither of these trials reported pressure ulcer healing data
so were excluded from the review. One further eligible ongoing trial (Nelson, 2003)
was also identified and these results will be incorporated in future updates of the
review.
The studies included a variety of patients and settings for example those in nursing
homes, care of the elderly, medical and surgical wards.
Only one trial evaluated the use of a cushion as a pressure-relieving support surface.
One trial assessed the use of sheepskins, and the remaining studies evaluated
different mattresses, mattress overlays and beds.
Methodological quality of included studies
The methodological quality of the trials was generally poor. Details on the quality of
each individual study are included in the Table of Included Studies (Appendix A).
Adequate allocation concealment was evident in nine (60%) of the fifteen trials
(Allman, 1987; Clark, 1999; Day, 1995; Devine, 1995; Evans, 2000; Ferrell, 1993;
Keogh, 2001; Groen, 1999; Russell, 2003). In eight of the fifteen included trials the
method of randomisation was unclear.
Blinded outcome assessment is rarely used in wound care studies and this was
certainly the case in these evaluations of pressure-relieving support surfaces. It can
be difficult or impossible to disguise the surface, on which a patient is, for assessment
of outcome. Patients are often too ill to be removed from their bed for assessment of
their pressure areas. Nevertheless, some studies minimise bias in outcome
assessment by having a second assessor and presenting interrater reliability data, or
by presenting photographic evidence of pressure area status, which can then be
assessed by an assessor blinded to treatment. Of the 15 randomised trials in this
review, we could be confident that some form of blinded outcome assessment had
been used in only four trials (Allman, 1987; Evans, 2000; Strauss, 1991; Russell,
2003).
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Importantly in pressure ulcer treatment trials it is essential to ensure baseline
comparability for initial area of ulcers. A change in wound area is often expressed as
the percentage change, which unlike the absolute change in area, takes into account
the initial size of the wound. For two wounds healing at the same linear rate (as
measured by diameter reduction) percentage area calculations will show a larger
change for a small wound than a big wound. The converse is true when the absolute
change in area is measured, since for any unit reduction in wound radius a bigger
area reduction will occur for a large wound.
trials, randomised allocation should ensure that the mean wound size and variance in
each group is similar. In a small trial random allocation is unlikely to result in an even
distribution of wound sizes. In a trial where there is poor comparability between
determined.
There were 15 trials of beds, mattresses and cushions for treating pressure ulcers
included in this review and of these:
eight presented data for baseline ulcer area (Allman, 1987; Clark, 1999; Day,
1993; Devine, 1995; Evans, 2000; Ferrell, 1993; Groen, 1999; Munro 1989)
six further treatment trial reports did not present baseline ulcer areas (Caley,
1994; Keogh, 2001; Mulder, 1994; Russell, 2000; Russell, 2003; Strauss, 1991).
one trial by Ewing (Ewing, 1964) focused on the effect of sheepskin on resolving
red skin and therefore the area of the damaged skin is less important.
The other major deficiency in most of the included trials was the small sample sizes
used. Although seven reports described an a priori sample size calculation, 12 of the
15 trials involved a total of 100 patients or fewer. The larger trials, involving over 100
patients, were Groen (1999) (120 patients), Russell (2000) (141 patients) and Russell
(2003) (158 patients).
Quality was not used to weight the studies in the analysis using any statistical
technique. However methodological quality was drawn upon in the narrative
interpretation of the results. Methodological flaws are discussed for each study in the
Table of Included Studies (Appendix A).
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Results
Results of dichotomous variables are presented as relative risk (RR) with 95%
confidence intervals (CI). Relative risk has been used rather than odds ratios as event
rates are high in these trials and odds ratios would give an inflated impression of the
magnitude of effect (Deeks, 1998). Relative risk is the rate of the event of interest
for example pressure ulcers healed in the experimental group divided by the rate of
this event in the control group, and indicates the chance of pressure ulcers healing on
the experimental treatment compared with the control treatment.
As, by definition, the risk of an event occurring in the control group is 1, then the
relative risk reduction associated with using an experimental treatment is 1-RR. The
relative risk indicates the relative benefit of a therapy but not the actual benefit, that is
it does not take into account the number of people whose pressure ulcer would have
healed anyway without treatment.
The absolute risk reduction (ARR) can be calculated by subtracting the event rate in
the experimental group from the event rate in the control group. The ARR tells us how
much the reduction is due to the experimental treatment itself, and its inverse is the
number needed to treat, or NNT. Thus a healing rate, for example, of 30% on a
control treatment that was reduced to 15% with an experimental treatment, translates
into an ARR of 30-15=15% or 0.15, and an NNT of 7. In other words seven patients
would need to receive the experimental treatment to cure one additional pressure
ulcer.
Secondary outcomes such as comfort, durability, reliability and acceptability were not
well reported, and valid and reliable measures for these concepts are underdeveloped. Where data were presented, they appear in the Table of Included Studies
(see Appendix A). However they are not incorporated in the meta-analysis.
Air-fluidised therapy (AFT)

Three trials compared AFT with a range of conventional therapies for the treatment of
pressure ulcers (Allman, 1987; Munro, 1989; Strauss, 1991). These studies
measured outcomes in slightly different ways and none reported the variability around
the mean healing rate data. A meta-analysis of two of these studies showed
significantly enhanced pressure ulcer healing associated with air-fluidised beds when
used in hospital (Allman, 1987; Munro, 1989) (see Figure 3). A home-based study
(Strauss, 1991) also showed a benefit from air-fluidised therapy on re-hospitalisation
outcomes (see Figures 4 and 5). Munro (1989) showed no significant impact on
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nursing time associated with the use of air-fluidised beds compared with standard
care (see Figure 6).
Figure 3:
Review:
Comparison:
Outcome:
Beds, mattresses and cushions for pressure sore treatment

04 Air-fluidised bed vs standard care
04 Proportion of patients improved
Study
or sub-category
AF
n/N
Allman 1987
Strauss 1991
Standard Care
n/N
22/31
19/22
RR (fixed)
95% CI
Weight
%
RR (fixed)
95% CI
16/34
9/13
57.43
42.57
1.51 [0.99, 2.30]

1.25 [0.84, 1.86]
47
100.00
1.40 [1.04, 1.88]
53
Total (95% CI)
Total events: 41 (AF), 25 (Standard Care)
Test for heterogeneity: Chi = 0.44, df = 1 (P = 0.51), I = 0%
Test for overall effect: Z = 2.20 (P = 0.03)
0.1
0.2
0.5
Favours Standard
10
Favours AF
Figure 4:
Review:
Comparison: 04 Air-fluidised bed vs standard care
Outcome:
02 Pressure sore related hospital days per patient
Study
or sub-category
Strauss 1991
AF
Mean (SD)
N
47
3.60(8.70)
47
Total (95% CI)
Test for heterogeneity: not applicable
Standard Care
Mean (SD)
50
WMD (fixed)
95% CI
16.90(30.60)
50
-100
-50
Favours AF
50
Weight
%
WMD (fixed)
95% CI
100.00
-13.30 [-22.14, -4.46]
100.00
-13.30 [-22.14, -4.46]
100
Favours Standard
Figure 5:
Review:
Comparison:
Outcome:

03 Pressure sore related hospitalisations
Study
or sub-category
Strauss 1991
N
47
47
Total (95% CI)
AF
Mean (SD)
0.20(0.50)
Standard Care
Mean (SD)
N
50
WMD (fixed)
95% CI
Weight
%
0.60(0.90)
50
-1
-0.5
Favours AF
0.5
WMD (fixed)
95% CI
100.00
-0.40 [-0.69, -0.1
100.00
-0.40 [-0.69, -0.1
Favours Standard
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Figure 6:
Review:
Comparison:
Outcome:

06 Nursing Time (mins per 8 hour shift)
Study
or sub-category
Munro 1989
20
AF
Mean (SD)
Standard Care
Mean (SD)
95.00(48.00)
20
Total (95% CI)
20
WMD (fixed)
95% CI
Weight
%
75.00(35.00)
20
-100
-50
Favours AF
50
WMD (fixed)
95% CI
100.00
20.00 [-6.04, 46.04
100.00
20.00 [-6.04, 46.04
100
Favours Standard
Low air loss therapy (LAL)

Three trials were identified which compared LAL with a foam mattress overlay (Day,
1993; Ferrell, 1993; Mulder, 1994). The combined analysis from two trials (Ferrell,
1993; Mulder, 1994) showed pressure ulcer healing rates on the LAL bed were not
significantly different to healing rates when using a corrugated foam overlay (see
Figure 7). Only one trial has compared different types of low air loss support surfaces
(Caley, 1994). This trial showed no significant differences in healing rates between
the two interventions but was small and of questionable quality.
Figure 7:
Review:
Comparison:
Outcome:

05 Low air-loss vs foam mattress overlay
01 Sores Completely Healed
Study
or sub-category
Mulder 1994
Ferrell 1993
Low Air-Loss
n/N
5/31
26/43
74
Total (95% CI)
Total events: 31 (Low Air-Loss), 22 (Foam Overlay)
Test for heterogeneity: Chi = 0.19, df = 1 (P = 0.66), I = 0%
Foam Overlay
n/N
RR (fixed)
95% CI
Weight
%
16.33
83.67
0.97 [0.26, 3.58]

1.30 [0.87, 1.96]
100.00
1.25 [0.84, 1.86]
3/18
19/41
59
0.1
0.2
0.5
Favours Foam Overlay
RR (fixed)
95% CI
10
Favours LAL
Alternating pressure (AP)

A variety of alternating pressure (AP) supports are used in hospital and in the
community. The depth of the air cells and mechanical robustness can vary between
support surfaces, and these factors may be important in determining effectiveness. It
is worth emphasising that most of the trials of AP supports did not adequately
describe the equipment being evaluated, including the size of the air cells, which may
limit the utility of the evidence to clinical practice.
One small trial of 41 patients (Devine, 1995) compared the effectiveness of the
Nimbus I DFS (composed of rows of figure-of-8-shaped cells) and the Pegasus
Airwave for the treatment of existing pressure ulcers but found no significant
difference. A more recent, larger trial (Russell, 2000) also failed to demonstrate any
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significant difference in pressure ulcer healing between two newer AP support
surfaces, the Nimbus 3 and the Pegasus Cairwave therapy system (see Figure 8).
Figure 8
Review:
Comparison:
Outcome:

07 Comparison between two alternative alternating pressure mattresses
01 Ulcers completely healed
Study
or sub-category
Devine 1995
Russell 2000
Pegasus Airwave
n/N
Nimbus
n/N
5/14
65/71
10/16
65/70
85
Total (95% CI)
Total events: 70 (Pegasus Airwave), 75 (Nimbus)
Test for heterogeneity: Chi = 2.67, df = 1 (P = 0.10), I = 62.5%
RR (fixed)
95% CI
Weight
%
86
0.2
0.5
Favours Nimbus
RR (fixed)
95% CI
12.48
87.52
0.57 [0.26, 1.27]

0.99 [0.90, 1.09]
100.00
0.93 [0.83, 1.05]
Favours Airwave
In a study by Evans et al. (2000), which was conducted in both hospital and nursing
home patients, an alternating pressure mattress replacement system (Huntleigh
Nimbus 3) resulted in no significant improvement in any measure of wound surface
area when compared with either another alternating pressure mattress replacement
system for hospital patients (Pegasus Biwave, Pegasus Airwave, or AlphaXcell) or an
alternating mattress overlay for nursing home patients (AlphaXcell or Quattro).
A large trial of 158 patients (Russell, 2003) also compared the Nimbus 3 alternating
pressure mattress with a static fluid overlay mattress, RIK static, and again found no
significant difference in rates of pressure ulcer healing (see Figure 9). However, in
this trial the co-intervention of re-positioning frequency was not standardised, and
patients could request additional turning. As this variable appears to be
disproportionate between the groups, the lack of treatment effect may be due to either
the non-effect of the experimental support surface and/or the effect of the differential
co-intervention distribution.
Figure 9:
Review:
Comparison:
Outcome:
Study
or sub-category

03 Alternating pressure vs constant low pressure mattress
01 Pressure sore healing
AP
n/N
01 AP vs fluid overlay mattress

60/83
Russell 2003
83
Subtotal (95% CI)
Total events: 60 (AP), 56 (Fluid overlay)
Fluid overlay
n/N
RR (fixed)
95% CI
56/75
75
Weight
%
100.00
100.00
RR (fixed)
95% CI
0.97 [0.80, 1.17]

0.97 [0.80, 1.17]
0.1
0.2
0.5
1
5
10
One study involving only 25 patients (Clark,
1999)
found
no2significant
difference
Favours AP
Favours fluid overla
between a dry flotation and an alternating pressure cushion in the number of ulcers
completely healed, as measured by either the proportion of ulcers healed (see Figure
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10) or the rate of change in pressure ulcer surface area for either superficial (see
Figure 11) or deep (see Figure 12) ulcers.
Figure 10:
Review:
Comparison:
Outcome:

08 Alternating air pressure vs static dry flotation seat cushions
01 Sores completely healed
Study
or sub-category
Proactive 2
n/N
ROHO dry flotation

n/N
3/14
5/11
100.00
0.47 [0.14, 1.56]
11
100.00
0.47 [0.14, 1.56]
Clark 1999
14
Total (95% CI)
Total events: 3 (Proactive 2), 5 (ROHO dry flotation)
RR (fixed)
95% CI
0.1
0.2
0.5
Favours ROHO
Weight
%
RR (fixed)
95% CI
10
Favours Proactive
Figure 11:
Review:
Comparison: 08 Alternating air pressure vs static dry flotation seat cushions
Outcome:
02 Superficial sores: rate of change in surface area (cm sq / day)
Study
or sub-category
Proactive 2
Mean (SD)
Clark 1999
14
0.13(0.37)
ROHO dry flotation

Mean (SD)
11
14
Total (95% CI)
WMD (fixed)
95% CI
Weight
%
0.27(0.56)
11
-1
-0.5
Favours ROHO
0.5
WMD (fixed)
95% CI
100.00
-0.14 [-0.52, 0.24
100.00
-0.14 [-0.52, 0.24
Favours Proactive
Figure 12:
Review:
Comparison:
Outcome:

08 Alternating air pressure vs static dry flotation seat cushions
04 Deep sores: rate of change in volume (cm cubed per day)
Study
or sub-category
Clark 1999
Proactive 2
Mean (SD)
14
14
Total (95% CI)
0.56(0.86)
ROHO dry flotation

Mean (SD)
11
WMD (fixed)
95% CI
Weight
%
0.49(0.86)
11
-1
-0.5
Favours ROHO
0.5
WMD (fixed)
95% CI
100.00
0.07 [-0.61, 0.7
100.00
0.07 [-0.61, 0.7
Favours Proactive
Continuous low pressure supports (CLP)

One small trial which used standard hospital mattresses with and without sheepskin
overlays was inconclusive and of poor quality (Ewing, 1964).
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A trial of 120 nursing home patients with grade 34 ulcers (Groen, 1999) found no
difference in ulcer healing rates between foam replacement mattresses and the
Secutex water mattress overlay (see Figure 13).
Figure 13:
Review:
Comparison:
Outcome:

02 Comparisons between continuous low pressure supports
01 Pressure sore healing
Study
or sub-category
CLP1
n/N
CLP2
n/N
01 foam replacement mattress vs water mattress overlay

27/60
Groen 1999
60
Subtotal (95% CI)
Total events: 27 (CLP1), 29 (CLP2)
RR (fixed)
95% CI
Weight
%
100.00
100.00
29/60
60
0.1
0.2
0.5
Favours CLP1
RR (fixed)
95% CI
0.93 [0.63, 1.37]

0.93 [0.63, 1.37]
10
Favours CLP2
In the Keogh (2001) trial a bed that enabled individual profiling was compared with a
standard hospital bed, both also with a pressure-reducing foam mattress or cushion.
In this small trial (14 patients) the proportion of those with existing grade 1 ulcers was
significantly improved using the profiling bed (see Figure 14). However these results
should be interpreted with caution as they are only a small subgroup of the 100
patients randomised in the trial for which further data are unavailable.
Figure 14:
Review:
Comparison:
Outcome:

09 Profiling vs standard beds
01 Healing of existing grade 1 sores
profiling bed
n/N
Study
or sub-category
Keogh 2001
4/4
4
Total (95% CI)
Total events: 4 (profiling bed), 2 (standard bed)
standard bed
n/N
RR (fixed)
95% CI
Weight
%
2/10
10
0.01
0.1
Favours standard bed
10
RR (fixed)
95% CI
100.00
5.00 [1.45, 17.27]
100.00
5.00 [1.45, 17.27]
100
Favours profiling bed
Discussion
Despite the frequency of pressure ulcer incidence and the myriad of treatment
modalities, this review demonstrates the paucity of good-quality evidence that guides
current clinical practice for the selection of pressure-relieving support surfaces.
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The confidence with which we can draw firm conclusions from the studies detailed in
this review is greatly tempered by (a) the poor quality of many of the trials and (b) the
lack of replication of most comparisons.
There is some evidence to show that air flotation supports reduce the size of more
established pressure ulcers compared to a modified alternating pressure support,
or standard care (standard bed with CLP supports, sheepskin, gel pads, air-filled
supports, water-filled mattresses and high-density foam pads).
There is no conclusive evidence to support the superiority of either alternating
pressure support surfaces or continuous low pressure supports in the treatment of
existing pressure ulcers.
Many of the trials included in this review are under-powered and therefore run a risk
of failing to detect clinically significant differences as statistically significant. Other
common methodological flaws such as open randomisation, lack of baseline
comparability and lack of blind outcome assessment further reduce the confidence
with which we can regard many of the individual study findings. Future trials should
consider the findings of this review and address these deficiencies.
6.3.1 Cost-effectiveness of pressure-relieving support surfaces (beds,

mattresses and overlays), mobility and positioning
Three economic evaluations of pressure-relieving support surfaces were identified for
review (Branom et al., 2001; Ferrell et al., 1995; Strauss et al., 1991). One study was
a full economic evaluation (Ferrell et al., 1995), the other two were partial economic
evaluations.
Ferrell et al. (1995) conducted a cost-effectiveness analysis comparing low air loss
therapy beds to conventional foam mattresses used in nursing homes in the US (see
data extraction table 25, Appendix A). Patients with grade 2, 3 or 4 pressure ulcers
were followed up until complete heal, death or transfer to another faculty.
Effectiveness data to compute this included a statistically significant reduction in
surface area of grade 3 and 4 pressure ulcers across the two treatments (9.9mm2 per
day vs. 0.7mm2 per day, p<0.02).
Pressure ulcers took an average of 75 days to cure for low air loss therapy and 172
days for conventional foam mattresses. Use of the pressure-relieving support
surfaces and associated nurse time was costed. While the lease cost per day of the
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low air loss mattresses evaluated was higher than the cost per day of the
conventional foam mattress, on average the low air loss bed was cost-saving due to a
much shorter time to heal.
Final results were reported as cost per added day free of a pressure ulcer and were
obtained by dividing the additional cost of the low air loss therapy by the additional
days without an ulcer. The cost-effectiveness estimate for low air loss therapy was
$26 per added day free of a pressure ulcer (1992 prices). No uncertainty associated
with this estimate was reported. However, a few one-way sensitivity analyses were
conducted and findings were sensitive to the lease cost of the low air loss bed as well
as patient and pressure ulcer healing characteristics.
The economic evaluation was based on an analysis of the RCT reported in Ferrell et
al. (1993) that is included in the clinical effectiveness review of pressure-relieving
support surfaces. In the clinical effectiveness review the healing rates of this trial were
combined with the Mulder et al. (1994) results. This revealed that pressure ulcer
healing rates were not statistically significantly different to healing rates using a
corrugated foam overlay.
Branom et al. (2001) conducted a cost-consequence analysis comparing constant
force technology with low air loss therapy beds used in patient care in the US (see
data extraction table 24, Appendix A). Patients with grade 3 or 4 pressure ulcers were
followed up for a maximum of eight weeks. Study exit criteria included discharge from
inpatient status, flap surgery and death.
Effectiveness results included: on average a smaller size pressure ulcer recorded at
discharge from the study for the constant force technology group (6.6cm3 vs.
24.6cm3), the average amount closed at discharge from the study was higher
(25.8cm3 vs. 22.2cm3), the average rate of closure per week was faster (3.5cm3 vs.
2.8cm3), the average proportion of pressure ulcers closed (60.0% vs. 39.6%) and a
higher average proportion of pressure ulcers closed per week (9.0% (+/-4.8) vs. 5.0%
(+/-3.7)) for the constant force technology group compared to the low air loss group.
The purchase price of constant force technology was $1,080 (price year not stated)
while the daily rental cost of the low air loss mattress was $35 per day, that totalled to
$1,960 over the maximum eight-week follow-up period.
In general, although costs and outcomes were not synthesised, results suggest that
constant force technology dominated low air loss therapy beds since associated costs
were lower and effects better. A number of caveats should be considered when
drawing conclusions from this study. This is the only economic evaluation to assess
the effectiveness of constant force technology beds. The study is based on a clinical
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trial but patients were allocated to treatments sequentially, which is not truly random
and can introduce bias. Only the costs of the mattresses were included, and the use
of nursing time or other resources used in conjunction with the interventions were
omitted. The total cost of the low air loss mattress was dependent on the length of
use. Very limited statistical analyses were reported to investigate uncertainty
associated with the results.
Strauss et al. (1995) conducted a cost-consequence analysis comparing air-fluidised
therapy to conventional therapy in the US (see data extraction table 26, Appendix A).
Patients with grade 3 or 4 pressure ulcers were followed up in the RCT over a
considerable length of time (36 weeks). However, only 50% of patients receiving airfluidised therapy completed the study compared to 56% in the conventional therapy
group. Two nurses independently assessed outcomes, blind to treatment groups. For
each patient who completed the 36-week regimen, and for whom interpretable
photographs were available, the nurses assessed the photographs and clinical notes.
They categorised each patients pressure ulcer as (i) improved (ii) unchanged (iii)
worse or (iv) not assessableii.
A higher proportion of pressure ulcers in the air-fluidised bed group were classified as
improved (82% classified as improved by one nurse versus 91% by the other nurse
for the air-fluidised bed group compared to 77% or 62% for the conventional therapy
group), however differences were not significant. Additionally, a small proportion of
pressure ulcers in this group were classified as unchanged.
The cost of treatments used was computed from the medical charges perspective,
and the Medicare DRG and doctor payment perspective. Cost per patient for the
former was $29,016 versus $34,747 for air-fluidised therapy compared to
conventional therapy respectively, and this was not statistically significantly different.
Cost per patient for the latter was $16,415 compared to $16,800 for air-fluidised
therapy compared to conventional therapy respectively, and again this was not
statistically significantly different.
Costs and outcomes were not synthesised and the cost-effectiveness implications are
not straightforward to determine. Overall, costs per patient were similar across groups
in spite of significant inpatient cost differences. No significant improvement in
pressure ulcers was detected across the two groups either.
The economic evaluation was included alongside the results of the RCT on which it
was based, and these results are reported in the clinical effectiveness review of
ii
These categories were defined explicitly for the nurses
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pressure-relieving support surfaces. There the air-fluidised therapy showed a
statistically significant benefit compared to standard care on re-hospitalisation
outcomes. Typically such an outcome would not be used in an economic evaluation
since the cost of hospital stays are factored into the cost analysis.
Overview of pressure-relieving support surfaces

Although the three studies reviewed are based on level one or two effectiveness
evidence, the economic evaluation quality assessments (see Appendix C) show that
there were a number of study limitations. Data collection aspects for the Branom et al.
(2001) and Ferrell et al. (1995) studies were moderate, but resource use and cost
data for the Strauss et al. study (1991) were less strong. Analysis and interpretation
of results were not strong for any of the studies, particularly in terms of exploration of
the uncertainty associated with costs and outcomes reported.
6.3.2 A cost analysis of an alternating pressure mattress replacement

system compared to a high-specification foam mattress with an
alternating pressure overlay for the management of pressure ulcers
To inform the recommendations on pressure-relieving surfaces, the GDG suggested
a comparison of two options: (i) an alternating pressure management replacement
system (APMRS) with (ii) a high-specification foam mattress and an alternating
pressure overlay.
No suitable comparison of products was found in the systematic review of the
effectiveness literature and therefore the analysis was based on the expert opinion of
the GDG. They argued that the benefits associated with each option are the same
and therefore a cost-minimisation analysis was undertaken. The cost analysis was
undertaken from the NHS perspective. The costs relate to the financial year 2004/5
and include 17.5% VAT.
The unit cost of the two options was calculated based on data obtained from the NHS
Purchasing and Supplies Agency (NHS PASA). A number of companies supply these
support surfaces and there is variation in the unit price of the products and their
specifications. Therefore an average (mean) cost was obtained based on standard
support surfaces. Two clinicians from the GDG checked that the products included in
the costing exercise were appropriate.
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Table 4: Unit cost of APMRS and a high-specification foam mattress with an
alternating pressure overlay
Product
Number
Average
Standar
Minimum
Maxim
(mean)
cost
um
cost
Deviatio
cost
n
APMRS
24
2,830
1,393
376
5,451
High-specification
207
250
140
53
938
21
1,128
734
353
3,139
foam mattress
Alternating pressure
overlay
Table 4 presents the unit costs of the pressure-relieving support surfaces being
analysed. The average (mean) cost of APMRS (2,830) is more than twice that of a
high-specification foam mattress used with an alternating pressure overlay (250 +
1,128 = 1, 378).
Assuming that for the five-year life span of the products, each option was used every
day, the daily cost of each option would be, on average, 1.55 for the APMRS and
0.75 for the average high-specification mattress with an alternating pressure overlay.
The difference in costs over a one-year period is illustrated in Figure 15 below. This
information suggests that, on average, option (ii) using a high-specification foam
mattress with an alternating pressure overlay provides greater value for money
compared to option (i) APMRS.
NHS usage vignette
APMRS
HSFM+APO
Usage of one or other systems by 1,000 patients:
2,830,000
1, 378,000
28, 300,000
13,780,000
283,000,000
137,800,000
These figures taken across a five-year lifespan of the equipment then equate to per
year in GRP as actual cost to the NHS based on mean calculations:
APMRS HSFM+APO
566,000
275,600
5,660,000
2,756,000
56, 600,000
27, 560,000
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Figure 15: Daily cost of APMRS compared to a high-specification foam mattress
used with an alternating pressure overlay
600.00
500.00
sterling 2004/5
APMRS
400.00
300.00
200.00
High
specification
mattress with
AP
l
100.00
0.00
0
100
Days
200
300
400
Based on the minimum cost data in Table 4, it is worth noting that the minimum cost
of APMRS supplied via the NHS PASA is 376 compared to 406 for the highspecification foam mattress and alternating pressure overlay (53 for the mattress
and 353 for the overlay). Therefore, APMRS is not always the more costly option.
To take this into consideration, an additional analysis was undertaken.
Figure 16: Assessing the probability that APMRS is cost-minimising compared
Probability APMRS = lower cost option
to a high-specification foam mattress with an alternating pressure overlay

1.2
1
Current
price
0.8
0.6
0.4
A
0.2
0
0
0.5
1.5
2.5
Cost indices
1=average (mean) cost, 0=zero cost, 2=twice the
average cost
If the individuals purchasing these options are unaware of the price of the products
and the products are chosen independently then, as Figure 16 illustrates, there is a
95 of 245

probability of less than 20% (point A) that the APMRS option will be the lower cost
option, whereas there is a probability of about 80% that the foam mattress with an
alternating pressure overlay will be the lower cost option. The cost of APMRS would
need to be more than halved (point B), on average, if there was to be an equal
probability (50%) of APMRS being the lower cost option compared to the highspecification foam mattress with an alternating pressure overlay.
A number of assumptions underline the analysis and these are important to bear in
mind when interpreting the results. A key assumption was that the benefits associated
with each type of product were the same and therefore that it was appropriate to
conduct a cost-minimisation analysis. No empirical effectiveness evidence was found
which compared these particular pressure-relieving support surfaces. It was also
assumed that the resource inputs, such as labour time, required to use either option
were the same so that the only cost to be considered was the cost of the products
themselves. An attempt was made to include the unit costs of standard pressurerelieving support systems. Therefore products for use on, for example, double beds
and those produced specifically for bariatric patients or for children, were also
excluded. The unit costs obtained from NHS PASA related to the purchase price of
one product. In practice, products may be purchased in bulk and if so, the unit cost
per product is likely to fall.
96 of 245

Evidence summaries
Level of
Evidence statement
evidence
1++
All pressure-relieving support surfaces: No conclusive

research evidence to indicate which pressure-relieving support
surfaces are most effective in the treatment of pressure ulcers.
1+
Air-fluidised therapy: some evidence from meta-analysis of two

trials indicate that ulcer healing was improved compared to
modified AP and a range of other CLP supports in adults with
1+
grade 2-4 pressure ulcers (conventional therapy).

Low air loss therapy: no evidence of a difference for complete
ulcer healing found when compared to foam mattress overlays in
individuals with grade 2-4 pressure ulcers.
Alternating pressure therapy: no evidence of a difference in
1++
complete ulcer healing found comparing different alternating

pressure support surfaces.
No evidence of a difference found compared to static fluid
overlay mattresses or cushions in the elderly with grade 2 or
greater pressure ulcers.
1+
Continuous low pressure therapy: no evidence of a difference

in ulcer healing rates for water-filled mattresses compared with
foam replacement mattresses in adults with grade 3 pressure
ulcers. Limited evidence of difference in ulcer healing for profiling
beds compared with standard hospital beds in adults with grade
1 or greater pressure ulcers.
Recommendations: pressure-relieving support surfaces

Patients with pressure ulcers should have access to appropriate pressurerelieving support surfaces and strategies for example mattresses, cushions,
and repositioning 24 hours a day and this applies to all support surfaces. [D]
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Decisions about choice of pressure-relieving support surfaces for patients with
pressure ulcers should be made by registered health care professionals. [D]
Initial choice and subsequent decisions, following re-assessments, related to

the provision of pressure-relieving support surfaces for patients with pressure
ulcers should be based on: [D]
ulcer assessment (severity)
level of risk: from holistic assessment
location and cause of the pressure ulcer
general skin assessment
general health status
acceptability and comfort for the patient
lifestyle of the patient
ability of the patient to reposition themselves
availability of carer/health professional to reposition the patient, and
cost consideration.
There is no conclusive research evidence that any one pressure-relieving

support technology is superior to another. However professional consensus
recommends that:
all individuals assessed as having a grade 1-2 pressure ulcer should,

as a minimum provision, be placed on a high-specification foam
mattress or cushion with pressure-reducing properties combined with
very close observation of skin changes, and a documented positioning
and repositioning regime. [D]
if there is any perceived or actual deterioration of affected areas or

further pressure ulcer development, an AP (replacement or overlay) or
sophisticated CLP system for example low air loss, air fluidised, air
flotation, viscous fluid should be used. [D] N.B. For individuals
requiring bed rails, AP overlay mattresses should be placed on a
reduced-depth foam mattress to maintain safety.
98 of 245

individuals assessed as having grade 3-4 pressure ulcers (including

intact eschar where depth, and therefore grade, cannot be assessed)
should, as a minimum provision, be placed on an AP mattress
(replacement or overlay) or sophisticated CLP system for example
low air loss, air fluidised, viscous fluid. [D]
if alternating pressure equipment is required the first choice should be

an overlay system, unless other circumstances such as patient weight
or patient safety indicate the need for a replacement system. N.B. To
ensure maximum effect the inflated cells of the overlay must support
the body weight of the patient in all bed positions (during use of
backrest, knee break) and all patient positions (sitting up, side lying).
[D]
Safe use of pressure-relieving mattresses

When selecting pressure-relieving devices consider the following factors:D[GPP]
1. Ensure that the mattress does not elevate the individual to an unsafe height in
relation to bed rails if used. (For individuals requiring bed rails, AP overlay
mattresses should be placed on a reduced-depth foam mattress.)
2. Ensure that the individual is within the recommended weight range for the
mattress.
3. Children and alternating pressure
Cell size of mattress small children can sink into gaps created by deflated
cells causing discomfort and reducing efficacy.
Position of pressure sensors within the mattress in relation to the child

small children positioned at the top of the mattress may not register as the
weight sensor is positioned in the middle of the mattress, thus producing
inappropriate cell calibration.
Many alternating pressure mattresses have a permanently inflated head end

which may place the occiput at risk in young children.

Intervention
GDG commentary
Air-fluidised
AFT is now rarely used in clinical practice. There is little evidence of
therapy
difference over AP or many other CLP surfaces, and there may be

considerations in terms of patient positioning, and moving and
99 of 245

handling.
Low air loss
Basic mattress replacement versions often require user calibration
therapy
(barrel test) which is very subjective. Tends to favour pressure relief

at sacrum at expense of the head and heels. Requires constant
power/pumped air supply (deflates if power supply removed) placing
patient at risk while being transported. High-end systems have more
sophisticated pressure monitoring but are often integrated into bed
frames and are therefore expensive for general use.
Alternating
Mechanical robustness is an artefact of old trials in early days of
pressure
technology. Small cell systems are rarely used.

AP is widely used in clinical practice. However more research is
required to understand the ideal depth, inflation pressure and cycle
time.
Research recommendations.
Independent, well-designed, multi-centre, randomised, controlled
trials are needed to compare the clinical and cost-effectiveness of
different types of pressure-relieving support surfaces to treat existing
pressure ulcers for patients in a variety of settings. In particular, this
research should aim to compare:
alternating pressure support surfaces with continous

low pressure supports.
Future research must address the methodological deficiencies

associated with much of the research described in this review.
Attention should be paid to:
description of inclusion and exclusion criteria used to

derive the sample from the target population
evidence of an a priori sample size calculation
description of baseline comparability of treatment

groups
evidence of blinded outcome assessment
clear description of main interventions
adequate description of associated care, and
Royal College of Nursing and National Institute for Health and Clinical Excellence 100 of 245

withdrawals reported by treatment group with

reasons.
Patients should:
be truly randomised (with concealed allocation)
be of sufficient size to detect clinically important

differences and have clear criteria for measuring
outcomes
have blinded interventions and assessment
have adequate follow-up, and
appropriate statistical analysis.
Measure patient experiences of pressure-relieving equipment:
comfort
pain
ease of use
appropriateness for users and settings, and
durability of equipment.
The studies should also have evaluations of the cost-benefit trade off
of pressure ulcer treatment alternatives undertaken.

6.4
Dressings and topical agents in the treatment of pressure ulcers

The methods described in this review were those used to update the following
systematic review:

Systematic reviews of wound care management: (2) dressings and topical agents
used in the healing of chronic wounds. Health Technology Assessment, 3(17) pt 2.
Health Technology Assessment, 3(17) pt 1.
Background
Technological advances have extended the range and complexity of dressing
products, making meaningful classification increasingly difficult.
For the purposes of this document dressings are divided into five basic categories:
1) Contact layers
The key features of a contact layer should be their ability to prevent adherence to
the wound bed and allow free drainage of exudate. These materials tend to be
used on superficial or lightly exuding wounds for example paraffin gauze (tulle
gras), knitted viscose, silicone-coated fabric dressings .
2) Passive dressings
Dressings that create a local wound environment conducive to healing by
controlling the local wound environment but which do not change their physical
state or directly modify or interfere with the physiology of the wound. Such
dressings are commonly used to control exudate but they may also be used, for
example to prevent contamination or control odour. Examples include films,
foams and hydrogels.
3) Interactive dressings
Dressings that change their physical state in contact with wound exudate. Such
products commonly form a gel-like covering on the wound surface that is claimed
to promote healing. Examples include hydrocolloids, alginates and products
containing carboxymethylcellulose fibre.

4) Active dressings
Products that aim to directly influence the physiology or biochemistry of the
wound healing process. They include:
Products containing physiologically active components that act at a

biochemical level in the wound bed. Typically influencing cell growth or
correcting chemical deficits for example growth factors, collagen and
hyaluronic acid.
Skin grafts the transplanting of human or animal skin onto a wound

bed. May be patients own (autograft), donated (allograft) or animal
usually pig (Xenograft).
Tissue-engineered products.
Also known as skin substitutes or skin replacements. Products that

replicate a layer (or layers) of human skin.
5) Antimicrobial dressings
Dressings containing antimicrobials agents for example iodine, chorhexidine
silver and honey.
A number of characteristics of the ideal dressing have been described by pharmacists
(see box, Functions of an ideal dressing). Many manufacturers refer to these
characteristics when marketing their products. However, as this is an ideal list, none
of the dressings in current use fulfil all of the criteria.
Gauze
Woven or non-woven fabric produced from cotton, viscose, polyester,

or other suitable fibres formed into a swab. Should not be used as a
primary dressing as it adheres strongly to wound bed due to capillary
looping into the structure.
Contact layers
Includes simple products such as paraffin gauze (tulle gras) (cotton

or cotton and viscose woven fabric, which has been impregnated
with white soft paraffin) and knitted viscose dressings. More
advanced products such as silicone-coated net dressings and
hydrocolloid or gel-impregnated viscose nets are now generally
preferred. Contact layers have no absorbent properties and generally
require a secondary absorbent layer.

Wound dressing pads

The basic wound dressing pad consists of an absorbent layer such
as cellulose fibre enclosed in a sleeve of a nonwoven fabric. Some
pads have a perforated plastic film layer to reduce adherence to the
wound surface e.g. Melolin, Smith & Nephew Healthcare Ltd.
Semi-permeable
film dressings
Consist of a transparent polyurethane film coated with a thin layer of

adhesive to enable the dressing to adhere to intact skin but not the
wound surface. These dressings are permeable to moisture vapour
and gases but impermeable to water and microorganisms.
Hydrocolloid
dressings
These dressings comprise an absorbent gel-forming mass,

commonly consisting of carboxymethylcellulose, which is contained
within their structure together with elastomers and adhesives. The
dressings are usually presented in the form of a self-adhesive wafer
that absorbs wound exudate and traps it in the form of a gel.
Hydrocolloid colloid dressings are generally occlusive in their intact
state but become semipermeable once in contact with wound fluid.
Hydrogels
These consist of hydrophilic polymer commonly made from

carboxymethylcellulose or modified starch dissolved or dispersed in
water or a mixture of water (80%) and propylene glycol (20%) as a
humectant and preservative. They have the ability to absorb exudate
or rehydrate slough or necrotic tissue in a wound depending on
whether the wound is exuding heavily or dry and necrotic for
example Intrasite, Smith & Nephew Healthcare Ltd.
Alginate
dressings
These are derived from seaweed, usually prepared as the calcium

salt of alginic acid. When in contact with serum, wound exudate or

solutions containing sodium ions, the insoluble calcium alginate is
partially converted to the soluble sodium salt, and a hydrophilic gel is
produced.
Foam dressings
Most foam dressings are designed to absorb and retain fluid. Modern
foams are available in a variety of formats (shaped, adhesive, nonadhesive, bordered, cavity) with varying levels of absorbency and
permeability.
CMC fibrous
A primary wound dressing made from sodium
dressing
carboxymethylcellulose fibres woven into a fleece similar in

appearance to the alginates.
Capillary dressing
A three-layer, non-woven/woven, low-adherent dressing, which

comprises 100% polyester filament outer layers and 65%/35%
poly/cotton fibres.
The functions of an ideal dressing
Allows excess exudate to be removed from the wound surface.
Provides a moist micro-environment.
Is sterile/contaminant free.
Does not shed dressing material in the wound.
Reduces wound pain.
Is easy to remove and apply.
Does not cause allergic reactions.
Causes no trauma when removed.
Is impermeable to micro-organisms.
Provides thermal insulation.
Topical preparations
Topical preparations eligible for inclusion in the present review include growth factors,
oxygen-free radical scavengers, zinc oxide paste, tri-peptide copper complex, and
silver sulphadiazine cream. Topical antiseptics and antibiotics are not covered here

but have been reviewed elsewhere.
Several of these preparations are applied to the wound to compensate for a
deficiency in a particular element considered important for wound healing. An
example of such a topical agent is zinc oxide; zinc deficiency has been associated
with poor wound healing. Other preparations are thought to modify the wound
environment by killing harmful bacteria for example silver sulphadiazine.
Debridement
Debridement involves the removal of dead or necrotic tissue, or other debris, from the
wound to reduce the wounds biological burden. A number of terms are used to
describe dead tissue in wounds:
necrosis
slough, and
eschar.
There are six main methods of debridement:
autolytic
enzymatic
sharp (or surgical)
chemical
mechanical
larval therapy, the use of sterile maggots
Debridement agents
All non-mechanical debridement agents, including the use of dressings and larval
therapy, were included in this review. These include:
dextranomer polysaccharide beads or paste
cadexomer iodine polysaccharide beads or paste
hydrogels
enzymatic agents, and
adhesive zinc oxide tape.
Mechanical debriding agent wet-to-dry dressings (saline gauze) were also included in
this review. Other types of mechanical debriding agents, such as surgery or sharp
debridement, were excluded from this review and will be examined separately.
Non-mechanical debridement techniques

Numerous non-mechanical techniques are available for wound debridement. Many

are easy to apply and may have additional properties that are beneficial for wound
healing. Such interventions include hydrogels and hydrocolloids. These materials
have largely replaced enzymatic agents and dextranomer beads.
Several different enzyme preparations are available that digest slough and necrotic
tissue. In the UK, only the formulation containing streptokinase and streptodornase
(Varidase Topical, Wyeth Laboratories) is licensed for use. This enzyme breaks
down the proteins fibrin and pus cells but is ineffective against collagen and elastin,
the main structural components of skin and by extension necrotic eschar/slough.
Other enzymatic debriding agents are available and used internationally; these
include trypsin and collagenase.
Dextranomer polysaccharide is supplied as anhydrous, porous beads with a diameter
of 0.1-0.3 mm or as a paste. The beads are highly hydrophilic and rapidly absorb
exudate from a necrotic sloughy mass. Prostaglandins, hormones and other relatively
small molecules enter the matrix of the beads, while larger particles such as bacteria
and wound debris become concentrated at the surface of the dextranomer layer.
When the beads are changed by washing with saline, the absorbed and trapped
necrotic material is removed.
Cadexomer iodine is similar to dextranomer, consisting of small spherical beads that
are hydrophilic in nature. The beads are made from a modified starch infused with
iodine at a concentration of 0.9%. Absorption of fluid from the wound results in a slow
controlled displacement of iodine from the matrix, which acts as a bactericidal agent.
The slow and consistent release of iodine overcomes the problem of iodine
inactivation by protein absorption in the wound. The antibacterial property,
biodegradability and high rate of fluid absorption distinguish cadexomer iodine from
dextranomer. Bead dressings are difficult to apply and remove, and are for this
reason now generally used in the form of pastes.
Hydrogels are a group of agents that were primarily developed as debriding agents.
These gels are biologically inert and have a significant water content. They
complement the bodys natural debriding process by providing an advantageous
environment for autolysis, while still acting to preserve living healthy tissue. The
hydrogel is usually applied directly into the wound bed and held in place by a nonadherent dressing. Once the gel is fully hydrated it is unable to absorb the copious
quantities of exudate that are released by some wounds. For this reason hydrogels
are often used in conjunction with a highly absorbent dressing. In addition to the
amorphous gel, hydrogels are also available in a sheet form. Several types of
hydrogel are available manufactured under different trade names (Intrasite Gel,

Smith & Nephew Healthcare Ltd; Sterigel, Seton Healthcare Group plc; Granugel,
CovaTec UK Ltd).
Larval therapy, also known as maggot therapy or biosurgery, exploits the natural
feeding behavior of maggots of Lucilia sericata, the common green bottle, for the
benefit of the patient. When placed in a wound maggots have the ability to selectively
and rapidly remove slough and necrotic tissue leaving healthy tissue intact. They also
ingest living bacteria from within the wound which are killed as they pass through the
insects gut.
In clinical practice there is wide variation in the use of debriding agents and no
consensus on which agent is most appropriate for use in pressure ulcers.
Mechanical debriding agents

These involve the use of physical force to remove necrotic tissue and debris from the
wound surface. Simple methods include the use of wet-to-dry dressings which
remove tissue, although unselectively i.e. healthy and unhealthy tissue. Other
methods include wound irrigation cleansing and pressure irrigation, whirlpool
therapy, ultrasonic therapy and laser therapy.
Objectives
To systematically assess the evidence for the effectiveness of dressings and topical
agents in the treatment of existing pressure ulcers.
Selection criteria
Types of studies
Only randomised controlled trials (RCTs) were included in this review. Studies that
did not use true random allocation of participants to treatment groups, such as quasiexperimental designs, were excluded. The units of allocation had to be patients or
lesions. Studies in which wards, clinics or physicians were the units of allocation were
excluded because of the possibility of non-comparability of standard care. Both
published and unpublished studies were included.
Studies that recruited people with existing pressure ulcers, of any grade or severity,
were eligible for inclusion in the review. The study could be in any setting including

hospital, clinic, community facilities or home.
Trials in which a dressing or topical agent was compared with another dressing or
topical agent(s), or were compared with a placebo, usual care, or no treatment were
eligible for inclusion in the review. All types of dressings or topical agents were
eligible for inclusion with the exception of topical antimicrobial agents (in a separate
review). Non-dressing mechanical debriding agents, sharp and surgical debridement
were excluded.
The primary outcome was wound healing.
Search strategy
Clinical effectiveness searching debridement

Searches were undertaken to update the following Health Technology Assessment
reviews for the aspects which were relevant to pressure ulcers:
Health Technology Assessment, 3(17) pt 1.
Lewis R, Whiting P, Ter Riet G, OMeara S and Glanville J (2001) A rapid and
systematic review of the clinical effectiveness and cost-effectiveness of debriding
agents in treating surgical wounds by secondary intention. Health Technology
Assessment, 5(14).
Clinical effectiveness searching dressings

Searches were undertaken to update the following Cochrane review:
Systematic reviews of wound care management: (2) dressings and topical agents
used in the healing of chronic wounds. Health Technology Assessment, 3(17) pt 2.

Searches were limited by study design to retrieve randomised controlled trials.

Searches were also limited to retrieve literature published in English, and to omit
animal studies and letters, comments and editorial publication types.
Databases were searched in April 2004 and searches were updated in August 2004.
The strategies are listed in Appendix B.
Description of included studies

Sixty eligible randomised trials, involving 3,230 participants, were identified for
inclusion in the review.
Most of the trials were conducted in either hospital or an aged-care facility, hence
most of the enrolled patients were elderly, around 7080 years old. There was a
range of pressure ulcer severity included in the trials with baseline area at enrolment
from 1-200cm2. This reflects the differing ulcer stages for participants in the trials. On
average, ulcers would be at grade 3-4 at the start of treatment. Thus, many of the
ulcers treated within the included trials had persisted for between three and 12
months without resolution.
In studies of pressure ulcer treatment it is important for trialists to report on the

baseline comparability of the treatment groups for important variables such as
baseline ulcer size. A change in wound area is often expressed as the percentage
change which, unlike the absolute change in area, takes into account the initial size of
the wound. For two wounds healing at the same linear rate (as measured by diameter
reduction) percentage area calculations will show a larger change for a small wound
than for a big wound. The converse is true when the absolute change in area is
measured, as for any unit reduction in wound radius, a bigger area reduction will
occur for a large wound.
distribution of wound sizes. This problem will persist in small trials, even when the
average wound size appears to be comparable between groups, because the
distribution of wound sizes about the mean is likely to differ. In a trial where there is
poor comparability between groups for wound size at baseline, and the outcome is

based on the change in area, the result can only be considered valid if it is obtained
either against the anticipated direction of the bias for wound size, or where
percentage area change and absolute area change are in the same direction. If
baseline data are not given then it is not possible to determine the direction of bias
and the validity of the result cannot be determined. Twenty-eight of the 60 trials
included in this review presented data on baseline ulcer size.
In some studies there were concurrent intervention and follow-up periods, ranging
from two to 25 weeks. Other studies delivered the intervention for less than the full
follow-up period. Twenty-two of the 61 included studies used photographic techniques
as part of their objective measurement of wound healing. Others used planimetry
(n=22), observer opinion of improvement (n=5), and other methods (n=13) such as
water displacement techniques and rating scales. Many trials used a combination of
these methods, while others failed to describe their assessment techniques in any
detail.
Topical interventions were assessed in 31 studies. One trial (n=14) compared a
topical agent against no treatment, nine trials (n=405) assessed a topical agent
against a placebo, seven trials (n=548) compared one topical agent versus another,
seven trials (n=197) examined topical agents compared with traditional dressings,
and a further seven trials (n=444) compared topical agents with modern dressings.
Modern dressings were compared with traditional dressings in 12 trials (n=573), with
other modern dressings in 16 trials (n=994), and against a placebo in one trial (n=49).
The Table of Comparisons details the individual comparisons examined under these
broad groupings.
There were 22 studies that were excluded from the review. The citations and reasons
for exclusion are detailed in the Table of Excluded Studies (Appendix D). The most
common reasons for exclusion were non-randomised study design or lack of objective
outcome measures reported.

Details of the quality assessment of each study are outlined in the Table of Included
Studies (see Appendix A). The key components of quality that were assessed
included: a priori sample size calculations, allocation concealment, masking of
outcome assessment and reporting of withdrawals by treatment group.
Sample size ranged from 14 to 168 patients per trial, with only six of the 60 trials
recruiting more than 100 patients (Rees, 1999; Pullen, 2002; Colin, 1996; BrownEtris, 1996; Belmin, 2002; Honde, 1994). A priori power calculations were reported in

only six trials. In 40 of the 61 included trials, the method of random sequence
generation was not stated. Only six trials (Sayag, 1996; Thomas, 1997; Banks,
1994c; Graumlich, 2003; Meaume, 2003; Price, 2000) described the method of
randomisation in enough detail that the reader could be sure of adequate allocation
concealment.
Of the 10 trials that used a placebo comparator, only three described the placebo in
sufficient detail to be confident that treatment allocation was masked to patients and
caregivers (Robson, 2000; Ritz, 2002; Landi, 2003). Thirteen trials reported masked
assessment of outcomes (Mustoe, 1994; Robson, 1992a,b; Robson, 2000; Landi,
2003; Pullen, 2002; Nasar, 1982; Moberg, 1983; Brown-Etris, 1996; Alm, 1989;
Graumlich, 2003; Bale, 1998b; Ritz, 2002).
Thirty-six of the 60 included studies reported their withdrawal rates and reasons by
treatment group. Withdrawals were common, and 34 studies reported withdrawals by
treatment group and gave reasons for these withdrawals. There were sufficient data
reported in 35 studies to enable results to be extracted and analysed on an intentionto-treat basis.
No attempt was made to weight the studies in the analysis using any statistical
interpretation of the results.
Results
Many of the comparisons included in this review include only one eligible trial and
many of these are of poor methodological quality. Hence, robust conclusions cannot
be drawn from such results.
Topical agents versus no treatment

There was only one trial that was included in this comparison category. The
incremental benefit of topical insulin (twice a day for five days) in addition to routine
supportive nursing care was assessed in a single small trial (van Ort, 1976). The
statistical analysis suggested that the addition of insulin resulted in a
significant improvement in both the healing rate and the number of days that
treatment was required. However, this trial was small (n=14) and no primary data or
findings were presented, so firm conclusions cannot be drawn from these results.

Topical agents versus placebo
Nine trials compared a topical agent with a placebo. One assessed an active cream,
referred to as F1400140 (formulation not stated but contained a barley plant extract)
(Le Vassueur, 1991), one assessed collagenase (Lee, 1975), and a further seven
trials assessed topical growth factors (rhPDGF-BB, rbFGF, interleukin I-beta, GMCSF) compared to placebo (Rees, 1999; Mustoe, 1994; Robson, 1992a,b; Robson,
1994; Robson, 2000; Landi, 2003).
A meta-analysis of available data on complete ulcer healing from four of these seven
trials (n=241) showed that overall, compared to placebo, there was no evidence that
topical growth factors significantly improved healing rates (relative risk for complete
healing with growth factor treatment 1.51; 95% confidence interval 0.96 to 2.38) (see
Figure 17).
Figure 17:
However, as there is considerably heterogeneity in these results, both statistical (I2

statistic 78.7%) and clinical, an assessment was made of the two trials (Mustoe,
1994; Rees, 1999) that used the same growth factor (rhBDGF-BB) in the same
dosages (100g/ml, 300g/ml) compared with placebos. Both dosages of this topical
agent showed evidence of improvement in ulcer healing (relative risk for ulcer healing
with 100g/ml rhBDGF-BB 7.17; 95% confidence interval 1.40 to 36.69) (see Figure
18); (relative risk for ulcer healing with 300g/ml rhBDGF-BB 6.23; 95% confidence
interval 1.17 to 33.34 (see Figure 19). It should be noted that, although these are
statistically significant differences, the confidence intervals are wide, suggesting the
results should be interpreted with caution.
No other data from this category of studies was suitable for pooling using metaanalysis.

Overall, topical growth factors did appear to reduce mean ulcer size. Robson and
colleagues (Robson, 1992a,b; Robson, 1994; Robson, 2000) found increased
reduction in wound size or volume with increasing concentrations of various growth
factors (see Table of Included Studies for individual results, Appendix A).
Figure 18:
Figure 19:
A recent trial that assessed the effect of 2.5S murine nerve growth factor compared
with placebo (Landi, 2003) found that this treatment reduced ulcer area by 74cm2 in
the treatment group compared to 49cm2 for those receiving placebo. This topical
agent also improved the rate of complete ulcer healing from one in 18 in the placebo
group to eight of 18 in the treatment group (see Figure 17).
Topical agents versus topical agents

One trial compared topical collagenase with a topical fibrinolysis agent (Pullen, 2002).
It reported no significant change in wound area, healing or depth, but primary data for
these results were not given. The one small trial (n=28) that compared topical
collagenase papain-urea ointment (Alvarez, 2002) showed that the percentage of
non-viable tissue after four weeks of treatment was only 1% in the collagenase group
compared with 75% in the group that received papin-urea ointment (weighted mean
difference -74.00; 95% confidence interval -121.17 to -26.83).

Another trial which compared collagenase paste (Santyl) with dextranomer
polysaccharide paste (Debrisan) (Parish, 1979) showed no difference in ulcer healing
rates (relative risk for ulcer healing for dextranomer paste 4.71; 95% confidence
interval 0.66 to 33.61).
One larger trial which compared collagenase ointment in two dosing regimes (Burgos,
2000a) (24 versus 48 hours) showed no difference in healing rates (relative risk of
ulcer healing 1.33; 95% confidence interval 0.63 to 2.830).
Although evidence in the form of RCTs is lacking, many clinicians believe that
debridement facilitates wound closure by removing necrotic tissue that acts as a
barrier to new tissue growth. This suggests that if debridement really does aid wound
closure, then the effectiveness of a debriding agent should be measured by an
outcome based on wound healing. Even though the debriding agent is not necessarily
used throughout the entire healing process, an outcome measure based on healing
remains valid as long as both comparison groups follow a similar schedule of nursing
care after the debridement period. In this way, any difference in healing rates
between groups can be attributed to the debriding agent used. Some researchers,
however, have attempted to estimate the effectiveness of these agents by measuring
the degree of debridement expressed as the percentage area of wound covered in
necrotic material. This measurement may not be a reliable indication of treatment
effect as the extent of debridement does not appear to have been scientifically
validated as a surrogate or proxy measure of wound healing.
Dextranomer polysaccharide paste (Debrisan) was compared with a hydrogel
(Intrasite) in two well designed trials (Colin, 1996; Thomas, 1993). The resulting metaanalysis of data from these trials showed no evidence of a significant difference in the
rate of complete debridement (relative risk of complete debridement 0.90; 95%
confidence interval 0.52 to 1.54) (see Figure 20). However, as neither of these trials
reported complete ulcer healing, these results should be interpreted in light of the
aforementioned comments.
Figure 20:

Topical agents versus traditional dressings

Modern topical agents such as dextranomer polysaccharide paste (Debrisan),
collagenase (Santyl), cadexomer iodine polysaccharide powder (Iodosorb),
streptokinase preparation (Varidase) and hydrogel (Clearsite) were compared with
traditional dressings such as saline-soaked gauze, zinc oxide gauze, eusol and
paraffin packs, and sugar and egg white in six trials (Ljungberg, 1998; Nasar, 1982;
Parish, 1979; Moberg, 1983; Agren, 1985; Mulder, 1993).
As these agents all had different pharmacology and modes of action, it was
inappropriate to combine the results from these trials in a meta-analysis. None of the
three trials that reported complete wound healing found a significant improvement in
ulcer healing rates with the use of either Debrisan (Parish, 1979; Nasar, 1982), Santyl
(Parish, 1979) or Varidase (Agren, 1985) compared to traditional dressings (see
Figure 21). Again, however, all these trials were small (ranging from 18 to 28
participants) and of only fair methodological quality.
Figure 21:
Topical agents versus modern dressings
Seven trials that met the inclusion criteria compared a topical agent with a modern
dressing. Three trials compared a hydrocolloid with a hydrogel (Brown-Etris, 1996;
Darkovitch, 1990; Mulder, 1993), two studies compared polysaccharide beads with
either a calcium alginate dressing (Sayag, 1996) or a collagen sponge dressing
(Palmieri, 1992), and two compared a hydrocolloid dressing with either collagenase
ointment (Burgos, 2000b) or a polyhydroxyethyl methacrylate paste (Brod, 1990).
One trial (Darkovitch, 1990) reported twice the rate of wound ulcer healing with the
use of a hydrogel compared to a hydrocolloid dressing (relative risk for ulcer healing
with hydrogel 2.23; 95% confidence interval 1.23 to 4.07). However a smaller, more
recent trial, which compared a hydrogel with a modified version of the previous
hydrocolloid (Mulder, 1993), found no significant difference in mean percent ulcer
area reduction (weighted mean difference -4.70; 95% confidence interval -20.12 to

10.72) with the use of a hydrogel. A further comparison of a hydrogel with the same
modified hydrocolloid (Brown-Etris, 1996) reported insufficient data to estimate a
measure of statistical precision and hence meta-analysis of these results was not
possible.
In both comparisons between polysaccharide beads and an alternative dressing
(Palmieri, 1992; Sayag, 1996), the results indicated a benefit for the alternative
treatment. However, this only reached statistical significance in the comparison with
calcium alginate dressings, which showed a mean difference of 2.12cm2/week in
ulcer area reduction in favour of the alginate dressing (weighted mean difference
2.12; 95% confidence interval 0.74 to 3.50). Unfortunately neither of these authors
reported ulcer healing rates, hence the significance of these findings should be
interpreted with caution.
Modern dressings versus traditional dressings

Six trials (n=296) that met the inclusion criteria compared a hydrocolloid with the
traditional treatment of saline-soaked gauze (Mulder, 1993; Alm, 1989; Colwell, 1993;
Xakellis, 1992; Chang, 1998; Matzen, 1999). Due to significant clinical and statistical
heterogeneity and missing outcome data for some trials, meta-analysis of results was
deemed inappropriate.
Four of these trials reported wound healing results (Alm, 1989; Xakellis, 1992;
Colwell, 1993; Matzen, 1999) (see Figure 22). The results are varied some trials
found large improvements in ulcer healing (Alm, 1989), others found little difference
between the modern hydrocolloid dressing and traditional saline-soaked gauze
(Xakellis, 1992). As these trials had quite different patterns of ulcer severity at
enrolment, such differences might be expected.
Figure 22:
The comparisons of saline-soaked gauze and other modern dressings (semi

occlusive dressings, polyurethane dressings or hydrogel dressings) were only
undertaken in small, single trials. They either had insufficient power to detect
differences or showed no statistically significant differences between the groups for
measures of ulcer healing. A trial of hydrocolloid dressing compared with povidone
iodine gauze (Barrois, 1992) showed no statistically significant difference between the
two groups for ulcer healing (relative risk for ulcer improvement with hydrocolloid
1.11; 95% confidence interval 0.51 to 2.42). Similarly, a semi-occlusive dressing was
compared in one small trial (n=28) with saline-moistened gauze (Kraft, 1993) and no
evidence of a difference between the two treatments was found (relative risk of ulcer
healing with semi occlusive dressing 2.92; 95% confidence interval 0.74 to 11.45). A
trial of 48 patients with 77 ulcers (Sebern, 1986) compared a polyurethane sterile
dressing with saline gauze and found a large improvement in ulcer healing with the
modern dressing (relative risk for ulcer healing with polyurethane dressing 16.39;
95% confidence interval 1.06 to 252.82). However the extremely wide confidence
intervals for this result would suggest it was not a robust finding. One trial compared a
hydrogel dressing with saline-soaked gauze (Thomas, 1998) and also found no
evidence of improved ulcer healing rates (relative risk for ulcer healing with hydrogel
0.97; 95% confidence interval 0.56 to 1.68).
A newer dressing type, noncontact normothermic dressing, was compared with
standard wound care in two trials (Kloth, 2002; Whitney, 2001). Wound healing
results for these two trials showed no evidence of improved healing with the modern
dressing (relative risk for ulcer healing with noncontact normothermic dressing 1.28;
95% confidence interval 0.76 to 2.16, see Figure 23).
Figure 23:

Modern dressings versus modern dressings

There were 16 trials that compared different types of modern dressings (Belmin,
2002; Seeley, 1999; Bale, 1997,1998a,b; Thomas, 1997; Banks,
1994a,b,c,1996,1997; Seaman, 2000; Graumlich, 2003; Honde, 1994; Meaume,
2003; Price, 2000).
Hydrocellular dressings were assessed against hydrocolloid dressings in two trials
(Seeley, 1999; Bale, 1998a). A meta-analysis of the results from these two trials did
not show a significant difference in ulcer healing rates (relative risk for ulcer healing
with hydrocolloid 0.61; 95% confidence interval 0.33 to 1.13 (see Figure 24).
However, again these trials were small and it is likely there was insufficient power to
detect real differences in treatment groups.
Figure 24:
Meta-analysis of results from the three trials that examined hydropolymer versus
hydrocolloid dressings (Banks, 1996; Thomas, 1997; Honde, 1994) showed no
evidence of a significant difference in rates of wound healing (relative risk for ulcer
healing with hydrocolloid 0.98; 95% confidence interval 0.71 to 1.35) (see Figure 25).
As there was a moderate level of statistical heterogeneity (I2 statistic = 63.4%), the
meta-analysis was also run using a random effects model, but this made little
difference to the results (relative risk for ulcer healing with hydrocolloid 1.07; 95%
confidence interval 0.61 to 1.87, random effects).
Figure 25:

Three trials assessed hydrocolloid versus polyurethane foam dressings (Banks,

1994a,b; Bale, 1997). A meta-analysis showed no evidence of a significant difference
in wound healing between these two types of dressings (relative risk for ulcer healing
with hydrocolloid 0.82; 95% confidence interval 0.57 to 1.170 (see Figure 26).
Figure 26:
Several other comparisons between hydrocolloid dressings and other dressing types
have been studied in randomised trials. A trial comparing hydrocolloid dressings with
collagen dressings (Graumlich, 2003) found no evidence of a difference in wound
healing (relative risk for ulcer healing with hydrocolloid 0.97; 95% confidence interval
0.60 to 1.57). The use of a calcium alginate dressing (UrgoSorb) for four weeks
followed by a hydrocolloid dressing (Algoplaque) was compared with a standard
hydrocolloid dressing (Duoderm E) for eight weeks in 100 patients (Belmin, 2002). A
significant change in wound surface area at eight weeks was found for the sequential
group with a reduction in mean surface area of 9.7cm2 compared with the regular
hydrocolloid dressing group whose mean surface area reduction was 5.2cm2
(weighted mean difference 4.50; 95% confidence interval 1.83 to 7.17). A small
(n=35) trial that compared a change indicator dressing (SIG) with a hydrocolloid
dressing (Comfeel) (Seaman, 2000) saw an increase in wound healing with the
change indicator dressings, but this was not statistically significant (relative risk for
ulcer healing with hydrocolloid 0.16; 95% confidence interval 0.02 to 1.18). As most of
these studies were small and have not been replicated, conclusive findings cannot
been drawn from their results.
Similarly, there were a variety of single trial comparisons between several other
dressing types. Hydrocellular and polyurethane dressings were compared in a trial of
20 patients (Banks, 1997) but although wound healing data were given for all
patients, data were not presented for pressure ulcer patients alone. A recent trial of

38 patients compared the effect of hydropolymer and silicone dressings on wound
healing (Meaume, 2003). This trial reported no evidence of a significant difference in
ulcer healing rates between the two treatments (relative risk for ulcer healing with the
hydropolymer dressing 1.13; 95% confidence interval 0.57 to 2.21). Polyurethane
foam dressings (Lyofoam A) and low adherence dressings (Tegaderm) were
compared in 50 patients (Banks, 1994c). Again, there was no evidence of a
significant difference in wound healing between the two treatments (relative risk for
ulcer healing with polyurethane 1.17; 95% confidence interval 0.79 to 1.72). When a
radiant heat dressing was compared with an alginate dressing (Price, 2000), no
evidence of a significant difference between the two groups was seen (relative risk for
ulcer healing with radiant heat dressing 1.50; 95% confidence interval 0.27 to 8.22).
Another study compared two types of hydrogel dressings (Sterigel and Intrasite) (Bale
1998b). This trial did not report wound healing data, only results for wound
debridement. There was no evidence of a significant difference in this outcome
between the two types of hydrogel (relative risk for wound debridement with Sterigel
1.44; 95% confidence interval 0.77 to 2.69). None of these fairly small trials showed
significant or conclusive results favouring any of the new treatments, suggesting the
need for further studies.
Modern dressings versus placebo

One small trial (n=49) compared a wound closure system (Provant) with a placebo
(Provant support surface transparently modified so that no treatment was given) (Ritz,
2002) and found no evidence of significant difference in wound closure rates for
grade 2 pressure ulcers at six weeks (relative risk for ulcer healing with wound
closure system 3.50; 95% confidence interval 0.50 to 24.41).
Discussion
Quality of the studies
Quality assessment suggests that methodological flaws are an issue affecting the
validity of studies in chronic wound care. In general, the studies were too small to
ensure that wounds of different sizes (and other prognostic variables) were evenly
distributed across trial arms, resulting in a bias at baseline in most trials. The majority
of studies also had a short follow-up and did not analyse the data by survival analysis,
which would account for both whether and when a wound healed, and which would
be a more efficient method for estimating the rate of healing. If future trials perpetuate
many of the methodological flaws highlighted in this review, they are unlikely to

provide the necessary evidence to determine an effective wound management
strategy. The variability between wounds at baseline for prognostic variables,
including size, indicates that recruitment numbers need to be large and that trials
should probably be multi-centred. If small single-centred trials are to be continued
they could be improved by the use of matched or stratified randomisation to ensure a
similar distribution of wound sizes between treatment groups at baseline, and the
data should be analysed by matched pairs analysis where appropriate. However,
even with this improved design a trial still needs to be large enough to ensure
comparability for both unknown and known confounding factors.
Dressings and topical agents as treatments for pressure ulcers

Studies that compare treatment with no treatment are very rare in the wound care
literature because of concern over ethical issues associated with withholding
treatment from a patient. In this review only a single trial was included that assessed
the incremental benefit of topical insulin when given in addition to routine supportive
care (not including direct management of the wound) for the treatment of pressure
ulcers. This trial suggested that application of topical insulin did have a statistically
significant benefit on wound healing. However, this requires further exploration and
replication.
The alternative to withholding treatment from a patient is to use a placebo. Eleven
trials were included in this review which assessed topical agents versus placebo or
dressings versus placebo. In wound care trials such placebo treatments are unlikely
to be inert as the application of the placebo or vehicle is likely to change the local
environment of the wound, thereby modifying the biological processes associated
with healing. A placebo is therefore not a substitute for withholding treatment in
studies to determine the rationale for active treatment. The possible interaction
between the vehicle and the healing process, together with small sample size, may
provide some explanation for why trials do not show a statistically significant
difference between an active treatment and a placebo.
Studies directly comparing topical agents for the treatment of pressure ulcers focused
primarily on biologically active agents. Most of these trials were too small to provide
conclusive results and their heterogeneity prevented pooling. At present the results
are highly inconsistent both within and between trials, and further, better-designed
studies with larger numbers are required.

6.4.1 Cost-effectiveness evaluation of dressings in the

treatment of pressure ulcers
Table 5: Overview of economic evaluations to assess dressings and topical
agents
Full or partial
Author
Country
economic
where study
evaluation
was
Interventions compared
conducted
Partial
Aguilo Sanchez et
Spain
al. (2001)
Partial
Bale et al. (1998)
Hydrocolloid dressing vs. salinemoistened gauze dressing
UK
Hydrocellular dressing vs.

hydrocolloid dressing
Partial
Bergemann et al.
Germany
(1999)
Gauze vs. impregnated gauze

vs. calcium alginate vs.
hydroactive wound dressing in
combination with enzymatic
wound cleaning collagenese vs.
wound cleaning collagenese
during the first seven days of
treatment
Full
Burgos et al.
Spain
(2000)
Full
Capillas Perez et
hydrocolloid occlusive dressing

Spain
al. (2000)
Partial
Colwell et al.
Gorse et al. (1987)
Hydrocolloid dressing vs. saline

gauze dressing
US
(1993)
Partial
Collagenese ointment vs.
Hydrocolloid wafer dressing vs.

sterile moist gauze dressing
US
Hydrocolloid dressing vs.

Dakins solution (chloramines-T)
soaked wet-to-dry dressing

Partial
Graumlich et al.
US
(2003)
Full
Harding et al.
dressing
UK
(2000/1)
Full
Kerstein et al.
Kim et al. (1996)
Saline-moistened gauze vs.

hydrocolloid 1, hydrocolloid 2
US
(2001)
Partial
Topical collagen vs. hydrocolloid
Saline-moistened gauze vs.

hydrocolloid 1, hydrocolloid 2
Korea
Hydrocolloid occlusive dressing

vs. wet-to-dry gauze dressing
Partial
Kraft et al. (1993)
US
Semi-permeable polyurethane
foam dressing vs. moist saline
gauze dressing
Partial
Mosher et al.
US
(1999)
Partial
Motta et al. (1999)
Autolysis vs. wet-to-dry saline

vs. collagenese vs. fibrinolysin
US
Synthetic polymer vs.

Full
Full
Muller et al. (2001)
Nasar et al. (1982)
The
Collagense containing ointment
Netherlands
vs. hydrocolloid dressing
UK
Debrisan vs. Eusol and paraffin

dressings
Full
Ohura et al. (2004)
Japan
Hydrocolloid vs. traditional care

with ointment and gauze with a
standardised wound
management algorithm vs.
traditional care with ointment
and gauze without a
standardised wound
management algorithm
Partial
Robson et al.
(1999)
US
Recombinant human plateletderived growth factor-BB: 100

g rhPDGF-BB per day vs. 300
g rhPDGF-BB per day vs. 100
grhPDGF-BB twice daily, vs.

placebo
Partial
Robson et al.
US
Cytokine growth factors (2.0

g/cm2 GM-CSF) therapy
(2000)
topically applied daily for 35

days vs. 5.0 g/cm2 bFGF
therapy applied daily for 35 days
vs. 2.0 g/cm2 GM-CSF applied
for 10 days followed sequentially
by 25 days of topically applied
5.0 g/cm2 bFGF vs. Placebo
applied daily for 35 days.
Partial
Sebern et al.
US
Transparent moisture vapour
(1986/9)
permeable dressing vs. gauze

and tape
Partial
Xakellis et al.
US
Hydrocolloid dressing vs. non-
(1992)
sterile saline gauze dressing
Dressing and topical agents including debridement

The majority (81%) of economic evaluations obtained for review assessed the costs
and outcomes associated with dressings and topical agents. Table 5 (above)
presents an overview of the treatments that were assessed in this area together with
the country where the study was conducted.
Table 6: Treatment comparisons

Treatment comparisons
Number of
References
studies
1
Hydrocolloid dressing versus

saline gauze dressing
Aguilo Sanchez et al.

(2001)
Capillas Perez et al.
(2000)
Colwell et al. (1993)

Harding et al. (2000/1)
Kerstein et al. (2001)
Kim et al. (1996)
Ohura et al. (2004)
Xakellis et al. (1992)
Gorse et al. (1987)
Bale et al. (1982)
Bergemann et al.
Dakins solution (chloraminesT)-soaked wet-to-dry

dressings
3

hydrocellular dressing
Gauze versus impregnated

gauze versus calcium alginate
(1999)
versus hydroactive wound

dressing in combination with
enzymatic wound cleaning
collagenese versus
wound cleaning collagenese
during the first seven days of
treatment
Collagenese ointment versus
Burgos et al. (2000)
Muller et al. (2001)
Semi-permeable polyurethane
Kraft et al. (1993)
foam dressing vs. moist saline

gauze dressing
Autolysis vs. wet-to-dry saline
Mosher et al. (1999)
Motta et al. (1999)
Graumlich et al. (2003)
Nasar et al., 1982
Robson et al. (1999)
vs. collagenese vs. fibrinolysin

8
Synthetic polymer vs.

Collagen vs. hydrocolloid

dressing
10
Debrisan vs. Eusol and

paraffin dressings
11
Growth factors versus placebo
Robson et al. (2000)
12
Transparent moisture vapour
Sebern et al. (1986/9)
permeable dressing versus

gauze tape
Seven (33%) full economic evaluations were reviewed together with 14 (67%) partial
economic evaluations. Eleven studies (52%) were conducted in the US, three in the
UK and three in Spain (14% each), and one in Germany, Korea, Japan and the
Netherlands (5% each). Twelve different treatment comparisons were made and may
be grouped as presented in Table 6. Companies who supply pressure ulcer
treatments funded most studies. Reviews of the groups of different treatment
comparisons follow.
Hydrocolloid dressings versus moist gauze dressings

Eight economic evaluations comparing hydrocolloid dressings to saline gauze
dressings were reviewed including three full economic evaluations (Harding et al.,
2000/1; Kerstein et al., 2001; Ohura et al., 2004) and six partial economic evaluations
(Aguilo Sanchez, 2001; Capillas Perez et al., 2000; Colwell et al., 1993; Gorse et al.,
1987; Kim et al., 1996; Xakellis et al., 1992).
Aguilo Sanchez et al. (2001)iii conducted a cost-consequence analysis based on data
obtained from an RCT conducted in a hospital in Spain (see data extraction table 1,
Appendix A). It is not clear from the abstract how long patient follow-up was. The
effectiveness measure reported was the number of patients whose pressure ulcers
were completely healed. Twenty (57%) pressure ulcers were completely healed in the
hydrocolloid dressing compared to ten (29%) in the saline-moistened gauze group.
The daily cost of treatment, based on the cost of materials and nursing time, was Pta
180.50 (price year not stated) and Pta 209.36 for the hydrocolloid dressing compared
to the saline-moistened gauze treatment. It is not clear how the daily cost of treatment
was calculated since this could be the cost per day or the cost per day until complete
heal of the ulcer. It appears that the hydrocolloid dressing is more effective and
associated with lower costs (if indeed the daily cost of treatment takes length of time
to heal into account). However, this needs verification before asserting that the
hydrocolloid dressing was found to be more cost-effective. No statistical analyses or
sensitivity analyses were conducted to assess uncertainty associated with the cost
and effect estimates across the two groups.
Capillas Perez et al. (2000) also conducted a cost-effectiveness analysis based on an
RCT conducted from the perspective of the district health authority in Spain (see data
extraction table 5, Appendix A). The two effectiveness measures assessed were time
to cicatrise an initial 1cm2 wound and proportion of surface healed daily. The median
nurse time to cicatrise an initial 1cm2 pressure ulcer was 7.12 (first quartile 5.33 to
third quartile 11.0) days compared to 12.18 (5.85 to 39.38) days for the hydrocolloid
and saline gauze groups respectively. The median proportion of surface area healed
daily was 1.42% (0.56% to 2.5%) versus 1.19% (0.59% to 1.55) for the hydrocolloid
and saline gauze groups respectively. Neither difference was statistically significant.
Costs were calculated based on use of materials and nursing time. The median cost
(1st and 3rd percentiles) of the cicatrisation of an initial 1cm2 pressure ulcer was Pta
4,388 (1,808 to 7,539) (no price data available) compared to Pta 17,983 (6,521 to
87,798) and this difference was found to be statistically significant. Average costeffectiveness rather than incremental cost-effectiveness was presented. However, it
iii
This review is based on an NHS EED abstract (NHS CRD, 2001). The original paper was written in
Spanish.

appears that hydrocolloid is cost-saving and is associated with better outcomes,
dominating the saline gauze intervention.
It is worth noting that patients were allocated to intervention sequentially, which is not
a truly random method of allocation. The effectiveness estimates were based on
intermediate outcomes rather than final outcomes (pressure ulcer healed). Median
costs were reported whereas, from the economics perspective, mean costs are the
most appropriate and informative type of costs to report. The advantage of reporting
the mean is the ability of parametric tests to make inferences about the arithmetic
mean that is useful for budgetary purposes (Barber and Thompson, 1998)
Colwell et al. (1993) conducted a cost-consequence analysis based on an RCT
conducted from the hospital perspective in the US (see data extraction table 6,
Appendix A). Patients were followed up between six and 56 days (mean 17) and the
outcome assessed was the proportion of pressure ulcers healed. Twenty-two percent
(n=11) of pressure ulcers healed in the hydrocolloid group compared to two percent
(n=1) in the moist gauze group. The total average cost (including cost of materials
and nurse time) per patient was $53.68 (no price date) versus $176.90 for the
hydrocolloid versus the gauze group. It appears that the hydrocolloid dressing costs
less and is associated with better outcomes, dominating the moist gauze intervention.
A few caveats should be mentioned alongside the study results. The authors
randomised by pressure ulcer rather than by patient and some patients had more
than one pressure ulcer, both of which were included in the study. This method can
introduce bias, for instance if the ulcers are allocated to different treatments then it
may be difficult to remember to treat each differently. Also there may be something
particular about the patient which impacts on the findings and this undermines the
randomisation process. There were statistically significantly more grade 2 pressure
ulcers allocated to the hydrocolloid treatment and these types of ulcers tend to have
better healing characteristics than grade 3 pressure ulcers, potentially advantaging
the hydrocolloid treatment.
Harding et al. (2000/1) conducted a cost-effectiveness analysis of saline-moistened
gauze compared to two hydrocolloid dressings (Comfeel and Granuflex) (see data
extraction table 9, Appendix A). The analysis was based on a probability based
decision model, utilising data from the published literature and informed by expert
opinion. The perspective of the analysis was the UK NHS. The effectiveness estimate
was the proportion of pressure ulcers healed in 12 weeks and a meta-analysis was
undertaken to pool data from 15 studies for use in the model. The proportion of
pressure ulcers healed at 12 weeks in the saline-moistened gauze group was 51%
compared to 48% in the hydrocolloid Comfeel group and 61% in the hydrocolloid
Granuflex group. The average cost per patient healed (with costs including materials,

ancillary supplies, nursing and doctor debridement) was 2,663, 642 and 422
(1999 prices) for saline-moistened gauze, hydrocolloid Comfeel and hydrocolloid
Granuflex respectively. Thus hydrocolloid Granuflex appears to be the most costeffective option.
Although the unit cost of gauze treatment was lower than the unit cost of either
hydrocolloid dressing, the total cost associated with the gauze treatment was highest
due to higher nurse input. As the authors state, nurse time is the single most
expensive cost for each treatment. The use of cost per wound healed does not take
the length of time to healing into consideration. The assumptions and use of expert
opinion on resource use and effectiveness were not described in a very transparent
way. Incremental cost-effectiveness analysis was not undertaken.
Kerstein et al. (2001) also conducted a cost-effectiveness analysis, using a similar
approach to Harding et al. (2000/1)iv, comparing saline-moistened gauze to two
hydrocolloid dressings (Comfeel and DuoDERMv). It was based on a probability
based decision model, utilising data from the published literature and informed by
expert opinion. However, the perspective of the analysis was different since the
Kerstein et al. (2001) study was based on a US hypothetical managed care plan
setting. The effectiveness results were identical but the cost estimates were
estimated using US resource use and costs. In terms of results, the average cost per
patient healed (with costs including materials, ancillary supplies, nursing and doctor
debridement) was $2,179 (2000 prices), $1,267 and $910 for saline-moistened
gauze, hydrocolloid Comfeel and hydrocolloid Granuflex respectively. The
hydrocolloid DuoDerm dressing appeared to be the most cost-effective option. The
same limitations as the Harding et al. (2000/1) study apply.
Kim et al. (1996) conducted a cost-consequence analysis based on an RCT
undertaken in Japan (see data extraction table 11, Appendix A). The length of followup was not stated. Effectiveness measures included in the study were proportion of
pressure ulcers completely healed, time to complete heal and rate of pressure ulcer
heal. A total of 80.8% of pressure ulcers in the hydrocolloid group and 77.8% of
pressure ulcers in the gauze group healed completely, and the difference between
the two groups was not statistically significant. The time to complete heal was 18.9
days versus 24.3 days for the two comparators and the pressure ulcer healing speed
was 9.1mm2 per day and 7.9 mm2/day for the hydrocolloid and the gauze group
respectively.
iv
Based on the results it appears the Harding and the Kerstein study may be using the same data,
however the perspective of the analysis differs.
v
DuoDerm is the US brand name equivalent of the Granuflex UK brand name

The average cost of the interventions was Won 8,204 (+/-2,664) and Won 14,571 (+/6,700) (no price date) for the two comparators respectively (P<0.05). It appears that
the hydrocolloid dressing is more cost-effective than the gauze dressing with lower
associated costs and better effects. However, in general, little detail was provided on
methods used to conduct the evaluation so it is not clear as to the validity and
reliability of the results. The costs calculated did not take the cost of staff into
account, which seems an important omission based on results from the evaluations
above.
Ohura et al. (2004) undertook a cost-effectiveness analysis of hydrocolloid DuoDERM
dressing with a standardised wound management algorithm, traditional care of
ointment and gauze with a standardised wound management algorithm and traditional
care of ointment and gauze without a standardised wound management algorithm
(see data extraction table 17, Appendix A). The study was based on a multi-centre,
non-randomised trial in Japan and considered grade 2 and 3 pressure ulcers over a
follow-up period of 12 weeks maximum. Effects were measured in terms of the
Pressure Ulcer Status Tool (PSST), with greater reductions in PSST being associated
with greater health benefits achieved, and costs were based on use of materials and
labour time.
The hydrocolloid dressing was associated with a 11.1 point reduction in PSST
compared to a 6.9 point reduction for gauze with standard management and a 9.0
reduction in PSST for the gauze without standard management comparator. The
reduction was statistically different when comparing the first two of these
interventions. In terms of costs across the three treatments, the average total cost
was Yen 87,715, Yen 131,283 and Yen 200,584 (2001 prices). The difference in the
cost of the hydrocolloid treatment compared to the gauze without the standardised
wound management strategy was as statistically significantly different as when
materials and total labour costs were analysed separately.
Across all pressure ulcers, the PSST unit difference per Yen was 0.127 for the
hydrocolloid dressing compared to 0.045 for gauze without standardised wound
management and 0.052 for gauze with standardised wound management. In terms of
cost-effectiveness, based on these results the hydrocolloid dressing dominates with
lower associated costs and higher associated outcomes.
The Ohura et al. study (2004) was based on a multi-centre clinical trial. No tests were
undertaken to assess variation across study centres. Patient allocation to groups was
non-random. Limited statistical testing was undertaken to explore uncertainty with no
sensitivity analysis being conducted to assess the robustness of findings to variables
included in the analysis. The generalisability of these results is unclear. Unlike the

large majority of other studies, the cost of doctors time was included which was a
high-cost input. Costs were not reported separately from resource use.
Xakellis et al. (1992) conducted a cost-consequence analysis of hydrocolloid
dressings compared to non-sterile saline gauze dressings, based on an RCT in a
long-term care setting in the US (see data extraction table 21, Appendix A). The study
period was 21 months and study endpoints included pressure ulcer heal, progression
to stage 4 pressure ulcer, doubling in pressure ulcer area, systemic infection from the
pressure ulcer, no decrease in size of the pressure ulcer at two months and six
months of treatment, patient discharge from the long-term care facility and death.
Effectiveness was measured in terms of proportions of pressure ulcers completely
healed, time to healing and healing rates. Eighty-nine percent (n=16) of pressure
ulcers were completely healed in the hydrocolloid group compared to 86% in the
comparator group. The median time to healing after randomisation was nine days for
hydrocolloid group and 11 days for the gauze group and this finding was not
statistically significantly different. Seventy-five percent of pressure ulcers healed
within 14 days in the hydrocolloid group compared to the 26 days in the gauze group.
After adjusting for exudates present at baseline, healing rates were not statistically
significantly different across groups although the trend was towards slower healing in
the gauze group.
The cost of use of materials and nurse time was assessed and the median total cost
per patient was $15.58 (1990 prices) for the hydrocolloid group and $22.65 for the
gauze group if local nurse wages were used, and the difference was not statistically
significant. If national nurse wages were used, the median total cost was $15.90 and
$25.31 respectively (p=0.04). Overall, the hydrocolloid was less costly and associated
with greater health effects, hence it appears to be the more cost-effective option.
The authors reported median costs and conducted statistical tests based on nonparametric techniques, rather than mean costs and, as mentioned above (see review
of Capillas Perez et al. (2000)), this makes findings difficult to interpret.
Overview of hydrocolloid dressings versus moist gauze dressings

Although there were a number of limitations associated with all the economic
evaluations comparing hydrocolloid dressings to moist gauze dressings, typically
hydrocolloid dressings were found to be the more cost-effective option.

Hydrocolloid dressings versus Dakins solution (chloramines-T)-soaked wet-todry dressings
Gorse et al. (1987) (see data extraction table 7, Appendix A) conducted a costconsequence analysis comparing hydrocolloid dressing with Dakins solution
(chloramines-T)-soaked wet-to-dry dressings in a hospital in the US. Patient follow-up
was from initiation of conservative treatment until healing, hospital discharge or failure
of the initial intervention. However, the time in days was not stated.
Effectiveness was measured in terms of the rate of healing for each pressure ulcer
healed: that is the initial surface area divided by the number of days until complete
healing. If patients died or were discharged before complete healing, the surface area
at the last examination was subtracted from the initial surface area, and the results
divided by the number of treatment days. In the hydrocolloid dressing group, 86.8% of
pressure ulcers improved compared to 69.2% in the wet-to-dry dressing group. The
number of days to complete heal for pressure ulcers that healed was 10.0 (+/-10.5) in
the hydrocolloid group compared to 8.7 (+/-6.2) for the wet-to-dry dressing group. The
rate of decrease (cm2 per day) for pressure ulcers that healed was 0.72 (+/-1.22)
compared to 0.55 (+/-0.59) for these groups respectively and this result was not
statistically significantly different. Among the incompletely healed pressure ulcer
group, the duration of follow-up was significantly longer for the wet-to-dry group but
the rate of decrease in surface area was not significantly different. Among the
pressure ulcers that worsened, a higher rate of increase in surface area was found in
pressure ulcers treated in the hydrocolloid group compared to the wet-to-dry group.
Based on treatment costs alone, a cost of $6.20 per week was estimated for treating
each pressure ulcer in the hydrocolloid group compared to $52.50 per week in the
wet-to-dry dressing group. Costs associated with the hydrocolloid dressings were
lower and more pressure ulcers healed in this group compared to those treated with
wet-to-dry dressings, and on this basis the former appears to be the more costeffective option, dominating wet-to-dry dressings.
The cost analysis undertaken as part of this study was particularly weak. As noted
above, the cost of nursing time can be substantial but these costs were omitted. Also,
the cost was not examined until time to heal or according to any other effectiveness
measure. Some patients had more than one pressure ulcer that was entered into the
trial and this could bias the results. The allocation of patients to interventions was not
random. The uncertainty associated with the estimates was only assessed statistically
for the effectiveness dimension of the study.

Hydrocolloid dressings versus hydrocellular dressings
Bale et al. (1998) conducted a cost-consequence analysis comparing hydrocolloid
dressings to hydrocellular dressings (see data extraction table 2, Appendix A). The
study was based on an RCT and the perspective of the analysis was the NHS.
Patient follow-up was for a maximum of eight weeks. The effectiveness measure
reported was the proportion of pressure ulcers healed completely at eight weeks. In
this time, 59% of pressure ulcers healed in the hydrocolloid dressing group compared
to 27% of the pressure ulcers in the hydrocellular dressing group.
Costs were based on materials and nursing time. The total cost of treatment per
patient, whether their pressure ulcer had healed or not, was 50 in the hydrocolloid
group and 76 in the hydrocellular group. A number of one-way sensitivity analyses
were undertaken, including varying the costs applied if withdrawn before eight weeks,
but did not alter the findings. Since more pressure ulcers healed in the hydrocolloid
group and the daily cost of treatment was lower, it appears that hydrocolloid
dressings may be the more cost-effective option.
There are a few study limitations that should be considered when interpreting the
results. The cost of labour time, typically an important contributor to overall cost, was
omitted. Some patients were withdrawn from the study (the authors do not say in
which wound group they were). More patients were withdrawn from the hydrocellular
group and this could bias results in favour of this group. Across all wounds, at seven
weeks the numbers of wounds healed was very similar across groups but
comparative data was not presented on pressure ulcers at seven weeks.
Gauze versus impregnated gauze versus calcium alginate versus hydroactive
wound dressing in combination with enzymatic wound cleaning collagenese
versus hydroactive wound dressing in combination with enzymatic wound
cleaning collagenese during the first seven days of treatment
Bergemann et al. (1999) conducted a cost-consequence analysis to compare five
different interventions used in four hospitals in Germany (see data extraction table 3,
Appendix A). A spreadsheet model was constructed, informed by an expert panel,
and data to populate it were obtained using the hospital databases. The treatment of
four sizes of pressure ulcers were considered: (i) 5cm x 8cm (ii) 8cm x 12cm (iii)
10cm x 15cm and (iv) 12cm x 20cm. It was assumed that the bigger the wound, the
longer the treatment duration required. Equal efficacy was assumed or a decrease in
the length of hospital stay of 10% for the two hydroactive treatments.
Resource use estimates were assumed to vary across wound surface areas, as
informed by the expert panel. Costs were based on materials used and nurse time to

provide pressure ulcer care. Cost savings of between DM1,138 (DM538 to 1739) for
the first hydroactive treatment compared to the impregnated gauze treatment and
DM8,234 (DM4610 to DM 11,858) for the first hydroactive treatment compared to
gauze only were found. Two-way sensitivity analysis was undertaken on the total
costs associated with each intervention as well as the following parameters used to
calculate costs (personnel costs per minute, time required to change a dressing, total
number of wound dressing changes) and results remained fairly robust. Monte Carlo
simulation was used to estimate the variation in inputs into the model (95% CI). The
main finding was that, despite the higher material costs of the two hydroactive
therapies, the reduced labour costs, due to quicker time to heal and reduced duration
of treatment or time to inpatient discharge that were assumed, resulted in lower total
costs relative to the three comparators.
The model assumed that use of the hydroactive treatments reduced inpatient stays by
10% but the evidence on this is not strong. Pressure ulcers were followed in the
model not only until they had healed but sometimes, instead, until inpatient discharge:
hence the pressure ulcer may remain unhealed and this does not fully take into
account effectiveness. It is unlikely that all treatments are equally efficacious. Length
of hospital stay was considered to be a proxy for health effect, however; this was
incorporated within the cost estimates.
Collagenese ointment versus hydrocolloid dressings
Burgos et al. (2000) conducted a cost-effectiveness analysis of collagenese ointment
compared to hydrocolloid occlusive dressings (see data extraction table 4, Appendix
A). The study was a multi-centre RCT conducted in Spanish hospitals. Patients were
followed up for 12 weeks or until complete pressure ulcer heal, whichever occurred
first. Reduction in pressure ulcer area was used as the measure of effect. The mean
(standard deviation) reduction in pressure ulcer area in the collagenese group was
9.1 (1.2) cm2 compared to 6.2 (9.8) cm2 in the hydrocolloid group, an area reduction
of 44% and 28% respectively. The pressure ulcer area decreased in 83% of cases in
the collagenese group compared to 74% in the hydrocolloid group after twelve weeks
of follow-up and these differences were not statistically significant. Pressure ulcers
were completely healed for three patients in each group.
Resource use assessed were treatment supply, including ancillary supplies, and
nurse time. Collagenese group pressure ulcers cost Pta 41,488 (95%CI: Pta 26,191Pta 56,784) (price year 1998) compared to Pta 32,963 (95%CI: Pta 23,389-Pta
42,538) for the hydrocolloid dressing group and the difference was not statistically
significant. The total cost per 1cm2 reduction in pressure ulcer was Pta 4,559 for the
collagenese group and Pta 5,310 for the hydrocolloid group. The cost per reduction in

pressure ulcer area was lower for the collagenese group, and on this basis it appears
to be the more cost-effective option. Material costs were very similar but the total cost
of collagenese tended to be higher than hydrocolloid dressings due to greater staff
input. There was no allowance for across site differences.
Muller et al. (2001) also conducted a cost-effectiveness analysis comparing
collagenese with hydrocolloid dressings (see data extraction table 15, Appendix A).
The analysis was based on an RCT conducted in a hospital in the Netherlands.
Effectiveness measures used included whether or not the ulcer was successfully
treated (that is if the pressure ulcer was completely healed), the rate of complete
wound healing and the average number of weeks required until pressure ulcer
healing was achieved. In the collagenese group, 91.7% (11/12) patients were
successfully treated compared to 63.6% (7/11) patients in the hydrocolloid group and
this finding was statistically significant (p<0.005). The time to pressure ulcer heal was
shorter for the collagenese group at, on average, 10 weeks compared to 14 weeks
(P<0.005).
Resource use measured use of materials used and labour time, including doctor and
nurse time. The average cost per patient of collagenese was NLG1,615.8 compared
to NLG1,692.7 for the hydrocolloid dressings (price year 1998). The cost per
successfully treated patient was NLG1,762.0 for collagenese compared to
NLG2,661.4 for hydrocolloids, therefore the former appears to be more cost-effective
with lower associated costs and better effects. A deterministic model and one-way
sensitivity analysis and a probabilistic model using Monte Carlo simulation were
conducted to explore uncertainty associated with the estimates. In all scenarios,
collagenese remained the more cost-effective treatment. The assumption of the
independency of model inputs is questionable. Average cost-effectiveness rather than
incremental cost-effectiveness was reported. Two patients, one in each group, had
two pressure ulcers (on the heel) but it was not mentioned which pressure ulcer (the
pressure ulcers would be likely to differ) was included in the study.
Overview of collagenese ointment versus hydrocolloid dressings
The two studies comparing collagenese ointment with hydrocolloid dressings were full
economic evaluations based on RCTs and were of moderate quality. Both economic
evaluations suggested that collagenese is more cost-effective than hydrocolloid
dressings. Neither study was conducted in the UK and currently, collagenese is not
licensed for use in the UK.

Semi-permeable polyurethane foam dressings versus moist saline gauze
dressings
Kraft et al. (1993) conducted a cost-consequence analysis comparing the use of
semi-permeable polyurethane foam dressings to moist saline gauze dressings in
stage 2 and 3 pressure ulcers (see data extraction table 12, Appendix A). The study
was conducted in the US and was based on an RCT conducted in a long-term
hospital care spinal cord injury centre. The effectiveness measure chosen was the
proportion of patients with completely healed pressure ulcers. At 24 weeks, the
follow-up duration, 42% (n=10) of pressure ulcers were healed in the semi-permeable
polyurethane foam dressing group compared to 21% (n=3) in the gauze group.
However this difference was not statistically significant. Treatment supply and nurse
time was costed and the average total cost per week was $20.48 for the foam
dressing group and $74.97 for the gauze dressing group.
Although costs and outcomes were not synthesised in the study more pressure ulcers
were healed in the foam dressing group and the daily cost of treatment was lower,
therefore this appears to be the more cost-effective option, dominating the gauze
treatment option. The methods used to conduct the study were not written up in much
detail so critical appraisal is a challenge. Some patients withdrew from treatment (two
in the foam dressing group) but no reason for their withdrawal was provided. The cost
analysis was not strong because only weekly costs per pressure ulcer treated were
provided. The total cost of treatment to, say, time to complete heal, was not
calculated. The length of time that the treatment is received can make a difference to
the total cost of treatment.
Autolysis compared to either wet-to-dry saline, collagenese or fibrinolysin
Mosher et al. (1999) conducted a cost-consequence analysis from the third party
payer (Medicare) perspective in the US (see data extraction table 13, Appendix A). A
decision analytic model was used and effectiveness data was obtained from the
literature and expert opinion. Median values of experts gained were used as
probabilities in the decision model.
The patient being studied was a hypothetical 78-year-old female in a long-term care
facility who had not been hospitalised in the prior 12 months. She has a new fullthickness pressure ulcer on her trochanter with 50% necrotic tissue (eschar) covering
the ulcer, mild odour, minimal draining, no undermining and intact peri-ulcer skin. A
modified Delphi approach was used to reach consensus on critical treatment choices
and possible outcomes. The effectiveness measure chosen was the probability of
obtaining a clean wound bed for each 28-day treatment of the hypothetical treatment.
Resource use measured included drugs, dressing and irrigation supply, doctor visits,

ancillary services (for example outpatient laboratory tests), hospitalisation and
associated resource use.
The probability of a clean wound bed was estimated to be 0.887 (87%) for
collagenese, 0.641 for autolysis, 0.376 for wet-to-dry saline and 0.449 for fibrinolysin.
The total cost per patient for 28 days was $610.96 (1995 prices) for collagenese,
$920.73 for autolysis, $986.38 for fibrinolysin and $1008.72 for wet-to-dry saline.
Probabilistic sensitivity analysis was conducted to investigate parameter uncertainty
and when all parameter inputs were varied by 10% and +10% the results remained
robust. It appears that collagenese was the most cost-effective option for the
management of pressure ulcers in long-term care based on the study findings.
The quality of the literature review process and the elicitation of expert opinion was
not clear. The authors note that the probability data was non-normally distributed and
non-random.
Synthetic polymer versus hydrocolloid dressings

Motta et al. (1999) conducted a cost-consequence analysis based on pilot, RCT
undertaken in the US and hence the sample size was small (n=10, 5 in each group)
(see data extraction table 14, Appendix A). They compared a synthetic polymer
dressing with a hydrocolloid dressing in home health care patients who were followed
up for eight weeks.
Effectiveness measures included healing rates, adverse reactions and product
performance (based on exudate performance, whether the dressing maintains a moist
environment, promotes autolytic debridement and its overall clinical performance
marked out of 1 to 5 with 1 being most favourable and 5 being least favourable). Two
pressure ulcers in each group completely healed and all other pressure ulcers
demonstrated substantial reductions in size. The overall healing rates were not
statistically significantly different. No adverse reactions occurred and the overall
performance of the interventions was assessed based on the average score obtained
during dressing change for each parameter. No statistically significant differences
were found.
Dressings and ancillary supplies and nurse time was costed. The total cost of
treatment over eight weeks was $57.76 (no price date was given) for the synthetic
polymer group and $9l.48 for the hydrocolloid dressing group. Since the same
number of pressure ulcers healed across groups, if this was taken as the measure of
effect, then it appears that the synthetic polymer may be cost saving compared to the

hydrocolloid dressing. The sample size was small and it is questionable as to whether
the results are generalisable to other settings.
Collagen versus hydrocolloid dressings
Graumlich et al. (2003) conducted a cost-consequence analysis to compare topical
collagen with hydrocolloid dressings (see data extraction table 8, Appendix A). The
study was based on a multi-centre RCT of patients with grade 2 or 3 pressure ulcers
in nursing homes in the US and the patients were followed up for eight weeks
maximum (median of five weeks). Effects measured included the proportion of
pressure ulcers completely healed within eight weeks and secondary outcomes
including time to heal, ulcer area healed per day and linear healing of wound edge.
Fifty-one percent of pressure ulcers were healed within eight weeks in the collagen
group compared to 50% in the hydrocolloid group (95% CI: - 26% to 29%). The mean
healing time in the topical collagen group was five weeks (95% CI: 4 to 6 weeks), and
for the hydrocolloid group it was six weeks (95% CI: 5 to 7 weeks). The mean area
healed per day was 6mm2 in both groups and the mean linear healing of the wound
edge was 3mm for both groups.
Treatment supply, including ancillary supplies and nurse time, was measured in order
to calculate costs. The average cost per patient pressure ulcer over eight weeks was
$627.56 (no price date) for topical collagen and $222.36 for the comparator.
Statistical tests to compare findings across groups were undertaken. There were no
statistically significant differences in the healing outcome across groups. Topical
collagen was considerably more expensive and offered no major benefits to patients
otherwise eligible for hydrocolloid dressings. As the authors state, no analysis was
undertaken to adjust for the heterogeneity in healing outcomes identified across
nursing homes. The cost analysis was not strong and quantities of resources used
was not reported separately from unit costs.
Debrisan versus Eusol and paraffin dressings
Nasar et al. (1982) conducted a cost-effectiveness analysis based on an RCT in a
hospital in the UK (see data extraction table 16, Appendix A). Patients were followed
up until the pressure ulcer was clear and granulating, and appeared to be less than
25% of its original surface area. For the Debrisan group six out of eight pressure
ulcers healed in approximately 39.3 days. One other patient died and one patient
withdrew from treatment. For the Eusol group, five out of eight pressure ulcers healed
in approximately 62 days. Three patients were switched to Debrisan. Resources
measured to calculate costs included use of materials and ancillary supplies and
hospital stay. The average cost of a pressure ulcer that healed was 1053.05 (price
year not stated) for the Debrisan group and 1667.00 for Eusol group. Overall the

Debrisan cost less and was associated with a higher number of pressure ulcers
healed compared to Eusol.
In summary, Debrisan appears to be more cost-effective than Eusol, costing less and
being associated with a faster time to heal, for those pressure ulcers that healed. It is
worth noting that some patients had more than one pressure ulcer entered into the
trial, the actual length of patient follow-up was not stated and costs only related to
those patients whose pressure ulcers had healed.
Growth factors versus placebo

Robson et al. (1999) conducted a cost-consequence analysis, based on a 16-week
long RCT in a hospital in the US (see data extraction table 18, Appendix A). They
compared Recombinant human platelet-derived growth factor-BB. (1) 100 g
rhPDGF-BB per day with (2) 300 g rhPDGF-BB per day, (3) 100 grhPDGF-BB
twice daily and (4) placebo.
The effectiveness measure used to compare treatments was wound volume decrease
over time. Four surgeons, who were blind to patients, assessed changes in the ease
of surgical closure of pressure ulcers on a scale from 0 (no need to close, healed) to
13 (not possible to close) based on photographs of pressure ulcers which were taken
from a set focal distance and which were obtained weekly. Ninety-four percent of the
maximum number of photographs possible were available for rating. At the end of the
trial, the pressure ulcers of patients in group one were rated to have improved by six
points (mean) on the scale from beginning to end of treatment. For group 2 and 3
patients, the mean pressure score assigned was five points compared to four points
assigned to pressure ulcers in the placebo group. All outcomes were statistically
significantly improved from their respective starting ease of closure scores of 10
(p<0.0001).
In terms of cost, the change in difficulty of wound closure was studied in relation to
the composite cost including surgeons fee, anaesthesia fee and operating room cost.
Costs were arrived at from charges to patients at two university centres. The range of
costs was $100 (no price date was stated) for a single-buttressed suture placed at the
patients bedside to $12,000 for a difficult musculocutaneous or free flap. At the
beginning of the trial, the mean and median cost of closure was estimated at $8,000
per pressure ulcer as they were rated as requiring a somewhat easy pedicle flap
procedure to close the wound. At the end of the trial, according to the raters, group 1
required a difficult direct wound application costing $800 to $1,000 (a cost saving of
$7,000 to $7,200), compared to an easy skin graft for pressure ulcers in group 2 and
3 costing $1,200 (a cost saving of $6,800). For the placebo group a slightly more

difficult procedure was recommended costing $1,700 (a cost saving of $6,300). The
cost savings were statistically significantly different even though 100% wound closure
was not routinely achieved.
Based on the results, it appears that the growth factor received by group 1 was more
cost-effective than that recommended to patients with pressure ulcers in groups 2 and
3 that, in turn, were more cost-effective than placebo. Statistical tests on
effectiveness and costs were undertaken but the results of the latter were not
reported. It is worth noting that the analysis assumes that pressure ulcers would have
otherwise been closed via surgical techniques, a very costly intervention. The costs of
the surgical interventions were given but no further details were provided. In an
attempt to explore uncertainty, the authors tested the correlation between the ease of
closure scale and the wound area, as photographs are only two-dimensional. Results
of the clinical trial are provided in another paper.
Robson et al. (2000) also conducted another study using cost-consequence analysis
(see data extraction table 19, Appendix A). The study was based on an RCT in a
hospital in the US (see data extraction table 18, Appendix A). The interventions
compared were cytokine growth factors: (1) 2.0 g/cm2 GM-CSF therapy topically
applied daily for 35 days (2) 5.0 g/cm2 bFGF therapy applied daily for 35 days (3)
2.0 g/cm2 GM-CSF applied for 10 days followed sequentially by 25 days of topically
applied 5.0 g/cm2 bFGF and (4) placebo applied daily for 35 days. Patients with
grade 3 or 4 pressure ulcers were followed up for 35 days (five weeks). Effectiveness
measures included the wound volume decrease over time. Surgeons rated changes
in ease of surgical closure on a scale from (0) (no need to close, healed) to (13) (not
possible to close) based on photographs of pressure ulcers at a set focal distance. An
arbitrary response rate of at least 85% wound closure during 35 days of follow-up was
chosen as indicative of a responder.
In terms of effectiveness, there were no differences in mean proportion of initial
pressure ulcer volume remaining on day 36 across all interventions. However (2) had
a trend toward greater pressure ulcer closure. The proportion of patients responding
was statistically significantly higher for all cytokine therapies compared to placebo (4)
(p=0.03), with (2) patients doing best. The median ease of closure for all four groups
was 11 on day 0. Group (2) patients pressure ulcers had improved seven points on
the ease of closure scale. Group (3) patients improved five points, group (1) patients
improved four points and group (4) patients improved three points.
Resource use on the amount of topical substance each week of treatment was based
on volumetrically-determined surface area at baseline and on study days 7, 14, 21,

28. The change in difficulty of pressure ulcer closure in relation to total cost
(surgeons fee, anaesthesia fee and operating room cost) was calculated. At the
beginning of the trial, the median cost of closure was estimated at $10,000 (no price
date) per pressure ulcer. At the end of the trial, patients pressure ulcers in group (2)
were recommended to be healed by a difficult wound approximation costing $800 to
$1,000 (a cost saving of $9,000 to $9,200). For patients pressure ulcers in group (3),
the rates recommended patients would require a somewhat easy skin graft costing
$1,700 (cost saving of 8,300). For group (1) a somewhat difficult procedure was
required costing $2,200 (cost saving of $7,800). For group (4) pressure ulcers could
be closed for $3,000 (cost-saving of $7,000). It appears that cytokine (1) was the
most cost-effective strategy.
The cost analysis was not strong and the uncertainty around cost estimates for
surgical procedures was not explored. A major assumption on which the analysis was
based is the assumption that pressure ulcers would have otherwise been closed via
surgical techniques. Assessment of inter-rater reliability, using the ease of closure
scale, was not undertaken.
Transparent moisture vapour permeable dressing versus gauze and tape
Sebern et al. (1986/9) conducted a cost-consequence analysis to compare
transparent moisture vapour permeable (TMVP) dressing to gauze and tape (see
data extraction table 20). An RCT was conducted using a sample of patients using
home care that was served by a metropolitan visiting nurse association in the US.
Patients were followed up for eight weeks and effect measures used included their
healing status at eight weeks (whether their pressure ulcer had healed, was
progressing towards healing, was unchanged, they discontinued treatment or their
ulcer deteriorated). Additionally, healing rates and patient comfort was considered.
Of the grade 2 pressure ulcers in the TMVP group 64% (n=14) healed compared to
none in the gauze and tape group. For grade 3 pressure ulcers there was no
significant difference between the two groups and no further details were provided. In
terms of healing rates, grade 2 pressure ulcers in the TMVP group had a 52% median
decrease in area of the wound compared to 100% median decrease in the gauze
group (P<0.01, Wilcoxon). For grade 3 pressure ulcers, in the TMVP group, there was
a 67% median decrease in pressure ulcer size compared to a 44% decrease in the
gauze group but this finding was not statistically significant. Patients who had intact
sensory input from their pressure ulcers reported less pain when the TMVP treatment
was used.
Resource use assessed included treatments and nurse time. The mean eight-week
treatment costs per grade 3 pressure ulcer was $1470 for the TMVP group and $1412
for the gauze group and this difference was not statistically significant. It appears that

TMVP was slightly more costly per pressure ulcer for the TMVP strategy; however,
effects across the two interventions differed depending on the grade of the pressure
ulcer and the effectiveness measure considered. There was no difference in outcome
for grade 3 pressure ulcers; however, this may be due to type 2 errorvi. Authors
incorrectly re-graded pressure ulcers at the end of the study. The authors randomised
by pressure ulcer rather than by patient and that can introduce bias. The variance
associated with cost estimates was not reported and the statistical tests applied to
costs were non-parametric when they should be parametric.
Level of
Evidence statement
evidence
1++
There is insufficient evidence to indicate which dressing/s are the

most effective in the treatment of pressure ulcers.
2Economics evidence
Although there were a number of limitations associated with all the
economic evaluations comparing hydrocolloid dressings to moist
gauze dressings, typically hydrocolloid dressings were found to be
the more cost-effective option.
Recommendations: dressings and topical agents

Decisions about choice of dressing or topical agent for those with pressure
ulcers should be made by registered health care professionals. [D]
vi
The probability of failing to reject the null hypothesis when the latter is false. This probability becomes
smaller with increasing sample size. The greater the probability of type 2 error, the weaker the power of
the study to detect differences as statistically significant when such differences exist.

Choice of dressings or topical agents for the treatment of pressure ulcers
should be based on: [D]
ulcer assessment (condition of wound)
treatment objective
dressing characteristics
previous positive effect of particular dressing
manufacturers indications for use and contraindications
risk of adverse events, and
patient preference (lifestyle, abilities and comfort).
There is insufficient research evidence to guide clinicians decision making

about which dressings are most effective in pressure ulcer management. [A]
However professional consensus recommends:
Create the optimum wound healing environment by using modern dressings
e.g. hydrocolloids, hydrogels, hydrofibres, foams, films, alginates, soft
silicones) in preference to basic dressing types e.g. gauze, paraffin gauze
and simple dressing pads. [D]
Debridement
Clinicians should recognise the positive potential benefit of debridement in the
management of pressure ulcers. Decisions about the method of debridement
should be based on: [D]
ulcer assessment (condition of wound)
previous positive effect of debridement techniques
manufacturers indications for use and contraindications
risk of adverse events
patient preference (lifestyle, abilities and comfort)
characteristic of dressing/technique, and
treatment objective.

Decisions about debridement methods for patients with pressure ulcers should
be made by registered health care professionals. [D]
The research concerning wound dressings and topical agents is of
varied quality.
In those trials reviewed, sample sizes were often not sufficient to
detect clinically important effects, and poor baseline comparability of
the groups introduced bias.
Several important messages can be identified for future studies.
Recruitment numbers should be based on an a priori

sample size calculation. In most trials the sample size is too
small to find a statistically significant difference between
treatment groups. Multi-centre trials should be considered to
recruit sufficient patient numbers. These large trials have
been undertaken in other areas of health care and, although
the field of wound care presents its own difficulties, there is
no reason why such trials should not be successful. If these
trials are to be commissioned they will require a strong
infrastructure to provide support, promote collaboration and
establish a common knowledge base.
A truly objective outcome measure should be used for

example time to complete healing of the wound or wound
healing should be expressed as both percentage and
absolute change in area.
For each patient a single reference wound should be

selected. Multiple wounds on a patient should not be
included in the analysis as they are not independent unless
specialised statistical analysis is performed to separate out
the effects of the intervention that is matched-pairs
analysis.
Experimental groups should be comparable at baseline. In

small RCTs, randomisation alone will not achieve
comparability; in such situations patients should be paired

by prognostically important baseline characteristics and then
the individuals of each pair randomised to treatment. Such
randomisation is particularly important if ulcers of different
aetiologies are to be assessed in the same trial.
Head-to-head comparisons of modern wound dressings are

required and should use agents that are recommended for
wounds of a similar nature.
A complete and thorough description of concurrent

treatments including secondary dressings should be given in
trial reports.
Assessment of outcomes should be blind to treatment.
Survival rate analysis should be adopted for all studies that

assess wound healing.
Studies to determine the biological mechanisms involved in

wound healing are needed. A better understanding of the
healing process may lead to the development of validated
outcome measures.
All trials should be published where possible. Those

involved in primary research should make their data
available to those undertaking systematic reviews.
Future trials should include cost-effectiveness and quality of

life assessments, as well as objective measures of dressing
performance. These measures would encapsulate those
aspects of patient quality of life on which wounds most
impact and would be sensitive to meaningful changes in
quality of life generated by a change in the wound, including
post healing of the wound.

6.5
Antimicrobial agents in the treatment of pressure

ulcers
The methods described are those used to update the following systematic review:
OMeara (2001) Systematic reviews of wound care management: (3) antimicrobial

agents for chronic wounds; (4) diabetic foot ulceration, Volume 4, number 21.
The role of antimicrobial agents in the treatment of pressure ulcers remains unclear.
The lack of clarity is due in part to uncertainty around the issues of whether bacterial
presence in an important factor in wound healing. While the results from some studies
indicate a positive association between higher bacterial counts and delayed wound
healing (Lookingbill, 1978; Halbert, 1992), others show no such association (Eriksson,
1984; Gilchrist, 1989). Clinicians may use systemic antibiotics as a last resort when
topical interventions have failed to produce healing (Huovinen, 1994).
Moist chronic pressure ulcers are an ideal medium for bacterial growth. Pressure
ulcers may have a varied bacterial flora, with aerobic organisms cultured more
frequently than anaerobes. Staph. aureus, Streptococcus species, Proteus species,
Escherichia coli, Pseudomonas, Klebsiella and Citrobacter species are the most
common isolates (Yarkony, 1994; Parish, 1983; Alvarez, 1991). In serious cases,
infected pressure ulcers can lead to osteomyelitis and septicaemia (Yarkony, 1994).
Antimicrobials in current use

Systemic agents
Systemic agents fall into four main groups: penicillins, cephalosporins,
aminoglycosides and quinolines. There are also several other drugs in use, including
clindamycin, metronidazole and trimethoprim.
The penicillins work by interfering with the development of bacterial cell walls and
cross-linkages. Broad spectrum agents such as ampicillin and amoxycillin are active
against certain Gram-positive and Gram-negative organisms, but are inactivated by
penicillinases produced by Staph. aureus and E. coli (BMA, 1999). Amoxycillin is
sometimes used in combination with clavulanic acid (Chantelau, 1996). This
combination produces an increased range of activity and is effective against both
Staph. aureus and E. coli (BMA, 1999).
The cephalosporins have a similar action to the penicillins and have a wide range of

activity against both Gram-negative and Gram-positive organisms (BMA, 1999).
The aminoglycosides, such as gentamycin, act by interfering with normal protein
synthesis. They have a wide range of action, but are potentially nephrotoxic and
ototoxic, and serum levels should be monitored. They are active against the more
resilient Gram-negative organisms. They are not absorbed from the gut and systemic
administration is therefore by injection (BMA, 1999).
The quinolones, such as ciprofloxacin, prevent the formation of DNA within the cell
nucleus. They are active against both Gram-positive and Gram-negative organisms.
Ciprofloxacin is licensed for skin and soft-tissue infections, but there is a high
incidence of staphylococcal resistance and it is recommended that its use is avoided
in methicillin-resistant Staph. aureus (MRSA) infections (BMA, 1999).
Clindamycin is active against Gram-positive cocci, including penicillin-resistant
staphylococci, and also against many anaerobes. It has an uncommon but serious
and potentially fatal side effect, namely antibiotic-associated colitis. Current
prescribing guidelines state that therapy should be withdrawn immediately in any
patient developing diarrhoea (BMA, 1999). Metronidazole is active against anaerobic
organisms (BMA, 1999), and has sometimes been used in combination with other
agents, such as ampicillin (Lundhus, 1989). Trimethoprim is commonly used to treat
urinary and respiratory tract infections (BMA, 1999), and has been shown to be active
against E. coli when used to treat these conditions (Minassian, 1998).
Topical agents
Topical agents include antibiotics, antiseptics and disinfectants. Although various
definitions exist for these terms, there appears to be a lack of consensus within the
literature as to the characteristics of each type of preparation. It has been suggested
that both antiseptics and disinfectants destroy micro-organisms or limit their growth in
the non-sporing or vegetative state. However, antiseptics are usually applied solely to
living tissues, while disinfectants may also be applied to equipment and surfaces
(Morgan, 1993).
Topical preparations may be divided into two categories, according to their function.
One group consists of lotions with antimicrobial properties, used to irrigate or cleanse
wounds. These usually have only a brief contact time with the wound surface, unless
they are used as a pack or soak. They include the hypochlorites (e.g. Eusol),
hexachlorophene (a constituent of some soaps and other skin cleansers), and
substances such as potassium permanganate and gentian violet (both used in
solution for skin cleansing).

The second group consists of preparations designed to stay in contact with the wound
surface for a longer period of time, ideally until the next dressing change. These
include creams, ointments and impregnated dressings. Most topical antibiotics come
into this category, and include mupirocin (available as 2% ointment) which has a wide
variety of activity, and fusicidic acid (available as an impregnated dressing, or
ointment, cream or gel, all 2%) for staphylococcal infections. Neomycin sulphate,
available as a cream (0.5%) or ointment (0.25%), is used to treat bacterial skin
infections. If large areas of skin are treated, ototoxicity is a possible adverse effect.
Silver-based products, such as silver sulphadiazine (1% cream and impregnated
dressing), have a broad-spectrum action against both Gram-positive and Gramnegative organisms, and also yeasts and fungi (Morison, 1997).
Some products that are available in different forms fall into both categories. These
include povidone iodine (available as 10% solution, 10% ointment, 5% cream, 2.5%
dry powder spray and impregnated dressing), chlorhexidine (available as 0.05%
solution, 5% ointment and medicated tulle dressing; it is also a constituent of skin
cleansers), benzoyl peroxide (available as lotions, creams and gels in various
strengths) and hydrogen peroxide (available as 3% and 6% solutions and 1% cream)
(BMA ,1999).
Objectives
To systematically assess the evidence for the clinical effectiveness of systemic and
topical antimicrobial agents in the treatment of existing pressure ulcers.
Selection criteria
Types of studies
Both randomised controlled trials (RCTs) and prospective controlled clinical trials
(CCTs) with concurrent controls were eligible for inclusion in this review. For both
RCTs and CCTs, the units of allocation had to be patients or lesions. Studies, in
which wards or clinics were the units of allocation, were excluded because of the
possibility of non-comparability of standard care.

hospital, clinic, community facilities or home.
Trials in which an antimicrobial was compared with another antimicrobial agent, or in
which antimicrobial agent(s) were compared with a placebo, usual care, or no
treatment, were eligible for inclusion in the review. Trials of antibiotics, antifungal and
antiviral agents were all considered. Reports of antibiotic cover used with skin grafting
of pressure ulcers and antimicrobials used in conjunction with debriding agents were
excluded.

The primary outcome was wound healing. Since some measures of wound healing
can be subjective, studies had to incorporate an objective assessment such as
change in ulcer size, rate of healing, frequency of complete healing or time to
complete healing to be included in the review.
Many evaluations of antimicrobial agents focus on microbiological outcomes such as
wound cultures, sensitivities of micro-organisms, bacterial counts and bacterial
eradication. Studies reporting only these types of results were excluded from this
review since these intermediate (surrogate) outcomes have not been shown to be
accurate and reliable indicators of healing. Where studies reported both wound
healing and microbiological outcomes, only the former were incorporated in the
review. Where available, data on adverse effects of interventions were to be included.
Search strategy
Searches were carried out in April 2004 and an update search performed in June
2004. Full details of the search strategies can be found in Appendix B.
Methods of the review

Full details are described in the methods section of this Guideline.
Description of studies
Five eligible randomised trials were identified. Two of the included trials assessed
antimicrobial agents on patients with other types of chronic wounds (Della Marchina,
1997; Worsley, 1991) but data relevant to patients with pressure ulcers were able to

be extracted separately and were thus included.
Most of the trials were conducted in either a hospital or an aged-care facility, resulting
in most of the enrolled patients being elderly. There was a range of pressure ulcer
severity requiring treatment in the included trials.
The period of either the interventions and/or follow-up assessments ranged from
about two to 14 weeks. Three of the five included studies used photographic
techniques as part of their objective measurement of wound healing.
No eligible trials were identified that assessed the effects of systemic antimicrobial
agents in the treatment of pressure ulcers.
A variety of topical interventions were assessed in the included studies. One trial
tested the effectiveness of an antiseptic spray (Della Marchina, 1997). Two trials
assessed the effects of ointments: Gerding (1992) tested an oxyquinoline-based
ointment, while Toba (1997) compared a gentian violet-based ointment with a
povidone iodine ointment. Two trials assessed the effects of hydrocolloid dressings
(Huchon, 1992; Worsley, 1991).

The studies included in this review were small and generally of poor methodological
quality. Details of the quality of each individual study are included in the Table of
Included Studies [see Appendix A? ].
Sample size ranged from 14 to 137 patients per trial and a priori power calculations
were not reported in any of the trials. In four of the five eligible trials, the method of
random sequence generation was not stated. Only one trial (Toba, 1997) reported
adequate allocation concealment. Blinding of treatment allocation and/or outcomes
assessment was only reported in one trial (Gerding, 1992). Only one study reported
withdrawal rates and reasons (Worsley, 1991).
In studies of pressure ulcer treatment it is extremely important for trialists to report on
the baseline comparability of the treatment groups for important variables such as
baseline risk. Risk of pressure ulcer development is usually reported as one of
various risk scores such as Norton, Waterlow, Gosnell or Braden. Only one of the
studies reviewed here (Huchon, 1992) presented such baseline data.
Even more importantly in pressure ulcer treatment trials it is essential to ensure
baseline comparability for initial area of ulcers. A change in wound area is often

linear rate (as measured by diameter reduction) percentage area calculations will
show a larger change for a small wound than a big wound. The converse is true when
the absolute change in area is measured, since for any unit reduction in wound radius
a bigger area reduction will occur for a large wound.
determined. Three of the five trials included in this review presented data on baseline
ulcer size (Gerding, 1992; Huchon, 1992; Toba, 1997).
Quality was not used to weight the studies in the analysis using any statistical
interpretation of the results. Methodological flaws are discussed for each study in the
Table of Included Studies (see Appendix A).
Results
Five eligible trials were identified that assessed the effectiveness of antimicrobial
agents in the treatment of existing pressure ulcers. All used topical antimicrobial
agents; no trials were identified that assessed the effects of systemic agents.
Two trials (Huchon, 1992; Worsley, 1991) compared the use of a hydrocolloid
dressing with one impregnated with povidone iodine. Neither trial individually, or when
their results were combined in a meta-analysis, demonstrated a significant difference
between the two treatments in terms of the number of pressure ulcers assessed as
completely or partially healed at follow up between eight and 12 weeks (RR 1.19,
95% CI 0.92, 1.54). Worsley (1991) drew attention to the fact that fewer dressing
changes per week were needed in the hydrocolloid group compared with the
povidone iodine group (mean + SD: 3 + 1.38 versus 4.9 + 1.69, respectively, p <
0.005).

Two trials evaluated the effects of different ointments on the rate of pressure ulcer
healing. A small trial (n=19) by Toba (1997) assessed the effects of GVcAMP
ointment (gentian violet 0.1% blended with dibutyryl cAMP) in elderly women with
pressure ulcers contaminated with MRSA. There was no statistically significant
difference (mean difference 11.1%, 95% CI 27.86, 5.66) between the two groups in
change in wound area at 14 weeks. The authors hypothesised that the lack of
difference seen might be due to the fact that the two largest wounds (area greater
than 50 cm2) were in the experimental group. However, an absence of power
calculations makes assessment of this comment difficult.
The results of the trial by Gerding and colleagues (1992) are difficult to assess as
although the unit of allocation was said to be patients, the unit of analysis was the
number of lesions. From the results presented it is not clear how many of the 74
patients were randomised to each group. It is likely that some patients had more than
one lesion. The results were presented and divided according to stage of lesion at
enrolment which demonstrates that although the result for all lesions combined
showed a significant increase in the number of ulcers either partially or completely
healed with the oxyquinoline ointment (90%) compared to the povidone iodine
ointment (63%) (RR 1.41, 95% CI 1.01, 1.91), when assessed by lesion stage subgroup no significant benefit was observed for either stage 1 or 2 lesions. Hence,
these results should be interpreted with caution.
In a small RCT (n=19) by Della Marchina and colleagues (1997) no difference was
found (RR 2.22, 95% CI 0.24, 20.57) in the rate of complete healing of pressure
ulcers between an antiseptic spray containing eosin 2% and chloroxylenol 0.3% and
an alternative spray.
No reliable or objective measures of secondary outcomes such as cost-effectiveness,
adverse events, comfort, durability, reliability and acceptability of topical antimicrobial
interventions were reported in any of the studies.
Discussion
Despite the frequency of pressure ulcer incidence, the cost of the condition to the
health care budget and the myriad of treatment modalities, this review demonstrates
the paucity of good-quality evidence that guides current clinical practice on the use of
antimicrobial agents in the treatment of existing pressure ulcers.
Oxyquinoline ointment may be more effective than a standard emollient for treating
existing pressure ulcers (Gerding, 1992) , but no significant differences were seen

when a hydrocolloid dressing was compared with povidone iodine ointment (Huchon,
1992; Worsley, 1991), or when a preparation based on gentian violet 0.1% was
compared with a povidone iodine and sugar ointment (Toba, 1997). The trial which
compared an antiseptic spray with an alternate spray (Della Marchina, 1997) was
small and of poor methodological quality, precluding a reliable assessment of the
effectiveness of this intervention.
These few interventions, tested in small trials of generally poor quality, were the only
studies identified that assessed the effectiveness of antimicrobials in the treatment of
existing pressure ulcers. There were no trials identified that assessed the effects of
systemic antimicrobial agents in pressure ulcer management. The confidence with
which we can draw firm conclusions from the few studies detailed in this review is
greatly tempered by (a) the poor quality of many of the trials and (b) the lack of
replication of most comparisons. Hence, much of the research into this subject
requires replication on a larger scale. Attention should be paid to detailed baseline
data collection and reporting, blinding of outcome assessors, reporting of withdrawals
and the use of the intention-to-treat protocol. Rigorous methods of blinding for wound
assessors are essential to establish the relationship between different types of
products and changes in nurse labour time required. Finally, concurrent interventions
should be described in detail, in particular pressure-relieving support surfaces,
debridement techniques and forms of topical dressing application.
There are very few data on the cost-effectiveness of antimicrobial agents in pressure
ulcer healing. Cost-effectiveness studies should be carried out in conjunction with
rigorous evaluations of clinical effectiveness to determine the relative difference
between cost per unit of the clinical effects of two or more treatments. A costeffectiveness or cost-utility analysis should include both a measure of the clinical
benefit from a non-biased study, and a measure of the net resources used
(Drummond, 1994). Data should be collected relating to both short- and long-term
patterns of wound healing and recurrence.
Information from two of the studies included in this review (Huchon, 1992; Worsley,
1991) suggests that certain treatments may be associated with reduced nurse labour
time, but further research is required to establish this more reliably. Hydrocolloid
dressings require significantly fewer changes than do dressings using conventional
antiseptics and wound coverings. For the two studies which assessed this
intervention (Huchon, 1992; Worsley, 1991) the effects on nursing time need to be
assessed in relation to the equivalent results seen in terms of clinical effectiveness
(wound healing).

Evidence summary
1++
There is insufficient evidence to indicate whether antimicrobials

are effective in the treatment of pressure ulcers.
No economic evaluations assessing antimicrobials for the
treatment of pressure ulcers were found.
The results summarised in this review are based on findings from
small trials with methodological problems. Therefore, much of the
required research needs replication in larger, well-designed
studies using contemporary interventions for antimicrobial activity.
Recommendations: antimicrobial therapy

In the presence of systemic and clinical signs of infection in the patient with a
pressure ulcer, systemic anti-microbial therapy should be considered. D[GPP]

6.6
Mobility and positioning in the treatment of pressure ulcers
Mobility, or more precisely immobility, is reported as a significant risk factor for both
the development of pressure ulcers as well as a contributory factor in delayed healing
(Guralnik et al., 1988; Berlowitz and Wilking, 1989; Ek et al., 1991; Allman et al.,
1995; Bergstrom et al., 1996; Schue and Langemo, 1998; Nixon et al., 2000 and
Bergquist, 2003). Clinicians and carers engage in a range of activities to reduce the
effects of immobility on the healing of pressure ulcers. Mobilising, positioning and
repositioning patients (turning) to best promote healing by reducing pressure on the
wound, and maintaining muscle mass and general tissue integrity are all central to the
aims of this activity.
The literature suggests that both seated and bed bound individuals are at risk of
delayed healing and many methods have been postulated to reduce this risk. Much of
the research around positioning and re-positioning reports interface pressures for
different sitting and lying positions with and without support surfaces. The effects of
these interventions on the healing of pressure ulcers is not clear.
Limited sitting and lying times are seen as one aspect of reducing the risks for those
with pressure ulcers. Another is posture and combining the sitting and lying regimes
with appropriate support surfaces. Re-positioning patients every two or three hours is
generally accepted as an effective method to prevent pressure ulcers in both patients
with and without existing pressure ulcers (Defloor, 2000). The research evidence to
support these interventions is not clear and is therefore the aim of this review. The
literature reports a range of re-positioning times from two hourly to six hourly (Defloor,
2001) and, despite the possible effects on patients and the impact on resources, this
evidence is limited with suggestion that re-positioning patients has no preventative
effect on the development of grade 1 pressure ulcers (Defloor and Grypdonck, 2000).
Clinical question
What is the evidence that mobility is effective in the treatment of pressure ulcers?
What is the evidence that re-positioning is effective in the treatment of pressure
ulcers?
Objectives

The objective is to undertake a systematic review of the evidence of mobility and
positioning in the treatment of pressure ulcers to determine:
What are the key mobility interventions/techniques used in pressure

ulcer treatment?
What are the key positioning techniques used in pressure ulcer

treatment?
What is the significance of these in pressure ulcer treatment?
What are the priorities in pressure ulcer treatment?
What is the existing evidence base for their use in the treatment of
pressure ulcers?
What is the empirical evidence that these processes are effective in

the management of pressure ulcers?
Selection criteria
Types of studies
RCTs evaluating the effectiveness of mobility and or positioning
interventions/techniques in the treatment of pressure ulcers. In the absence of any
RCTs, evidence-controlled studies evaluating the effectiveness of mobility and
positioning interventions in the treatment of pressure ulcers. Studies reporting
interface pressure will not be included in this review because it is not clear how such
outcomes relate to delayed healing and complications.
Mobilising (exercise interventions) compared to standard care. Different
positioning/re-positioning interventions compared and compared to standard care.
Types of outcome
Healing rates, all objective measures of wound change over time.

Clinical evidence
anecdotal reports or fell outside the inclusion criterion for this review. Out of the six
selected studies, five were excluded and one was included.
Bates-Jensen et al.(2004)
Bates-Jensen et al. (2004) undertook a randomised controlled trial with blinded
assessment of outcomes at three points. A total of 190 incontinent nursing home
residents were randomised to receive standard care or exercise and incontinence
care every two hours between 8am and 4.30pm five days per week for 32 weeks.
Skin health outcomes were the outcome measures of interest which included
pressure ulcers. Assessors were blind to treatment group. A priori was performed.
Intervention subjects had significantly better skin health outcomes than controls.
However this was limited to the sacral and trochanter regions (p = <.001).
Because this is a duel intervention trial it is not clear what proportion of the improved
outcome is attributed to the exercise (mobilising) intervention. This trial included a
range of skin conditions which included: maceration, papules, macules, blanching
erythema, non blanching erythema, non pressure ulcers and pressure ulcers
combined. The effects of the interventions on pressure ulcer healing are not clear
from this study.
Due to the lack of evidence for mobility and positioning recommendations were
sought from formal consensus methods.
Recommendations: mobility and positioning

Mobilising, positioning and repositioning interventions should be considered for
all individuals with pressure ulcers (including those in beds, chairs and
wheelchairs). [D]
All patients with pressure ulcers should actively mobilise, change their position
or be re-positioned frequently. [D]

Avoid positioning individuals directly on pressure ulcers or bony prominences

(commonly the sites of pressure ulcer development). [D]
Mobilising, positioning and re-positioning interventions should be determined

by: [D]
location of ulcer
acceptability (including comfort) to the patient, and
the needs of the carer.
Frequency of re-positioning should be determined by the patients individual

needs and recorded e.g. a turning chart. [D]
Passive movements should be considered for patients with pressure ulcers

who have compromised mobility. [D]
There needs to be rigorous research to evaluate the effects of
mobility interventions on the healing of pressure ulcers.

6.7
Nutrition in the treatment of pressure ulcers
The methods described in this review are those used to update the following
systematic review:
Langer G, Schloemer G, Knerr A, Kuss O, Behrens J (2004) Nutritional interventions
for preventing and treating pressure ulcers (Cochrane Review) in: The Cochrane
Library, Issue 3, Chichester, UK: John Wiley & Sons, Ltd.
The treatment of pressure ulcers involves a number of strategies designed to address

both extrinsic factors e.g. reducing the pressure duration or magnitude at the skin
surface by repositioning or using pressure-relieving cushions or mattresses and
intrinsic factors, which are concerned with providing the optimum tissue environment
for wound healing i.e. optimum hydration, circulation and nutrition.
It has been reported that malnutrition is positively correlated with pressure ulcer
incidence and severity (Berlowitz, 1989; Bergstrom, 1992). Also that decreased
calorie intake, dehydration, and a drop in serum albumin may decrease the tolerance
of skin and underlying tissue to pressure, friction and shearing force, increasing the
risk of skin breakdown and reducing wound healing (Mueller, 2001). Serum albumin is
commonly used as a measure of the amount of protein in the blood for healing.
However the effect of serum albumin level on wound healing is not clear there is
difference of opinion as to the relevance of such levels in pressure ulcer healing and
thus it has limited value as an inclusion/exclusion criterion in controlled clinical trials
(Hill et al., 1994). Low energy and low protein intake feature in reports of nutrition and
wound healing. The combination of low energy and low protein intake is often
described as protein-calorie or protein-energy malnutrition.
The Prinz (prevalence and incidence) study, which collected data from more than
45,000 patients in Austria between 1995 and 1999, reported that malnutrition
defined as a serum albumin less than 3.5 g/dl was identified as a risk factor in 25%
of patients (van Steelandt, 2000). Further studies suggest a correlation between
protein-calorie malnutrition and pressure ulcers (Breslow, 1991; Finucane, 1995;
Strauss, 1996).

The effectiveness of special diets in preventing and treating pressure ulcers has not
yet been examined sufficiently despite the fact that risk assessment tools (for
example Braden, 1994; Gosnell, 1989) include nutritional status as a part of the
assessment process in the prevention of pressure ulcers. Nevertheless, there is a
consensus that nutrition is an important factor in both the prevention and treatment of
pressure ulcers.
This has been reiterated by the incorporation of nutritional factors in various
guidelines e.g. the EPUAP Pressure Ulcer Prevention Guidelines ("There should be
clarification of a full risk assessment in patients to include: [...] nutrition [...]") or the
EPUAP Pressure Ulcer Treatment Guidelines ("Ensure adequate dietary intake to
prevent malnutrition [...]") (EPUAP 1998, EPUAP 2003). A systematic review is
therefore required to summarise the best available research evidence and enable
evidence-based guidance on the role of nutritional interventions in pressure ulcer
prevention and treatment.
Objectives
To evaluate the effect of nutritional support and supplementation in the treatment of
pressure ulcers.
Selection criteria
Types of studies
Randomised controlled trials (RCTs) of parallel or crossover design evaluating the
effect of enteral and/or parenteral nutrition in the treatment of pressure ulcers by
measuring ulcer healing rates or changes in pressure ulcer severity. Controlled
clinical trials (CCT) were only considered eligible for inclusion in the absence of
RCTs.
People of any age and sex with existing pressure ulcers, in any care setting,
irrespective of primary diagnosis. A pressure ulcer was defined as an area of
localised damage to the skin and underlying tissue caused by pressure, shear, friction
and/or a combination of these.

Clearly described nutritional support (enteral or parenteral nutrition); supplementation
or special diet. Comparisons between support or supplementary nutrition plus
standard diet versus standard diet alone, and between different types of
supplementary nutrition e.g. enteral vs. parenteral were eligible.

The primary outcome was:
time to complete healing.
The following secondary outcomes were summarised:
acceptability of supplements
side effects
costs
rate of complete healing
rate in change of size of ulcer (absolute and relative), and
quality of life.

Searches were undertaken to update the following Cochrane Review:
Langer G, Schloemer G, Knerr A, Kuss O, Behrens J (2004) Nutritional interventions
for preventing and treating pressure ulcers (Cochrane Review) in: The Cochrane
Library, Issue 3, Chichester, UK: John Wiley & Sons, Ltd.
Databases were searched in August 2004.
Full search strategies are listed in Appendix B.

Criteria for inclusion (methodological quality is reported in the evidence tables).
No economic evaluations assessing nutritional support in the treatment of pressure
ulcers were found.

Clinical evidence
Ascorbic acid (Vitamin C), two trials
Taylor (1974) carried out a double-blind, RCT with 20 surgical patients with pressure
ulcers. Patients in the treatment group received an additional 500mg ascorbic acid
twice daily for four weeks.
ter Riet (1995) conducted a multi-centre blinded RCT with 88 patients with pressure
ulcers in 11 nursing homes and one hospital. Patients in the intervention group
received 500mg ascorbic acid twice daily with or without ultrasound for a period of 12
weeks. Patients in the control group received 10mg ascorbic acid twice daily with or
without ultrasound. Most patients had nutritional deficiencies on admission.
Protein, one trial

Chernoff (1990) undertook a RCT with 12 institutionalised tube-fed patients with
pressure ulcers. Patients were randomised to a high-protein or a very high-protein
dietary formula and monitored for eight weeks to assess pressure ulcer healing.
Zinc, two trials

Norris (1971) performed a randomised, double-blind, crossover study with 14 patients
with pressure ulcers. Patients received either 3 x 200mg zinc sulphate per day or
placebo for a period of 24 weeks. After 12 weeks the patients switched groups.
Brewer (1967) conducted a randomised, double-blinded, placebo-controlled trial with
14 spinal cord injury patients. Patients received either zinc sulphate 220mg, or a
placebo capsule, three times a day for two to three months.
Multinutrient supplementation, one trial
Ek (1991) performed a randomised, controlled trial of 501 patients newly admitted to
a long-term medical ward. Patients in the standard care group received the standard
hospital diet containing 2200 kcal/day. The intervention group received 200ml liquid
supplement, twice daily for the duration of their hospital stay or for 26 weeks,
whichever was the shorter. Each 100ml of the liquid supplement contained 4g protein,
4g fat, 11.8g carbohydrates, 419 kJ, and minerals and vitamins.

The included studies were small (average sample size was 33, with a range from 12
to 88 patients) and of poor methodological quality. None of the included studies
reported a power calculation.
Ascorbic acid (Vitamin C), two trials

The RCT by Taylor (1974) with 20 surgical patients was placebo-controlled, and
patients were allocated to the treatment groups according to their year of birth,
indicating that they were likely to be aware of the allocation. Patients were
comparable at baseline, and no dropouts were reported. Outcome assessors were
blinded to treatment.
ter Riet (1995) carried out a multi-centre RCT in 88 patients where investigators,
nursing staff, physiotherapists and patients were blinded as to treatment allocation
but allocation concealment was not described. They performed an intention-to-treat
and a per-protocol analysis.
Protein, one trial

Chernoff (1990) undertook a RCT with 12 patients. Follow up was for eight weeks.
They published no information about randomisation and allocation method, blinding,
baseline characteristics or follow up.
Zinc, two trials

The trial by Norris (1971) was a randomised crossover study, which was described as
double-blind but the method of allocation was not specified. Only three of 14 patients
(21%) completed the study after 24 weeks. Pressure ulcer volumes have been
measured in four-week intervals. No intention-to-treat analysis was given.
The trial by Brewer (1967) was a randomised, double-blinded, placebo-controlled trial,

although the methods of random allocation and blinding are not described. Thirteen of
the fourteen enrolled patients completed the trial after two to three months of
treatment. Pressure ulcer healing was described as complete, definite improvement
or no change, but the method of outcome assessment was not described.
Multinutrient supplementation, one trial

Ek (1991) was a randomised controlled trial but the method of allocation was not
specified. The numbers of patients who completed the treatment (to discharge or 26
weeks, whichever was shorter) was not stated. Methods of assessing pressure ulcer

healing were not reported but methods of assessing several other outcome
measures, such as serum protein analyses, anthropometry, skin testing, malnutrition
and the modified Norton Scale score, were reported in detail.
Results
The included trials were heterogeneous in terms of patients for example some
surgical, some critically ill, some residents in nursing homes and to interventions,
including, for example, type, application form, timing, dose and duration of nutritional
supplementation. Furthermore different primary outcomes have been evaluated in the
studies; therefore it was considered inappropriate to perform a meta-analysis.
Ascorbic acid (Vitamin C)

Taylor (1974): 20 people in surgical wards were followed up and data reported at one
month. In the group treated with ascorbic acid there was a statistically significant
mean reduction in pressure ulcer area of 84% (SE 7.60) after one month compared
with 42.7% (SE 7.41) in the placebo group WMD 41.30 (95% CI 34.72 to 47.88
p<0.005) (see Figure 27). Complete healing of pressure ulcers occurred in six
patients in the nutritional intervention group versus three patients in the placebo
group. Relative risk for healing with supplement was 2 (95% CI 0.68 to 5.85) (see
Figure 28). The mean healing rate was 2.47cm2/week in the intervention group
compared with 1.45cm2/week in the control group.
ter Riet (1995): The mean absolute healing rate in the intervention group (n=43) was
0.21cm2/week and 0.27cm2/week in the control group (n=45)(difference 0.06cm2/week; no standard deviations were reported).The mean volume reduction
was 0ml/week in the intervention group and 0.20ml/week in the control group
(difference -0.20ml/week). The mean clinical change where improvements i.e.
surface reduction, healing velocity, volume reduction were scored on a scale from 100 to +100% was 17.89%/week in the intervention group and 26.08%/week in the
control group (difference -8.19%/week).
ter Reit displayed the healing survival curves for both groups and there was no
difference in the hazard of healing. From Figure 28 the proportion healed at 84 days
was 17/43 in the treatment group and 22/45 in the control group (RR 0.81 95%CI 0.50
to 1.30 calculated by the reviewers).

Figure 27:
Figure 28:
Protein
Chernoff (1990): At the start of the study, pressure ulcers ranged in size from 1.6cm2
to 63.8cm2 in the high-protein group and from 1.0cm2 to 46.4cm2 in the very highprotein group. On both diets ulcer size decreased, but the improvement was greater
in the very high-protein group. None of the patients in the high-protein group and four
patients in the very high-protein group had complete healing of their ulcer. This gives
a relative risk of healing of 0.11 (95%CI 0.01 to 1.70) which is not statistically
significant (see Figure 29). The average decrease in ulcer size was 42% in the highprotein group compared with 73% in the very high-protein group.
Figure 29:

Zinc
Norris (1971): 14 patients treated with zinc sulphate had pressure ulcers with a mean
net change in volume of 10ml (SD 9ml), 14 patients receiving placebo had pressure
ulcers with a mean net change in volume of 6.0ml (SD 17.5ml), which is not
statistically significant (weighted mean difference (WMD 4.1ml; CI 95% -8.10 to
16.30; p=0.5).
Figure 30:
Brewer (1967): This early and small (n=14) trial reported no significant difference in
the rate of pressure ulcer healing in spinal cord injury patients treated with zinc
sulphate 220mg, three times a day for two to three months (one of six patients had
complete ulcer healing), compared with patients receiving placebo capsules (two of
seven patients).
Figure 31:

Multinutrient supplementation
Ek (1991): The total number of sores that developed in the experimental group was
67 and in the control group 83. This was from a total of 495 patients on whom data
was available (of the 501 patients randomised). However, it is not known how many
patients were in each treatment group. Of the 67 sores that developed in the
experimental group, 41.8% (28/67) healed completely compared with 30.3% (25) of
the 83 pressure sores in the control group. These results were reported as not
reaching statistical significance.
Figure 32:
Discussion
Studies of nutritional support/supplementation vary in terms of interventions, outcome
measurements and follow up. Interpretation of these findings should be made with
caution. Studies included too few patients and had a high drop-out rate. Furthermore,
follow-up time was found to be very short. Hence trials are not likely to detect the true
effects of the intervention. Some trialists reported that laboratory markers of
malnutrition improved during treatment but the clinical effects of protein, calories, and
vitamin or zinc supplementation on the healing of existing sores is unclear.
Ascorbic acid
The Taylor (1974) trial included a small number of participants (n=20). The method of
randomisation (by year of birth) is open to the researchers, and there is the potential
that people were recruited into the trial according to clinical judgment rather than truly
randomly. They found significant effects on the reduction of pressure sore area with
the intervention (500mg ascorbic acid twice daily up to 12 weeks for surgical patients)
but the clinical relevance of a reduction in area (rather than complete healing) is not
known.

In the trial by ter Riet (1995) most patients were based in nursing homes (n=88) and
had nutritional deficiencies on admission. The control group received 10mg ascorbic
acid, and the experimental group received 500mg. Patients in the control group had
better clinical outcomes at 12 weeks. This study used a reasonable control
intervention and a larger sample size, which would suggest that the effect of ascorbic
acid on the treatment of pressure ulcers seems to be at least unclear.
Protein
Chernoff (1990) had a small number of institutionalised tube-fed patients (n=12), and
the lack of information about randomisation and allocation method, blinding, baseline
characteristics and follow up contribute to the poor trial quality. They reported an
average decrease in ulcer size which was better in the very high-protein group (73%
vs. 42%). There is only weak evidence on the effect of very high-protein
supplementation rather than regular protein supplements for the treatment of
pressure ulcers in tube-fed patients.
Zinc
The RCT of Norris (1971) is limited by the small number of patients (n=14). Only three
patients completed the study after 12 weeks. They found no significant effects of zinc
for pressure ulcers, but the trial is far too small to detect clinically important effects as
statistically significant.
The trial by Brewer (1967) was also small (n=14) but had a good treatment
completion rate (13 of the 14 patients). Again, although not significant, differences
were not found in the effect of zinc on pressure ulcer healing. The small sample size
did not permit the detection of statistically significant or clinically important treatment
effects.
Multinutrient supplementation
The trial by Ek (1991) was poorly reported in terms of results by treatment group
allocation. It is not known how many of the 501 patients randomised were allocated to
each group, making an assessment of the effects of the treatment on either pressure
sore prevention or healing difficult. Many secondary analyses were reported,
including results on the patients state of malnourishment, functional level of activity,
mobility, food intake, albumin levels and other measures, but there were very limited
data on pressure ulcer healing rates.

Most treatment studies have short trial periods. Therefore, improvement or healing of
pressure ulcer wounds is unlikely to be detected.
Most patients in the studies described above seem to have laboratory defined and
confirmed nutritional deficiencies, which improved throughout treatment with
additional nutritional supplements. Whether this has an effect on clinically relevant
outcomes, such as pressure ulcer healing, remains unclear.
Evidence summaries
1++
There is no evidence to support the routine administration of

nutritional support/supplementation included in this review to
promote the healing of pressure ulcers.
1+
In patients who have detected deficiencies, supplementation

to correct the deficiency according to the daily
recommended amounts may be indicated following a
nutritional evaluation.
1++
The effect of corrective nutritional supplementation on

pressure ulcer healing remains unclear however.
Recommendations: nutritional support
Nutritional support should be given to patients with an identified nutritional
deficiency. [C]
Nutritional support/supplementation for the treatment of patients with pressure

ulcers should be based on: [D]
The link between correcting this deficiency and its causal relationship with pressure ulcer healing has not been
clearly established.

nutritional assessment (using a recognised tool, e.g. MUST Tool)
patient preference, and
expert input supporting decision-making (dietician or specialists).
Further research with larger numbers of patients and
sound methodology is required to procure evidence
on the impact of nutrition on pressure ulcers.
Consideration should be given to the constituents of
the supplement and method of administration, as
studies have reported low tolerance of nasogastric
tube feeding.

Surgery for the treatment of pressure ulcers
6.8
Surgery has been indicated for the treatment of pressure ulcers since the early part of
the 20th century. As early as 1950, in a review of 59 ischial pressure ulcers, surgery
was the method of treatment described, and an evaluation of complications and shortterm outcomes reported (Cannon et al., 1950).
Surgery may be indicated:
when conservative measures have failed to heal the pressure ulcer
to accelerate debridement to expedite spontaneous healing
to provide a quick by-pass to conservative measures for reasons of comfort,

economy or achievement of a superior repair, and
to achieve a more robust repair than could be achieved by conservative

treatment.
Identifying candidates for surgical interventions is based on a thorough assessment of

the individual including:
aetiology of the pressure ulcer
anatomical site, staging
infection status
any underlying medical condition
nutritional status
neurological status
psychosocial status, and
social factors.
(Foster et al., 1997; Margara et al., 2003).
Surgery is not usually indicated in patients who have grade 1 or 2 pressure ulcers
(apart from minor debridement). It is usually used as an intervention in those with
grade 3 or 4 pressure ulcers (Henderson, 2004).
The current surgical management of pressure ulcers broadly consists of
debridement, which can be superficial and may or may not include the removal of
bone tissue followed by flap coverage. There is a plethora of different techniques,
which have been described in the literature. Pressure ulcers can be surgically
debrided and left as an open wound to heal conservatively, surgically closed with or
without debridement, or repaired using a range of myocutaneous flaps or skin

grafting.
Types of surgery
Surgery can be subdivided into:
emergency (drainage or abscess)
urgent (debridement of necrotic eschar), or
elective (further debridement followed by closure).
Which techniques are currently considered to be the most effective is not clear. How
clinicians reach decisions about which technique to use is also not clear. Indications
about choice of technique from the available literature depends on the assessment of
the patient and the site of the ulcer (a flap which is specifically indicated for the area
involved and the ability of that chosen flap to be re-harvested if the ulcer reoccurs).
Methods of wound closure can be divided into:
direct closure of the wound margins
skin grafting
preservation of the walls of the ulcer to conserve tissue, followed by direct closure
or flap closure over this retained tissue, and
radical excision of the walls of the pressure ulcer followed by flap closure.
This review aims to consider the contribution of surgery in the treatment of pressure
ulcers and its effect on wound healing.
Clinical question
What is the evidence that surgery is effective in the treatment of pressure ulcers?
OBJECTIVES
The objective was to undertake a systematic review of the evidence of surgical

interventions for individuals with pressure ulcers to determine:
What are the surgical techniques and interventions used?
In which populations are these techniques and interventions used?

What are the safety implications?
What is the empirical evidence that surgery is effective in the management of

pressure ulcers?
Selection criteria
Types of studies
RCTs comparing surgery versus conservative treatment, surgical technique versus
surgical technique, surgery versus other interventions (that do not come under the
definition of conservative) for the treatment of pressure ulcers.
All: adults and children.
Types of outcome
Time to heal, time to wound closure, all objective healing measures. Mortality rates,
safety information, quality of life measures.
Search strategy
This involved searching a range of medical, nursing, psychological and grey literature
databases. All databases were searched from inception date and searches were not
limited by study design. The searches were limited to retrieve literature published in
English, and to omit animal studies and letters, comments and editorial publication
types.
Databases were searched in February 2004 and an update search was performed in
August 2004.
DATA ABSTRACTION

Papers were screened for relevance and study design. The methodological quality of
the papers was assessed using pre-defined principles as outlined in Appendix E.
Data were extracted by a single reviewer and the evidence tables compiled.
No RCTs were identified from the search strategy and so the decision was taken to
follow a narrative review with an open study design criteria. The body of evidence for
this review was found to be case series.
Case series and case reports consist either of collections of reports on the treatment
of individual patients, or of reports on a single patient. Case series and case reports
have limited or no use in a review of an effectiveness of an intervention. However
they have an important role in alerting to the potential rare harms or the benefits of an
effective treatment (Vandenbrouke, 2001).
Case series and case reports have no control group with which to compare outcomes
and therefore have no statistical validity.
Case series studies were assessed against eight quality variables to provide a guide
of the extent to which the findings or reporting of each study could be relied upon, and
to highlight any methodological flaws. The eight variables were:
case series collected in more than one centre (multi-centre study)
aims of case series clearly stated
case definition clearly reported
explicit statement that patients were recruited consecutively
prospective data collection
reporting of confidence intervals or other estimate of random variability
reporting of mortality/recurrences/complications, and
baseline data for ulcers.

Quality criteria for case reports and case series are not well established. This is an
adaptation of criteria used in other systematic reviews of case series (Vardulaki et al.,
2000) ).
Search results
530
N screened for relevance
53
following sift
N included
24
N excluded
11
Clinical evidence
anecdotal reports or fell outside the inclusion criterion for this review. Out of the
selected studies 11 were excluded, 24 included.
The majority of the included studies were case reports, case series and retrospective
chart reviews of variable quality.
Total study population for this review is 1,085 cases represented in both individual
case reports and case series. Case series number of participants ranged from two to
297. Less than 10 participants were included in this review. However a further 16
studies could have been excluded if this criterion was to have been used.
The reported locations of ulcers were:
sacral area
trochanteric area
ischial area

heel
malleollar, and
plantar.
The age range from reported studies was 5-83 years although not all studies reported
full demographic details. The grade or stage of ulcer was only described in five
studies (Aggarwal et al., 1996; Gusenoff, 2002; Higins et al., 2002; Margara et al.,
2002; Tizian et al., 1986) and a range of grading systems was used. Grades ranged
from grade 3 to 7 indicating that, despite the grade or staging system, it was the
higher grades that were indicated for surgical interventions. However surgical
intervention in lower grades cannot be ruled out due to the grading and staging
systems not adequately being described. Baseline data for ulcer size was only given
in seven studies (Aggarwal et al., 1996; Akan et al., 2001; Aydan et al., 2003; Benito;
Forster et al., 1997; Gusenoff, 2002; Higins et al., 2002; Hiroyuki et al., 1995; Little et
al., 1982; Margara et al., 2002; Tizian et al., 1986) either as a range, or largest and
smallest ulcer.
Follow-up period varied greatly from less than one month to 60 months.
Complications as a result of surgery were reported in 21 studies with rates of up to
60% reported on one study (Klien, 1988).
Reported complications were:
wound dehiscence
flap necrosis
wound infection
osteomyelitis
sepsis
seroma
muscle atrophy
blisters
suture sinuses
haematoma
abscess
recurrent ulcer
death
aspiration pneumonia
intraoperative myocardial infarction, and

deep venous thrombosis.
Generally co-interventions were poorly described in the included studies. Studies that
did report on co-interventions were Bocchi et al. (2004), Margara et al. (2002), Rubayi
(1999), Waiter et al. (1999), and Tizian et al. (1986).
Reported co-interventions were:
two-hourly position changes
water mattresses
air mattresses
vacuum-assisted closure
oral fluids 30ml/kg/24 hours
vitamins/minerals
no smoking
nutrition 30-35cal/kg/body weight
protein of 1-2g/kg/24 hours
physiotherapy
compliance interventions, and
sitting programme.
Conclusions
The lack of any randomised studies means that reporting on the effectiveness of
surgical interventions is not possible given the available evidence.
There is no evidence to indicate whether surgery is effective in the treatment of
pressure ulcers and consequently no evidence to indicate which technique is the
most effective in the treatment of pressure ulcers. However surgery is clearly
indicated as a treatment option. Its use is mainly indicated in those with spinal cord
injury, the elderly and in children, although the latter is less frequently reported.
Recurrence rates are variable in the limited evidence but reports indicate that they
can be as high as 50%.

Evidence summary
3
Surgical management of pressure ulcers should be based on an

overall assessment of the individual with everyone involved in the
patients care. With high reported recurrence rates, risk factors for
delayed healing and pressure ulcer development need to be
minimised.
No economic evaluations assessing surgical interventions for the

treatment of pressure ulcers were found.
Recommendations for this area of the guideline have been made using formal
consensus methods.
Recommendations: surgery
Referral for surgical interventions for patients with pressure ulcers should be
based on: [D]
level of risk (anaesthetic and surgical intervention; recurrence)
patient preference (lifestyle, abilities and comfort)
ulcer assessment
competing care needs
assessment of psychosocial factors for the risk of recurrence
practitioners experience
previous positive effect of surgical techniques, and
failure of previous conservative management interventions.

6.9
Topical negative pressure, electrotherapy and

electromagnetic therapy, and therapeutic ultrasound in
the treatment of pressure ulcers
The methods described in this review are those used to update the following systematic
review:
Cullum N, Nelson EA, Flemming K, Sheldon TA (2000) Systematic reviews of wound
care management: (5) beds; (6) compression; (7) laser therapy, therapeutic
ultrasound, electrotherapy and electromagnetic therapy. Health Technology
Assessment, 4(21).
The treatment of pressure ulcers can be broken down into four main areas:
local treatment of the wound using wound dressings and other topical
applications
pressure relief using beds, mattresses or cushions, and repositioning of the

patient
treatment of concurrent conditions which may be delaying healing for

example poor nutrition, infection, and
the use of adjunct therapies such as electrical stimulation, ultrasound, laser

therapy and negative pressure.
Adjunct therapies are being used increasingly to assist the

healing of pressure ulcers (Lyder, 2003; Hess, 2003), usually when
conventional therapy has failed to make significant improvements
in wound healing. The clinical and cost-effectiveness of many of
these treatments have not been rigorously assessed.

Description of adjunct therapies to be included in the review

Topical negative pressure
One way of manipulating the wound environment in order to promote healing is to
apply a topical negative pressure (TNP) (measured in mmHg) across the wound
surface via a dressing (Davydov, 1992; Davydov, 1994; Fleischmann, 1993;
Fleischmann, 1995; Argenta, 1997). The concept of negative pressure to create a
suction force, enabling the drainage of surgical wounds and the promotion of wound
healing is well documented (Fox, 1976; Fay, 1987). It has been suggested that if
excess fluid is not adequately removed from a wound following surgery, its
components may serve as both physical and chemical deterrents to wound healing
(Fay, 1987). The basic concept that mechanical forces influence the shape and
growth of tissues is also well documented (Ovington, 1999).
TNP is reported to do both, that is remove excess interstitial fluid, and transmit
mechanical forces to surrounding tissues with resultant deformation of the
extracellular matrix and cells (Morykwas, 1998). Both factors are thought to result in
increased wound healing through a variety of mechanisms (Banwell, 1999). The
transparent adhesive used to secure the dressing may also help maintain a moist
wound environment (Mendez-Eastman, 1998; Banwell, 1999).
There are a number of names to describe the treatment of a wound with TNP
including sub-atmospheric pressure therapy or dressing, vacuum sealing technique,
vacuum-assisted wound closure, vacuum-assisted closure, negative pressure therapy
or dressing, foam suction dressing, vacuum compression, vacuum pack, sealed
surface wound suction (Banwell, 1999; Banwell, 2003), or sealing aspirative therapy.
For the purposes of this review this intervention will be referred to as TNP.
TNP requires an open cell dressing (e.g. foam) to pack the wound, tubing to connect
the dressing to a suction pump via a cannister which collects any exudate, and an airtight seal around the dressing (Baxandall, 1997). All non-viable tissue is removed
beforehand (Argenta, 1997). TNP is generally viewed as contraindicated if the wound
or surrounding tissues are cancerous, if there are fistulas to organs or body cavities,
there is necrotic tissue, or if there is untreated osteomyelitis (Mendez-Eastman,
1998).
Laboratory evidence of the effectiveness of TNP on the wound environment has been
obtained from several animal studies (Morykwas, 1993; Morykwas, 1997; Fabian,

2000).
The use of TNP in chronic human wounds has been described by a number of
clinicians (Morykwas, 1995; Das Gupta, 1996; Argenta, 1997; Mullner, 1997; Banwell,
1998; Holmich, 1998; Genecov, 1998; Deva, 2000; Ladin, 2000; Lange, 2000 ;
Mooney, 2000; Wu, 2000; Thomas, 2001 ; Heath, 2002). The use of TNP for the inhome treatment of chronic wounds has been reviewed (Weinberg Group, 1999) by
referring to trials using non concurrent/historical control groups. This review examines
the impact of TNP on chronic human wounds by referring to trials where the patients
have been randomised to concurrent control groups. In 2001, a group of Canadian
wound care opinion leaders was convened (with the financial assistance of a TNP
support surface manufacturer) to assess the potential role of TNP in the treatment of
chronic wounds (Sibbald, 2003). They noted that there was a gap between the
evidence base and current practice with regard to this form of adjunct therapy.
Theraputic ultrasound
The mechanisms by which ultrasound may affect wound healing have been reviewed
by Dyson (1982). The cellular effects of ultrasound can be divided into thermal and
non-thermal (Dyson, 1982); the lower intensities used therapeutically mean that any
beneficial effects are likely to be due to non-thermal mechanisms (Dyson, 1987).
Non-thermal effects include the production of standing waves, acoustic streaming,
microstreaming and cavitation. Some of these effects may be beneficial while others
are potentially harmful; standing waves may cause the arrest of blood flow, while
cavitation may cause bubble formation within the blood stream (Dyson, 1987). Careful
choice of exposure time, intensity, and continuous movement of the ultrasound
applicator should minimise these effects. Therapeutic ultrasound has been evaluated
in a number of different regimens: varying pulse duration, power output and
frequency.
Electrotherapy and electromagnetic therapy
Electrical stimulation has been used for decades as a treatment for chronic wounds
(Hewitt, 1956) and is often applied by physical therapists. However, its role in
promoting pressure ulcer healing as an adjunct to or in the absence of other proven
therapies is unclear.
Research into the role of electricity in wound healing has been undertaken since at
least the 1940s (Burr, 1940). Experimental animal studies have shown that electrical
potentials over the wound during healing are initially positive, becoming negative after

the fourth day of healing (Weiss, 1990). It has been concluded that the proliferative
phase of healing is related to a negative electrical potential over the wound; however,
some studies have experimented with positive wound electrodes, and others by
reversing the electrode during healing. It is hypothesised that electrical stimulation
influences the migratory, proliferative and synthetic functions of fibroblasts, and also
results in increased expression of growth factors (Weiss, 1990). It seems likely that a
moist wound environment is essential to maintain endogenous or applied current flow.
There are several types of electric treatment modalities including: low-voltage direct
current (LVDC), high-voltage pulsed direct current (PDC), low-voltage alternating
current (LVAC) and pulsed electromagnetic field (PEMF) (Sheffet, 2000; Unger,
2000). All have different administration regimes and equipment required.
Electromagnetic therapy is distinct from most other forms of electrotherapy in that it is
a field effect, and not a direct electrical effect or a form of radiation. The terminology
Pulsed Electromagnetic Field (PEMF) is used to distinguish it from short-wave
diathermy, which uses either capacitance or induction to produce indirect heating of
tissues and can be thought of as a field effect (Stiller, 1992).
Objective
To systematically assess the evidence for the effectiveness of adjunct therapies in the
treatment of existing pressure ulcers.
Selection criteria
Types of studies
Only randomised controlled trials (RCTs) were included in this review. Studies that
did not employ true random allocation of participants to treatment groups, such as
quasi-experimental designs, were excluded. The units of allocation had to be patients
or lesions. Studies in which wards, clinics or physicians were the units of allocation
were excluded because of the possibility of non-comparability of standard care. Both
published and unpublished studies were included, with no restriction on date or
language.

hospital, clinic, community facilities, or home.
Trials in which an adjunct therapy or therapies were compared with a placebo, usual
care, or no treatment were eligible for inclusion in the review. All modes of
delivery/administration/dose for the named adjunct therapies were considered for the
review. It was anticipated that, where appropriate, similar regimens would be grouped
and subjected to sub-group analyses.
The primary outcome was wound healing. Since some measures of wound healing
can be subjective, studies had to incorporate at least one objective assessment
such as change in ulcer size, rate of healing, frequency of complete healing or time to
complete healing to be included in the review. Change in ulcer size may have been
presented as a percentage or absolute change over a period of time. Objective
methods of measuring changes on wound size included tracing the ulcer outline
followed by counting grids on graph paper, weighing uniform-density tracing paper,
planimetry or computerised image analysis.
A single standard outcome measure for wound healing does not exist. Both objective
and subjective measures are widely used by researchers, but little effort has been
made to determine the validity of many of these measurements. Comfort, ease of
application, ease of removal, exudate and handling are frequently-used measures of
dressing performance, but they are not validated outcomes on which to base
decisions of effectiveness. In this review the most commonly validated outcome
measures encountered were based on wound healing. The non-ambiguity of
complete healing, and its importance to clinicians and patients alike (because of its
potential impact on quality of life and burden of care), make it the preferred outcome
measure with which to compare studies of clinical effectiveness.
Objective measures of healing are usually based on wound area. Planimetry, often
aided by computer analysis, is the most frequently used method of calculating wound
area, though other methods, such as the measurement of wound diameter or weight
of a tracing drawn around the area of the wound, are also used. Measurements of

wound volume are infrequently reported in the literature; these methods are often
cumbersome and their accuracy has not been proven. Computerised image analysis
may in the future, as the equipment becomes more affordable and portable, prove to
be a useful technique for the assessment of wound volume.
Even though objective measures reduce or eliminate subjective biases and reduce
random measurement errors, they have certain inherent biases if the patients being
compared have wounds with different baseline size. A change in wound area is often
linear rate (as measured by diameter reduction) percentage area calculations will
show a larger change for a small wound than for a big wound. The converse is true
when the absolute change in area is measured, as for any unit reduction in wound
radius, a bigger area reduction will occur for a large wound.
possible to determine the direction of bias and the validity of the results cannot be
determined. Despite the potential for objective outcomes to be biased by differences
in wound size at baseline, they remain the most reliable assessment of wound
healing as, unlike subjective measures, they reduce the biases of the assessor which
cannot be estimated.
Secondary outcomes such as costs, quality of life, pain and acceptability of the
adjunct therapy were assessed where possible.
Search strategy

Clinical effectiveness searching
Searches were undertaken to update the following Cochrane review:
Cullum N, Nelson EA, Flemming K, Sheldon TA (2000) Systematic reviews of wound
care management: (5) beds; (6) compression; (7) laser therapy, therapeutic
ultrasound, electrotherapy and electromagnetic therapy. Health Technology
Assessment,4(21).
Searches were limited by study design to retrieve randomised controlled trials.
Searches were also limited to retrieve literature published in English, and to omit
animal studies and letters, comments and editorial publication types.
Databases were searched in February 2004 and update searches were carried out in
June 2004:
Description of included studies

Ten eligible randomised trials were identified for inclusion in the review. One trial
(Joseph, 2000) assessed the effect of topical negative pressure on a variety of
chronic wounds including pressure ulcers. Three RCTs examined the effect of
therapeutic ultrasound in the treatment of pressure ulcers (McDiarmid, 1985; ter Riet,
1995; Nussbaum, 1994). Four trials compared electrotherapy to sham therapy for the
treatment of pressure ulcers (Gentzkow, 1991; Griffin, 1991; Wood, 1993; Ritz, 2002).
A further two trials assessed the effect of electromagnetic therapy for the treatment of
pressure ulcers (Comorosan, 1993 ; Salzburg, 1995).
Included studies for topical negative pressure

Joseph and colleagues (2000) assessed 24 patients with 36 chronic wounds
(resulting from pressure, wound dehiscence, trauma, venous stasis or radiation),
defined as present for greater than one month, in a randomised parallel group study.
Eighteen wounds received TNP (open cell foam dressing with continuous suction
(125 mmHg) changed every 48 hours. Eighteen wounds received normal saline wetto-moist gauze dressings (with an occlusive dressing used to secure the gauze)
changed three times a day. If patients had multiple wounds, it appears that the

individual wounds were treated during randomisation and data analysis as if they
were independent from each other.
At three and six weeks the percent change in wound volume was measured by
volume displacement of alginate impression moulds. Additional outcome measures
were given by Joseph, such as histology and culture, but they did not fulfil the
selection criteria of this review. The trial used a commercially available therapy unit
and integral dressing (VAC Therapy, KCI, OXON, UK) to apply the negative pressure.
A total of twenty-one studies reporting the effects of TNP on pressure ulcer healing
were excluded from the review (see Table of Excluded Studies, Appendix D). The
main reason for exclusion was that they were not RCTs. Patients were either not
randomly allocated to the two concurrent treatment groups, or the control group was
non concurrent/historical, or, as in the majority of studies, there was no control or
comparison group at all. Some of the studies were prospective RCTs, but on animals
not humans, and some assessed the effect of TNP on types of chronic wounds other
than pressure ulcers. Those prospective RCTs on humans were reporting the effects
of TNP on acute wounds.
A further seven studies are still awaiting assessment. This is mainly due to publication
as abstracts only without a subsequent full publication, and thus insufficient
information to assess inclusion criteria or to extract results data, or the primary paper
is yet to be sourced and assessed for inclusion. The citations and reasons for not yet
being assessed are detailed in the Table of Studies Awaiting Assessment
Included studies for therapeutic ultrasound
Three RCTs were identified that examined the effectiveness of ultrasound treatment
in the healing of pressure ulcers. The studies all contained small numbers of patients
with group sizes varying from 20 patients in three arms to 88 patients in two arms.
Two trials (McDiarmid, 1985; ter Riet, 1995) compared ultrasound therapy delivered
at approximately 3MHz to sham therapy. A third (Nussbaum, 1994) compared a
combination of ultrasound and ultraviolet with laser treatment (820nm laser diode)
with standard wound care. McDiarmid (1985) and Nussbaum (1994) studied patients
with superficial pressure ulcers. ter Riet (1995) studied patients with stage 2 pressure
ulcers (partial skin thickness or worse).
The first of these studies (McDiarmid, 1985) compared 3MHz of ultrasound with sham
treatment for patients with pressure ulcers. Treatment was for a minimum of five

minutes (timing dependent on wound size), three times per week. The duration of
follow up for the study was unclear.
ter Riet (1995) randomised 88 nursing home patients with pressure ulcers to receive
either ultrasound or sham treatment five times a week over a 12-week period. The
ultrasound was at a frequency of 3.28MHz with a pulse duration of 2ms.
Nussbaum (1994) compared a combination of ultrasound and ultraviolet treatment
(given alternately for five days a week) with laser treatment (820nm laser diode), and
with standard wound care twice daily (cleansing with 0.05% chlorine solution, paraffin
tulle dressing and pressure relief). Treatment continued until healing occurred.
Two trials were excluded from the review as they were not RCTs (see Table of
Excluded Studies, Appendix D).
Included studies for electrotherapy and electromagnetic therapy

Four trials comparing electrotherapy to sham therapy for the treatment of pressure
ulcers were suitable for inclusion in this review (Gentzkow, 1991; Griffin, 1991; Wood,
1993; Ritz, 2002). These four studies contained a total of 137 patients.
The first of these RCTs (Gentzkow, 1991) recruited both hospital and community
patients with stage 2, 3 or 4 pressure ulcers who were randomised to receive either
electrical stimulation twice daily for four weeks or sham stimulation. Patients with
more than one pressure ulcer could have all ulcers randomised into the study. Both
groups received standard treatment of cleansing with normal saline, a wound
dressing (type not stated), and turning to relieve pressure on the affected area in
addition to the electrotherapy or sham electrotherapy. The grading of ulcers was
described by the authors as stage 2: full thickness skin defect to subcutaneous tissue;
stage 3 to muscle; stage 4 to bone/joint.
The second study (Griffin, 1991) examined 17 male patients with spinal cord injury
and a pressure ulcer graded between 2 and 4 on the Delisa system. Participants were
randomised to receive electrotherapy and standard treatment or sham therapy plus
standard treatment. The standard treatment consisted of wound cleansing and
dressing pressure ulcers were cleansed using Cara-Klenz application of Carrington
gel (dermal wound cleanser) and dressed using a dry dressing. Mechanical
debridement was as necessary. There was no change of mattress for any patient
during the study.

The third study (Wood, 1993) compared electrotherapy with sham therapy for the
treatment of chronic stage 2 or 3 pressure ulcers which had shown no improvement
with standard nursing care over the proceeding five weeks. Both groups received
standard treatment of wound cleansing, simple moist dressings and whirlpool baths.
No hydrocolloids, films or foam dressings were used. There was no description of the
system for grading pressure ulcers in the study.
The final study (Ritz, 2002) compared the Provant wound closure system (which uses
radiofrequency stimuli to induce fibroblast and epithelial cell proliferation) twice daily
with sham treatment in high-risk patients with grade 2 to 4 pressure ulcers. This
treatment was in addition to standard care. Patients treated with concurrent adjunct
therapy support surfaces e.g. hyperbaric oxygenation, electrical stimulation were
excluded.
Two studies of electromagnetic therapy for the treatment of pressure ulcers were
included in the review (Comorosan, 1993; Salzburg, 1995). These two studies
contained a total of 60 patients. The first study (Comorosan, 1993) was a three-arm
study comparing electromagnetic therapy, a combination of sham electromagnetic
therapy and standard therapy, and standard therapy alone, over a two-week
treatment and follow-up period. Treatment was given for 30 minutes, twice a day. The
participants were all patients in an elderly care unit with grade 2 or 3 pressure ulcers.
The grading system for the ulcers was not described.
The second study (Salzburg, 1995) compared electromagnetic therapy with sham
electromagnetic therapy over a 12-week period. The patients included in the study
were all male hospital inpatients with a spinal cord injury. This study also gave
treatment for 30 minutes twice a day, although the electromagnetic therapy regimen
differed from the Comorosan study.
The pressure ulcers were graded as 2 or 3 with an even distribution of each between
the groups. A clear definition of the grading of the ulcers was provided by the authors.
Grade 2 ulcers were defined as partial-thickness skin loss involving epidermis or
dermis, superficial, and clinically presenting as a deep crater, abrasion, blister or
shallow crater. Stage 3 was defined as full-thickness skin loss involving damage or
necrosis of subcutaneous tissue extending down to, but not through, underlying
fascia, clinically presenting as a deep crater with or without undermining of adjacent
tissue.

Two trials that assessed either electrotherapy or electromagnetic therapy were
excluded from the review as they were not RCTs (see Table of Excluded Studies,
Appendix D)

Details of the quality assessment of each study are outlined in the Table of Included
Studies (Appendix, A). The key components of quality that were assessed included a
priori sample size calculations, allocation concealment, masking of outcome
assessment and reporting of withdrawals by treatment group. Quality was not used to
weight the studies in the analysis using any statistical technique; however
methodological quality was drawn upon in the narrative interpretation of the results.
Methodological quality of included topical negative pressure studies

In Joseph (2000), of the 24 patients recruited to the study, 12 patients had multiple
wounds resulting in a total of 36 wounds. It is not clear how many patients in each
arm of the study had multiple wounds and if these patients were evenly distributed
across groups. This could potentially impact on baseline comparability of groups.
Baseline comparability was reported for age, sex, initial wound volume, ethnicity,
smoking status and wound duration. Each wound was randomised to either TNP or
saline gauze dressings. Of the 12 patients with multiple wounds, three patients were
randomised to both therapies.
It is inappropriate to randomise and analyse multiple wounds as if they were
independent from each other unless using a within subjects design. The preferable
way of dealing with multiple wounds using a between patients design is to have a
single reference wound. Random assignment of wounds to treatments was achieved
using files, marked with silver or black labels on the inside panel that were randomly
organised in a locked cabinet. It is not clear if these files were sealed so the
adequacy of allocation concealment is unclear.
Neither the patient nor the providers were blind to the treatment used. The outcome
assessors were blinded as they were not involved in the daily care of the study
patients and they only assessed the wounds once the dressings had been removed.
Appropriate outcome measures were used, for example percent change in wound
volume over time, but also extraneous ones which would be reflected in the change in
volume. The authors stated that follow up beyond the six-week study period
continued until complete wound closure was shown for each patient but unfortunately

this time to complete healing data was not reported. It was not reported if there were
any withdrawals. It is unclear whether intention-to-treat analysis was performed.
Methodological quality of included therapeutic ultrasound studies

None of the three included trials that assessed therapeutic ultrasound (McDiarmid,
1985; Nussbaum, 1994; ter Riet, 1995) included information on the method of
randomisation although ter Riet (1995) stated that the method of allocation was
concealed that is the person randomising the patient to the trial was unaware of
which group they would enter before randomisation. The two trials that evaluated only
ultrasound (McDiarmid, 1985; ter Riet, 1995) attempted to mask the patients to which
group they were in by using a sham therapy group. All three trials used blinded
outcome assessment. None of the trials used intention-to-treat analysis. Concurrent
interventions, such as support surfaces, were described in two of the three studies
(ter Riet, 1995; Nussbaum, 1994).
Methodological quality of included electrotherapy and electromagnetic therapy

studies
It was difficult to extract some of the details on methodological quality due to poor
reporting in the five studies that assessed either electrotherapy or electromagnetic
therapy (Comoroson, 1993; Salzberg, 1995). Attempts to contact the authors for
clarification were unsuccessful.
None of the studies that assessed electrotherapy (Gentzkow, 1991; Griffin, 1991;
Wood, 1993; Ritz, 2002) provided information about the method of randomisation
used for their trials, and none incorporated an intention-to-treat analysis. However all
four studies did provide information about the baseline features of the pressure ulcer
area which enables more accurate interpretation of the results. While all three studies
reported the type of wound dressing used during the trials, none reported other
concurrent interventions such as support surfaces (beds, mattresses and cushions)
used.
Neither study that assessed electromagnetic therapy (Comoroson, 1993; Salzberg,
1995) stated the method of randomisation, nor conducted an intention-to-treat
analysis. Both studies however used blinded outcome assessment. While both
studies reported the types of wound dressings used during the study, neither reported
other concurrent interventions such as support surfaces (bed, mattresses and
cushions) used. The study by Comorosan (1993) did not provide information on the

strategies used for randomisation and so there is no rationale as to why the three
arms in the study contain an uneven distribution of patients.
Results
Results for topical negative pressure studies
Synthesis of results using statistical pooling methods was not appropriate, as only
one trial fulfilled the selection criteria.
Joseph (2000) reported a significantly greater reduction in wound volume (expressed
as a percentage of the initial volume at six weeks) in favour of TNP dressings when
compared with standard wet-to-moist saline gauze dressings (78% vs 30% p=0.038).
It was not clear whether mean or median values were provided. No standard
deviations, ranges or confidence intervals were provided. The trialists stated that
follow up beyond the six-week study period continued until complete wound closure
and that all patients were offered operative wound closure for any remaining open
wounds. Unfortunately these time-to-healing data were not reported. Adverse
outcomes were three out of eighteen wounds with TNP had osteomyelitis and/or
calcaneal fractures. Two of the patients suffered calcaneal fractures while ambulating
on the TNP dressing, which Joseph (2000) states is against the manufacturer's
recommendations and medical advice. Both patients eventually required amputation.
Eight out of eighteen wounds with control dressing had osteomyelitis, other wound
infections or fistulas (p=0.0028).
There were no RCTs evaluating the effectiveness of TNP on cost, quality of life, pain
or comfort and there were no RCTs evaluating the effectiveness of different TNP
regimens.
Results for therapeutic ultrasound studies

Two trials compared therapeutic ultrasound with sham ultrasound (McDiarmid, 1985;
ter Riet, 1995). The third trial compared a combination of ultrasound and ultraviolet
light with laser therapy and standard treatment (Nussbaum, 1999).
Ultrasound therapy versus sham therapy

McDiarmid (1985): 10/21 (48%) pressure ulcers healed in the ultrasound group
compared with 8/19 (42%) in the sham group (RR 1.13, 95% CI 0.57, 2.26).
Treatment was delivered three times a week for an unspecified period of time.

ter Riet (1995): 18/45 (40%) of pressure ulcers healed in the intervention group
compared with 19/43 (44%) in the control group (RR 0.91, 95% CI 0.55, 1.48).
Treatment was given five times a week for 12 weeks or until healing had occurred.
The trials by McDiarmid (1985) and ter Riet (1995) were considered sufficiently similar
to pool (chi-squared = 0.26, I2=0%), giving a pooled relative risk of 0.97 (95% CI 0.65,
1.45; p=0.89). Thus two studies involving only 128 patients in total found no evidence
of a benefit of ultrasound on the healing rates of pressure ulcers (see Figure 33).
Figure 33:
Ultrasound and ultraviolet therapy versus laser therapy versus standard

treatment
Ultrasound combined with ultraviolet (UV) therapy was compared with laser alone and
standard therapy in 20 patients with spinal cord injury and pressure ulcers up to 1cm
in depth (Nussbaum, 1994). Groups were broadly similar in terms of area and depth
of ulcers. Four patients dropped out leaving 16 patients with 18 wounds. After 12
weeks all ulcers (6/6) had healed in the combined ultrasound/ultraviolet treatment
group. In the laser treatment group 4/6 (66%) ulcers healed, and in the standard
wound care group 5/6 (83%) ulcers healed. There was no statistically significant
difference between the groups due to the extremely small sample size, and the
consequent lack of power, as shown below:
ultrasound/UV therapy versus laser therapy: RR 1.5,95% CI 0.85, 2.64
ultrasound/UV therapy versus standard treatment: RR 1.2, 95% CI 0.84, 1.72
laser therapy versus standard therapy: RR 0.8, 95% CI 0.41, 1.56
No secondary outcome measures, including costs, quality of life, pain and

acceptability, were measured in any of the RCTs included.

Results for electrotherapy and electromagnetic therapy studies
Electrotherapy versus sham electrotherapy

Four trials compared electrotherapy with sham electrotherapy.
Gentzkow (1991): After four weeks there was a mean percentage ulcer healing of
49.8% (SD 30.9) in the electrotherapy group and a 23.4% (SD 47.4) mean
percentage ulcer healing in the sham group (p=0.042). The baseline ulcer areas given
demonstrated larger ulcers in the intervention group. Thus the result is against the
direction of bias, as the outcome of percentage healing favoured the control group.
Griffin (1991): 3/8 (37.5%) ulcers healed in the electrotherapy group compared with
2/9 (22%) in the control group (RR 1.69, 95% CI 0.37-7.67).
Wood (1993): 25/43 (58%) of electrotherapy group ulcers healed, compared to only
1/31 (3%) in the sham therapy group (RR 18.02, 95% CI 2.58-126.01). As the ulcers
were larger at baseline in the intervention group, this result is against the direction of
bias.
Ritz (2002): 4/8 (50%) ulcers in the electrotherapy group healed completely,
compared with only 1/7 (14%) in the sham therapy group (RR 3.50, 95% CI 0.50,
24.41). This was a very small, industry-sponsored study.
Three studies had outcomes on the numbers of ulcers healed and were considered
sufficiently similar to pool (Griffin, 1991; Wood, 1993; Ritz 2002) (Chi-square 4.69,
I2=57%). This resulted in a pooled relative risk of 4.41 (95% CI 0.9-21.35; p=0.07)
(see Figure 34). This shows no evidence of improved healing of pressure ulcers
treated with electrotherapy compared with sham therapy. Again, however, as this
result is drawn from three small studies with a total of 106 patients, the results should
be interpreted with caution.
Figure 34:

Electromagnetic therapy versus sham therapy

Two trials compared electromagnetic therapy with sham therapy, although the trial by
Comorosan included a third arm in which only standard therapy was applied.
Comorosan (1993): 17/20 (85%) ulcers healed in the electromagnetic therapy group
within two weeks compared with no ulcers healing in either of the other two groups
(0/5 and 0/5) (RR 10, 95% CI 0.7-143.7).
Salzburg (1995): For grade 3 pressure ulcers, 3/5 (60%) healed in the
electromagnetic therapy group compared with no ulcers healing in the sham
electrotherapy group (0/5) at 12 weeks (RR 7, 95% CI 0.45-108.26). For grade 2
pressure ulcers, there was a median of 84% healing in the electromagnetic therapy
group at one week compared with 40% in the sham therapy group (p=0.01). Groups
could not be combined due to the different timings and outcome measures between
the grade 2 and grade 3 pressure ulcers.
Secondary outcome measures, such as financial costs, quality of life, pain and
acceptability, were not measured in either of the RCTs included.
Discussion
Quality of the included studies
Quality assessment suggests that methodological flaws are an issue affecting the
validity of most studies in chronic wound care. In general, the studies were too small
to ensure that wounds of different sizes (and other prognostic variables) were evenly
distributed across trial arms, resulting in a bias at baseline in most trials. The majority
of studies also had a short follow-up and did not analyse the data by survival analysis,
which would account for both whether and when a wound healed and which would be
a more efficient method for estimating the rate of healing.
If future trials perpetuate many of the methodological flaws highlighted in this review,
they are unlikely to provide the evidence needed to determine an effective wound
management strategy. The variability between wounds at baseline for prognostic
variables, including size, indicates that recruitment numbers need to be large and that
trials should probably be multi-centred. If small single-centred trials are to be

continued they could be improved by the use of matched or stratified randomisation to
ensure a similar distribution of wound sizes between treatment groups at baseline,
and the data should be analysed by matched pairs analysis where appropriate.
However, even with this improved design a trial still needs to be large enough to
ensure comparability for both unknown and known confounding factors.
It is important to ensure, when conducting an RCT, that systematic differences in
comparison groups (selection bias), care provided apart from the intervention being
evaluated (performance bias), outcome assessment (detection bias), and withdrawals
from the trial (attrition bias) are avoided (or made explicit) (Clarke, 2003). The logical
basis for this being that any differences in group outcomes could be due to these
systematic differences. Differences in group outcomes could then be wrongly
attributed to the intervention being evaluated.
Selection bias can be eliminated by assembling comparison groups in such a way
that the process is impervious to any subconscious influence by the individuals
making the allocation. This is most securely achieved if an assignment schedule
generated using true randomisation is concealed. Allocation concealment can always
be implemented (Clarke, 2003). Performance and detection biases can occur if there
are unintended differences in the way the treatment and placebo groups are treated,
either while receiving the intervention or being assessed at follow up. The best way to
avoid these potential biases is for those providing and receiving care, and those
undertaking the outcome assessments, to be blinded so that they do not know the
group to which the recipients of care have been allocated (Clarke, 2003). There is
limited empirical evidence of a relationship between parameters thought to measure
validity and actual trial outcomes. More research is needed to establish which criteria
for assessing validity are important determinants of study results and when (Clarke,
2003).
When critically appraising the validity of the studies, the reviewers had to rely on
adequate reporting of the trials. Assuming that if something was not reported it was
not done is not necessarily correct. The reviewers relied on the good will of experts in
the field to provide information on completed, or ongoing, published or unpublished
studies.
The reviewers did attempt to obtain additional clarifying data from investigators;
however no response was received.

The alternative to withholding treatment from a patient is to employ a placebo. In
wound care trials such placebo treatments are unlikely to be inert, as the application
of the placebo or vehicle is likely to change the local environment of the wound,
thereby modifying the biological processes associated with healing. A placebo is
therefore not a substitute for withholding treatment in studies to determine the
rationale for active treatment. The possible interaction between the vehicle and the
healing process, together with small sample size, may provide some explanation for
why so few of the trials included in this review showed a statistically significant
difference between an active treatment and a placebo.
Generally, the methodological quality and sample size of the trials included in this
review was only fair. Very few trials reported their methods of randomisation or
allocation concealment, and few calculated a priori sample size estimates. However,
several studies used sham therapy in order to maintain blinding of treatment
allocation to the patients, clinicians and outcomes assessors.
Topical negative pressure as an adjunct treatment for pressure ulcers

In the study by Joseph (Joseph 2000) the assignment schedule appeared to be
generated using true randomisation but the adequacy of allocation concealment was
unclear, hence risking selection bias. The study was also at risk of performance bias
as the experimental group received TNP delivered via a foam dressing whereas the
control groups had saline gauze dressings so it was impossible to blind those
providing and receiving care. However, outcome assessors were blind on treatment
allocation thereby reducing the risk of detection bias. It is uncertain whether the
Joseph (2000) study was at risk of attrition bias. In this study it was not clear whether
intention-to-treat analysis was used, if exclusions were made, and, if they were, the
reasons for these (protocol deviations, withdrawals, dropouts and losses to follow up).
Due to the poor reporting of this study, precise effects measures cannot be
calculated. This, coupled with the small sample size and methodological flaws, means
that this trial does not provide any evidence of benefit on the use of topical negative
pressure as an adjunct therapy for pressure ulcer treatment. Further controlled trials
are needed to address this question.
Therapeutic ultrasound as an adjunct treatment for pressure ulcers

The results of the two included trials in this review (McDiarmid, 1985; ter Riet, 1995)
do not suggest a benefit associated with therapeutic ultrasound in the healing of

pressure ulcers. Again however, as the numbers of randomised patients are small
and methodological quality relatively poor, the results should be viewed with caution.
Further randomised trials are warranted.
Electrotherapy or electromagnetic therapy as an adjunct treatment for pressure

ulcers
The four trials identified that assessed these interventions (Getzkow, 1991; Griffin,
1991; Wood, 1993; Ritz, 2002) all suggested a trend toward benefit associated with
using electrotherapy to treat pressure ulcers. However this suggestion is drawn from
a total of only 186 patients.
The three studies whose results were pooled (Griffin, 1991; Wood, 1993; Ritz, 2002)
all had unmatched groups for ulcer size at baseline. Griffin (1991) had larger ulcers in
the control group. The result (RR 1.69, 95% CI 0.37-7.67), while not statistically
significant, favours electrotherapy, and is therefore with the direction of bias. There
were only small numbers of patients in each group in this study.
Wood (1993) included patients whose ulcers were larger in the intervention group.
The result of this study (RR 18.02, 95% CI 2.58-126.01) is statistically significant
while being against the direction of bias. Overall, there was no evidence of a
statistically significant benefit in pressure ulcer healing with the use of electrotherapy.
The extent to which electrotherapy contributes to healing in patients who are
otherwise receiving pressure relief and moist wound-healing strategies needs to be
explored further using rigorous methodology.
While the two trials (Comorosan, 1993; Salzburg, 1995) that assessed the effect of
electromagnetic therapy are both suggest a benefit for the healing of pressure ulcers,
neither reaches statistical significance and the evidence is rather unreliable. Both
trials contained small numbers of patients, and had differing regimens of treatment
over varying time scales. The extent to which electromagnetic therapy contributes to
healing in patients who are otherwise receiving pressure relief and moist woundhealing strategies should be explored further. The trials do not adequately report the
severity of pressure ulcers and baseline comparisons. As such the results should be
viewed as unreliable and further research is needed involving larger numbers of
patients.

6.9.1
Cost-effectiveness of adjunct therapies (topical negative
pressure, therapeutic ultrasound, electrotherapy and

electromagnetic therapy)
One full economic evaluation and one partial economic evaluation of adjunct
therapies were identified for review (Macario et al., 2002; Philbeck et al., 1999
respectively).
Macario et al. (2002) conducted a cost-utility analysis comparing noncontact
normothermic wound therapy to current standard care (see data extraction table 22,
Appendix A). The study was conducted in a long-term care institution in the US. The
authors reported that the perspective of the analysis was societal. The analysis
included societal-based utilities, however the costing was undertaken from the
perspective of the health care payer (see data extraction table 22, Appendix A). The
study was based on a decision-analytic model. The base case analysis involved a
hypothetical 72-year-old patient with a two-month old, ischial grade 3 pressure ulcer
who was living in a nursing home. The secondary analysis involved a grade 4
pressure ulcer. Monte Carlo simulation was undertaken to resample from the data to
estimate results for 10,000 hypothetical patients.
Data to populate the model were obtained from national statistics, the literature and
author opinion. A Markov model was used which comprised of six mutually exclusive
health states including: (i) grade 3 pressure ulcer, (ii) grade 4 pressure ulcer, (iii)
healing wound, (iv) closed wound healed back to normal, (v) complications requiring
hospitalisation, and (vi) death. Patient progression through the model was divided into
eight-week cycles over 40 months.
Utility estimates were based on author assumption, informed by the literature. The
quality of life of a patient with a pressure ulcer was determined by assigning levels of
disability and distress to each health state. The authors used the Rosser-Kind index,
which includes disability and distress dimensions to attach utilities to each of the six
health states (above). The change in utility attached to patients health status as they
progressed through the model was combined with life expectancy to calculate QALY
estimates. The resources measured and costed included nurse and doctor time, use
of supplies and equipment, and the cost of complications.

Over the 40-month timeframe, it was estimated that for grade 3 pressure ulcers 0.10
(SEvii = 0.0005) QALYs were gained per patient using noncontact normothermic
wound therapy over current standard care. For grade 4 pressure ulcers the gain in
QALYs was 0.14 (SE = 0.0010) per patient. In terms of costs, for grade 3 pressure
ulcers it was estimated that noncontact normothermic wound therapy cost $6,3340
(SE = $98) (price year 2000) less than current standard care and for grade 4 pressure
ulcers the cost was estimated to be $15,216 (SE = $186) less. Thus noncontact
normothermic wound therapy was identified as the dominant strategy in treating
grade 3 and 4 pressure ulcers.
Probabilistic sensitivity analysis was undertaken to test the robustness of the results
by simultaneously considering uncertainty associated with all probabilities, utilities
and costs included in the model. Results were most sensitive to the following model
inputs: daily treatment costs and the probability of healing to a normal closed wound
with standard care; the cost of the complication state; and the acquisition cost of
noncontact normothermic wound therapy. If the cost of the latter increased to $421 its
use increased overall costs. The Monte Carlo simulations showed that noncontact
normothermic wound therapy is likely to reduce costs and increase quality of life for at
least 75% (SE=0.4%) of patients with stage 3 pressure ulcers and to reduce costs by
around 81% (SE=0.4%) for patients with stage 4 pressure ulcers.
These results should be considered in the light of a number of assumptions that
underpin the Macario et al. (2002) model. As the authors mention, their assumption
that transition probabilities remain constant over time may be questioned. For
instance, in practice the probability of healing after the first eight-week cycle may not
be equal to the probability of healing after the fourth eight-week cycle. Utilities were
attached to health states indirectly, that is the patients themselves did not value
health states as this data was not available. The model assumed that reduction in
wound size directly improved the probability of wound healing. Data to populate the
model was obtained from numerous sources, based on controlled and randomised
trials. There was much variability due to differences in the delivery of care across
settings (standard care varies in particular), confounding comorbidities, variability in
types, sizes and locations of pressure ulcers.
Philbeck et al. (1999) conducted a cost-consequence analysis comparing negative
pressure wound therapy (TNP) to saline-soaked gauze dressing applied to patients
vii
SE = Standard Error. This statistic indicates the degree of uncertainty in calculating an

estimate from a sample

placed on either a low air loss mattress or a foam mattress bed for grade 3 or 4
pressure ulcers (see data extraction table 23, Appendix A). The analysis was
conducted from the perspective of the health care payer although this was not stated.
For the negative pressure wound therapy group a Medicare observational dataset
was used which covered a 180-day follow-up period. For the comparator, data from
the Ferrell et al. study (1993) were used (see Appendix A data extraction table 25,
which presents an economic evaluation by Ferrell et al. ((1995)) which was also
based on this trial). The study was excluded from the clinical effectiveness review
because it was based on retrospective, observational data for the negative pressure
wound therapy and a historical control (Ferrell et al., 1993) for the comparator.
Effectiveness measures from both studies included healing rates as a reduction in
wound area and volume over 30 days, and time to heal. The reduction in cm2 per day
of the wound was faster for negative pressure wound therapy at 0.230cm2 per day
compared to 0.090cm2 for the comparator. Time to heal, based on wound healing
rates, was expected to be 97 days for negative pressure wound therapy compared to
247 days for the comparator. The total cost of negative pressure wound therapy per
day, including the cost of materials and nursing visits was $149.96 versus $95.00 (the
price year was not stated). However, due to a faster expected healing rate, the
expected total cost to complete heal was lower on average for each patient in the
negative pressure wound therapy group ($14,546 versus $23,465).
It appears that negative pressure wound therapy dominates saline-soaked gauze
dressings applied to patients placed on either a low air loss mattress or a foam
mattress bed for grade 3 or 4 pressure ulcers. However, there are a number of
substantial limitations associated with the study that cast doubts on the validity and
reliability of the results. While the authors aimed to closely match patients from either
study, the potential variability and uncertainty introduced into the study as a result of
the study design was not explored. The authors state that the Medicare dataset did
not contain data on the duration of previous interventions, medical history and
laboratory values relevant to wound healing, and the homogeneity of the patients
across the two groups, apart from the treatment received, is questionable. The initial
surface area of the wounds was very different (22.2cm2 versus 4.3cm2 for the
negative pressure and comparator treatments respectively). However this may be
expected to favour the latter.

Overview of adjunct therapies
Research evidence
1-
Topical negative pressure treatment was only assessed in one

trial with a small sample size and methodological limitations.
While the trial results suggested that topical negative pressure
treatment may increase healing rates of pressure ulcers
compared with saline gauze dressings, the findings must be
viewed with extreme caution. Practitioners ought to make
patients aware of the limited trial-based evidence for the
effectiveness of topical negative pressure for pressure ulcer
healing and that further research is required to validate the
preliminary findings.
1+
There is no evidence of a benefit of using ultrasound therapy in

the treatment of pressure ulcers. The possibility of a beneficial or
a harmful effect cannot be ruled out, however, due to the small
number of trials with methodological limitations and small
numbers of participants.
1+
The meta-analysis of the results of three trials which assessed

the effect of electrotherapy on pressure ulcer healing showed no
evidence of benefit for this treatment. However this suggestion is
drawn from three studies with a total of only 137 patients.
Therefore the results should be viewed with caution as it is
difficult to determine clinically important effects from such small
samples. Further research is required into this potentially
beneficial treatment before definitive recommendations for
practice can be made.
1+
There is no reliable evidence of benefit of using electromagnetic

therapy in the treatment of pressure ulcers. The possibility of
benefit or harm cannot be ruled out due to the small number of
trials with methodological limitations and small numbers of
participants.

1++
Overall, while adjunct therapies are increasingly being used in

clinical practice, there is currently little good-quality evidence to
support their use.
Cost-effectiveness
The effectiveness evidence on which the two economic
evaluations were based was moderate to low, primarily due to
lack of data. The two studies compare different treatments so it
was not appropriate to synthesise the data. The economic
evaluation presented by Macario et al. is the stronger of the two
studies and it appears that noncontact normothermic wound
therapy may be more cost-effective than current standard care.
Although the Philbeck et al. (1999) study suggests that negative
pressure wound therapy might be a more cost-effective option
than saline-soaked gauze dressings applied to patients placed
on either a low air loss mattress or a foam mattress bed for grade
3 or 4 pressure ulcers, the internal validity and generalisability of
the findings is questionable.
One partial economic evaluation compared (TNP) to standard
care and found that TNP was more cost-effective.
Recommendations: adjunct therapies

The use of adjunct therapies (electro-therapy technologies and topical negative
pressure therapy) for the treatment of pressure ulcers should be based on: [D]
ulcer assessment
level of risk from holistic assessment
previous positive effects of the technology/therapy
patient preference (lifestyle, abilities and comfort), and
practitioners competence.

There is a need for well-designed, adequately powered, multicentre RCTs to evaluate the contribution of adjunct therapies to
the healing of pressure ulcers.
Evidence for the relative effectiveness of adjunct therapies
compared to other treatment modalities in pressure ulcer
management is likely to be provided by trials in which the
comparison is an adjunct therapy against a background of
standard care (preferably treatments based on the best available
evidence), or adjunct therapies compared with sham therapies.
Well-designed, multi-centre RCTs evaluating the effectiveness of
adjunct therapies on healing rates, healing times, cost, quality of
life, pain and comfort, and whether there are optimal regimes for
patients with existing pressure ulcers of varying degrees of
severity, are thus required.

7. RECOMMENDATIONS FOR RESEARCH
The following research gaps were identified by the GDG. Following NICE requirements, the
first five are those that were prioritised by the GDG using a group consensus process, in
which every research recommendation was ranked by each group member.
Risk of delayed healing/complications to healing

Well designed, large-scale prospective cohort studies including those with pressure ulcers,
and including relevant identified risk factors to show how the identified risk factors lead to
more severe ulcers or delayed healing or complications.
Pressure ulcer assessment

Pressure ulcer assessment is a fundamental activity for both evaluating treatment
interventions and communicating that information. Research needs to focus on which
methods of measurement and which parameters are of use to clinicians to allow accurate
wound evaluation.
Support surfaces for pressure support

Independent, well-designed, multi-centre, randomised, controlled trials are needed to
compare the clinical and cost-effectiveness of different types of pressure-relieving support
surfaces to treat existing pressure ulcers for patients in a variety of settings. In particular, this
research should aim to compare, for example:
different types of high-specification foam mattresses and other constant lowpressure devices, and
alternating pressure, air fluidised and low air loss devices.
The studies should also evaluate the cost-benefit trade off of pressure ulcer treatment
alternatives.
Positioning and repositioning should be investigated in those with existing pressure ulcers to
determine:
the need for repositioning with pressure-relieving devices
methods of repositioning on different devices with frequency, and
practitioner time involved in repositioning.

Future research must address the methodological deficiencies associated with much of the
research described in the reviews. Particular attention should be paid to:
description of inclusion and exclusion criteria used to derive the sample from
the target population
evidence of an a priori sample size calculation
description of baseline comparability of treatment groups
evidence of blinded outcome assessment
clear description of main interventions
adequate description of associated care, and
withdrawals reported by the treatment group with reasons.
Attention should also be paid to:
true randomisation (with concealed allocation)
a sample of sufficient size to detect clinically important differences, and clear

criteria for measuring outcomes
blinded interventions and assessment
adequate follow up
appropriate statistical analysis
measuring patient experiences of pressure-relieving equipment
comfort
pain
ease of use (for devices)
appropriateness for users and settings, and
durability of equipment.
Antimicrobials/nutrition
The results summarised in this review are based on findings from small trials with
methodological problems. Therefore, much of the required research needs replication in
larger, well-designed studies using contemporary interventions for antimicrobial activity, and
nutritional support/supplementation.
Surgery
Research needs to focus on the effectiveness of different types of surgery, and surgery
compared to conventional treatments, in those with pressure ulcers.

Combined Quick Reference Guide

8. AUDIT CRITERIA
The audit criteria below are to assist with implementation of the Guideline
recommendations. The criteria presented are considered to be the key criteria
associated with the Guideline recommendations. They are suitable for use in primary
and secondary care, and for all patients with pressure ulcers.
Caveats for Guideline users
Objectives for an audit.
Individuals to be included in an audit.
Data sources and documentation of audit.
Systems for recording the necessary information, which will provide data sources for
audit, should be agreed by trusts.
Whatever method is used for documentation, it should be accessible to all members
of the multidisciplinary team.
Documentation of the factors taken into consideration when deciding the most
appropriate intervention should occur.
The fact that carers and patients have been informed about pressure ulcers should be
documented. Patients and carers should be directly questioned about their
satisfaction with, and the adequacy of, the information provided. This should be
documented in either the patients notes or in another source as agreed by the trust.
Trusts should establish a system of recording when staff have been educated in the
management of pressure ulcers and should implement a process for reviewing
pertinent education needs.

Criterion
Exception
Definition of terms
1.
The individuals plan of

care contains a
classification/grade for all
pressure ulcers using the
European Pressure Ulcer
Advisory Panel (EPUAP)
classification system.
None
2.
A pressure ulcer that is

identified as a grade 2 or
above is documented as
a clinical incident.
Individuals with pressure
ulcers have their ulcer
assessed initially (within
six hours) and the
assessment is ongoing.
The assessment is
supported by tracings
and or a photograph of
the ulcer.
None

ulcers have access to
appropriate pressurerelieving support
surfaces or strategies
throughout a 24-hour
period. This includes all
surfaces used by the
individual, including
mattresses and
cushions.
Individuals with grade 12 pressure ulcers have a
high-specification foam
mattress/cushion as a
minimum and are very
closely observed for
deteriorations.
Individuals have a
documented
repositioning regime.
Individuals with grade 34 pressure ulcers have
alternating pressure
None
The grade of ulcers should

be clearly documented in
the plan of care to be
available to the interdisciplinary team.
Pressure ulcers should be
given a grade of 1-4.
Pressure ulcers should not
be reverse graded in that
a healing grade 4
pressure ulcer should be
described as such and not
as a grade 3 pressure
ulcer.
The reporting should
follow trust procedure for
reporting of clinical
incidents.
The ulcer is assessed for
cause, site/location,
dimensions, stage/grade,
exudates (amount and
type), local signs of
infection, pain, wound
appearance, appearance
of surrounding skin,
undermining/tracking
(sinus or fistula), and
odour. Clinical experts are
involved as appropriate
e.g. tissue viability nurse.
Support surfaces include
all surfaces used by an
individual, which will
include mattresses for
beds (including theatre
trollies), and cushions for
chairs and wheelchairs.
Strategies include the use
of repositioning to
minimise prolonged
pressure on the body.
Repositioning is
documented in the plan of
care.
3.
4.
5.
6.
None
Those in whom this is

contraindicated.
Those with perceived
or further deterioration.
Need input from
clinician.
Those in whom this is

contraindicated i.e
due to patient weight
Repositioning is
care.

7.
overlay or sophisticated
low pressure support as
a minimum and are
closely observed.
or issues of safety.
Where a replacement
system or alternative
support may be
indicated.

ulcers have their ulcers
dressed with modern
wound dressings to
create the optimum
wound healing
environment.
Those individuals in
whom these dressings
are contraindicated.
Patient informed
choice.
The dressing should be

care with rationale for its
use. Choice of dressings
should be based on the
ulcer assessment, general
skin assessment,
treatment objective, risk of
adverse events, patient
preference, dressing
characteristics, and
manufacturers indications
for use. Decisions about
choice should be made by
registered health care
professionals. Examples
of modern dressings are:
hydrocolloids, hydrogels,
hydrofibres, foams, films,
alginates and soft
silicones.

9. DISSEMINATION OF GUIDELINES
The Guideline will be produced in a full and summary format, and a version for the
public (Information for the public).
Full copies of the Guideline will be available through the NICE website
(http://www.nice.org.uk) in PDF format and the summary through the National
Electronic Library for Health (NeLH) (http://www.nelh.nhs.uk/) and National Guideline
Clearinghouse (http://www.guidelines.gov).

10.
VALIDATION
The Guideline has been validated through two stakeholder consultation processes.
The first and second drafts were submitted in December 2004 and March 2005 to
NICE, who obtained and collated stakeholders comments for consideration by the
GDG.

11. SCHEDULED REVIEW OF GUIDELINE

The process of reviewing the evidence is expected to begin four years after the date
of issue of this Guideline. Reviewing may begin earlier than four years if significant
evidence that affects the Guideline recommendations is identified sooner. The
updated Guideline will be available within two years of the start of the review process.

References
Adeoke BOA and Badmos KA (2001) Acceleration of pressure ulcer healing in
spinal cord injured patients using interrupted direct current. Afr J Med
Sci,30,pp.195-197.
Agren MS and Stromberg HE (1985) Topical treatment of pressure ulcers. A
randomized comparative trial of Varidase and zinc oxide. Scand J Plast Reconstr
Surg,19,pp.97-100.
Aguilo Sanchez S, Figueiras Mareque L, Quintilla Gatnau A and Veiga Bogo L.
(2001) Traditional dressings or cures in a moist environment? (Spanish). Revista
Rol de Enfermeria,24,pp.50-54.
AHCPR (1994) Treatment of pressure ulcers, clinical practice guideline No 15.
USA Department of Health and Human Services, Rockville: USA.
Alarcon T, Barcena A et al. (1999).Factors predictive of outcome on admission to
an acute geriatric ward. Age & Ageing,28(5),pp.429-32.
Allman RM, Walker JM, Hart MK, Laprade CA, Noel LB and Smith CR (1987) Airfluidized beds or conventional therapy for pressure sores. A randomized trial.
Annals of Internal Medicine,107(5),pp.641-8.
Allman RM, Goode P, Patrick M, Burst N and Bartolucci AA (1995) Pressure ulcer
risk factors among hospitalised patients with activity limitation. Journal of the
American Medical Association,273(11),pp.865-70.
Allman RM (1997) Pressure ulcer prevalence, incidence, risk factors, and impact.
Clinical Geriatric Medicine,13,pp.421-36.
Alm A, Hornmark AM, Fall PA, et al. (1989) Care of pressure sores: a controlled
study of the use of a hydrocolloid dressing compared with wet saline gauze
compresses. Acta Derm Venereol Suppl (Stockh),149,pp.1-10.
Altman DG, Schulz KF, Moher D, et al. (2001) The revised CONSORT statement
for reporting randomized trials: explanation and elaboration. Annals of Internal
Medicine,134,pp.663-694.
Alvarez OM and Childs EJ (1991) Pressure ulcers. Physical, supportive and local
aspects of management. Clin Podiatr Med Surg,8,pp.869-90.
Alvarez OM, Fernandez-Obregon A, Rogers RS, Bergamo L, Masso J and Black
M. (2002) A prospective, randomized, comparative study of collagenase and
papain-urea for pressure ulcer debridement. Wounds-A Compendium of Clinical
Research & Practice,14(8),pp.:293-301.
Amundson J A, Sherbondy A et al. (1994) Early identification and treatment
necessary to prevent malnutrition in children and adolescents with severe
disabilities. Journal of the American Dietetic Association,94(8),pp.880-883.
Andersen KE and Kvorning SA (1982) Medical aspects of the decubitus ulcer.
International Journal of Dermatology,21(5),pp.265-270.
Andrychuk MA (1998) Orthopaedic essentials. Pressure ulcers: causes, risk
factors, assessment, and intervention. Orthopaedic Nursing,17(4),pp.65-83.

Andrychuk MA (1998) Pressure ulcers: causes, risk factors, assessment, and
intervention. Orthopaedic Nursing,17(4),pp.65-81;quiz 82-3.
Argenta LC and Morykwas MJ (1997) Vacuum-assisted closure: a new method for
wound control and treatment: clinical experience. Annals of Plastic Surgery,
38,pp.563-576.
Avanzi A, Martinelli R, Accardi S, et al. (2000) Adhesive hydrocellular dressing vs
hydrocolloid dressing in the treatment of pressure sores. First World Wound
Healing Congress 2000,p.90.
Ayello E (1992) Teaching the assessment of patients with pressure ulcers.
Decubitus,5(7),pp.53-4.
Ayello E (1996) Keeping pressure ulcers in check. (Assessment tool).
Nursing,26(10),pp.62-3.
Ayello EA (1997) Assessment of pressure ulcer healing. Advances in Wound Care,
10(5),p.10.
Ayello EA, Mezey M et al. (1997) Educational assessment and teaching of older
clients with pressure ulcers. Clinics in Geriatric Medicine,13(3),pp.483-96.
Ayello EA, Thomas DR et al. (1999) Nutritional aspects of wound healing. Home
Healthcare Nurse,17(11),pp.719-29;quiz 730.
Azad S and Nishokawa H (2002) Topical negative pressure may help chronic
wound healing. Bmj,3247,pp.345,1100.
Baggerly J and DiBlasi M (1996) Pressure sores and pressure sore prevention in a
rehabilitation setting: building information for improving outcomes and allocating
resources. Rehabilitation Nursing,21(6),pp.321-5.
Baker P and Haig G (1981) Metronidazole in the treatment of chronic pressure
sores and ulcers: a comparison with standard treatments in general practice.
Practitioner,225,pp.569-73.
Bale S, Banks V and Harding KG (1996) A 100 patient cost-effectiveness trial of a
hydrocellular and hydrocolloid dressing. Proceedings of the 5th European
Conference on Advances in Wound Management, 21-24 Nov 1995. Harrogate,
London, UK: Macmillan Magazines,p294.
Bale S, Squires D, Varnon T, Walker A, Benbow M and Harding KG. (1997) A
comparison of two dressings in pressure sore management. Journal of Wound
Care,6,pp.463-6.
Bale S, Banks V, Haglestein S and Harding KG (1998) A comparison of two
amorphous hydrogels in the debridement of pressure sores. Journal of Wound
Care,7,pp.65-8.
Bale S, Hagelstein S, Banks V and Harding KG (1998) Costs of dressings in the
community. Journal of Wound Care,7,pp.327-30.
Bale S (1999) The preliminary results of a comparative study of performance
characteristics and safety of a foam dressing Biatain Adhesive versus Tielle on
pressure sores. 9th European Conference on Advances in Wound Management.
Harrogate, UK,8.
Banks V, Bale S and Harding K (1994) The use of two dressings for moderately
exuding pressure sores. J Wound Care,3,pp.132-4.

Banks V, Bale S and Harding KG (1994) Superficial pressure sores: comparing two
regimes. J Wound Care,3,pp.8-10.
Banks V, Bale S and Harding KG (1994) Comparing two dressings for exuding
pressure sores in community patients. J Wound Care,4,pp.175-178.
Banks V, Riggs R, Bale S and Harding K (1994) Comparison of an absorbent semipermeable polyurethane dressing (Spyrosorb/Mitraflex) and a hydrocolloid dressing
(Granuflex E) for the treatment of moderately exuding pressure sores in community
patients. In: Harding Kg DCCGGF (ed.) Proceedings of the 3rd European
Conference on Advances in Wound Management, 19-22 Oct 1993, Harrogate,
London, UK: Macmillan Magazines,p.159.
Banks V, Fear M, Orpin J, et al. (1996) A comparative open multi-centre trial of
hydroploymer dressing and hydrocolloid. Proceedings of the symposium on
Advanced Wound Care and Medical Research Forum on Wound Repair, 20-24 Apr
1996, Atlanta GA. Wayne GA: Health Management Publication,p.113.
Banks V, Hagelstein S, Bale S and Harding KG (1996) A comparison of a new
polyurethane dressing versus a hydrocellular dressing in the treatment of moderate
to heavily exudating wounds. Proceedings of Symposium on Advanced Wound
Care & Medical Research Forum on Wound Repair,p.113.
Banks V, Bale S, Harding K and Harding EF (1997) Evaluation of a new
polyurethane foam dressing. Journal of Wound Care,6,pp.266-9.
Banks V (1998) Nutrition and pressure area management. Journal of Wound
Care,7(6),pp.318-9.
Banwell PE, Holten IW and Martin DL (1998) Negative pressure therapy: clinical
applications and experiences with 200 cases. Wound Repair and Regeneration,8,
6,p.A460.
Banwell PE (1999) Topical negative pressure therapy in wound care. Journal of
Wound Care,8,pp.79-84.
Banwell PE and Teot L (2003) Topical negative pressure (TNP): the evolution of a
novel wound therapy. J Wound Care,12,pp.22-28.
Baranoski S and Thimsen K (2003) OASIS skin and wound integumentary
assessment items: applying the WOCN guidance document. Home Healthcare
Nurse, suppl:3-13.
Barbenel JC (1981) A technique for the routine assessment of elderly patients
while in bed.1st annual report. Bioengineering Unit, Glasgow: University of
Strathclyde.
Barbenel JC (1982) A technique for the routine assessment of the mobility of
elderly patients while in bed. Final report. Bioengineering Unit, Glasgow: University
of Strathclyde.
Barrois B (1992) Comparison of Granuflex and medicated paraffin gauze in
pressure sores. Proceedings of the 2nd European Conference on Advances in
Wound Management, 20-23 Oct 1992. Harrogate, London, UK: Macmillan
Magazines,p.209.
Barton AA and Barton M (1973) The clinical and thermographical evaluation of
pressure sores. Age & Ageing,2(1),pp.55-9.
Bates-Jensen BM (1994) The Pressure Sore Status Tool: An outcome measure for
pressure sores. Topics in Geriatric Rehabilitation,9(4),pp.17-34.

Bates-Jensen B and McNees P (1996) The Wound Intelligence System: early
issues and findings from multi-site tests. Ostomy Wound Management,42(10A
Suppl),pp.53S-61S.
Bates-Jensen BM (1995) Indices to include in wound healing assessment.
Advances in Wound Care,8(4),suppl 25-33.
Bates-Jensen BM and McNees P (1995) Toward an intelligent wound assessment
system. Ostomy Wound Management,41(7A Suppl),80S-86S,discussion 87S.
Bates-Jensen BM, Alessi CA et al. (2003) The effects of an exercise and
incontinence intervention on skin health outcomes in nursing home residents.
Journal of the American Geriatrics Society, 51(3),pp.348-55.
Baxandall T (1997) Healing cavity wounds with negative pressure. Elderly
Care,9,pp.20-22.
Baumgarten M, Margolis D, Berlin JS et al. (2003) Risk factors for pressure ulcers
amoung elderly hip fracture patients. Wound Repair and Regeneration,11,pp.96103.
Bedi A (1993) A tool to fill the gap. Developing a wound risk assessment chart for
children. Professional Nurse,9(2),pp.112-20.
Begg C et al. (1996) Improving the quality of reporting of randomised controlled
trials: the CONSORT statement. Jama,276,pp.637-9.
Belmin J, Meaume S, Rabus MT and Bohbot S (2002) Investigators of the
sequential treatment of the elderly with pressure sores T. Sequential treatment with
calcium alginate dressings and hydrocolloid dressings accelerates pressure ulcer
healing in older subjects: a multicenter randomized trial of sequential versus
nonsequential treatment with hydrocolloid dressings alone. Journal of the American
Geriatrics Society,50,pp.269-74.
Benati G, Delvecchio S, Cilla D and Pedone V (2001) Impact on pressure ulcer
healing of an arginine-enriched nutritional solution in patients with severe cognitive
impairment. Arch Gerontol Geriatr,Jan,33 Suppl 1,pp.43-7.
Benbo M (1996) Pressure sore guidelines: patient/carer involvement and
education. British Journal of Nursing,5(3),pp.182,184-7.
Bendy R, Nuccio P, Wolfe E, Collins B, Tamburro C, Glass W et al. (1964)
Relationship of quantitative wound bacterial counts to healing decubiti: effect of
topical gentamycin. Antimicrob Agents Chemother,4,pp.147-55.
Bennett G and Moody M (1995) Wound care for health professionals, London:
Chapman and Hall.
Bennett G, Dealey C and Posnett J (2004) The cost of pressure ulcers in the UK.
Age and Aging,33,pp.230-235.

Bennett RG, Baran PJ, DeVone LV, Bacetti H, Kristo B, Tayback M and Greenough
WB. (1998) Low air loss hydrotherapy versus standard care for incontinent
hospitalized patients. J Am Ger Soc,46(5),pp.569-76.
Belmin J, Meaume S, Rabus MT and Bohbot S (2002) Investigators of the
sequential treatment of the elderly with pressure sores T. Sequential treatment with
calcium alginate dressings and hydrocolloid dressings accelerates pressure ulcer
healing in older subjects: a multicenter randomized trial of sequential versus
nonsequential treatment with hydrocolloid dressings alone. Journal of the American
Geriatrics Society,50,pp.269-74.
Bergemann R et al. (1999) Economic evaluation of the treatment of chronic
wounds: hydroactive wound dressings in combination with enzymatic ointment
versus gauze dressings in patients with pressure ulcer and venous leg ulcer in
Germany. PharmacoEconomics,16,pp.367-77.
Bergquist S (2003) Pressure ulcer prediction in older adults receiving home health
care: implications for use with the OASIS. Advances in Skin and Wound
Care,16(3),pp.132-139.
Bergstrom N, Braden B and Milne D (1987) Are dietary and serum zinc and copper
factors in the development of pressure sores in institutionalized elderly. Federation
Proceedings,46,p:902.
Bergstrom N and Braden B (1992) A prospective study of pressure sore risk among
institutionalized elderly. Journal of the American Geriatrics Society,40(8),pp.747758.
Bergstrom N, Allman RM et al. (1995) Pressure ulcer treatment: quick reference
guide for clinicians. Advances in Wound Care, 8(2 part 1),pp.22.
Bergstrom N, Braden B, Kemp M et al. (1996) Multi-site study of incidence of
pressure ulcers and the relationship between risk level, demographic
characteristics, diagnosis and prescription of preventive interventions. Journal of
American Geriatrics Society,44,pp.22-30
Bergstrom N, Demuth PJ and Braden BJ [1998] A clinical trial of the Braden scale
for predicting pressure sore risk. Nursing Clinics of North America,22,pp417-428.
Berlowitz DR and Wilkin SVB (1990) Risk factors for pressure sores: a comparison
of cross-sectional and cohort derived data. Journal of American Geriatrics Society,
37(11),pp.1043-1050.
Berlowitz DR and Wilkin SV (1990) The short-term outcome of pressure sores.
Journal of the American Geriatrics Society,38(7),pp.748-52.
Berlowitz DR, Brandeis GH et al. (1997) Predictors of pressure ulcer healing
among long-term care residents. Journal of the American Geriatrics
Society,45(1),pp.30-4.
Berlowitz DR, Brandeis GH et al. (1997) Effect of pressure ulcers on the survival of
long-term care residents. Journals of Gerontology Series A-Biological Sciences &
Medical Sciences,52(2),pp.M106-10.
Bianchetti A, Zanetti O et al. (1993) Risk factors for the development of pressure
sores in hospitalized elderly patients: results of a prospective study. Archives of
Gerontology & Geriatrics,16(3),pp.225-232.

Bo M, Massaia M et al. (2003) Predictive factors of in-hospital mortality in older
patients admitted to a medical intensive care unit. Journal of the American
Geriatrics Society,51(4):529-33.
Bohanannon RW and Pfaller BA (1983) Documentation of wound surface area from
tracings of wound perimeter: clinical report on three techniques. Physical Therapy,
63(10),pp.1622-1624.
Bonnefoy M, Coulon L et al. (1995) Implication of cytokines in the aggravation of
malnutrition and hypercatabolism in elderly patients with severe pressure sores.
Age & Ageing,24(1),pp.37-42.
Bourdel-Marchasson I, Dumas F, Pinganaud G, Emeriau JP and Decamps
A. (1997) Audit of percutaneous endoscopic gastrostomy in long-term enteral
feeding in a nursing home. Int J Qual Health Care,Aug,9(4),pp.297-302.
Bourdel-Marchasson I, Barateau M, Rondeau V, Dequae-Merchadou L, SallesMontaudon N, Emeriau JP, Manciet G and Dartigues JF (2000) A multi-center trial
of the effects of oral nutritional supplementation in critically ill older inpatients.
GAGE Group. Groupe Aquitain Geriatrique d'Evaluation. Nutrition,Jan,16(1),pp.1-5.
Boyle M and Green M (2001) Pressure sores in intensive care: defining their
incidence and associated factors and assessing the utility of two pressure sore risk
assessment tools. Australian Critical Care,14(1),pp.24-30.
Boynton PR and Paustian C (1996) Wound assessment and decision-making
options. Critical Care Nursing Clinics of North America,8(2),pp.125-39.
Bradley M, Cullum N and Sheldon T (1999a) The debridement of chronic wounds:
a systematic review. Health Technology Assessment,no.17(pt 1).
Bradley M, Cullum N, Nelson E et al. (1999b) Systematic reviews of wound care
management: (2) dressings and topical agents use in the healing of chronic
wounds. Health Technology Assessment,3,no.17(pt2).
Brandeis GH, Ooi WL, Hossain M et al. (1994) A longitudinal study of risk factors
associated with the formation of pressure ulcers in nursing homes. Journal of the
American Geriatrics Society,42(4),pp.388-393.
Breslow RA, Hallfrisch J and Goldberg AP (1991) Malnutrition in tubefed nursing
home patients with pressure sores. J Parenter Enteral Nutr,Nov-Dec,15(6),pp.6638.
Breslow RA, Hallfrisch J, Guy DG, Crawley B and Goldberg AP (1993) The
importance of dietary protein in healing pressure ulcers. J Am Geriatr
Soc,Apr,41(4),pp.357-62.
Brewer Jr RD, Mihaldzic N and Dietz A (1967) The effect of oral zinc sulfate on the
healing of decubitus ulcers in spinal cord injured patients. Proceedings of the
Annual Clinical-Spinal Cord Injury Conference,pp.70-2.
British Medical Association (BMA) (1999) Royal Pharmaceutical Society of Great
Britain. British National Formulary, London: BMA and The Pharmaceutical Press.

Brod M, McHenry E, Plasse TF, Fedorczyk D and Trout JR (1990) A randomized
comparison of polyhema and hydrocolloid dressings for treatment of pressure
sores [letter]. Arch Dermatol,126,pp.969-70.
Brooks R and Semylen A (1997) Economic appraisal in pressure sore
management. Journal of Wound Care,6,10,pp.491-494.
Brown-Etris M, Fowler E, Papen J, et al.(1996) Comparison and evaluation of the
performance characteristics, usability and effectiveness on wound healing of
Transorbent versus Duoderm CGF. In: Negus DJG (ed.) Proceedings of 5th
European Conference on Advances in Wound Management, 21-24 Nov 1995,
Harrogate, UK: Macmillan Magazines,pp.151-5.
Brown-Etris M, Bateman D, Shields D, et al. [1992] Final report of a clinical study
designed to evaluate and compare a collagen alginate dressing and a calciumsodium alginate dressing in pressure ulcers. In: Proceedings of European Wound
Conference.
Bulstrode CJK et al (1987) Measurement and prediction of progress in delayed
wound healing. Journal of the Royal Society of Medicine,80,pp.210-212.
Burgos A, Gimenez J, Moreno E et al. (2000) Collagenase ointment application at
24- versus 48-hour intervals in the treatment of pressure ulcers. A randomised
multi-centre study. Clinical Drug Investigation,19,pp.399-407.
Burgos A, Gimenez J, Moreno E et al. (2000) Cost, efficacy, efficiency and
tolerability of collagenase ointment versus hydrocolloid occlusive dressing in the
treatment of pressure ulcers. A comparative, randomised, multicentre study.
Clinical Drug Investigation,19,pp.357-365.
Burr RG and Rajan KT (1972) Leucocyte ascorbic acid and pressure sores in
paraplegia. British Journal of Nutrition,28(2),pp.275-81.
Burr HS, Taffel M and Harvey SC (1940) An electrometric study of the healing
wound in man. Yale J Biol Med,12,pp.483-5.
Caley L, Jones S, Freer J et al. (1994) Randomised prospective trial of two types of
low air loss therapy.
Capillas PR, Cabre AV, Gil CAM, Gaitano GAG and Torra iBJE (2000) A
comparison of the effectiveness and cost of moist environment dressings treatment
as compared to traditional dressings treatment: randomized clinical trial on patients
suffering venous leg ulcers or pressure ulcers treated by primary health care
nurses. Revista Rol de Enfermeria,23,pp.17-24.
Capillas Perez R, Cabre Aguilar V, Gil Canedo-Dorantes L, Garcia-Cantu R,
Barrera R, Mendez-Ramirez I, Navarro VH and Serrano G (2002) Healing of
chronic arterial and venous leg ulcers with systemic electromagnetic fields. Arch
Med Res,33,pp.281-289.
Casey G (1997) Nutrition helps wound healing. Nursing New Zealand (Wellington),
3(11),p.19.
Casey G (1998a) Three steps to effective wound care. Nursing Standard,12(49),pp.
43-4.
Casey G (1998b) Tissue viability supplement. The importance of nutrition in wound
healing. Nursing Standard,13(3),pp.51-2.
Cassino R, Veroni C, Ricci E, Carusone A and Mercanti A (1997) Vacuum assisted
closure therapy in pressure ulcer management. European Wound Management

Association Conference 1997. London: European Wound Management
Association,p.39.
Chang KW, Alsagoff S, Ong KT and Sim PH (1998) Pressure ulcers randomised
controlled trial comparing hydrocolloid and saline gauze dressings. Medical Journal
of Malaysia,53,pp.428-31.
Chantelau E, Tanudjaja T, Altenhofer F, Ersanli Z, Lacigova S and Metzger C.
(1996) Antibiotic treatment for uncomplicated neuropathic forefoot ulcers in
diabetes: a controlled trial. Diabetic Med,13,pp.156-9.
Cheneworth CC, Hagglund KH, Valmassoi B and Brannon C (1994) Portrait of
practice: healing heel ulcers. Adv Wound Care,7,pp.44-48.
Chernoff RS, Milton KY and Lipschitz DA (1990) The effect of a very high-protein
liquid formula on decubitus ulcers healing in long-term tube-fed institutionalized
patients. J Am Diet Assoc,90,pp.A-130.
Clark M and Donald IP (1999) A randomised controlled trial comparing the healing
of pressure sores upon two pressure-redistributing seat cushions. In: Proceedings
of the 7th European Conference on Advances in Wound Management. London:
Macmillan Magazines Ltd.,pp.122-125.
Clark M and Kadhon HM (1988) The nursing prevention of pressure sores in
hospital and community patients. Journal of Advanced Nursing,13(3),pp.365-373.
Clark M and Watts S (1994) The incidence of pressure sores in a National Health
Service Trust hospital during 1991. Journal of Advanced Nursing,20,pp.33-36.
Clarke M and Oxman AD (2003) (editors) Cochrane reviewers' handbook version
4.2.0 in Review Manager (RevMan 4.2.2). Oxford, UK: Update Software.
Clough N P (1994) The cost of pressure area management in an intensive care
unit. Journal of Wound Care,3,pp.33-35.
Coggrave M et al (2002) Topical negative pressure for pressure ulcer
management. Br J Nurs,116,suppl.S29-36.
Colome AM, Gaitano Garcia A and Torra i Bou JE (2000) [Comparison of the
effectiveness and cost of treatment with humid environment as compared to
traditional cure. Clinical trial on primary care patients with venous leg ulcers and
pressure ulcers]. [Spanish]. Revista de Enfermeria,23,pp.17-24.
Cooper DM (1995) Indices to include in wound assessment. Adv Wound
Care,8:15s.
Colin D, Kurring PA, Quinlan D and Yvon C (1996) Managing sloughy pressure
sores. J Wound Care,5,pp.444-6.
Collier J (1992) A moist, odour-less environment. A multicentered trial of a foamed
gel and a hydrocolloid dressing. Professional Nurse,7,pp.804-808.
Collier M E (1999) Pressure ulcer development and principles for prevention. In
Miller M and Glover D Wound management theory and practice. London: NTBooks
Emap.

Colwell JC, Foreman MD and Trotter JP (1993) A comparison of the efficacy and
cost-effectiveness of two methods of managing pressure ulcers. Decubitus,6,pp.2836.
Coutts P, Sibbald RG, Inman K and Maltby-Stephens N (2000) The use of an
adhesive hydrocellular foam compared to a hydrocolloid dressing for the treatment
of Stage II and III pressure ulcers. The 13th Annual Symposium on Advanced
Wound Care & 10th Annual Medical Research Forum on Wound Repair,D7.
Crim JR and Seeger LL (1994) Imaging evaluation of osteomyelitis. Critical
Reviews in Diagnostic Imaging,35(3),pp.201-56.
Cruse J M, Lewis RE et al. (2000) Review of immune function, healing of pressure
ulcers, and nutritional status in patients with spinal cord injury. Journal of Spinal
Cord Medicine,23(2),pp.129-35.
Cruse JM, Lewis RE et al. (2000) Facilitation of immune function, healing of
pressure ulcers, and nutritional status in spinal cord injury patients. Experimental &
Molecular Pathology,68(1),pp.38-54.
Cruse JM, Wang H et al. (2002) Cellular and molecular alterations in spinal cord
injury patients with pressure ulcers: a preliminary report. Experimental & Molecular
Pathology,72(2),pp.124-31.
Culley F (1998) Clinical. Nursing aspects of pressure sore prevention and therapy.
British Journal of Nursing,7(15),pp.879-80.
Cullum N A, Deeks J J and Fletcher A W et al (1995) Preventing and treating
pressure sore. Quality in Health Care,4,pp.289-297.
Cullum N A (2001) Pressure ulcer prevention and treatment: A synopsis of the
current evidence. Critical Care Nursing Clinics of North America,13(4),pp.547-554.
Cullum N, Nelson E, Flemming K et al. (2001) Systematic review of wound care
management: (5) beds; (6) compression; (7) laser therapy, therapeutic ultrasound,
electrotherapy and electromagnetic therapy. Health Technology Assessment,5,9.
Cullum N, Nelson EA and Nixon J (2003) Pressure sores. Clinical Evidence.BMJ
Publishing Group.
Cullum N, Deeks J, Sheldon, TA, Song F and Fletcher AW (2004) Beds, mattresses and
cushions for pressure sore prevention and treatment (Cochrane Review) in: The
Cutler NR et al. (1993) Comparison of quantitative methodologies to define chronic
pressure ulcer measurement. Decubitus,6(6),pp.22-30.
Dallam L, Smyth C et al. (1995) Pressure ulcer pain: assessment and
quantification. Journal of Wound, Ostomy, & Continence Nursing,22(5),pp.2115,discussion pp.217-8.
Danielson JR and Tasche C (1990) Pressure sores: evaluating quality of care. QA
Review,2(9),p.5.

Darkovich SL, Brown E and Spencer M (1990) Biofilm hydrogel dressing: a clinical
evaluation in the treatment of pressure sores. Ostomy Wound Manag,29,pp.47-60.
Darouiche RO, Landon GC et al. (1994) Osteomyelitis associated with pressure
sores. Archives of Internal Medicine,154(7),pp.753-758.
Das Gupta R, Twyman L, Morgan B and McGrouther DA (1996) An introduction to
VAC therapy in the treatment of chronic wounds. European Tissue Repair
Society,3.
David JA, Chapman RG et al. (1983) An Investigation of the current methods used
in nursing for the care of patients with established pressure sores.Funded by the
DHSS. DOH Stationary Office London.
Day A and Leonards F (1993) Seeking quality care for patients with pressure
ulcers. Decubitus,6(1),pp.32-43.
Davidson M (2002) Sharpen your wound assessment skills: learn how impeccable
assessment and documentation can help your patient heal. Nursing, 32(10):
Hospital Nursing:32hn1-2.
Davydov Iu A, Larichev AB and Abramov A (1992) Wound healing after vacuum
drainage. Khirurgiia Mosk,7,pp.21-26.
Davydov Iu A, Abramov A and Darichev AB (1994) Regulation of wound process by
the method of vacuum therapy in middle-aged and aged patients. Khirurgiia Mosk,
9,pp.7-10.
Day A and Leonard F (1993) Seeking quality care for patients with pressure ulcers.
Decubitus,6(1),pp.32-8.
De Lange MY, Schasfoort RA, Obdeijn MC, Van der Werff JFA and Nicolai JPA
(2000) Vacuum-assisted closure: indications and clinical experience. European
Journal of Plastic Surgery,23,pp.178-182.
Dealey C (1994) The care of wounds, Oxford: Blackwell Scientific Publications.
Dealey C and Keogh A (1997) A randomized, controlled, parallel-group clinical trial
of a new polyurethane foam island dressing versus a hydrocolloid island dressing
in the treatment of grade II and III pressure sores. 6th European Conference on
Advances in Wound Management,pp.94-95.
Dealey C (1999) The care of wounds a guide for nurses, Oxford: Blackwell
Science.
Deeks JJ (1996) Pressure sore prevention: Using and evaluating risk assessment
tolls, British Journal of Nursing,5,pp.313-20.
Deeks J (1998) Odds ratios should be used only in case control studies and logistic
regression analyses. BMJ,317,pp.1155-1156.
Defloor T (2000) Do pressure relief cushions really relieve pressure? Western
Journal of Nursing Research,22(3),pp.335-350.
Defloor T (2000) Does turning patients really prevent pressure ulcers? PhD Thesis,
Ghent University. Ghent.
Defloor T (2000) The effects of position and mattress on interface pressure.
Applied Nursing Research,13,1,pp 2-11.

Defloor T (2001) Manual repositioning of patients. Journal of Tissue Viability,11,3,
p.117.
Defloor T (2001) Wisselhouding, Minder frequent en toch minder decubitus.
Tijdschrift Gerontol Geriatr,32,pp.174-7.
Defloor T and Grypdonck MHF (1999) Sitting posture and prevention of pressure
ulcers. Applied Nursing research,12,3,pp.136-142.
Department of Health (1993) Pressure sores: a key quality indicator. London:
Department of Health.
Della Marchina M and Renzi G. (1997) Disinfezione di piaghe e ferite del paziente
anziano con un nuovo preparato antisettico. Chron Dermatol,7,pp.873-885.
Delmi M, Rapin CH, Bengoa JM, Delmas PD, Vasey H and Bonjour JP
(1990) Dietary supplementation in elderly patients with fractured neck of the
femur. Lancet,Apr 28,335(8696),pp.1013-6.
Dennis M (1989) Poor nutritional status on admission predicts poor outcomes after
stroke observational data from the food trial. Stroke,34(6),pp.1450-1455.
Deva AK, Buckland GH, Fisher E et al. (2000) Topical negative pressure in wound
management. Medical Journal of Australia,173,pp.128-131.
Devine B. (1995) Alternating pressure air mattresses in the management of
established pressure sores. Journal of Tissue Viability,5,pp.94-98.
Drummond M (1994) Economic analysis alongside controlled trials: an introduction
for clinical researchers. London: Department of Health.
Drummond MFand Jefferson TO (1996) Guidelines for authors and peer reviewers
of economic submissions to the BMJ. British Medical Journal,313,pp.275-283.
Drummond M, OBrien B, Stoddart G and Torrance G. (1997) Methods for the
economic evaluation of health care programmes. 2nd Edition. Oxford University
Press:Oxford.
Dyson M (1982) Non-thermal cellular effects of ultrasound. British Journal of
Cancer Supplement,45,165-71.
Dyson M (1987) Mechanisms
Physiotherapy,73,116-20.
involved
in
therapeutic
ultrasound.
Dzwierzynski WW and Spitz K et al. (1998) Improvement in resource utilization

after development of a clinical pathway for patients with pressure ulcers. Plastic &
Reconstructive Surgery,102(6),pp.2006-11.
Eccles M and Mason J (2001) How to develop cost conscious guidelines, Health
Technology Assessment,5,16.
Edsberg LE, Brogan MS, Jaynes D and Fries K (2002) Topical hyperbaric oxygen
and electrical stimulation: exploring possible synergy. Ostomy Wound
Management,48,pp.42-50.
Ek AC, Unosson M et al. (1989) The modified Norton scale and the nutritional
state. Scandinavian Journal of Caring Sciences,3(4),pp.183-7.

Ek AC, Larsson J et al. (1990) The correlation between anergy, malnutrition and
clinical outcome in an elderly hospital population. Clinical Nutrition,9(4),pp.185-189.
Ek AC, Unosson M et al. (1991) The development and healing of pressure sores
related to the nutritional state. Clinical Nutrition,10(5),pp.245-250.
Elliott TR (1999) Social problem-solving abilities and adjustment to recent-onset
spinal cord injury. Rehabilitation Psychology,44(4),pp.315-332.
Elliott TR, Shewchuk RM et al. (1999) Caregiver social problem-solving abilities
and family member adjustment to recent-onset physical disability. Rehabilitation
Psychology,44(1),pp.104-123.
Emflorgo CA (1999) The assessment and treatment of wound pain. Journal of
Wound Care,8(8),pp.384-5.
Eriksson G. (1984) Bacterial growth in venous leg ulcers its clinical significance in
the healing process. In: An environment for healing: the role of occlusion. Royal
Society of Medicine International Congress and Symposium Series,vol. 88,
London:Royal Society of Medicine,pp.45-9.
Evans D, Land L and Geary A. (2000) A clinical evaluation of the Nimbus 3
alternating pressure mattress replacement system. Journal of Wound
Care,9(4),pp.181-186.
Evans D and Land L (2001) Topical negative pressure for treating chronic wounds. The
Evans D and Land L (2001) Topical negative pressure for treating chronic wounds:
a systematic review. British Journal of Plastic Surgery,54,pp.238-242.
Ewing MR, Garrow C, Presley TA, Ashley C and Kinsella NM (1964) Further
experiences in the use of sheep skins as an aid in nursing. The Australian Nurses'
Journal,Sept,pp.215-219.
Fabian TS, Kaufman HJ, Lett ED et al. (2000) The evaluation of submatmospheric
pressure and hyperbaric oxygen in ischemic full thickness wound healing. The
American Surgeon,66,pp.1136-1143.
Fader M, Clarke-O'Neill S et al. (2003) Management of night-time urinary
incontinence in residential settings for older people: an investigation into the effects
of different pad changing regimes on skin health. Journal of Clinical
Nursing,2(3),pp. 374-86.
Fay MF (1987) Drainage systems. Their role in wound healing. Aornj,46,pp.442455.
Ferguson M, Cook A et al. (2000) Pressure ulcer management: the importance of
nutrition. MEDSURG Nursing,9(4),pp.163-75,quiz 176-7.
Ferrell BA, Osterweil D and Christenson P (1993) A randomised trial of low air loss
beds for treatment of pressure ulcers. JAMA,269,pp.494-497.
Ferrell BA, Artinian BM et al. (1995) The Sessing scale for assessment of pressure
ulcer healing. Journal of the American Geriatrics Society,43(1),pp.37-40.

Fischer H, Gilliet F, Hornemann M et al.(1984) Enzymatische Wundreinigung beim
venosen Ulcus cruris. Bericht uber eine multzentrische klinische Vergleichsstudie
mit verschiedenen Enzympraparaten. Fortschr Med,102,pp.281-283.
Fishman T D (1999) Wound assessment and evaluation. Dermatology
Nursing,11(3),pp.201-2.
Fishman TD (1999) Wound assessment and evaluation. Unstageable pressure
ulcer due to eschar formation. Dermatology Nursing,11(3),pp.201-2.
Fleischmann W, Becker U, Bischoff M and Hoekstra H (1995) Vacuum sealing:
indication, technique and results. Eur J Orthop Surg Traumatol,5,pp.37-40.
Fishman T D (2001) Wound assessment and evaluation... pressure ulcer.
Dermatology Nursing,13(1),pp.59-60.
Fleischmann W, Strecker W, Bombelli M and Kinzl L. (1993) Vacuum sealing as
treatment of soft tissue damage in open fractures. Unfallchirurg,96,pp.488-492.
Flemming K and Cullum N (2000) Therapeutic ultrasound for pressure sores. The
Flemming K and Cullum N (2001) Electromagnetic therapy for treating pressure sores.
The Cochrane Database of Systematic Reviews, Issue 1.
Flock P (2003) Pilot study to determine the effectiveness of diamorphine gel to
control pressure ulcer pain. Journal of Pain & Symptom Management,25(6),pp.54754.
Ford CN, Reinhard ER, Yeh D et al (2002) Interim analysis of a prospective,
randomized trial of vacuum-assisted closure versus the healthpoint system in the
management of pressure ulcers. Ann Plast Surg,491,pp.55-61,discussion 61.
Fowler EM (1983) New, once-daily pressure sore dressing speeds healing.
Registered Nurse,46,pp.56-57.
Fox JW and Golden GT (1976) The use of drains in subcutaneous surgical
procedures. Am J Surg,132,pp.673-674.
Franks PJ and Moffatt CJ (1999) Focus on wound management. Quality of life
issues in chronic wound management. British Journal of Community
Nursing,4(6),pp. 283-4.
Franks PJ, Winterberg H et al. (2002) Health-related quality of life and pressure
ulceration assessment in patients treated in the community. Wound Repair &
Regeneration,10(3),pp.133-40.
Freeman K, Smyth C et al. (2001) Pain measurement scales: a comparison of the
visual analogue and faces rating scales in measuring pressure ulcer
pain.[comment]. Journal of Wound, Ostomy, & Continence Nursing,28(6),pp.290-6.
Fu X, Shen Z, Guo Z, Zhang M and Sheng Z (2002) Healing of chronic cutaneous
wounds by topical treatment with basic fibroblast growth factor. Chinese Medical
Journal,115,pp.331-5.
Gallagher SM (1997) Morbid obesity: a chronic disease with an impact on wounds
and related problems. Ostomy Wound Management,43(5),pp.18-24,26-7.
Gallagher J and Gray M. (2003) Is aloe vera effective for healing chronic wounds?
J WOCN,30,pp.68-71.

Gardner SE, Frantz RA and Schmidt FL (1999) Effect of electrical stimulation on
chronic wound healing: a meta-analysis. Wound Repair and Regeneration,7(6),pp.
495-503.
Gardner SE, Frantz RA et al. (2001) A tool to assess clinical signs and symptoms
of localized infection in chronic wounds: development and reliability. Ostomy
Wound Management,47(1),pp.40-7.
Garrigues NN (1987) Pressure ulcers: current concepts in wound care,10(1),p4.
Journal of Wound Care.
Genecov DG, Schneider AM, Morykwas MJ, Parker D, White WL and Argenta LC.
A controlled subatmospheric pressure dressing increases the rate of skin graft
donor site reepithelialisation. Annals of Plastic Surgery,1998,40,pp.219-225.
Gentzkow GD, Pollack SV, Kloth LC and Stubbs HA (1991) Wounds: A
Compendium Of Clinical Research And Practice,3,pp.158-170
Gerding GA and Browning JS (1992) Oxyquinoline-containing ointment vs standard
therapy for stage I and stage II lesions. Dermatol Nurs,4,pp.389-398.
Gilchrist B and Reed C (1989) The bacteriology of chronic venous ulcers treated
with occlusive hydrocolloid dressings. Br J Dermatol,121,pp.337-44.
Gilmore SA, Robinson G et al. (1995) Clinical indicators associated with
unintentional weight loss and pressure ulcers in elderly residents of nursing
facilities. Journal of the American Dietetic Association,95(9),pp.984-92.
Giovannini UM, DeMaria R, Chaptal PA and Teot L (2000) The role of aspiration
therapy for the non healing wounds in cardiac surgery. First World Wound Healing
Congress 2000: Australian Wound Management Association,p.114.
Gorse GJ and Messner RL (1987) Improved pressure sore healing with
hydrocolloid dressings. Arch Dermatol,123,pp.766-71.
Gosnell DJ (1987) Assessment and evaluation of pressure sore. Nursing Clinics of
North America,22,pp.399-416.
Granick MS, McGowan E et al. (1998) Outcome assessment of an in-hospital
cross-functional wound care team. Plastic & Reconstructive
Surgery,101(5),pp.1243-7.
Graumlich JF, Blough LS and McLaughlin RG et al. (2003) Healing pressure ulcers
with collagen or hydrocolloid: a randomized, controlled trial. Journal of the
American Geriatrics Society,51,pp.147-54.
Gray M (2003) Does oral supplementation with vitamins A or E promote healing of
chronic wounds? Journal of Wound, Ostomy & Continence Nursing,30(6),pp.290-4.
Gray M (2003) Does oral zinc supplementation promote healing of chronic
wounds? (Review) (36 refs) Journal of Wound, Ostomy & Continence
Nursing,Nov;30(6).

Does vitamin C supplementation promote pressure ulcer healing? Journal of
Wound, Ostomy & Continence Nursing,30(5),pp.245- 247
Greer SE, Longaker MT and Margiotta M (1999) Preliminary results from a
multicentre randomised controlled study of the use of subatmospheric pressure
dressing for pressure ulcer healing. Wound Repair and Regeneration,7,p.A255.
Greer SE (2000) Whither sub-atmospheric pressure dressing. Annals of Plastic
Surgery,45,pp.332-4.
Griffin JW, Tooms RE, Mendius RA, Clifft JK, Vander Zwaag R and el-Zeky F
(1991) Efficacy of high voltage pulsed current for healing of pressure ulcers in
patients with spinal cord injury. Physical Therapy,71,pp.433-442,discussion 442-4.
Griffin et al (1993) Comparison of photographic and transparency-based methods
for measuring wound surface area. Physical Therapy,73(2),pp.117-122.
Groen HW, Groenier KH and Schuling J (1999) Comparative study of a foam
mattress and a water mattress. Journal of Wound Care,8(7),pp.333-335.
Gunningberg L, Lindholm C et al. (2001) Risk, prevention and treatment of
pressure ulcers nursing staff knowledge and documentation. Scandinavian
Journal of Caring Sciences,15(3),pp.257-263.
Guralnik JM, Harris TB , White LR et al. (1988) Occurrence and prediction of
pressure sores in the national health and nutrition examination survey follow-up.
Journal of the American Geriatrics Society,36(9),pp.807.
Hagelstein SM and Banks V (1995) Maintaining quality of life for elderly patients in
residential care. Journal of Wound Care,4(8),pp.347-8.
Halbert AR, Stacey MC, Rohr JB and Jopp-McKay A (1992) The effect of bacterial
colonization on venous ulcer healing. Australas J Dermatol,33,pp.75-80.
Halfens RJG, Van Achterberg T and Bal RM (2000) Validity and reliability of the
Bradeb scale and the influence of other risk factors: a multi-centre prospective
study. International Journal of Nursing Studies,37(4),pp.313-319.
Halfens RJ, Bours GJ et al. (2001) Relevance of the diagnosis 'stage 1 pressure
ulcer': an empirical study of the clinical course of stage 1 ulcers in acute care and
long-term care hospital populations. Journal of Clinical Nursing,10(6),pp.748-57.
Hanan K and Scheele L (1991) Albumin vs. weight as a predictor of nutritional
status and pressure ulcer development. Ostomy Wound Management,33,pp.22-7.
Harding K, Cutting K and Price P (2000) The cost-effectiveness of wound
management protocols of care. British Journal of Nursing,9,S6,S8,S10-S20.
Harding K, Cutting K and Price P (2001) Wound management protocols of care.
British Journal of Health Care Management,7,pp.191-197.
Hardy MA (1989) Biology of scar formation. Physical Therapy,69,pp.1014-1024.
Hartgrink HH, Wille J, Konig P, Hermans J and Breslau PJ. (1998) Pressure sores
and tube feeding in patients with a fracture of the hip: a randomized clinical
trial. Clin Nutr,Dec,17(6),p.287Hartmann D (1977) Considerations in the choice of inter-observer reliability
estimates. J Appl Behav Anal,10,pp.103-116.

Hartman D and Coetzee JC (2002) Two US practitioners' experience of using
essential oils for wound care. J Wound Care,11(8),pp.317-20.
Healy M (2003) Wound care and pain. World of Irish Nursing,11(5),pp39-40.
Heath T, Moisidis E and Deva A (2002) A prospective controlled trial of vacuum
assisted closure (VAC) in the treatment of acute surgical wounds requiring split
skin grafting. Fourth Australian Wound Management Association Conference 2002.
Adelaide, South Australia.
Hefley ML and Radcliffe J (1990) The 1988-1989 decubitus study. Can a
standardization of treatment be set for the elderly patient with decubiti ulcers stage
III? Hawaii Medical Journal,49(9),346,pp.349-50.
Heissing R, Kirschner P and Romer H (1995) Wound drainage with continuous high
vacuum vs variable vacuum suction drainage. Unfallchirurg,98,p.525.
Hewitt GK (1956)Chronic leg ulcers. Physiotherapy,42,pp.43-45.
Hess CL, Howard MA and Attinger CE (2003) A review of mechanical adjuncts in
wound healing: hydrotherapy, ultrasound, negative presure therapy, hyperbaric
oxygen, and electrostimulation. Ann Plast Surg,51,pp.210-218.
Holmich LR, Sim E, Krag C, Dahlfeldt H and Norden A (1998) Vacuum assisted
wound closure clinical experience. Wound Repair and Regeneration,6,A470.
Honde C, Derks C and Tudor D (1994) Local treatment of pressure sores in the
elderly: amino acid copolymer membrane versus hydrocolloid dressing. J Am
Geriatr Soc,42,pp.1180-3.
Hoshowsky and Schramm CA (1994) Intraoperative pressure prevention: an
analysis of bedding materials. Research in Nursing in Health,17(5),pp.333-339.
Houghton PE et al (2000) Photographic assessment of the appearance of pressure
and leg ulcers. Ostomy Wound Management,46(4),pp.20-30.
House A, House B and Campbell M (1981) Measures of inter-observer agreement.
Journal of Behavioural Assessment,3,1,pp.37-57.
Houwing R, Rozendaal M, Wouters-Wesseling W, Beulens JWJ, Buskens E and
Haalboom J (2003) A randomised, double-blind assessment of the effect of
nutritional supplementation on the prevention of pressure ulcers in hip-fracture
patients. Clinical Nutrition,22(4),pp.401-405.
Huchon D (1992) Comparison between granuflex and parrafin-impregnated
medical gauze in the treatment of pressure sores. Eurosci Commun,pp.23-26.
Huck SW and Cormier WH (1996) Reading Statistics and Research, New
York:Harper Collins.
Huovinen S, Kotilainen P, Jarvinen H, Malanin K, Sarna S, Helander I et al. (1994)
Comparison of ciprofloxacin or trimethoprim therapy for venous leg ulcers: results
of a pilot study. J Am Acad Dermatol,31,pp.279-81.
Isago T, Nozaki M, Kikuchi Y, Honda T and Nakazawa H (2003) Negative-pressure
dressings in the treatment of pressure ulcers. Journal of Dermatology,30,pp.299305.

Jackobs MK (1999) The cost of medical nutrition therapy in healing pressure
ulcers. Topics in Clinical Nutrition,14(2),pp.41-7.
Jones I, Tweed C et al. (2001) Pressure area care in infants and children: Nimbus
Paediatric System. British Journal of Nursing,10(12),pp.789-95.
Joseph E, Hamori CA, Bergman S, Roaf E, Swann NF and Anastasi GW (2000) A
prospective randomised trial of vacuum assisted closure versus standard therapy
of chronic nonhealing wounds. Wounds,12,pp.60-67.
Karba R, Semarov D, Vodovnik L, Benko H and Savrin R (1997) DC electrical
stimulation for chronic wound healing enhancement. Part 1. Clinical study and
determination of electrical field distribution in the numerical wound model.
Bioelectrochemistry and Bioenergetics,43,pp.265-270.
Kartes SK (1996) A team approach for risk assessment, prevention, and treatment
of pressure ulcers in nursing home patients. Journal of Nursing Care Quality, 10(3):
34-45.
Keogh A and Dealey C (2001) Profiling beds versus standard hospital beds: effects
on pressure ulcer incidence outcomes. Journal of Wound Care,10(2),pp.15-19.
Kemp MG, Keithley JK, Smith DW et al. (1990) Factors that contribute to pressure
sores in surgical patients. Research in Nursing and Health,13(5),pp.293-301.
Kerstein MD, Gemmen E, Van Rijswijk L, Lyder CH, Phillips T, Xakellis G et al.
(2001) Cost and cost-effectiveness of venous and pressure ulcer protocols of care.
Disease Management & Health Outcomes,9,pp.651-663.
Kim YC, Shin JC, Park CI, Oh SH, Choi SM and Kim YS (1996) Efficacy of
hydrocolloid occlusive dressing technique in decubitus ulcer treatment: a
comparative study. Yonsei Medical Journal,37,pp.181-5.
Kloth L and Feedar J (1988) Acceleration of wound healing with high voltage,
monophasic, pulsed current. Phys Ther,68,pp.503-508.
Kloth LC, Berman JE, Dumit-Minkel S, Sutton CH, Papanek PE and Wurzel J.
(2000) Effects of a normothermic dressing on pressure ulcer healing. Advances in
Skin & Wound Care,13,pp.69-74.
Kloth LC, Berman JE, Nett M, Papanek PE and Dumit-Minkel S (2002) A
randomized controlled clinical trial to evaluate the effects of noncontact
normothermic wound therapy on chronic full-thickness pressure ulcers. Advances
in Skin & Wound Care,15,pp.270-6.
Kraft MR, Lawson L, Pohlmann B, Reid-Lokos C and Barder L (1993) A
comparison of Epi-Lock and saline dressings on the treatment of pressure ulcers.
Decubitus,6,pp.42-8.
Krainski MM (1992) Pressure ulcers and the elderly. Ostomy Wound Management,
38(5),p.22.
Krasner D (1997) Wound healing scale, version 1.0: a proposal. Advances in
Krause JS (1997) Skin sores after spinal cord injury: relationship to life adjustment.
Spinal Cord,36(1),pp 51-6.
Kucan JO, Robson MC, Heggers JP and Ko F (1981) Comparison of silver
sulfadiazine, povidone-iodine and physiologic saline in the treatment of chronic
pressure ulcers. J Am Geriatr Soc,29,pp.232-5.

Ladin D, Hou Z and Philbeck TE (2000) Vacuum assisted closure in the
management of lower-extremity wounds. Advances in Wound Care (submitted).
Lamond DFS (1998) The treatment of pressure sores: a comparison of novice and
expert nurses' knowledge, information use and decision accuracy. J Advanced
Nursing,27(2),pp.280-6.
Landi F, Aloe L, Russo A et al. (2003) Topical treatment of pressure ulcers with
nerve growth factor: a randomized clinical trial. Annals of Internal
Medicine,139,pp.635-41.
Langer G, Schloemer G, Knerr A, Kuss O and Behrens J (2004) Nutritional interventions
for preventing and treating pressure ulcers (Cochrane Review) in: The Cochrane Library,
Issue 3, Chichester, UK: John Wiley & Sons, Ltd.
Langkamp-Henken B, Herrlinger-Garcia KA, Stechmiller JK, Nickerson-Troy JA,
Lewis B and Moffatt L (2000) Arginine supplementation is well tolerated but does
not enhance mitogen-induced lymphocyte proliferation in elderly nursing home
residents with pressure ulcers. J Parenter Enteral Nutr,Sep-Oct,24(5),pp.280-7.
Larsson J, Unosson M, Ek AC and Nilsson L (1990) Effect of dietary supplement on
nutritional status and clinical outcome in 501 geriatric patients: a randomized
study. Clinical Nutrition,9,pp.179-84.
Lazzara DJ and Buschmann MBT (1991) Prevention of pressure ulcers in elderly
nursing home residents: are special support surfaces the answer?
Decubitus,4,pp.42-26.
Lee LK and Ambrus JL (1975) Collagenous therapy for decubitus ulcers.
Geriatrics,30,pp.91-8.
LeVasseur SA and Helme RD (1991) A double-blind clinical trial to compare the
efficacy of an active based cream F14001 against a placebo non-active based
cream for the treatment of pressure ulcers in a population of elderly subjects. J Adv
Nurs,16,pp.952-6.
Lewis B (1996) Protein levels and the aetiology of pressure sores. Journal of
Ljungberg S (1998) Comparison of dextranomer paste and saline dressings for
management of decubital ulcers. Clinical Therapeutics,20,pp.737-43.
Lookingbill DP, Miller SH and Knowles RC (1978) Bacteriology of chronic leg
ulcers. Arch Dermatol,114,pp.1765-8.
Lucas C, Coenen CHM and de Haan RJ (2000) The effect of low level laser
therapy (LLLT) on Stage III decubitis ulcers (pressure ulcers); a prospective
randomised single blind, multicentre pilot study. Lasers Med Sci,14,pp.94-100.
Lum CC, Cheung W, Chow PM, Woo J, Hui E and Or KH (1996) Use of a hydrogel
in pressure sore management. A randomised controlled clinical trial. Proceedings
of the 5th European Conference on Advances in Wound Management,vol. 5.,
London: Macmillan Ltd,p.283.
Lundhus E, Gjode F, Holm CN and Terpling S (1989) Bacterial antimicrobial cover
in primary suture of perianal or pilonidal abscess. A prospective, randomized,
double-blind clinical trial. Acta Chirurg Scand,155,pp.351-4.
Lyder CH (2003) Pressure ulcer prevention and management. Jama,289,pp.223226.
Maas-Irslinger R, Hensby CN and Farley KL (2003) Efficacy and safety of
XENADERM ointment: a novel formulation for treatment of injured skin due to
pressure ulcers. Wounds: A Compendium of Clinical Research &
Practice,15(3),suppl:2S-8S.

Macario A and Dexter F (2002) Is noncontact normothermic wound therapy costeffective for the treatment of stages 3 and 4 pressure ulcers? Wounds-A
Compendium of Clinical Research & Practice,14(3),pp.93-106.
Maklebust J (1987) Pressure ulcers: aetiology and prevention. Nursing Clinics of
North America,22(2),pp.359-377.
Maklebust J (1997) Policy implications of using reverse staging to monitor pressure
ulcer status. Advances in Wound Care,10(5),pp.32-5.
Maklebust J (1997) Pressure ulcer assessment. Clinics in Geriatric
Medicine,13(3),pp.455-81.
Maklebust J and Magnan MA (1992) Approaches to patient and family education
for pressure ulcer management. Decubitus,5(7),pp.18-20,24,26passim.
Maklebust J and Magnan MA (1994) Risk factors associated with having a
pressure ulcer: a secondary data analysis. Advances in Wound Care,7(6),pp.25,
27-8,31-4passim.
Maklebust J and Margolis D (1995) Session I: pressure ulcers: definition and
assessment parameters. Advances in Wound Care,8(4),pp.28/6-28/7.
Maklebust J and Sieggreen MY (1996) Attacking on all fronts: how to conquer
pressure ulcers. Nursing,26(12),pp.34-40.
Malone C (2000) Pressure sores in the labour ward. RCM Midwives
Journal,3(1),pp.20-3.
Malone ML, Rosen LB et al. (1998) Complications of acute myocardial infarction in
patients. American Journal of Cardiology,81(5),pp.638-41.
Manfredi PL, Breuer B et al. (2003) Pain assessment in elderly patients with severe
dementia. Journal of Pain & Symptom Management,25(1),pp.48-52.
Marchand AC and Lidowski H (1993) Reassessment of the use of genuine
sheepskin for pressure ulcer prevention and treatment. Decubitus,6(1),pp.44-47.
Marchette L, Arnell I and Redick E (1991) Skin ulcers of elderly surgical patients in
critical care units. Dimensions of Critical Care Nursing,10(6),pp.321-329.
Matthews Kirk P (1996) Pressure ulcer management following spinal cord injury.
Topics in Spinal Cord Injury Rehabilitation,2(1),pp.9-20.
Matzen S, Peschardt A and Alsbjorn B (1999) A new amorphous hydrocolloid for
the treatment of pressure sores: a randomised controlled study. Scandinavian
Journal of Plastic & Reconstructive Surgery & Hand Surgery,33,pp.13-5.

McCallon SK, Knight CA, Valiulus JP, Cunningham MW, McCulloch JM and
Farinas LP. (2000) Vacuum assisted closure vs saline-moistened gauze in the
healing of postoperative diabetic foot wounds. Ostomy/Wound
Management,46,pp28-32,34.
McDiarmid T, Burns PN, Lewith GT and Machin D (1985) Ultrasound in the
treatment of pressure ulcers. Physiotherapy,71,pp.66-70.
Meaume S (1999) A randomized controlled study to compare a sequential
treatment using alginate-CMC and hydrocolloid dressing or hydrocolloid dressing
alone in decubitus ulcer management. 9th European Conference on Advances in
Wound Management. Harrogate, UK, 9-11 Nov, 1999,p.11.
Meaume S, Van de Looverbosch D, Heyman H, Romanelli M, Ciangherotti A and
Charpin S (2003) A study to compare a new self-adherent soft silicone dressing
with a self-adherent polymer dressing in stage II pressure ulcers. Ostomy Wound
Melhuish et al. (1994) Circumference, area and volume of the healing wound.
Journal of Wound Care,3(8),pp.380-384.
Mendez-Eastman S (1998) When wounds won't heal. Rn,61,pp.20-24.
Meraviglia M, Becker H et al. (2002) Maintenance of skin integrity as a clinical
indicator of nursing care. Advances in Skin & Wound Care,15(1),pp.24-9.
Milward P, Siddle H and Bridgewater A (1995) A user evaluation on the Triple Care
cleanser and cream system examining impact on pressure ulcer incidence in a long
term care centre. In Proceedings of 5th European Conference on Advances in
Wound Management, Nov21-24. Harrogate, UK, 1995.
Minassian M, Lewis D, Chattopadhyay D, Bovill B, Duckworth G and Williams J
(1998) A comparison between single-dose fosfomycin trometamol (Monuril) and a
five day course of trimethoprim in the treatment of uncomplicated lower urinary
tract infection in women. Int J Antimicrob Agents,10,pp.39-47.
Moberg S, Hoffman L, Grennert ML and Holst A (1983) A randomized trial of
cadexomer iodine in decubitus ulcers. J Am Geriatr Soc,31,pp.462-5.
Mooney JF, Argenta LC, Marks MW, Morykwas MJ and DeFranzo AJ (2000)
Treatment of soft tissue defects in pediatric patients using the V.A.C. system.
Clinical Orthopaedics and Related Research,376,pp.26-31.
Morgan D (1993) Is there still a role for antiseptics? J Tissue Viability,3:80-4.
Morison M, Moffatt C, Bridel-Nixon J and Bale S (1997) Nursing management of
chronic wounds. 2nd edition. London:Mosby.

Morykwas MJ (1995) Effect of VAC therapy on total charge and length of stay of
patients in DRG 263: a 21 month analysis. 27th Annual Conference, Wound,
Ostomy and Continence Nurses 1995.
Morykwas MJ and Argenta LC (1993) Use of negative pressure to increase the rate
of granulation tissue formation in chronic open wounds. Annual Meeting:
Federation of American Societies for Experimental Biology 1993.
Morykwas MJ, Argenta LC, Shelton-Brown EI and Wyman McGuirt W (1997)
Vacuum-assisted closure: a new method for wound control and treatment: animal
studies and basic foundation. Annals of Plastic Surgery,38,pp.553-562.
Morykwas MJ (1998) External application of sub-atmospheric pressure and
healing: mechanisms of action. Wound Healing Society Newsletter,8.
Mosher BA, Cuddigan J, Thomas DR and Boudreau DM (1999) Outcomes of 4
methods of debridement using a decision analysis methodology. Advances in
Motta G, Dunham L, Dye T, Mentz J, O'Connell-Gifford E and Smith E (1999)
Clinical efficacy and cost-effectiveness of a new synthetic polymer sheet wound
dressing. Ostomy/Wound Management,45,pp.41-49.
Mulder GD, Altman M, Seeley JE and Tintle T (1993) Prospective randomized
study of the efficacy of hydrogel, hydrocolloid, and saline solution-moistened
dressings on the management of pressure ulcers. Wound Repair Regen,1,pp.21318.
Mulder GD, Taro N, Seeley J and Andrews K (1994) A study of pressure ulcer
response to low air loss beds vs. conventional treatment. J Geriatr
Dermatol,2(3),pp.87-91.
Muller E, van Leen MWF and Bergemann R (2001) Economic evaluation
collagenase-containing ointment and hydrocolloid dressing in the treatment of
pressure ulcers. PharmacoEconomics,19,pp.1209-16.
Mullner T, Mrkonjic O and Vecsei V (1997) The use of negative pressure to
promote the healing of tissue defects: a clinical trial using the vacuum sealing
technique. British Journal of Plastic Surgery,50,pp.194-199.
Munro BH, Brown L and Heitman BB (1989) Pressure ulcers: one bed or another?
Geriatric Nursing,10,pp.190-2.
Murdoch V (2002) Pressure care in the paediatric intensive care unit. Nursing
Standard,17(6),pp.71-6.
Mustoe TA, Cutler NR, Allman RM et al. (1994) A phase II study to evaluate
recombinant platelet-derived growth factor-BB in the treatment of stage 3 and 4
pressure ulcers. Arch Surg,129,pp.213-19.
Myers SA, Takiguchi S, Slavish S and Rose CL (1990) Consistent wound care and
nutritional support in treatment. Decubitus,Aug,3(3),pp.16-28.
Nasar MA and Morley R (1982) Cost-effectiveness in treating deep pressure sores
and ulcers. Practitioner,226,pp.307-10.
National Institute for Clinical Excellence (2003) Clinical Guideline 7; Pressure ulcer
prevention.NICE 2003.

Naylor IL (1999) Ulcer care in the Middle Ages. Journal of Wound Care,8,4,pp.208212.
Nelson M (2001) Pressure ulcer assessment and documentation: the beginning of
a plan of care. Journal of Legal Nurse Consultants,12(4),pp.22-5.
Nesselroth SM and Gahtan V (2000) Management of pressure ulcers in the home
care setting. Home Healthcare Consultant,7(4),pp.34-42.
Newton C (1993) On-line assessment. Nursing Times,89(25),Wound Care:62.
NHS Centre for Reviews and Dissemination (2001) Improving access to costeffectiveness information for health care decision-making. CRD6 Report, 2nd
edition.
Nixon J, Smye S et al. (1999) The diagnosis of early pressure sores: report of the
pilot study. Journal of Tissue Viability,9(2),pp.62-6.
Nixon J, Brown J and McElvenny D et al. (2000) Prognostic factors associated with
pressure sore development in the immediate post-operative period. International
Journal of Nursing Studies,37(4),pp.279-289.
Norris JR and Reynolds RE (1971) The effect of oral zinc sulfate therapy on
decubitus ulcers. J Am Geriatr Soc,19,pp.793-7.
North G and Booth A (1999) Why appraise the evidence? A case study of vitamin C
and the healing of pressure sores. Journal of Human Nutrition & Dietetics,12(3),pp.
237-244.
Norton D, McLaren R and Exon-Smith A (1962) An investigation of geriatric nursing
problems in hospital.1st edition. London:Churchill Livingstone.
Nussbaum EL, Biemann I and Mustard B (1994) Comparison of
ultrasound/ultraviolet-C and laser for treatment of pressure ulcers in patients with
spinal cord injury. Physical Therapy;74,pp.812-825.
Ohura T, Sanada H and Mino Y (2004) Clinical activity-based cost-effectiveness of
traditional versus modern wound management in patients with pressure ulcers.
Wounds A Compendium of Clinical Research & Practice,pp.157-163.
Oke S and Davies S (1995) A holistic approach to pressure sore management.
British Journal of Nursing,4(6),pp.319-20,322,339-40.
Oleske DM, Smith XP, White P, Pottage J and Donovan MI (1986) A randomized
clinical trial of two dressing methods for the treatment of low-grade pressure ulcers.
J Enterostomal Ther,13,pp90-8.
O'Meara S, Cullum N, Majid M and Sheldon T (2000) Systematic reviews of wound
care management: (3) antimicrobial agents for chronic wounds. Health Technology
Assessment,4(21),pp.3-107.
Oppenheim AN (1984) Questionnaire Design and Attitude Measurement. London,
Heinemen.
Orlando PL (1998) Pressure ulcer management in the geriatric patient. Annals of
Pharmacotherapy,32(11),pp.1221-7.

Ovington LG (1999) 1, 2, 3, s-t-r-e-t-c-h; vacuum enhances wound closure.
Advances in Wound Care, the 1999 Edition Source Book,pp.125-127.
Palmieri, B. (1992) Heterologous collagen in wound healing: a clinical study.
Dextranomer vs lyophilized collagen sponge. Int J Tissue React,14(Suppl),pp.21-5.
Papanikolaou P, Lyne P A and Lycett E (2003) Pressure ulcer risk assessment:
application of logistic analysis. Journal of Advanced Nursing,44(2),pp.128-36.
Parish LC and Collins E (1979) Decubitus ulcers: a comparative study.
Cutis,23,pp.106-10.
Parish LC and Joseph AW (1983) Decubitus ulcer: how to intervene effectively.
Drug Therapy Hospital Education,1983,8,pp.95-8.
Pase MN and Hoffman RG (1998) Selection and use of pressure ulcer riskassessment tools and treatment protocols in extended-care facilities in the
southwest. Journal of Wound, Ostomy, & Continence Nursing,25(1),pp.44-50.
Payne JF (1896) On an unpublished English anatomical treatise of the fourteenth
century. BMJ,1,pp.200-203.
Pedley G (1998) Prevention and management of pressure sores. Journal of
Community Nursing,12(11),pp.4.
Perier C, Granouillet R et al. (2002) Nutritional markers, acute phase reactants and
tissue inhibitor of matrix metalloproteinase 1 in elderly patients with pressure sores.
Gerontology,48(5),pp.298-301.
Peschardt A, Alsbjorn B and Gottrup F (1997) A comparative randomized study on
performance characteristics of a new hydrogel versus saline gauze for the
treatment of pressure sores. 6th European Conference on Advances in Wound
Management,p.283.
Philbeck TE, Whittington KT, Millsap MH, Briones RB, Wight DG and Schroeder
WJ (1999) The clinical and cost-effectiveness of externally applied negative
pressure wound therapy in the treatment of wounds in home healthcare medicare
patients. Ostomy/Wound Management. The Journal for Extended Patient Care
Phillips L (2000) Cost-effective strategy for managing pressure ulcers in critical
care: a prospective, non-randomised, cohort study. Journal of Tissue Viability,10(3
su),pp.2-6.
Pierce GF, Tarpley JE, Allman RMG, P.S., Serdar CM and Morris B (1994) Tissue
repair processes in healing chronic pressure ulcers treated with recombinant
platelet-derived growth factor BB. RPDGF-BB 100 micrograms/ml x rPDGF-BB 300
micrograms/ml x placebo. Am J Pathol,145,pp.1399-1410.
Pittl G, Milnes M, McMackin S, Boughey F and Fako W [1998] A multi-phase, open
label, randomized, parallel comparative study of two hydrocolloid dressings on
patients with stage II and stage III exudating pressure ulcers. Comfeel Plus
dressing vs Duoderm CGF. Poster presented at the Wound Ostomy and
Continence Nurses Annual Conference.
Plassmann P and Jones TD (1998) MAVIS: a non invasive instrument to measure
area and volume of wounds. Medical Engineering & Physics,20,pp.332-338.

Pontieri-Lewis V (1995) Focus on wound care. Pressure ulcers: assessment to
evaluation. MEDSURG Nursing,4(3),pp.220-1.
Pontieri-Lewis V (1995) Pressure ulcers: assessment to evaluation. MEDSURG
Nursing,4(3),pp.220-1.
Prescott Jr WA and Regal RE (2003) Pressure ulcers: what to think when giving
zinc. P & T,28(7),pp.473-474.
Preston KM (1987) Dermal ulcers: simplifying a complex problem of pressure
sores. Journal of Gerontological Nursing,12(7),pp.11-16.
Price P, Bale S, Crook H and Harding KG (2000) The effect of a radiant heat
dressing on pressure ulcers. Journal of Wound Care,9,pp.201-5.
Prior J (2002) The pressure is on: midwives and decubitus ulcers. RCM Midwives
Journal,5(5),pp.196-200.
Pullen R, Popp R, Volkers P and Fusgen I (2002) Prospective randomized doubleblind study of the wound-debriding effects of collagenase and
fibrinolysin/deoxyribonuclease in pressure ulcers. Age & Ageing,31,126-130.
Ratliff CR and Rodeheaver GT (1999) Pressure ulcer assessment and
management. Lippincott's Primary Care Practice, 3(2),pp.242-58.
Rawcliffe C (1995) Medicine and Society in Later Medieval England. Stroud:
Sutton.
Reed RL, Hepburn K, Adelson R et al. (2003) Low serum albumin levels, confusion
and fecal incontinence: are these risk factors for pressure ulcers in mobilityimpaired hospitalized adults? Gerontology,49,pp.255-259.
Rees RS, Robson MC, Smiell JM and Perry BH (1999) Becaplermin gel in the
treatment of pressure ulcers: a phase II randomized, double-blind, placebocontrolled study. Wound Repair & Regeneration,7,pp.141-7.
Rhodes RS, Heyneman CA, Culbertson VL, Wilson SE and Phatak HM (2001)
Topical phenytoin treatment of stage II decubitus ulcers in the elderly. Annals of
Pharmacotherapy,35,pp.675-81.
Ribbons RM and McKenna LG (1997) Facilitating higher order thinking skills in
nurse education: a prototype database for teaching wound assessment and
management skills. Studies in Health Technology & Informatics,46,pp.389-92.
Richardson G, Wonderling D, Simon J, Wailoo A, Douglas H-R, Culyer A, Tsuchiya
A, Roberts J and Drummond MF, on behalf of Health Economists in Guidelines. In
National Institute for Clinical Excellence (2004) Guideline Development Methods.
Information for National Collaborating Centres and Guideline Developers. London.

Riet ter G, van Houtem H and Knipschild P (1992) Health care professionals views
of the effectiveness of pressure ulcer treatments. A survey amongst nursing home
physicians, dermatologists, and nursing staff in the Netherlands. Clinical Exp
Dermatology,17,pp.328-31.
Rippon MG, Springett K and Walmsley R (1999) Ultrasound evaluation of acute
experimental
and
chronic
clinical
wounds.
Skin
Research
and
Technology,5,pp.228-236.
Ritz MC, Gallegos R, Canham MB, Eskalai M and George FR (2002) PROVANT
Wound-Closure System accelerates closure of pressure wounds in a randomized,
double-blind, placebo-controlled trial. Annals of the New York Academy of
Sciences,961,pp.356-9.
Robson MC, Phillips LG, Heggers JP, McPherson MA and Heiner LS (1991)
Clinical studies on growth factors in pressure sores: preliminary report. Prog Clin
Biol Res,365,pp.95-102.
Robson MC, Phillips LG, Thomason A et al. (1992) Recombinant human plateletderived growth factor-BB for the treatment of chronic pressure ulcers. Ann Plast
Surg,1992,29,pp.193-201.
Robson MC, Phillips LG, Lawrence WT et al. (1992) The safety and effect of
topically applied recombinant basic fibroblast growth factor on the healing of
chronic pressure sores. Ann Surg,216,pp.401-6.
Robson MC, Abdullah A, Burns BF et al. (1994) Safety and effect of topical
recombinant human interleukin-1 beta in the management of pressure sores.
Wound Repair Regen,2,pp.177-81.
Robson MC, Maggi SP, Smith PD, Wassermann RJ, Mosiello GC, Hill DP et al.
(1999) Original articles: ease of wound closure as an endpoint of treatment
efficacy.[comment]. Wound Repair & Regeneration,7,pp.90-6.
Robson MC, Hill DP, Smith PD et al. (2000) Sequential cytokine therapy for
pressure ulcers: clinical and mechanistic response. Annals of Surgery,231,pp.60011.
Ronda L and Falce RL (2002) Skin care in older people. Primary Health
Care,12(7),pp.51-7.
Rook J L (1996) Wound care pain management. Advances in Wound Care,9(6),pp.
24-31.
Rook JL (1997) Wound care pain management. Nurse Practitioner,22(3),pp.1226,131,134-6.
Rosenthal MJ, Felton RM, Hileman DL, Lee M and Friedman M (1996) A
wheelchair cushion designed to redistribute sites of sitting pressure. Arch Phys
Med Rehabil,77,pp.278-82.
Russell L, Taylor J et al. (1998) Development and validation of the Burton Score: a
tool for nutritional assessment. Journal of Tissue Viability,8(4),pp.16-22.
Russell L (2000) Malnutrition and pressure ulcers: nutrition assessment tools. (37
refs). Br J Nursing,9(4),pp.194-204.
Russell L, Reynolds TM, Carr J, Evans A and Holmes M (2000) Randomised
controlled trial of two pressure-relieving systems. Journal of Wound
Care,9(2),pp.52-55.

Russell L, Reynolds TM, Towns A, Worth W, Greenman A and Turner R (2003)

Randomized comparison trial of the RIK and the Nimbus 3 mattresses. British
Journal of Nursing,12(4),pp.254-259.
Russell L, Nebbioso G, Munter KC, Beele H and Basse PB (2004) The CONTOP
study: a hydro-activated silver-containing foam dressing versus standard care,
WUWHS meeting, Paris, July 2004.
Rycroft-Malone J and McInnes E (2000) Pressure ulcer risk assessment and
prevention. Technical Report. RCN: London.
Sae-Sia W and Wipke-Tevis D (2002) Pressure ulcer prevention and treatment
practices in inpatient rehabilitation facilities. Rehabilitation Nursing,27(5),pp.192-8.
Sayag J, Meaume S and Bohbot S (1996) Healing properties of calcium alginate
dressings. J Wound Care,5,pp.357-62.
Saydak SJ (1990) A pilot test of two methods for the treatment of pressure ulcers. J
Enterostomal Ther,17,pp.140-2.
Schnelle JF, Ouslander JG et al. (1993) Nighttime sleep and bed mobility among
incontinent nursing home residents. Journal of the American Geriatrics
Society,41(9),pp.903-9.
Schnelle JF, Adamson GM, Cruise PA et al (1997) Skin disorder and moisture in
incontinent nursing home residents: intervention implications. Journal of the
American Geriatric Society,45(10),pp.1182-1188.
Schnelle JF, Cruise PA et al. (1998) Individualizing nighttime incontinence care in
nursing home residents. Nursing Research,47(4),pp.197-204.
Schoonhoven L, Defloor T, van der Tweel I et al (2002) Risk indicators for pressure
ulcers during surgery. Applied Nursing Research,16(1),pp.163-173.
Schubert V, Perbeck L et al. (1994) Skin microcirculatory and thermal changes in
elderly subjects with early stage of pressure sores. Clinical Physiology,14(1),pp113.
Schue RM and Langemo DK (1998) Pressure ulcer prevalence and incidence and
modifications of the Braden scale for rehabilitation unit. Journal of Wound Ostomy
and Continence NURSE,25(1),pp.36-43.
Schulz KF, Chalmers I, Hayes RJ and Altman DG (1995) Empirical evidence of
bias dimensions of methodological quality associated with estimates of treatment
effects in controlled trials. Jama,273,pp.408-412.
Schwarzl F, Moshammer H and Haas F (1998) Treatment of pressure ulcers with
V.A.C. Acta Chir Austriaca,150,pp.:8-9.
Scott F and Newens A (1999) Hospital monitoring of pressure ulcers in the UK.
Journal of Wound Care, 8(5),pp.221-4.
Scotts A. et al (2001) An instrument to measure healing in pressure ulcers:
developmemt and validation of the pressure ulcer scale for healing (PUSH).
Journal of Gerontology,56A,12,pp.795-799.

Seaman S, Herbster S, Muglia J, Murray M and Rick C (2000) Simplifying modern
wound management for nonprofessional caregivers. Ostomy Wound
Sebern MD (1986) Pressure ulcer management in home health care: efficacy and
cost-effectiveness of moisture vapor permeable dressing. Med Rehabil,67,pp.7269.
Sebern MD (1989) Cost and efficacy of pressure ulcer management in a
metropolitan visiting nurse association. Decubitus,2,pp.58-9.
Seeley J, Jensen JL and Hutcherson J (1999) A randomized clinical study
comparing a hydrocellular dressing to a hydrocolloid dressing in the management
of pressure ulcers. Ostomy Wound Management,45,pp.39-44, 46-7.
Seiler WO and Stahelin HB (1985) Decubitus ulcers: treatment through five
therapeutic principles. Geriatrics,40(9),pp.30-44.
Selkowitz DM, Cameron MH, Mainzer A and Wolfe R (2002) Efficacy of pulsed lowintensity ultrsound in wound healing: a single-case design. Ostomy/Wound
Senapati, AG, Jenner G and Thompson RPH (1989) Zinc in the elderly. Quarterly
Journal of Medicine,70(261),pp.81-7.
Shea JD(1975) Pressure sores: classification and management. Clinical
Orthop,112,pp.89-100.
Sheffet A, Cytryn AS and Louria DB (2000) Applying electric and electromagnetic
energy as adjunctive treatment for pressure ulcers: a critical review.
Ostomy/Wound Management,46,pp.28-44.
Shiraishi T, Oka R and Nakagawa Y. (1997) Pharmaceutical and bacteriological
study on povidone-iodine sugar ointment. Dermatology,195,pp.100-3.
Shubert V (1997) Measuring the area of chronic ulcers for consistent
documentation in clinical practice. Wounds A Compendium Of Clinical Research
& Practice,9(5),pp.153-9.
Shutler S, Stock J, Bale S, Harding KG, Squires D and Wilson I (1995) A multicentre comparison of a hydrocellular adhesive dressing (Allevyn Adhesive) and a
hydrocolloid dressing (Granuflex) in the management of stage 2 and 3 pressure
sores. In Conference Proceedings of 5th European Conference on Advances in
Wound Management, Nov 21-24. Harrogate, UK, 1995.
Smith DB and Lekan-Rutledge D (1997) Continence management and wound care
for a patient in a residential facility. Journal of Wocn,24(3),172-8.
Smith DM, Winsemius DK and Besdine RW (1991) Pressure sores in the elderly:
can this outcome be improved? J Gen Intern Med,6:81-93.
Smith LN (1996) Managing surgical wounds: a study report. Nursing Standard,10.
Smith-Temple J and Johnson JY (1998) Hospital extra. Clinical procedures.
Pressure ulcer management. AJN, American Journal of Nursing,98(2),Contin Care
Extra Ed:16D.

Song C and Tan KC (2000) Vacuum dressings in chronic wounds. First World
Wound Healing Congress: Australian Wound Management Association,p113.
Sopata M, Luczak J et al (2002) Effect of bacteriological status on pressure ulcer
healing in patients with advanced cancer. Journal of Wound Care,11(3),pp.107-10.
Specht JP, Bergquist S et al. (1995) Adoption of a research-based practice for
treatment of pressure ulcers. Nursing Clinics of North America,30(3),pp.553-63.
Spoelhof GD (2000) Management of pressure ulcers in the nursing home. Annals
of Long Term Care,8(8),pp.69-77.
Spooner R (1993) Managing a patient's multiple pressure sores. (Care of an
elderly demented woman with little mobility). Journal of Wound Care,2(3),pp.139141.
Sprigle S, Linden M et al. (2001) Clinical skin temperature measurement to predict
incipient pressure ulcers. Advances in Skin & Wound Care,14(3),pp133-7.
Sprigle S, Linden M et al. (2003) Analysis of localized erythema using clinical
indicators and spectroscopy. Ostomy Wound Management,49(3),pp.42-52.
Standards Of Reporting Trials Group. (1994) A propsal for structured reporting of
randomised controlled trials. JAMA,272,pp.1926-1931.
Stiller MJ, Pak GH, Shupack JL, Thaler S, Kenny C and Jondreau L (1992) A
portable pulsed elctromagnetic field (PEMF) device to enhance healing of
recalcitrant venous ulcers: a double-blind, placebo controlled trial. British J
Dermatol,127,pp.147-154.
Stoneberg C, Pitcock N and Myton C (1986) Pressure sores in the homebound:
one solution. American Journal of Nursing,April,pp.426-8.
Strauss MJ, Gong J, Gary BD et al. (1991) The cost of home air-fluidized therapy
for pressure sores. A randomized controlled trial. Journal of Family
Practice,33,pp.52-59.
Subramanian T, Vijayarathinam P, Sathyavan V, Navaneethakrishnan S,
Anugraham S, Anbalagan K et al. (1990) Effects of placental dressings in indolent
ulcers. J Ind Med Assoc,88,pp.314-16.
Sugarman B, Hawes S et al. (1983) Osteomyelitis beneath pressure sores.
Archives of Internal Medicine,143(4),pp.683-8.
Sugarman B (1987) Pressure sores and underlying bone infection. Archives of
Internal Medicine,147(3),pp.553-5.
Taylor A (2000) Managing pressure ulcers: the need for pain assessment.
Community Outlook,6(3),pp.45-6.
Taylor TV, Rimmer S, Day B, Butcher J, Dymock IW (1974) Ascorbic acid
supplementation in the treatment of pressure-sores. Lancet,Sep 7,2(7880),pp.5446.
ter Riet G, Kessels AG and Knipschild PG (1995) Randomized clinical trial of
ascorbic acid in the treatment of pressure ulcers. J Clin
Epidemiol,Dec,48(12),pp.1453-60.

ter Riet G, Kessels AGH and Knipschild P (1995) A randomized clinical trial of
ultrasound treatment for pressure ulcers. British Medical Journal,310,pp.1040-1.
The Weinberg Group (1999) Technology assessment of the V.A.C for in-home
treatment of chronic wounds. Washington, USA, The Weinberg Group Inc.
Theaker C, Mannan M, Ives N et al (2000) Risk factors for pressure sores in the
critically ill. Anaesthesia,55,pp.221-224.
Thomas DR, Goode PS, Tarquine PH , Allman RM (1996) Hospital acquired
pressure ulcers and risk of death. Journal of American Geriatric
Society,44,pp.1435-40.
Thomas DR, Goode PS, LaMaster K and Tennyson T (1998) Acemannan hydrogel
dressing versus saline dressing for pressure ulcers. A randomized, controlled trial.
Advances in Wound Care,11,pp.273-6.
Thomas DR (2001) Improving outcomes of pressure ulcers with nutritional
interventions: a review of the evidence. Nutrition,17,pp.121-125.
Thomas DR (2001) Age-related changes in wound healing. Drugs &
Aging,18(8),pp.607-20.
Thomas S and Fear M (1993) Comparing two dressings for wound debridement. J
Thomas S, Fear M et al. (1994) Assessment of patients with chronic wounds.
Journal of Wound Care,3(3),pp.151-4.
Thomas S, Banks V, Bale S et al. (1997) A comparison of two dressings in the
management of chronic wounds. Journal of Wound Care,6,pp.383-6.
Thomas S (2000) Alginate dressings in surgery and wound management - part 1. J
Thomas S (2000) Alginate dressings in surgery and wound management - part 2. J
Thornhill-Joynes M, Gonzales F et al. (1986) Osteomyelitis associated with
pressure ulcers. Archives of Physical Medicine & Rehabilitation,67(5),pp.314-8.
Toba K, Sudoh N, Nagano K, Eto M, Mizuno Y, Nakagawa H et al. (1997)
Randomised prospective trial of gentian violet with dibutyryl cAMP and povidone
iodine with sugar as treatment for pressure sores infected with methicillin-resistant
Staphylococcus aureus in elderly patients. Jpn J Geriatr,34,pp.577-585.
Torrance C (1983) Pressure sores: aetiology, treatment and prevention. Croom
Helm, London.
Touche Ross (1993) The cost of pressure sores. Touch Ross & Company:
London.
Tytgat H and Van Asch H (1988) Topical ketanserin in the treatment of decubitus
ulcers: a double blind study with 2% Ketanserin ointment against placebo. Adv
Ther,5,pp.143-52.

Unger PG and Raimastery S (1991) A controlled study of the effect of high voltage
pulse current on wound healing. Phys Ther,71,S119.
Unger PG (2000) Update on high-voltage pulsed. Current research and application.
Top Geriatr Rehabil,16,pp.35-46.
van de Berg JS, Robson MC and Mikhail RJ (1995) Extension of the life span of
pressure ulcer fibroblasts with recombinant human interleukin-1beta. Am J
Pathol,146,pp.1273-1282.
van Ort SR and Gerber RM (1976) Topical application of insulin in the treatment of
decubitus ulcers: a pilot study. Nurs Res,25,pp.9-12.
van Rijswijk L (1993) Full-thickness pressure ulcers: patient and wound healing
characteristics. Decubitus, 6(1),pp.16-21.
van Rijswijk L and Polansky M (1994) Predictors of time to healing deep pressure
ulcers. Ostomy Wound Management,40(8),40-2,44,46-8 passim.
Verhonick R (1961) Decubitus ulcers observations measured objectively. Nursing
Research,10(4),p.211.
Vesmarovich S, Walker T et al. (1999) Innovations in practice. Use of
telerehabilitation to manage pressure ulcers in persons with spinal cord injuries.
Advances in Wound Care,12(5),pp.264-9.
Viehbeck M, McGlynn J et al. (1995) Pressure ulcers and wound healing: educating
the spinal cord injured individual on the effects of cigarette smoking. Sci Nursing,
12(3),pp.73-6.
Walker P (2001) Management of pressure ulcers. Oncology
(Huntington),15(11),1499-508,1511;discussion1511,1515-6.
Walker TL, Kreutz D et al. (2002) On mobility. Planning for comfort: pressure ulcers
are a problem for people who use wheelchairs. Advance for Directors in
Rehabilitation,11(8),pp.21-2.
Waltman NL, Bergstrom N et al. (1991) Nutritional status, pressure sores, and
mortality in elderly patients with cancer. Oncology Nursing Forum,18(5),pp.867-73.
Weiss DS, Kirsner R and Eaglstein WH (1990) Electrical stimulation and wound
healing. Arch Dermatol,126,pp.222-25.
Wellard SJ (2001) An Australian experience of managing pressure ulcers in
persons with SCI. Sci Nursing,18(1),pp.11-7.
Whitney JD, Salvadalena G, Higa L and Mich M (2001) Treatment of pressure
ulcers with noncontact normothermic wound therapy: healing and warming effects.
Journal of Wound, Ostomy, & Continence Nursing,28,pp.244-52.
Williams DF, Stotts NA et al. (2000) Patients with existing pressure ulcers admitted
to acute care. Journal of Wound, Ostomy, & Continence Nursing,27(4),pp.216-26.
Willock J, Hughes J, Tickle S, Rossiter G, Johnson C and Pye H (1999) Pressure
sores in children the acute hospital perspective. Journal of Tissue
Viability,10(2),pp.59-65.

Willock J, Hughes J et al. (2000) Pressure sores in children the acute hospital
perspective. Journal of Tissue Viability,10(2),59-62.
Winter GD (1962) Formation of the scab and the rate of epithelialisation of
superficial wounds in the skin of the domestic pig. Nature,193,p.293.
Wollina U (1997) A hydropolymer dressing for chronic wounds: Clinical experiences
with 478 patients in an open multicenter trial. Anais Brasileiros de
Dermatologia,72,pp.527-532.
Wood JM, Evans PEd, Schallreuter KU et al. (1993) A multicentre study on the use
of pulsed low-intensity direct current for healing chronic stage II and stage III
decubitus ulcers. Archives of Dermatology,pp.999-1009.
Wongworawat MD, Schnall SB, Holtom PD, Moon C and Schiller F (2003) Negative
pressure dressings as an alternative technique for the treatment of infected
wounds. Clinical Orthopaedics & Related Research,414.
Worsley M and Buchanan L (1991) Comparing efficacies. This study compared two
products used in the treatment of leg ulcers and pressure sores. Nurs
Stand,5,pp.4-6.
Wu SH, Zecha PJ, Feitz R and Hovius SER (2000) Vacuum therapy as an
intermediate phase in wound closure: a clinical experience. European Journal of
Plastic Surgery,23,pp.174-177.
Wysocki AB (1996) Wound fluids and the pathogenesis of chronic wounds. Journal
of Wound Ostomy and Continence Nursing,23,pp.238-290.
Xakellis GC and Chrischilles EA (1992) Hydrocolloid versus saline-gauze dressings
in treating pressure ulcers: a cost-effectiveness analysis. Arch Phys Med
Rehabil,73,pp.463-9.
Yarkony GM (1994) Pressure ulcers: a review. Arch Phys Med Rehab,75,pp.908-1.

Appendices.

20 Cavendish Square London W1G ORN
The management of pressure ulcers in primary and

secondary care
Appendices
22 September 2005
This guideline has been developed by the Royal College of Nursing
Page 1 of 219

Appendices.
Appendix A: Evidence tables for holistic assessment review.

Study
Objective
Design/
Method
Population/Setting
Measurements
Results/Findings
Authors conclusions
Williams DF
et al (2000)
USA
To describe the
characteristics of
patients with pressure
ulcers present on
admission to the
hospital, and predictors
of pressure ulcer
presence and severity.
Prospective
cohort
267 adults admitted to a

Pacific Basin military hospital
who were expected to stay
for more that 24 hours.
Instruments:
Braden scale, portable vital sign
machine and pulse oximeter.
12.8% (34) of the 267 had a pressure ulcer.
Poorer nutritional status and decreased oxygen

perfusion were predictors of pressure ulcers on
admission. Nutrition and length of stay were
predictors of ulcer severity.
Demographic, physiological and

laboratory data were obtained.
Medical history and patient
acuity were recorded.
The Braden scale was higher for those

without a pressure ulcer (19.7) than for those
with (15.9).
Pressure ulcer group:
Lower albumin levels, total lymphocyte count,
haematocrit level, and haemoglobin levels.
Significantly longer length of hospital stay and
albumin p < .001 for ulcer severity.
Reviewers comments.
Paper was found to be of medium quality.
Patients are admitted to military hospital and may therefore be a specialised group of patients, and the results may not be generalisable to UK population.
While the paper reports to some extent on the effectiveness of the Braden Scale to predict patients with ulcers it does not report the significance of the assessment process or data.
Although factors associated with pressure ulcers (p<.01 on univariate analysis) were regressed and odds ratios calculated, they are not reported in this paper and the primary data is not available.
Page 2 of 219

Appendices.
Appendix A: Evidence tables for ulcer assessment review.

Study
Objective
Design/
Method
Population/Setting
Measurements
Results/Findings
Authors conclusions
Cutler NR et
al. (1993)
USA
To evaluate and
compare various
methodologies of
measuring the
characteristics of
pressure ulcers
namely area.
Prospective study
20 patients, 17 remained in the

study on completion.
Long term care facility.
California.
Ulcer size range: 1.2- 61.6cm2

All measurements detected a
significant change in wound size at the
week 4 assessment.
Significant changes in stratified wound
sizes were detected in all four
measurements with all methodologies
with the exception of photographic area
measurement in the 10cm2 group.
Statistically significant change in
wound size was detected earlier in
<10cm2 group than >10cm2 group
Wound volume (direct measurements)
detected significant wound closure at 4
weeks in both groups (p=.05).
Impression material estimations on
significant (p=.05) in the >10cm2 group.
Direct wound measurement, wound tracing and tracing

planimetry were the most sensitive methodologies for
detecting early changes in wound size.
Inclusion criteria:
Male or female with one or more
ulcers.
Ulcer judged as stage 3 or 4 and
approximate size of 2-150cm2 .
Patients with clinical signs of
infection in the ulcer, exposed
bone or cellulitis were excluded.
Baseline assessment. Weekly assessment

thereafter.
All assessments performed by the same
research nurse.
Duplicate measurements, tracings and
photographs were obtained at each week.
Direct measurement of the ulcer at the
bedside by longest length and longest width.
Depth measured as the deepest point of the
ulcer.
All measurements rounded to the nearest
millimeter.
Ulcer margins were traced onto a clear plastic
bag placed directly over a ruler.
A photograph was taken of each ulcer. 35
mm (Minolta) with a macro lens view included
a calibration ruler.
All measurements taken with patient in same
position.
Surface area was calculated from ulcer
dimensions.
Planimetric measurements were obtained
using the tracings.
3 measurements from each photograph and
tracing.
Volume estimated using impression material.
Reviewers comments
Paper was found to be of medium quality.
This is a small study with only n= 17 patients. Interpretation of these results should be made with caution.
All ulcer assessments were performed by the same research nurse.
Page 3 of 219

Appendices.
Study
Objective
Design/
Method
Population/Set Measurements
ting
Results/Findings
Authors conclusions
Griffin W et al.
(1993)
USA
To compare test-retest
reliability of measurements
obtained by the use of a
photographic methodology
and those obtained by use
of transparency
methodology, and to
compare wound surface
area measurements
obtained.
Prospective study
20 patients 18 male 2
female.
Aged 31 +/- 16 years.
Rehabilitation center
Memphis.
22 ulcers identified.
All pelvic region.
Ulcer size 688mm +/228mm.
Duration of ulcer 13+/26 weeks.
Test-retest reliability obtained

measuring 5 ulcers using both
methods and repeating
assessments after 1 hour. ICC=.99
No evidence of superiority found.

Methods found to provide equivalent information. Precision of
measurements improved using the mean of 3 measurements
as opposed to a single measurement.
3 photographs taken at each assessment using

35mm color Olympus camera.
Metric ruler was taped adjacent to the ulcer.
Distance between ulcer and camera 29.930.5cm.
Transparency placed over ulcer.
3 tracings made at each assessment.
Tracings generated from both methods were
digitalised.
Test- retest reliability obtained measuring

5 ulcers using both methods and repeating
assessments after 1 hour.
To compare the 2 methodologies all 22

ulcers were measured on a single
occasion.
To compare the 2 methodologies over

time 16 ulcers were measured at 5-day
intervals for 20 days.
Comparison of the 2 methodologies

all 22 ulcers were measured on a
single occasion. PCC=.99
Comparison of the 2 methodologies

over time 16 ulcers were measured
at 5 day intervals for 20 days.
Significant correlation r=.996-.999.
p=001
Reviewers comments
This study was found to of medium quality.
Interrater reliability not investigated in this study.
Location of wounds limited to pelvic area, results may not be representative for wounds in other locations.
Page 4 of 219

Appendices.
Study
Objective
Design/
Method
Population/Setting
Intervention/
Measurements
Results/Findings
Authors Conclusions
Houghton
PE (2000)
Canada
To examine the
validity and
reliability of using
photographs of
wounds to
accurately assess
wound status.
Prospective
study
13 patients with pressure

ulcers and 46 patients with
leg and foot ulcers.
Measurements performed by
trained health care professionals
including a nurse reactionary,
physician and a physical therapist.
Reliability
Total scores assigned by one trained rater
viewing 56 photographs of 13 pressure ulcers on
2 separate occasions ICC =0.96.
Intrarater reliability for scores assigned on 2
occasions for 81 photographs of 34 leg ulcers
ICC =0.86.
Wound size estimates from photographs ICC =
0.96.
Interrater reliability for pressure ulcers (from
score assigned by several raters that evaluated
the same set of photographs)
ICC =0.75.
Leg ulcers ICC = 0.83
Correlation for same observer for individual
domain r .0.75 with exception of skin colour r
=0.56.
Between raters correlation for six domains r.0.75
with exception of wound edges r =0.68.
Concurrent validity
PSST & PWAT
r =0.70 for PSST and r= 0.66 six domain PWAT.
Agreement of surface area calcs from PWAT
and wound tracings PSST ICC = 0.87.
Using the photographic wound

assessment tool to assess the wound
appearance provided interrater and
intrarater reliability score considered
to be excellent ICC>0.75. This was
using the PSST as a reference
standard which had ICC scores of
0.99 and 0.91 respectively in reported
studies.
Intrarater reliability was higher for
pressure ulcers than other wounds
within study.
Ulcers that had extensive

tunneling or undermining,
were too deep and could not
be fully visualized, or were
wrapped around the limb or
bony prominence, were
excluded from the study.
Photographs taken using an

Olympus OM-2 or Nikon FM-2
camera. Photographs were taken
in a range of light settings using a
macro lens. 15cm rule was place
next to wound with clear millimeter
divisions. Patient identification was
in the field of view.
Blinded assessment.
All patients received assessment
using the pressure ulcer status
tool.
Six parameters using photographs.
Wound edges
Necrotic tissue
type/amount
Skin colour
Granulation tissue type
Epithelialisation
Reviewers comments
This study was found to be of medium quality.
Reference standard used is PSST, not a generally accepted standard.
PSST designed for pressure ulcers, which may reflect positive results for pressure ulcers than other wounds within study.
Page 6 of 219

Appendices.
Study
Objective
Design/
Method
Population/Setti
ng
Intervention/
Measurements
Results/Findings
Authors conclusions
Shubert V
(1997)
Sweden.
To evaluate
pressure ulcer
surface area using
four different
methods of
measurement.
Not clear
Division of geriatric
medicine, University
Hospital Huddinge,
Sweden.
1.
373 different pressure ulcers

Length/ width significantly higher
31%, p ,0.001 compared with
reference standard. Largest error
being +21.5cm2
Counting number of whole squares
significantly lower value 13%, p
,0.001 compared with reference
standard. Largest error-7.3cm2.
Counting the number of whole squares (N0 and partial

squares (Nc) within the tracing area gives the best
estimate of wound size and can be easily used at the
bedside.
Direct measurement with

digital planimeter
2. Measurement of length and
width with millimeter ruler
3. Number of whole squares of
0.25cm2 within the outline.
4. Number of squares whole(N)
and partial (Nc) 0.25cm2
within the outline.
5. Estimate the effective
number of squares of
0.25cm2 within the tracing.
Planimeter was used as a
reference standard.
Counting number of whole and

partial squares inside the boundary
line. Deviation much smaller than
methods 2 & 3. +1% according to
the formula (N + 0.50xNc)x
0.25cm2.
After regression analysis the
above formula was amended to ( N
+ 0.45 xNc)x 0.25cm2 to give a
more accurate estimate as each
partial square was found to equal
0.45 cm2 as opposed to the
assumed 0.50cm2.
Reviewers comments
This study was found to medium quality.
Although 373 different ulcers assessed, no indication of number of participants.
Study design not clear.
Page 7 of 219

Appendices.
Study
Objective
Design/Method Population/Setting Intervention/

Measurements
Results/Findings
Authors conclusions
Plassmann
P and Jones
TD (1998)
UK
Compare the
performance of
the MAVIS
instrument to
measure area and
volume with three
traditional wound
measurement
techniques.
Controlled trial.
MAVIS gave overall better

results than those of the
other three methods.
MAVIS gave overall better results than those of the other

three methods.
50 patients
Excluded patients: those
with painful ulcers,
undermining, extremely
flexible and small ulcers,
and very large ulcers.
MAVIS is based on colour

coded structure light and is
recorded by a camera.
Measures area and volume.
Measurement of length of
wound using ruler, area using
transparency tracing and
alginate for wound volume.
Plastercast made of several
wound types and each
measured 20 times using
each technique to establish
precision.
Reviewers comments
This study was found to be of medium quality.
Few details of population.
Results presented in graphical format as a percentage SD of the respective dimensions without clear precise axis.
Page 8 of 219

Appendices.
Table of included studies:

Study
Methods
Participants
Interventions
Outcome measures
Della
Marchina
(1997)
RCT. Method of allocation

not stated. Trial duration:
15 days. Setting not
noted, Italy.
Patients aged > 64 years with

diabetic foot ulcers, venous leg
ulcers or pressure ulcers.
Wounds had to be classified as
first or second degree (not
defined). Excluded patients
sensitive to test medication or
receiving other treatment.
Intv (n=20): wounds were

cleaned with normal saline
and dried with gauze. 2%
eosin and 0.3%
chloroxylenol in
hydroglycolic solution
antiseptic spray was
applied to the wound
surface using gauze. The
wound was then covered
with gauze and changed
2-3 times/day. No details
of co-interventions (e.g.
pressure relief) given.
During study period,
treatment with other
antiseptics, antibiotics,
analgesics,
antinflammatory or
absorbing agents was
discontinued.
Ctrl (n=20): as intervention
group, except an
alternative spray (not
described) was used.
Healing progress, assessed

at 5, 10, 15 days. Wound
gradings: 0 = <25% healed
relative to baseline; 1 = 2550% healed relative to
baseline; 2 = > 50% relative
to baseline; 3 = complete
healing. No information
about methods of
measurement, or number of
assessors involved.
Notes
Blinding procedures
unclear. No power calcs
reported.
Page 9 of 219

Appendices.
Study
Gerding
(1992)
Methods
Participants
Interventions
Outcome measures
Notes
Double blinded RCT.

Random allocation lists
used (unclear whether
open or closed). Follow up
at 28 days or until lesion
resolution.
Geriatric residents of long-term

care facilities (USA) with one or
more newly diagnosed stage 1
or 2 pressure ulcers.
Stage 1: area of erythema that
persists for >30 mins after
pressure relief, no skin
breakdown, area does not
blanch or fade.
Stage 2: area of superficial
breakdown involving epidermis
and/or dermis, appears as an
abrasion, blister or shallow
crater.
Intv (n=55?): area washed

with soap and water,
DermaMend (oxyquinoline
ointment) applied 3 times
per day or whenever area
cleansed.
Ctrl (n=47?): area washed
with soap and water, A&D
ointment (a standard
emollient) applied, 3 times
per day or whenever area
cleansed.
No details re extent of
ointment application, type
of dressing or use of
pressure-relieving support
surfaces.
Complete healing,
improvement, no change or
worse. Lesions assessed
daily by blinded assessor.
Healing evaluated on basis
of change in lesion size,
intensity and extent of
surrounding erythema,
presence or absence of
drainage or granulation.
Time to complete healing.
Nurses' preferences for two
treatments (unblinded).
Approx. twice as many

patients allocated to
intervention than to control,
not known if this was
intentional. No details of
withdrawals. No power
calcs. Unit of allocation was
patients, unit of analysis
was lesions. Numbers
allocated to each group
unclear as possible overlap
because some patients had
both stage 1 and 2 lesions.
No intention-to-treat
analysis.
Page 10 of 219

Appendices.
Study
Huchon
(1992)
Methods
Participants
Interventions
Outcome measures
Notes
Multicentre, open RCT.

Method of random
allocation not stated.
Study setting: France, six
centres (1 surgical, 2
functional rehab, 3 elderly
care). Trial duration 56
days or until healing.
Patients with pressure ulcers

which were graded, after
debridement, as either stage 2
(loss of epidermal tissue) or
stage 3 (slough, or slough with
loss of substance). Exclusions:
diabetes, corticosteroid
treatment.
Mean age 81 years. Mean
Norton score 14.1 and 13.8 for
Intv and Ctrl groups
respectively. Predominantly
heel pressure ulcers.
Intv (n=38): lesions

cleaned with saline,
debrided with forceps if
necessary, then
applied (Granuflex,
ConvaTec). No antiseptics
used. Dressings changed
weekly or more often in
cases of excessive gel
leak.
Ctrl (n=38): cleaned as in
intervention group, then
dressed with gauze
impregnated with
povidone iodine ointment.
Dressings changed daily
or every other day.
Clinical assessment
classified into 4 stages: 1 =
healing or reepithelialisation of wound
area; 2 = improvement
(reduction in wound area or
ongoing granulation); 3 = no
change; 4 = deterioration.
Wound surface area
(tracing onto acetate and
photography).
No power calcs. Stated that

baseline characteristics
comparable but data not
given. Withdrawals not
reported.
Page 11 of 219

Appendices.
Study
Toba
(1997)
Methods
Participants
Interventions
Single centre RCT with

14-week follow-up period.
Study setting: inpatients,
Japan. Random number
tables used to generate
sequence. Unit of
allocation was pressure
ulcers.
Elderly women who had

suffered a stroke, with pressure
areas contaminated with MRSA
during the month preceding the
trial.
Exclusions: diabetes, malignant
tumour, respiratory disease,
liver or kidney disease,
prostaglandin, anticoagulant or
steroid therapy.
Mean age 83.5 years. Stated
similar prevalence of
underlying disease and
nutritional status, but no data
given. Baseline pressure ulcer
area: Intv 25.4 +/- 8.1 cm sq,
Ctrl 12.8 +/- 4.2 cm sq.
Intv (n=8 pressure ulcers):

ointment containing
gentian violet 0.1% was
blended with cAMP
ointment in equal
amounts, to produce
preparation called
GVcAMP, enough applied
to cover pressure ulcer,
every day.
Ctrl (n=11 pressure
ulcers): povidone iodine
(concentration not stated)
and sugar ointment
applied to pressure ulcers
every day.
Both groups: other
dressings and use of
pressure-relieving support
surfaces not described.
Outcome measures
Change in wound area
assessed fortnightly using
photography; method for
calculating percentage
change in area relative to
baseline not reported.
Eradication of MRSA,
assessed fortnightly using
wound surface cultures.
Notes
No power calcs. No details
of withdrawals or blinding
measures used reported.
Page 12 of 219

Appendices.
Study
Worsley
(1991)
Methods
RCT. Method of allocation
not stated. Trial duration:
12 weeks. Setting not
noted, UK.
Participants
Patients with leg ulcers or
pressure ulcers. Mean age 75
years (intv), 80 years (ctrl).
Interventions
Outcome measures
Notes
Intv (n=6): hydrocolloid

dressing applied
(Comfeel, Coloplast); no
other details given.
Ctrl (n=8): wounds
covered with povidone
iodine ointment, followed
by non-adhering dressing
and gauze.
Change in ulcer area

(calculated using
computerised photographic
techniques).
No reporting of power calcs

or blinding procedures.
Large (56%) drop-out rate
from study overall, unknown
number of withdrawals from
pressure ulcer patients.
Page 13 of 219

Appendices.
Table of included studies: adjunct therapies

Study
and
setting
Intervention
(I)
Topical negative pressure
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
Objective
outcome
measures /
results
Quality
assessment
notes
Primary:
% change in wound
volume over time
(using volume
displacement of
alginate impression
molds) 78%
reduction with TNP
vs 30% reduction
with saline gauze
dressings at 6
weeks (p=0.038).
It was not clear
whether mean or
median values were
provided. No
standard deviations
or ranges were
provided to go with
these figures. No
confidence intervals
were provided.
The authors stated
that follow up
beyond the 6-week
study period was
Files marked
with silver or
black labels on
the inside
panel were
randomly
organised in a
locked cabinet.
A file was
randomly
picked for each
wound with the
treatment
determined by
label colour. It
is not clear if
these files
were sealed so
the adequacy
of allocation
concealment is
unclear.
Withdrawals
Other notes
Placebo / standard care
(TNP)
Joseph
(2000)
Setting and
length of
treatment:
hospital,
nursing
home or
home
patients
with chronic
wounds
(associated
with
pressure,
dehiscence,
trauma,
venous
stasis or
radiation);
follow up at
3 and 6
weeks.
TNP (open cell

foam dressing with
continuous suction
(125 mm Hg)
changed every
48hours) (18
wounds).
Standard care:
both groups had
necrotic
tissue/debris
mechanically
debrided within 48
hours of initiation
of therapy; both
groups received
standard
nutritional
supplements
including zinc and
a multivitamin; and
a pressurerelieving surface.
Normal saline wet-tomoist gauze

dressings with
occlusive covering
used to secure
gauze changed 3x
daily (18 wounds).
24
pts
36
ulce
rs
Inclusion criteria: any

patient with an open
wound that had failed to
close or show signs of
healing within 4 weeks
or greater.
Exclusion criteria:
infection (urinary tract,
pneumonia, wound
infection); albumin
<3.0g/dl; renal,
pulmonary or other
chronic disease
requiring ongoing
therapy for stabilisation;
uncontrolled diabetes
mellitus, thyroid disease
or hypertension;
systemic steroids, other
immunosppressive
therapy or
anticoagulants; pregnant
or breast feeding;
osteomyelitis
(determined by bone
biopsy); considered
It is not clear how

many patients in each
arm had multiple
wounds.
There were no
statistically significant
differences with regard
to age (56 vs 49), and
the proportion of males
(66% vs 44%). Initial
wound volumes were
different in the two
groups (38cc in TNP
group vs 24cc in
control group).
The authors reported
that the two groups
were comparable at
baseline for ethnicity,
smoking status and
wound duration.
Neither the
patient nor
provider were
Partially funded with a

grant from KCI, San
Antonio, Texas.
No a priori sample size
calculation evident.
The authors appeared to
randomise and analyse
multiple wounds as if
they were independent
from each other which is
inappropriate when using
a between patients
design.
It was not reported if
there were any
withdrawals.
It was not made explicit
whether intention-to-treat
analysis was used.
The alternative
hypothesis was one
tailed, so presumably so
Page 14 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
uncooperative or
unsuitable candidates
for participating in
dressing changes by
investigators;
malignant/neoplastic
diseases in wound
margin; fistulas (rectal,
stomal or urethral
fistulas to the wound).
Objective
outcome
measures /
results
Quality
assessment
notes
Withdrawals
done until complete

wound closure was
demonstrated for
each patient - all
were offered
operative wound
closure for any
remaining open
wounds. This time
to complete healing
data was not
reported.
blind to the
treatment used
but outcome
assessors
were.
were the statistical tests.
Allocation
concealment
unclear.
Method of
randomisation
described as
random
allocation. No
a priori sample
size calcs.
Blinding of
treatment
allocation.
Allocation
concealment
unclear.
Method of
randomisation
reported as
randomly
assigned, no
other details.
No a priori
Theraputic ultrasound
McDiarmid
(1985 )
Placebo ultrasound
using same machine
but no pulse. Same
treatment frequency.
40
Patients with pressure

ulcers limited to
superficial tissues
Awaiting original
paper to assess
Number of ulcers
healed
1. 10/21 (48%)
2. 8/19 (42%)
Not significant
Standard wound care

(cleansing with
Hygeol (1:20),
Jelonet dressing and
avoidance of
pressure on the
area)
20
pts
Patients with a diagnosis

of spinal cord injury and
skin wound
Some baseline data

reported including age:
mean 42 years (gp 1),
42 years (gp 2), 36
years (control gp);
baseline wound area,
depth, duration and
aetiology reported.
These differences
reported as not
Number of ulcers
healed at 12 weeks
1. 4/6 (66%)
2. 6/6 (100%)
3. 5/6 (83%)
Nussbaum
(1994)
Setting and
length of
treatment:
hospitalised
spinal cord
patients;
treatment
3 MHz of
ultrasound for a
minimum of five
minutes for all
pressure ulcers up
to 3cm2. One
additional minute
was added for
each additional
0.5cm2, up to a
max of 10
minutes. Delivered
3x weekly.
1. Laser (800
cluster probe)
820nm laser diode
2. Ultrasound/
ultraviolet
treatment
alternated for 5
days a week
18
ulce
rs
Significant
difference between
1 and 2, p=0.032
Otherwise no
Other notes
The author was

contacted for missing
information but no reply
was received.
20 patients randomised
(laser n=6, US/UV n=5,
control n=9). 4
withdrawals: laser n=1
(transfer), US/UV n=0,
control n=3 (1 transfer, 3
surgical repair of wound).
Page 15 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
continued
until wound
healed.
ter Riet
(1995)
Setting and
length of
treatment:
nursing
home
patients;
treatment
for 12
weeks or
until healing
had
occurred.
Ultrasound of
frequency 3.28
MHz, pulse
duration 2ms,
pulse repetition
frequency 100Hz,
spatial average
temporal average
intensity 0.10
W/cm2, beam non
uniformity ratio *4
effective radiating
area 4cm2, given
5 times per week.
Detuned (sham)
ultrasound 5 x week.
88
Gentzkow
(1991)
Sham stimulation
(n=24)
Setting and
length of
treatment:
length of
treatment 4
Negative polarity
until wound
debrided and
serosanguinous
drainage
appeared) then
polarity alternated
every 3 days. 128
Both groups: 100%

received wound
cleansing with
normal saline and
dressing, 10%
49
Objective
outcome
measures /
results
significant.
significant
difference.
Patients with stage 2

pressure ulcers.
Limited reporting of
baseline
characteristics. Noted
that prognostic
baseline covariates
grouped in cogent
clusters and used in
the analysis to control
for confounders.
Number of ulcers
healed at 12 weeks
1. 18/45 (40%)
2. 19/43 (44%)
p=0.61
Inclusion criteria: stage

2, 3, or 4 pressure ulcer
Reported ulcers in the

intervention group
were larger at
baseline.
After four weeks

there was a mean
percentage ulcer
healing of 49.8%
(SD 30.9) in the
electrotherapy
group and a 23.4%
(SD 47.4) mean
All patients received

standard nursing
care including water
beds, repositioning,
wound care.
Electrotherapy
Baseline
characteristics
Quality
assessment
notes
sample size
calcs. Blinded
outcome
assessment.
Adequate
allocation
concealment:
ultrasound
support
surfaces had
20 codes
randomly
divided over
two treatment
groups.
Randomisation
was blocked
and stratified.
No a priori
sample size
calcs. Blinding
of patients,
clinicians and
outcome
assessors.
Withdrawals
Other notes
11 withdrawals (not
reported by treatment
group). Noted sensitivity
analysis where trend of
each drop out was
extrapolated using the
same group trend, and
deletion (i.e. omitting
such patients from the
analysis), and found no
difference in results.
Method of
randomisation
not stated.
Double-blind.
Adequate
allocation
concealment. A
priori sample
Page 16 of 219

Appendices.
Study
and
setting
weeks.
Griffin
(1991)
Setting and
length of
treatment:
20 days.
Intervention
(I)
pps, 35 mA, 0.89
coulombs per 30
min treatment. 2x
daily for 4 weeks.
When ulcer healed
to stage 2,
treatment at 64pps
and polarity
changed daily
(n=25)
Ultrasound at
frequency 100pps,
200V, negative
polarity, 1 hour
day x 20
consecutive days
(n=8).
Plus routine
dressings.
Pressure ulcer
cleansed using
Cara-Klenz
application of
Carrington gel and
a dry dressing.
Mechanically
debrided as
necessary.
Wood
(1993)
Setting and
length of
treatment:
Pulsed, low
intensity direct
current of 600 mA,
pulse frequency
0.8Hz. 3
applications
around each ulcer,
alternate days 3x
weekly. Larger
ulcers had one or
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
surgical or whirlpool
debridement, 100%
turning to relieve
pressure, 55% bed
rest and elevation of
an extremity.
Sham stimulation
plus routine dressing
as above (n=9).
17
All patients received

two-hourly turning.
No change of
mattress during the
study
Sham PLIDC, plus

standard treatment,
wound cleansing,
simple moist
dressing, whirlpool
baths. No
hydrocolloids, films
or foam dressings
were used (n=30
patients, 31 ulcers)
Inclusion criteria: male,

SCI, pressure ulcer
grade 2-4 of Delisa
system on
sacral/coccygeal or
gluteal/ischial region.
74
ulce
rs

2 or 3 chronic pressure
ulcers showing no
improvement with
standard nursing care
over preceding 5 weeks.
Exclusion criteria:
patients receiving
steroids, or other drugs
Quality
assessment
notes
percentage ulcer
healing in the sham
group (p=0.042).
size calcs
stated.
Mean ulcer size at day

0 (mm2) (range)
I: 234.1 (126-1027)
C: 271.8 (41-4067)
3/8 (37.5%) ulcers

healed in the
electrotherapy
group compared
with 2/9 (22%) in the
control group (RR
1.69, 95% CI 0.377.67)
Method of
randomisation
not stated but
stratified by
grade of ulcer
and smoking
status.
Adequate
allocation
concealment.
No a priori
sample size
calcs. No
blinding.
Mean ulcer area (cm2)

I: 2.61
C: 1.91
p<0.05
25/ 43 (58%)
electrotherapy
group ulcers healed,
compared to only
1/31 (3%) in the
sham therapy group
(RR 18.02, 95% CI
2.58-126.01)
Method of
randomisation
not stated.
Double blind.
Adequate
allocation
concealment.
No a priori
sample size
calcs.
Exclusion criteria:
severe cardiac disease,
cardiac arrhythmia,
uncontrolled autonomic
dysreflexia, cardiac
pacemaker.
71
pts
Objective
outcome
measures /
results
Withdrawals
Other notes
Page 17 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
more additional
placements of
electrodes plus
standard treatment
(n=41 patients, 43
ulcers).
Ritz (2002)
Setting and
length of
treatment:
high-risk
patients,
setting not
stated.
Treatment
was for 12
weeks or
until ulcer
closure or
until
discharge
home,
whichever
occurred
first.
Provant wound
closure system
(uses
radiofrequency
stimuli to induce
fibroblast and
epithelial cell
proliferation),
active, twice daily
plus standard
care, n=16.
Inclusion /
exclusion criteria
Baseline
characteristics
Objective
outcome
measures /
results
Quality
assessment
notes
Wound closure at 6
weeks for stage 2
ulcers:
I: 8/8
C: 4/11
No a priori
sample size
calcs. Blinded
outcome
assessment.
Randomisation
procedure not
stated.
Withdrawals
Other notes
that influence wound

healing.
Sham stimulation:
standard care plus
twice daily treatment
with a Provant
support surface
transparently
modified so that no
treatment was given,
n=18.
49

2 or 3 pressure ulcers,
>18 years age.
Exclusion criteria:
change in Norton Risk
Assessment score >7
within 30 days,
osteomyelitis, immune
dysfunction or repeated
systemic infection,
cancer, concurrent
treatment with other
wound-healing support
surfaces (e.g. hyperbaric
oxygenation, electrical
stimulation).
?Mean wound area

(cm2):
Stage 2 ulcers:
I: 3.0
C: 4.4
Stage 3 ulcers:
I: 11.3
C: 4.4
?Mean age (years):
Stage 2 ulcers:
I: 72
C: 69
Stage 3 ulcers:
I: 75
C: 63
Wound closure at
12 weeks for stage
3 ulcers:
I: 4/8
C: 1/7
No reporting of
withdrawals.
?Mean (SD?)
wound closure
rates, stage 2 ulcers
(cm2/day):
I: 1.192 (0.20), n=8
C: 0.68 (0.17), n=11
?Mean (SD?)
wound closure
(cm2/day):
I: 1.29 (0.41), n=8
C: 0.36 (0.22), n=7
Not stated how
measurements were
assessed.
Electromagnetic therapy
Page 18 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comorosan
(1993)
1. Diapulse - local
application frequency 600pps,
peak power 6
(117V, 27.12
MHz), for 30
minutes 2x daily.
Hepatic
application - 400
pps, peak power 4
(117V, 27.12
MHz), 20 minutes
1x daily, following
initial treatment
(n=20)
Setting and
length of
treatment:
Salzberg
(1995)
Setting and
length of
treatment:
12 weeks
2. Conventional
therapy - H2O2
cleansing,
application of
talcum powder,
methylene blue in
solution,
tetracycline
ointment, plus
sham Diapulse
(n=5)
Electromagnetic
therapy
27.12MHz, pulse
repetition 80-600
pps, pulse width
65 microseconds,
per pulse power
range of 293 &
975 watts delivered through
wound dressing,
30 minutes
treatment 2 x daily
Comparator
(C)
Conventional
therapy (n=5)
30
No report of
concurrent pressure
relief.
Sham treatment as
above (n=15)
All ulcers dressed
with moist saline
gauze.
No report of
concurrent pressure
relief.
Inclusion /
exclusion criteria
Patients on an elderly
care unit with either one
grade two or grade three
pressure ulcer. Grading
system not defined.
Baseline
characteristics
Some elements
reported. Patients
were not matched at
baseline for ulcer size.
Objective
outcome
measures /
results
Number of ulcers
healed at 2 weeks
I1: 17/20
I2: 0/5
C: 0/5
Allocation
concealment
unclear. No a
priori sample
size calcs.
Blinded
outcome
assessment.
Randomisation
procedure not
stated.
Number of grade 3
pressure ulcers
healed at 12 weeks:
I: 3/5
C: 0/5
Adequate
allocation
concealment.
No a priori
sample size
calcs. Blinded
outcome
assessment.
Randomisation
procedure
unclear.
No report on patients'
mobility status.
30
Male inpatients with

spinal cord compression
and a grade 2 or grade 3
pressure ulcer. Grading
defined by authors.
Reported that patients

were not matched at
baseline for ulcer size.
Quality
assessment
notes
Grade 2 pressure
ulcers
I: median of 84%
healing
C: median 40%
healing
Withdrawals
Other notes
Page 19 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
Objective
outcome
measures /
results
Quality
assessment
notes
Withdrawals
Other notes
for 12 weeks
(n=15)
Page 20 of 219

Appendices.
Table of included studies: support surfaces

Study
Allman (1987)
Caley (1994)
Clark (1999)
Patients
Support surfaces (sample size)
Surgical patients aged 18 or over with

pressure ulcers. Patients expected to
be limited to bed/chair and in hospital
for a minimum of 1 week. Groups
appear well matched at baseline
including for baseline ulcer area.
1.
Acute care patients with existing

pressure ulcers and for whom an
enterostomal therapy nurse had
recommended low air loss therapy.
60% of participants were female; aged
42-98 (mean 76); average LOS 23.9
days; 87% Caucasian; average Norton
Score of 10. Baseline ulcer areas not
presented.
1.
33 patients in elderly care wards within

acute care hospitals, and nursing
homes. Age >65 yrs. Established
pressure ulcers over sacrum or ischial
tuberosities. Moderate-high risk of
developing further ulcers.
1.
Groups well matched for pressure

ulcer risk status, mobility, nutritional
status, continence at baseline.
All patients had an alternating

pressure system (Pegasus
Airwave) on their bed.
2.
2.
2.
Follow-up period
Healing of established ulcers
Notes
Air-fluidised therapy
(CLINITRON) (n=31)
repositioned every 4 hours.
Conventional treatment
(including two-hourly turns,
heel and elbow protectors,
mattresses) (n=34)
Low air loss bed (Monarch,
Mediscus) (n=23)
Low air loss overlay (SPR
Plus, Gaymar) (n=32)
Mean 13 days
(range 4-77)
Median change in total surface area of

ulcers:
1. -1.20
2. 0.50
Proportion of patients improved:
1. 22/31
2. 16/34
A priori sample size calculation. 90% follow up.

4 patients withdrew because of difficulty
transferring in and out of the air-fluidised bed.
Mean 24 days.
Median change in ulcer area measured

by multiplying ulcer length by ulcer
width:
2
1. 2.4 mm /day
2
2. 4.9 mm /day
Very little data provided; (median change in

area and range). Unclear (and unlikely) that
outcome assessment was blind to treatment
group. No description of co-interventions
except that routine skin care protocol applied
to both groups. N.B. only 55/93 (59%) of
patients randomised completed the study,
reasons for which are not completely clear
except that those discharged before the 3rd
week of the study were not included in
analysis (ie. those who improved quickest).
4 cell alternating air pressure

cushion (Pro-active 2,
Pegasus Airwave Ltd) (n=14).
Static air-filled dry flotation
cushion (ROHO, Quadtro,
Raymar Ltd) (n=11).
Not defined: until

ulcers healed:
1. Mean 58.6
days
2. Mean 43.7
days
Results reported for only 25 patients with

final outcomes.
Ulcers healed:
1. 3/14 (21.4%)
2. 5/11 (45.5%)
No statistically significant differences found,

but small sample size precludes ability to draw
definitive results.
24% attrition; no intention-to-treat analysis.
Superficial ulcers: mean (SD) rate of

change in surface area - cm sq / day:
1. 0.13 (0.37)
2. 0.27 (0.56)
Deep ulcers: mean (SD) rate of change
in volume - cm cubed / day:
1. 0.56 (0.86)
2. 0.49 (0.86)
Page 21 of 219

Appendices.
Study
Day (1993)
Devine (1995)
Patients
Hospitalised, adult patients with
existing stage 2-4 pressure ulcers.
Elderly patients in hospital admitted

with ulcers of grade 2 or above. Mean
age 82.5 years (69-98 yrs). More
people incontinent of urine in Nimbus
group; more people catheterised in
Airwave group.

1. Air suspension bed
(Therapulse, Kinetic
concepts). N=44.
2. Foam mattress overlay
(Geomatt, SpanAmerica).
N=33.
Wound care standardised for two
groups.
1. Nimbus I alternating pressure

mattress (n=22)
Modular with rows of figure of 8
shaped cells. Two sets of cells
are inflated and deflated over
10-minute cycle.
2. Pegasus Airwave alternating
pressure mattress (n=19)
Double layer mattress with a 3cell alternating cycle lasting 7.5
mins.
Follow-up period
Minimum 7 days

Mean ulcer size (SD) Stage 2 (initial end):
1. 12.7(3.2) - 7.3(3.2)
2. 10.0(3.9) - 5.3(2.1)
Notes
No p values given, but all analyses reported as
not statistically significantly different.
Comfort score results only completed by half
the subjects (Gp 1 n=20, Gp 2, n=21).
Stage 3/4 (initial / end):

1. 51.8(11.9) - 37.1(8.1)
2. 13.7(2.9) -12.4(3.5)
4 weeks
Mean comfort scores (SD):

1. 4.1 (1.3)
2. 3.7 (1.3)
Complete healing at 4 weeks:
1. 10/16
2. 5/14
Median rate of reduction in ulcer area:
2
1. 11cm /day
2
2. 8 cm /day
Allocation by random number list kept

separate from trial coordinator.
Withdrawal rates by group and reasons for
withdrawal stated. 11 patients (24%) died or
moved to other hospitals.
All patients were subject to the

standard hospital protocol for
wound dressings; details of this
are not provided.
Page 22 of 219

Appendices.
Study
Evans (2000)
Patients
12 hospital and 20 nursing patients,
>65 years with either grade 3 or 4
ulcer, or grade 2 ulcer and one or
more of the following: difficult to
reposition in bed, unable to tolerate 30
degree tilt, unable to move in bed, in
bed for >20hr/24hr, >108kg and bed
bound, undergone spinal anaesthetic.

1. NIMBUS 3 alternating
pressure mattress
replacement system (n=17)
2. APMRS for hospital patients
or alternating pressure
mattress overlay for nursing
home patients (n=15).
Turning and wound care
standardised for two groups.
Follow-up period
2 weeks.
Wound surface
area (WSA) was
calculated twiceweekly by
planimetry.
Notes
Median (range) absolute reduction in

WSA /day:
Hospital subjects:
2
1. 0.12 cm (0-0.21)
2
2. 0.08 cm (0.04-0.33)
All measures of wound surface area showed

no statistically significant differences.
Nursing home subjects:

2
1. 0.11 cm (0.04-0.41)
2
2. 0.05 cm (0-0.48)
Small study sample size means that

differences in clinical effectiveness cannot be
demonstrated.
Median (range) relative reduction in

WSA/day:
Hospital subjects:
1. 2.44% (0-7.14)
2. 1.34% (1.11-2.88)
Large proportion of patients did not complete

follow-up (11/20 in nursing home group, 75%
on hospital group). But intention-to-treat
analysis was undertaken.
The NIMBUS 3 patients had statistically

significantly higher comfort scores.
Nursing home subjects:

1. 1.57% (0.45-5.00)
2. 0.99% (0-2.54)
Median comfort scores:
Hospital patients:
1. 5 (very comfortable)
2. 4 (comfortable)
Ewing (1964)
Elderly patients, average age 72.5

years, confined to bed, with reduced
mobility in the legs due to neurological
disorder, or fixed joints, peripheral
vascular disease. No baseline data
given and baseline comparability not
described.
1.
Sheepskin under both legs

(n=18)
2. No sheepskin (n=18)
Both groups received 4-hourly
washing, drying, powdering of the
skin, light massage of pressure
points, bed cradle.
6 months.
Nursing home patients:

1. 5 (very comfortable)
2. 4 (comfortable)
Relief of redness and pressure ulcer
healing:
1. 14/18
2. 0/18
Mode of allocation unclear - stated as random

selection. Poorly designed and reported study.
Page 23 of 219

Appendices.
Study
Ferrell (1993)
Patients
Groen (1999)
Follow-up period
Low air loss bed (KINAIR)

(n=43)
2. 10cm convoluted foam
overlay on top of standard
foam mattress (n=41)
Both groups similar cointerventions as per standard care
ie. mobilisation as much as
possible; 2-hourly turning during
waking hours; avoidance of headof-bed elevation; avoidance of
dragging patients on sheets;
nutritional support; infection
control.
33-40 days
Patients from two surgical and two

medical wards who were: >18 years;
Waterlow score of 15-25; tissue
damage no greater than grade 1.
1. Profiling bed with a pressurereducing foam mattress/cushion

(n=50)
2. Flat-based bed with a pressurerelieving/redistributing
mattress/cushion (n=50)
5-10 days
Nursing home patients, >60 yrs with

pressure ulcer on trunk of grade 3I
(superficial cutaneous or
subcutaneous necrotic) or grade 4
(deep subcutaneous necrotic).
1.
4 weeks
Elderly nursing home residents with

multiple medical problems, and with
trunk or trochanter pressure ulcers
(Shea stage 2 or greater). Where
patient had multiple ulcers, larger ulcer
chosen as index ulcer. Patients
excluded if expected to survive less
than 1 month; if they had already
participated in the study; if surgery to
the ulcer was planned.
Groups appear well matched at
baseline including for ulcer area;
exception is patients in LAL Bed group
had significantly lower serum albumin.
Keogh (2001)

1.
Foam replacement mattress:

3 layers polyurethane foam
designed to be a comfort,
load-distributing and support
layer. N=60
2. Secutex water mattress:
placed on top standard
hospital mattress, 3 PVC
sections holding 26 litres
water each, with heating
element. N=60.
Standard turning protocol (every 23 hours) for both groups.
Notes
Wound surface area was traced 2x per

week on plastic film and area measured
using planimetry.
Randomisation in blocks of 10; 5 to each

treatment. Assignments were sealed in
individual envelopes and opened sequentially.
Ulcers completely healed (covered with

epithelium):
1. 26/43 (60%)
2. 19/41 (46%)
A priori sample size calculation; study

terminated at interim analysis as difference
much larger than expected.
Median (IQR) decrease in ulcer area

2
(mm /day):
1. 9.0 (4.0-19.8)
2. 2.5 (0.5-6.5)
Not clear how many randomised therefore,

while numbers and reasons for withdrawal are
listed, it is impossible to calculate attrition
rates.
Healing of existing grade 1 ulcers

1. 4/4
2. 2/10
The extent of follow-up difficult to ascertain.
Patients with healed ulcers at 4 weeks:

1. 45%
2. 48%
Authors noted that water mattresses are heavy

and difficult to transport, are potentially
unhygienic and may induce hypothermia.
Mean pressure ulcer severity score at 4

weeks (SD not given):
1. 1.1
2. 1.7
Withdrawals: 11 from Group 1, 8 from Group

2, but not stated at which timepoints
withdrawals occurred. Reasons for
withdrawals included severe illness and
discharge.
Ulcers reported to have improved at the

same rate in each group.
No difference between the groups in terms of

transferring in and out of bed.
No intention-to-treat analysis
No significant differences at four weeks

reported for pain, maceration or eczema.
Page 24 of 219

Appendices.
Study
Mulder (1994)
Patients
Follow-up period
49 nursing home patients with stage 34 pressure ulcers. Single centre trial.
1. Air suspension bed

(Therapulse, Kinetic
concepts): a pulsating air
suspension therapy (cushions
alternatively inflate and
deflate but classed as LAL
rather than AP). N=31.
2. Convoluted foam mattress
overlay (Geomatt,
SpanAmerica). N=18.
Maximum 12
weeks or until
ulcers healed,
whichever first.

Wound closure:
1. 5/31 (16.1%) if intention-to-treat
analysis undertaken
2. 3/18 (16.6%)
Wound surface area assessed by

photoplanimetry. Ulcer volume = ulcer length x
width x depth (of deepest ulcer point).
Pressure ulcer improvement (by stage 1

or more, including healed completely):
1. 15/31 (48%)
2. 8/18 (44%)
No intention-to-treat analysis. Enrolled 49: 10

dropped from study (no reasons given), 8 died,
1 lost to follow up, 1 dropped due to protocol
violation. No information from which groups
withdrawals came from.
Wound care and repositioning

standardised for two groups.
Munro (1989)
40 male patients, mean age 67.2 yrs,

from Veterans Administration Medical
Center, with grade 2-3 pressure
ulcers.
1. Air-fluidised bed (Clinitron).

N=20.
2. Standard bed plus usual
nursing measures such as
sheepskin or gel pads placed
beneath pressure ulcers.
N=20.
Notes
No explanation of why stated 1:1

randomisation ratio resulted in such
disproportionate groups.
15 days
Average ulcer diameter at day 15:

2
1. 1158mm (from baseline average of
2
2660mm )
2
2. 2051mm (from baseline average of
2
1464mm )
i.e. mean size of ulcers shrank over time
in the Clinitron group and expanded over
time in the standard care group.
Mean patient satisfaction score (n=18
only):
1. 57.5 (SD 6.1), n=8
2. 48.6 (SD 12.3), n=10
p=0.067
No statistically significant difference in patient

pain perception, nursing time.
No economic evaluation undertaken.
Assessed cost of supplies used to treat ulcers
(significantly less in Clinitron group) but no
cost-benefit analysis that included cost of beds
themselves or bed-related supplies or
maintenance costs.
Methods of randomisation and allocation
concealment not stated.
Final ulcer area as % of baseline area:

1. 44%
2. 140%
Mean (SD) nursing time (minutes per 8
hour shift):
1. 95 (48)
2. 75 (35)
Page 25 of 219

Appendices.
Study
Russell (2000)
Patients
141 patients from care of the elderly
units with pressure ulcer of >grade 2.
Enrolled over 18 months during 19978. Average age 83.9 and 84.6 years in
the two groups.
N.B. Patients excluded if randomised
equipment unavailable (not stated how
often this occurred).

Two types of alternating cell
mattress systems with pressurerelieving cushions:
Follow-up period
18 months.
Unclear re length
of the intervention
period.
1. Huntleigh Numbus 3 with Aura

cushion and 4 hourly turning.
N=70.
2. Pegasus Cairwave Therapy
System with Proactive 2 seating
cushion and 8 hourly turning.
N=71.

Ulcer healing - any type:
1. 65/71 (91%)
2. 65/70 (93%)
No differential difference in losses to follow up

between the groups: 13/70 in Gp1, 16/71 in Gp
2.
Sacral ulcer healed:

1. 32/71 (45%)
2. 36/70 (51%)
Denominators listed in Table 2 of results (Gp

1:71, Gp 2: 70) appear different from abstract
(Gp 1: 70, Gp 2: 71).
Heel ulcer healing (at 12 months, N=86:

1. 13/40 (33%)
2. 26/46 (57%)
p=0.025
Insufficient information on outcome

measurements. Ulcer healing was recorded by
weekly camera and nurse gradings - called
improvement factor.
No information on randomisation processes or
allocation concealment.
No control group used.
Heel ulcers (at 18 months, N=113:

1. 19/58 (33%)
2. 30/55 (55%)
p=0.019
Russell (2003)
158 patients with grade 1 or 2

pressure ulcers admitted to hospital
between April 2001 and April 2002.
Mean age 80 years. Baseline
Waterlow scores 21.8 and 21.3 in
each group. Baseline Burton scores
14.6 and 14.2 in each group.
Excluded patients previously enrolled
in the trial, obese patients (>25 stone),
those with > grade 3 ulcers.
Patients well matched at baseline.
1. Nimbus 3 alternating pressure,

multicell mattress with 10
minute cycle time (n=83).
2. RIK static, fluid overlay mattress
(n=75).
All patients had standard 4 hourly
re-positioning, but could have
additional turning at the patients
request. The effect of this cointervention on treatment effect is
unclear.
Unclear,
presumably until
discharge from
enrolment
hospital.
Notes
Improved ulcer response - overall

1. 60/83 (72.3%)
2. 56/75 (74.750 p=0.67
Improved ulcer response - worst ulcer
1. 63/83 (75.9%)
2. 63/75 (84.0%) p=0.053
Length of stay
1. 22.17 days
2. 20.05 days p=0.23
Robust randomisation and allocation

concealment methods. Power calcs stated.
No blinding of treatment allocation to patients
or clinicians described. Blinded photographic
assessment of ulcer grading was carried out.
Enrolled 199 patients, excluded 41 from
analysis as discharged before more than one
outcome assessment could be made.
No information re reliability, specificity or
sensitivity for identification and/or classification
of ulcers.
Page 26 of 219

Appendices.
Study
Strauss (1991)
Patients
People with at least one grade 3 or 4

pressure ulcer (Shea classification);
who would probably require future
hospitalisation for the pressure ulcer;
who had severely limited mobility; for
whom home air-fluidised therapy was
a practical option; likely to comply; live
at least one year; aged 16 or over.
1. Home air-fluidised therapy

(CLINITRON) when grade 3 or 4
ulcers present plus the
consultative and technical services
of a visiting nurse specialist (n=47)
2. Conventional or standard
therapy, patient specific and as
prescribed (n=50) but included
alternating pressure pads, air-filled
mattresses, water-filled
mattresses, high-density foam
pads.
N.B. While baseline data were

presented by group for many
variables, baseline ulcer area was not
presented or discussed.
Follow-up period
36 weeks

Pressure ulcers classified by blinded
observers as improved; unchanged;
worse; or not assessable.
Proportion of patients improved:
1. 19/22
2. 9/13
Pressure ulcer-related hospitalisations
per patient - mean (SD):
1. 0.2 (0.5)
2. 0.6 (0.9)
Notes
Method of randomisation not stated.
7 AF patients and 17 standard therapy patients
had missing or uninterpretable pressure ulcer
photogaphs/nurse notes and could not be
reviewed for improvement by the blinded nurse
assessors (73% follow up).
Six air-fluidised beds had minor bead leaks
and seven overheated. Several patients noted
dry skin and one experienced mild
dehydration.
Pressure ulcer-related hospital days per

patient - mean (SD):
1. 3.6 (8.7)
2. 16.9 (30.6)
Page 27 of 219

Appendices.
Table of comparisons: dressings

Number of
trials
Number of
patients
1. topical agent vs no treatment

1.1 insulin vs no treatment
1
1
14
14
2. topical agent vs placebo

2.1 topical growth factor vs placebo
2.2 topical collagenase vs placebo
2.3 active cream vs placebo
9
7
1
1
405
356
28
21
3. topical agent vs topical agent

3.1 topical collagenase vs topical collagenase
3.2 topical collagenase vs other topical agent
3.3 dextranomer polysaccharide paste vs hydrogel
3.4 dextranomer polysaccharide paste vs collagenase
3.5 topical growth factor vs topical growth factor
7
1
2
2
1
1
548
92
163
175
25
93
4. topical agent vs traditional dressing

4.1 dextranomer polysaccharide paste vs standard tx
4.2 collagenase vs standard treatment
4.3 hydrogel vs gauze dressing
4.4 streptokinase enzyme prep vs zinc oxide gauze
7
4
1
1
1
197
109
20
40
28
5. topical agent vs modern dressing

5.1 polyhydroxyethyl methacrylate paste vs hydrocolloid
5.2 hydrogel vs hydrocolloid
5.3 collagenase vs hydrocolloid
5.4 dextranomer polysaccharide paste vs collagen sponge
5.5 dextranomer polysaccharide paste vs calcium alginate
7
1
3
1
1
1
444
43
254
43
12
92
6. modern dressing vs traditional dressing

6.1 hydrocolloid vs moistened gauze
6.2 hydrocolloid vs povidone iodine gauze
6.3 semi occlusive dressing vs moistened gauze
6.4 polyurethane dressing vs moistened gauze
6.5 hydrogel dressing vs moistened gauze
6.6 noncontact normothermic tx vs standard wound care
12
6
1
1
1
1
2
579
296
76
38
48
41
80
7. modern dressing vs modern dressing

7.1 hydrocellular dressing vs hydrocolloid dressing
7.2 hydrocellular dressing vs polyurethane foam dressing
7.3 hydrocolloid dressing vs calcium alginate dressing
7.4 hydrocolloid dressing vs polyurethane foam dressing
7.5 hydrocolloid dressing vs hydropolymer dressing
7.6 hydrocolloid dressing vs collagen dressing
7.7 hydrocolloid dressing vs change indicator dressing
7.8 hydropolymer dressing vs silicone dressing
7.9 hydrogel dressing vs hydrogel dressing
7.10 polyurethane foam vs low adherence dressing
7.11 radiant heat dressing vs alginate dressing
16
2
1
1
3
3
1
1
1
1
1
1
994
72
20
110
130
366
65
35
38
50
50
58
Comparisons
Page 28 of 219

Number of
trials
Appendices.
Number of
patients
8. modern dressing vs placebo

8.1 wound closure system vs placebo
1
1
49
49
All comparisons
60
3,230
Comparisons
Page 29 of 219

Appendices.
Table of included studies: dressings

Study
and
setting
Intervention
(I)
Comparator
(C)
Topical agent
No treatment
van Ort
(1976) [5]
C: All participants
received routine
supportive nursing
care including
position changes,
increased fluid
intake, high protein
diet, and local
massage. Only
patients in the
treatment group
received insulin
therapy, n = 8.
Setting and
length of
treatment:
nursing
home.
Treatment
continued
for 15 days.
I: Topical
application of ten
units of U-40
regular insulin
(USP) twice a day
for 5 days. Insulin
was dropped from
a syringe and
exposed to the air
to dry. No dressing
was applied, n = 6.
14
Inclusion /
exclusion criteria
Inclusion criteria:
Decubitus ulcers; skin
break due to
pressure, evidence by
epidermal injury
involving
erythema, pallor,
cyanosis and
superficial erosion.
Size of ulcer between
1.0 cm and 7.0 cm.
Skin breakdown in
existence 14 days or
less prior to
admission to study.
Exclusion criteria: Not
stated.
Topical agent
Placebo
Lee (1975)
[6]
Placebo (heatinactivated Santyl)

applied in the same
proportions as for I, n
= 11.
Setting and
length of
treatment:
Collagenase
enzyme
preparation
(Santyl) applied at
250 units per
gram of white
28
Inclusion criteria:
Patients with
advanced pressure
ulcers.
Exclusion criteria:
Baseline
characteristics
Area of wound: Not

stated.
Other characteristics:
mean age (years):
72.5 (all groups)
M:F 1:5 (I) 1:7 (C)
Authors state no
statistically significant
differences on a range
of other variables,
including body build,
blood glucose, fluid
and protein intake,
number and location of
ulcers, mobility,
incontinence, diabetes
mellitus, endocrine,
circulatory, digestive,
genitourinary or
musculoskeletal
disease, use of
antibiotics,
anticoagulants,
parenteral insulin, oral
hypoglycaernic,
steroids or vitamins.
Mean wound area

(cm2):
Not stated.
Mean wound volume
Objective
outcome
measures /
results
Quality
assessment
notes
Withdrawals
Other notes
Healing rate:
healing rate
favoured
intervention group
(p=0.05).
Primary data not
available.
Assessed by
photography.
No a priori
sample size
calcs. No
blinding.
Randomisation
procedure
stated.
No withdrawals.
Mean (SD) %
change in wound
volume:
I: +13.14 (59.8),
n=17
C: +78.79 (94.6),
No a priori
sample size
calcs. No
description of
blinding.
Randomisation
Withdrawals:
I: Patients were removed
from day 6 to day 30
(termination of the trial).
C: Patients were
withdrawn from day 3 to
Time to healing appeared

to depend on age,
number of pressure
ulcers, respiratory,
nervous system and
musculoskeletal disease
and mental disorder, and
antibiotic therapy, but the
results of significance
tests are not presented.
Page 30 of 219

Appendices.
Study
and
setting
Intervention
(I)
setting not
stated.
Patients
were
treated for
4 weeks or
until
complicatio
ns
developed
or the
patient
died.
Measureme
nts were
taken
weekly and
on
completion
of the
study.
petroleum, n = 17.
Le
Vassueur
(1991) [7]
Active cream
F14001 (extract of
barley plant at 1%
concentration in
cetomacrogol
cream base), n =
8.
Setting and
length of
treatment:
hospital and
nursing
home
patients.
Treatment
Comparator
(C)
Before application of
either treatment the
wound was washed
with sterile saline (pH
7.5). Each
application was
applied once daily to
each wound unless
more frequent
cleansing was
required because of
contamination from
incontinence of urine,
faeces or both. All
wounds were
covered with a sterile
gauze pad.
Placebo cream
(not stated), n = 13.
Inclusion /
exclusion criteria
Not stated.
Baseline
characteristics
(cm3):
I: 15.44 (19.92 SD)
C: 1.25 (1.62 SD)
All groups
Mean age (years):
67.6 (13.7 SD)
M:F ratio: 1:2.7
Baseline wound
volume is significantly
different between
groups (p < 0.01).
21
Inclusion
criteria:grade 1 and 2
pressure ulcers.
Exclusion criteria:
not stated.
11 patients with 28
advanced pressure
ulcers were included in
the study. All had
chronic disease and
were in poor physical
condition. Four had
neoplastic disease;
four had
atherosclerotic heart
disease or had a
cerebrovascular
accident, or both; two
had Parkinsons
disease; and one had
a femoral neck
fracture.
Ulcer size (cm2):
I: 9.6 (3.9 SD)
C: 9.0 (2.0 SD)
Age (years): 82.5 (I),
81.5 (C)
Norton score: 10.9 (I),
12.9 (C)
Duration (months): 7.6
(1), 3.5 (C)
Objective
outcome
measures /
results
n=11
Quality
assessment
notes
procedure not
stated.
Two diameters of
the wound
measured and a
colour photograph
taken. In addition
a volume mould was
made with Jeltrate
or Kerr No.1, and
the volume
determined by water
displacement.
Mean (SD) time to

healing (days):
I: 18.4 (12.4), n=8
C: 29.1 (13.0), n=13
Ulcer size: not
enough data given
at 4 weeks of
treatment to enable
meta-analysis, only
p<0.05.
Withdrawals
Other notes
day 10. No patient in this
group continued to be
treated after 10 days.
One wound treated with I
(enzyme) experienced
mild bleeding and a
burning sensation.
No a priori
sample size
calcs. No
description of
blinding.
Randomisation
procedure not
stated.
No statement of
withdrawals.
Assessed by weekly
Page 31 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
continued
for 6 weeks.
Rees
(1999) [8]
Setting and
length of
treatment:
14 USA
hospitals.
Treatment
continued
for 16
weeks or
until ulcer
completely
healed,
whichever
came first.
Objective
outcome
measures /
results
Quality
assessment
notes
Withdrawals
Other notes
photography.
rhPDGF-BB
Becaplermin gel
(all 3 formulae,
n=93)
I1: Growth factor
(rhPDGF-BB
100g/ml daily)
alternated with
placebo gel every
12 hours, n=31
I2: Growth factor
(rhPDGF-BB
300g/ml daily)
alternated with
placebo gel every
12 hours, n=32
I3: Growth factor
(rhPDGF-BB
100g/ml twice
daily), n=30
Placebo gel twice

daily, (n=31)
All patients:
debridement of
ulcers to remove
fibrin and necrotic
tissue, systemic
treatment of wound
infections, off-loading
pressure from
affected area,
maintenance of moist
wound environment,
nutritional support.
124
Inclusion criteria:
patients with 1-3
chronic (minimum 4
weeks of previous
treatment) full
thickness (stage 3-4)
pressure ulcers with
bone tissue
involvement; target
ulcer volume between
10-150ml after
debridement.
Exclusion criteria:
Albumin <2.5g/dl,
total lymphocyte
count <1000, vitamin
A or C levels outside
normal range;
osteomyelitis of
affected area; target
volume after
debridement <10 or
>150 ml; topical
antibiotics,
antiseptics, enzymatic
debriding agents used
within preceding
seven days; ulcers
due to electrical,
chemical or radiation
insult; patients with
cancer, concomitant
diseases (e.g.
connective tissue
disease), treatment
(eg radiation therapy)
or medication (e.g.
corticosteroids,
chemotherapy,
immunosuppressive
agents); women who
were pregnant,
Median (+ IQR) target

ulcer volume (ml):
I1: 16.6 + 15.1
I2: 17.2 + 19.7
I3: 17.6 + 33.8
C: 19.6 + 21.9
Mean (+ SD) age
(years):
I1: 48 + 13.1
I2: 49 + 12.5
I3: 51 + 18.3
C: 50 + 13.6
Complete healing:
I1: 7/31
I2: 6/32
I3: 1/30
C: 0/31
>90% healing:
I: 49/93 (all GF)
C: 9/31
No a priori
sample size
calcs. No
description of
blinding.
Randomisation
procedure not
stated.
No statement of
withdrawals.
Wound-related,
treatment-emergent
adverse events (no.
patients with an event):
I1: 2/31
I2: 6/32
I3: 9/30
C: 4/31
M:F ratio:
I1: 5.2:1
I2: 5.4:1
I3: 6.5:1
C: 4.2:1
Median (+ IQR)
duration (weeks):
I1: 22 + 32
I2: 33 + 40
I3: 22 + 52
C: 30 + 43
Page 32 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
Objective
outcome
measures /
results
Quality
assessment
notes
Withdrawals
Mean wound volume

(cm3):
C1: 10.8 13.2
I1: 5.5 6.1
I2: 7.1 8.8
Complete healing at
4 weeks:
I1: 4/16
I2: 3/14
C: 1/14
No withdrawals reported.
Healing at 5 mths:
majority remained
unhealed, no data
suitable for metaanalysis.
No a priori
sample size
calcs. Blinded
outcome
assessment
reported.
Randomisation
procedure not
stated.
No a priori
sample size
calcs. Blinded
outcome
assessment
reported.
Withdrawals: one patient

in placebo group
removed from trial
because of possible
neoplasm.
Other notes
breastfeeding or not
on acceptable birth
control.
Mustoe
(1994) [9]
Setting and
length of
treatment:
nursing
homes or
hospitals.
Treatment
for 28 days,
follow-up of
5 months.
Robson
(1992a) [10]
Setting and
length of
treatment:
I1: Growth factor

(rhPDGF-BB
100g/ml), n=15
C1: Placebo, n=14
41 pts
44
ulcers
I2: Growth factor

(rhPDGF-BB
300g/ml), n=12
Treatments
applied daily as a
topical spray, at a
volume of 10
ml/cm2. All
wounds dressed
daily with moist
saline gauze
dressings and
mechanically
debrided as
necessary during
treatment period.
Intermittent
pressure relief was
obtained through
turning regimens
according to
nursing home and
hospital routines.
Pressure-reducing
mattresses were
not used.
Growth factor (rbFGF at 3

concentrations:
100 g/ml (n=11)
500 g/ml (n=11)
1000 g/ml (n=12)
Inclusion criteria:
clinical confirmation of
grade 3 or 4 pressure
ulcers in adults, with
total surface area
between 4 and 100
cm2 and no evidence
of surrounding
cellulites or malignant
neoplasms in the area
of the ulcer or
elsewhere.
Exclusion criteria:
venous or arterial
ulcer implicated in the
cause of the ulcer;
existence of
significant endocrine
disease or malignant
neoplasms in past
5 years; use of
immunotherapy,
cytotoxic
chemotherapy or an
investigational drug or
drugs.
Mean age: 73.4 (C1),

73.5 (I1), 67.5 (I2)
M:F 1:1.8 (C1), 1:2.8
(I1), 1:1.4 (I2)
Duration (months): 2
(C1), 5.2 (I1), 3.9 (I2)
% of patients at grade:
III 21.4 (C1), 26.7 (I1),
25 (I2)
IV 78.6 (C1), 73.3 (I1),
75 (I2)
Location (%):
Ischium 29 (C1), 20
(I1), 17 (I2)
Sacrum 43 (C1), 33
(I1), 42 (I2)
Trochanter 21(C1), 27
(I1), 17 (I2)
Other 7 (C1), 20 (I1),
25 (I2)
Groups were also
comparable on
baseline laboratory
values e.g. blood
albumin, haemoglobin
and protein.
Placebo, not stated

(n=14)
All patients were
denervated in the
area of ulceration
50
Inclusion criteria:
Hospitalised patients
aged 1865 years,
ulcers between 10
and 200 cm2
Baseline data are only

present for all r-bFGF
groups combined
Initial ulcer size:
not stated, but
After 5 months follow-up,

the majority of ulcers
remained unhealed and
static in size.
Reduction in wound
area: after
adjustment for initial
wound size,
reported as no
significant
differences, primary
data not given.
Time to achieve
50% healing:
reported as p=0.22,
primary data not
given.
Assessed by
acetate moulding
and planimetry; time
to healing.
?Men % reduction in
wound volume:
I: 69%
C: 59% (no
measure of
precision)
Page 33 of 219

Appendices.
Study
and
setting
multicentre
trial of
hospitalised
patients.
Treatment
continued
for 22 days.
Robson
(1992b) [11]
Setting and
length of
treatment:
inpatient
setting.
Treatment
continued
for 28 days;
follow-up
for up to 5
months.
Intervention
(I)
Treatments given
at different
application
schedules, at a
dose volume of
1.01 ml/cm2.
Wound packed
with salinemoistened sterile
gauze changed
after 12 hours.
(Note: 35 patients
entered this arm of
the trial, but data
were only provided
for 34).
Growth factor rbFGF at 3

concentrations:
1 g/ml (n=4)
10 g/ml (n=4)
100 g/ml (n=5)
Treatment given
daily for 4 weeks
at a dose of 0.01
ml/cm2 of ulcer
surface. After
treatment the
wound was left
open to allow
absorption. Each
ulcer was packed
with sterile gauze
and closed with
Biobrane.
Comparator
(C)
because of
congenital or
acquired spinal cord
pathology.
Standard pressurerelieving support
surfaces were used
as appropriate.
Placebo, not stated

(n=7)
20
Inclusion /
exclusion criteria
Baseline
characteristics
extending from bone

to subcutaneous
tissue. Mechanical
debridement > 24
hours before
treatment. Normal or
clinically insignificant
abnormalities in
complete blood count,
coagulation, blood
chemistry, and
urinalysis.
reported that there

were no significant
group differences.
Exclusion criteria:
Arterial or venous
disorder, or wound
due to vasculitis;
clinically significant
systemic disease or
malnutrition; recent
steroidal therapy;
penicillin allergy.
Inclusion criteria:
Ulcers between 25
and 95 cm2 with fullthickness skin loss
(grade 3 or 4) or
penetrating to bony
prominence (grade 4),
with no past or
present evidence of
malignancy, with
mechanical
debridement of
necrotic tissue at least
two days prior, and
normal or clinically
insignificant results on
pretreatment blood
count, and
coagulation,
chemistry and
urinalysis.
No statistically
significant differences
were found between
baseline
characteristics
(Wilcoxon test). No
group differences in
ethnicity.
Exclusion criteria:
Arterial or venous
Age (years): 37.8 (I),
37.9 (C)
Duration (months):
17.7 (I), 25.9 (C)
Objective
outcome
measures /
results
> 70% wound
volume reduction:
I: 21/35
C: 4/14
Quality
assessment
notes
Randomisation
procedure not
stated.
Measured by
planimetry and
acetate moulding.
Mean wound volume

(cm3):
C1: 12.9 3.8 (range
5-33)
I1: 13.8 4.8 (range 526)
I2: 15.8 4.0 (range 928)
I3: 11.6 5.5 (range 433)
(Comparison of means
Other notes
Blinded observers
reported significant
differences in visual
improvement of overall
healing, favouring
r-bFGF (I1, I2,
I3). No statistical tests
reported.
Fibroblast and capillary
counts appear from a
histogram to favour rbFGF but the differences
appear small and no
statistical tests are
reported.
M:F 3.9:1 (all groups)
Mean wound depth

(cm):
C1: 2.8 0.4 (range
1.5-5.2)
I1: 1.7 0.5 (range
0.5-2.7)
I2: 1.6 0.6 (range
0.8-3.5)
I3: 2.8 1.0 (range
1.6-6.8)
by ANOVA: NS.)
Withdrawals
Mean (SD) %
reduction in wound
volume at 4 weeks:
I1 (1 g/ml): 63 (30),
n=4
I2 (10 g/ml): 55
(30), n=4
I3 (100 g/ml): 93.5
(8.9), n=5
C: 78.2 (14.8), n=7
Assessed using
wound gauge,
mould weight.
No a priori
sample size
calcs. Blinded
outcome
assessment
reported.
Randomisation
procedure not
stated.
Histological evaluation of
the tissue biopsies found
no treatment-related
group differences in
cellular influx or
extracellular matrix
deposition.
The 100 g/ml tended to
have greater fibroblastic
and endothelial cell
influx, but no data
presented.
Page 34 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
disorder resulting in
ulcerated wounds;
clinically significant
disease; significant
malnutrition; recent
use of steroidal
therapy;
immunotherapy or
cytotoxic
chemotherapy;
diabetes.
Robson
(1994) [12]
Setting and
length of
treatment:
inpatients.
Treatment
until healing
or
maximum
of 28 days.
Growth factor
interleukin I-beta
at 3 strengths
(n=18):
2
I1: 0.01 g/cm
2
I2: 0.1 g/cm
2
I3: 1.0 g/cm
2
0.01 ml/cm was

delivered by spray
after saline
cleansing.
Wounds were then
air-dried and
dressed with
saline-moistened
dressing, changed
12 hours later.
Treatment applied
C1: Placebo, not

stated (n=6)
All patients were
denervated in the
area of ulceration
because of
congenital or
acquired spinal cord
pathology.
Pressure-relieving
support surfaces
were used as
appropriate.
Patients on non air
fluidised beds repositioned every
2 hours.
24
Inclusion criteria:
Pressure ulcers
extending from the
bone to the
subcutaneous tissue
(grade 3/4 ulcers).
Exclusion criteria:
Significant renal,
hepatic, cardiac,
endocrine or
haematologic
disease, or neoplastic
disease producing
ulcerated wounds;
arterial or venous
disorders resulting in
ulcerated wounds;
systemic sepsis from
Baseline
characteristics
Objective
outcome
measures /
results
Quality
assessment
notes
?Mean % of initial
wound size by 4
weeks:
I1: 22
I2: 35
I3: 45
C1: 22
No a priori
sample size
calcs. No
description of
blinding.
Randomisation
procedure not
stated.
Withdrawals
Other notes
by ANOVA: NS.)
Wound duration
(months):
C1: 14.2 6.2 (range
1-37)
I1: 11.6 5.5 (range 327)
I2: 16 7.1 (range 436)
I3: 17.3 12.4 (range
4-67)
by ANOVA: NS.)
Age (years):
C1: 272 (range 2235)
I1: 40 8 (range 2156)
I2: 43 5 (range 3254)
I3: 29 4 (range 2145)
by ANOVA: NS.)
No statistically
were reported between
groups in race,
gender, tobacco use,
ulcer location, age,
height, weight, or ulcer
stage or size at
baseline.
No data are presented.
All pressure ulcers
were located on the
sacrum, ischium or
trochanter.
Measured by
photography,
planimetry and
acetate moulding.
Withdrawals:
I1: 1
I2: 0
I3: 1
C1: 0
Of the two withdrawals,
one left hospital before
completion of study and
one was withdrawn
because of osteomyelitis
at base of ulcer.
These were replaced;
unclear how this was
done.
Effect of treatment on
fibroblasts assessed but
not reported in detail.
Page 35 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
at three different
dosages of 0.01,
0.1 and 1.0 to six
patients per group
(total n = 18).
Robson
(2000) [13]
Growth factor 3
types:
2
Setting and
length of
treatment:
inpatients,
USA
hospital.
Treatment
until healing
or 35 days
maximum.
I1: 2 g/cm GMCSF (granulocyte

macrophage
colony stimulating
factor) applied
topically for 35
days (n=15).
Applied as a
spray, 15 minutes
of air drying, nonadherent dressing
next to the wound
then dry gauze to
fill the ulcer crater.
2
I2: 5 g/cm bFGF

(basic fibroblast
growth factor)
applied topically
for 35 days
(n=15). Applied as
above.
2
I3: 2 g/cm GMCSF applied

topically for 10
days, followed by
2
5 g/cm bFGF
applied topically
for 25 days
C: Comparative
placebo (n=15).
Applied as in
intervention group.
All patients were kept
on pressure-relief
surfaces for the 35day treatment period,
and fixed turning
schedules were
maintained.
61
Inclusion /
exclusion criteria
the pressure ulcer;
lack of cooperation;
unsuitability, inability
to provide informed
consent; whirlpool
therapy requirements;
HIV+; use of
investigational drugs
within one month
before study entry; or
treatment of the target
ulcer with cytokines
within three months of
entry.
Inclusion criteria:
Spinal patients with
grade 3/4 pressure
ulcers of >8 weeks
duration and ulcer
3
volume of 10-200 cm
Exclusion criteria:
Significant diabetes,
renal insufficiency,
vasculitis, hepatic,
immunologic, cardiac
or haemorrhagic
disease, malnutrition,
systemic steroidal
therapy,
immunotherapy,
chemotherapy,
cytokine therapy
within 90 days or
investigational study
drug within 30 days.
Baseline
characteristics
Objective
outcome
measures /
results
Mean (+ SD) ulcer

3
volume (cm ):
I1: 32.77 21.06
I2: 33.81 26.12
I3: 38.16 38.3
C: 45.19 34.79
>85% healing rate

at 36 days:
I1: 3/15
I2: 6/15
I3: 4/16
C: 0/15
Mean (+ SD) ulcer

duration (months):
I1: 6.8 6.1
I2: 14.9 16.4
I3: 12.1 14.6
C1: 13.1 14.2
Complete closure at
1 yr:
I1: 8/14
I2: 10/14
I3: 9/13
C: 10/13
Median (range)
3
wound volume (cm )
at day 36:
I1: 9.29 (0.88-40.62)
I2: 4.42 (0.22-20.80)
I3: 7.48 (0.22-99.65)
C: 8.85 (2.12-45.84)
Mean (+ SD) age

(years):
I1: 48.8 11.8
I2: 51.7 11.3
I3: 51.3 11.2
C1: 47.1 10.8
Quality
assessment
notes
Withdrawals
No a priori
sample size
calcs. Blinded
outcome
assessment
reported (used
comparative
placebos).
Randomisation
procedure not
stated.
Withdrawals:
Nil at 35 days in any
group.
At 1 year:
I1: 1 lost, 0 deaths
C: 1 lost, 1 death
Other notes
Payne (2001) paper had

long-term (one year
follow up) outcomes.
Costing data:
Procedural cost saving
per ulcer healed:
I1: US$7,800
I2: US$9,000
I3: US$8,300
C: US$7,000
Median (range) %
wound closure on
day 36:
I1: 70% (3-99)
I2: 79% (42-99)
I3: 73% (29-98)
C: 72% (39-84)
Assessed by
planimetry, alginate
moulds and colour
Page 36 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
(n=16). Applied
as above.
Landi
(2003) [14]
Setting and
length of
treatment:
USA &
Italian
nursing
homes. 6week
treatment
period, or
until ulcer
healed.
2.5S murine nerve

growth factor
solution 50 g/ml,
dropped daily on
the lesion and
allowed to dry for
2-3 minutes, n=19.
All patients
received routine
care which
included turning
program,
pressure-relieving
mattress, wound
irrigation with
normal saline, use
of debriding
enzymes, and
application of
opaque
hydrocolloid
occlusive barriers.
Placebo: balanced
salt solution,
indistinguishable
from intervention
solution in
presentation, colour,
density or odour;
dropped onto the
lesion in an identical
manner, n=19.
38
Inclusion criteria:
ulcer of the foot that
ranged in size from 12
30 cm .
Exclusion criteria: had
lesion for <1month
before admission,
terminal illness,
diabetes, peripheral
vascular disease.
Mean (+ SD) ulcer

area (mm2):
I: 1012 + 633
C: 1012 + 655
Mean (SD) ulcer

area (cm2):
I: 27.4 (32.9), n=18
C: 52.6 (33.4), n=18
Mean (+ SD) ulcer

duration (days):
I: 13 + 4
C: 12 + 5
Mean (SD)
reduction in ulcer
area (cm2):
I: -73.8 (39.3), n=18
C: -48.5 (38.4),
n=18
Mean (+ SD) ulcer

stage:
I: 3.2 + 0.8
C: 3.0 + 0.7
Mean (+ SD) age

(years):
I: 80.2 + 3.0
C: 80.2 + 4.7
M:F ratio:
I: 1:2.6
C: 1:2.6
Burgos
(2000a) [15]
Collagenase
ointment 48
application interval,
n=46
All ulcers were

cleaned with
saline,
collagenase
ointment applied
and then covered
with paraffin gauze
and a conventional
dressing.
Withdrawals
Other notes
Complete healing:
I: 8/18
C: 1/18
No a priori
sample size
calcs. Blinded
outcome
assessment
reported.
Randomisation
procedure
stated:
computergenerated list,
stratified by
age group, sex,
ulcer surface
area.
Withdrawals:
I: 1 death
C: 1 lost
These patients were not
included in the analysis.
No a priori
sample size
calcs. No
blinding of
treatment
allocation.
Randomisation
procedure not
stated.
Withdrawals:
I: 3 discontinued during
first week, no reasons
given.
C: 3 discontinued during
first week, no reasons
given.
Noted that none of

patients had systemic or
local side effects during
either treatment regime.
Topical agent
Setting and
length of
treatment:
multicentre
trial at 8
Spanish
hospitals.
Treatment
was for 8
weeks or
until ulcer
healing,
whichever
Quality
assessment
notes
photography.
Topical agent
Collagenase
ointment 24
application
interval, n=46
Objective
outcome
measures /
results
92
Inclusion criteria:
hospitalised or
institutionalised
patients, either
gender, >55 years,
with stage 3I pressure
ulcer for <1 year.
Exclusion criteria:
end-stage diseases,
localised or systemic
signs and/or
symptoms of
infection, or
hypersensitivity to
collagenase.
No information
regarding how
measurements were
carried out.
Mean (+ SD) ulcer

size:
Not stated.
Complete healing:
I: 12/43
C: 9/43
Mean (+ SD) ulcer

duration (months):
I: 3.3 + 2.3
C: 3.3 + 2.2
Mean (SD) ulcer

area reduction at 8
weeks (cm2):
I: 7.9 (12.2), n=34
C: 9.5 (11.8), n=29
Mean (+ SD) ulcer

score (Arnell scale):
I: 17.3 + 6.8
C: 18.5 + 6.0
Assessed at 1 week
intervals with
photography,
acetate tracing and
planimetry; and
graded ulcer
Less pain intensity seen

in the 24 hour interval
group (p=0.004).
Adverse reactions:
I: 3/43 (rash, ulcer bed
necrosis, ulcer
worsening)
Page 37 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
came first.
Rees
(1999) [8]
Setting and
length of
treatment:
14 USA
hospitals.
Treatment
continued
for 16
weeks or
until ulcer
completely
healed,
whichever
came first.
I3: rhPDGF-BB
Becaplermin gel
100 microgm twice
daily
I3: rhPDGF-BB
Becaplermin gel
100 microgm twice
daily
I1: rhPDGF-BB
Becaplermin gel
100 microgm once
daily
I1: rhPDGF-BB
Becaplermin gel 100
microgm once daily
I2: rhPDGF-BB
Becaplermin gel 300
microgm once daily
I2: rhPDGF-BB
Becaplermin gel 300
microgm once daily
61
63
62
All eligible patients

had an active run-in
period with
collagenase ointment
for 1-5 weeks. If 1030% tissue
granulation developed
(assessed visually),
then they qualified for
randomisation.
Inclusion criteria:
patients with 1-3
chronic (minimum 4
weeks of previous
treatment) full
thickness (stage 3-4)
bone tissue
involvement; target
ulcer volume between
10-150ml after
debridement.
Exclusion criteria:
albumin <2.5g/dl, total
lymphocyte count
<1000, vitamin A or C
levels outside normal
range; osteomyelitis
of affected area;
target volume after
debridement <10 or
>150 ml; topical
antibiotics,
antiseptics, enzymatic
debriding agents used
within preceding 7
days; ulcers due to
electrical, chemical or
radiation insult;
patients with cancer,
concomitant diseases
(e.g. connective
tissue disease),
treatment (eg
Baseline
characteristics
Mean (+ SD) age
(years):
I: 80.1 + 9.7
C: 79.0 + 11.7
Objective
outcome
measures /
results
Quality
assessment
notes
characteristics on 5point scale.
Withdrawals
Other notes
C: 3/43 (infection, ulcer
bed necrosis x 2 patients)
M:F ratio:
I: 1:1.9
C: 1:2.3
Median (+ IQR) target

ulcer volume (ml):
I1: 16.6 + 15.1
I2: 17.2 + 19.7
I3: 17.6 + 33.8
C: 19.6 + 21.9
Complete healing:
I3: 7/31
I1: 1/30
>90% healing:
I3: 18/31
I1: 12/30
Complete healing:
I3: 7/31
I2: 6/32
>90% healing:
I3: 18/31
I2: 19/32
Mean (+ SD) age

(years):
I1: 48 + 13.1
I2: 49 + 12.5
I3: 51 + 18.3
C: 50 + 13.6
M:F ratio:
I1: 5.2:1
I2: 5.4:1
I3: 6.5:1
C: 4.2:1
No a priori
sample size
calcs. No
description of
blinding.
Randomisation
procedure not
stated.
No statement of
withdrawals.
Wound-related,
treatment-emergent
adverse events (no.
patients with an event):
I1: 2/31
I2: 6/32
I3: 9/30
C: 4/31
Complete healing:
I1: 1/30
I2: 6/32
>90% healing:
I1: 12/30
I2: 19/32
Median (+ IQR)
duration (weeks):
I1: 22 + 32
I2: 33 + 40
I3: 22 + 52
C: 30 + 43
Page 38 of 219

Appendices.
Study
and
setting
Pullen
(2002) [16]
Setting and
length of
treatment:
patients in
17 German
hospitals
that
provided
acute care
and rehab
services for
the elderly.
Treatment
was until
complete
wound
debridemen
t or 4 weeks
maximum.
Alvarez
(2002) [17]
Setting and
length of
treatment: 3
Intervention
(I)
Collagenase (1.2
U/g) ointment
twice daily, n=66
Both ointments
were applied by
nurses in 2mm
layer to the ulcer
and covered with
gauze. They were
not irrigated
between
treatments.
Physician
determined type of
mattress and
frequency of
repositioning.
Collagenase
ointment 250
bacterial
collagenase units
per gram of white
petroleum USP
Comparator
(C)
Fibrinolysin /
deoxyribonuclease (1
U Loomis and 666 U
Christensen /g) twice
daily, n=69
135
Inclusion /
exclusion criteria
radiation therapy) or
medication (e.g.
corticosteroids,
chemotherapy,
immunosuppressive
agents); women who
were pregnant,
breastfeeding or not
on acceptable birth
control.
Inclusion criteria:
stage 2-4 pressure
ulcers with fibrinous
and/or necrotic
slough, over 54 years
age, ulcer size
between 2-14.5 cm. If
several ulcers
present, the worst
was chosen as the
reference ulcer.
Exclusion criteria:
history of alcohol or
drug dependency,
end-stage malignant
disease, known
hypersensitivity to
collagenase or
fibrinolysin/DNAse,
planned comedication with local
antiseptics,
antibiotics, occlusive
wound dressings,
hydrogels or
hydrocolloids, ulcers
covered with black
eschar only.
Papain-urea
3
ointment: 8.3 x 10
papain USP units per
gram and urea
100mg per gram
(Accuzyme), once
28
Inclusion criteria: >18

years old, in hospital
for > 2 weeks, full or
partial thickness
pressure ulcer
requiring debridement
Baseline
characteristics
Mean (+ SD) ulcer

size: Not stated.
Mean (+ SD) ulcer
duration (months):
I: 1.3 + 0.6
C: 1.4 + 1.0
Ulcer staging (Seiler):
Stage 2:
I: 18/66
C: 20/69
Stage 3:
I: 44/66
C: 43/69
Stage 4:
I: 4/66
C: 6/69
Mean (+ SD) age
(years):
I: 78.4 + 8.9
C: 79.7 + 8.1
Objective
outcome
measures /
results
> 50% decrease in

necrotic area:
I: 28/60
C: 22/61
Decrease in wound
area, wound
healing, wound
depth:
no primary data
given, only noted
there were no
statistically
significant (p>0.1)
differences.
Visual assessment
of photographs
every 4 days by
masked,
independent
dermatologist
assessors.
Quality
assessment
notes
Withdrawals
A priori sample
size calcs
undertaken.
Described as
double-blinded
but no
description of
blinding
methods for
care-givers, but
stated outcome
assessors
blinded to
treatment
used.
Randomisation
procedure not
stated.
Withdrawals:
I: 16 protocol violations, 6
photos not assessable
C: 27 protocol violations,
8 photos not assessable
No a priori
sample size
calcs. No
blinding of
outcome
assessment.
Withdrawals:
I: 2 not assessable
C: 0
Other notes
Adverse events:
I: 45 patients, 118 events
C: 34 patients, 103
events
No serious events were
attributed to probably or
possibly the effect of the
study medication.
M:F ratio:
I: 1:1.1
C: 1:0.9
Mean (SD) ulcer size
(cm2):
I: 9.9 (10.66)
C: (9.8 (8.25)
Ulcer staging (Seiler):
Mean (SD) %
nonviable tissue
(compared with
baseline) at 4
weeks:
I: 1 (3), n=8
Both treatments reported

to be easy and
Page 39 of 219

Appendices.
Study
and
setting
Intervention
(I)
centres.
Treatment
was for 4
weeks or
until
complete
ulcer
debridemen
t, whichever
occurred
first.
(Santyl), once
daily in 2mm thick
layer, n=14
Parish
(1979) [18]
Setting and
length of
treatment:
community
(nursing
home) 4week trial.
Pre-randomisation
2 week screening
period where
target ulcer was
cleaned with
saline and a nonadherent dressing
applied. Patients
with stable or
improving ulcers
were eligible for
enrolment.
Dextranomer
polysaccharide
beads (Debrisan)
applied to a depth
of at least 3 mm
covered with a dry
dressing. Changed
1-3 times daily
depending on
exudate, n = 14
wounds from
seven patients.
Comparator
(C)
daily in 2mm thick

layer, n=14
(i.e. have nonviable

tissue attached to the
base of the wound),
normal vascular
studies ulcer was
located on the foot.
All patients had

pressure-relieving
surfaces provided.
Collagenase enzyme
preparation (Santyl)
applied daily after a
saline wash and
covered with a dry
dressing, n=11
wounds from five
patients.
Inclusion /
exclusion criteria
25
ulcers
Exclusion criteria:
clinical signs of
infection, cellulites,
osteomyelitis,
inadequate nutrition,
uncontrolled diabetes,
other clinically
significant conditions
that would impair
wound healing
inclusive of renal,
hepatic,
haematologic,
neurologic,
immunologic disease;
received
corticosteroids,
immunosuppressive
agents, radiation or
chemotherapy <1
month prior to study
entry.
Inclusion criteria:
ulcers, residing in a
nursing home.
stated.
Baseline
characteristics
Stage 2:
I: 2/12
C: 2/14
Stage 3:
I: 2/12
C: 3/14
Stage 4:
I: 6/12
C: 4/14
Objective
outcome
measures /
results
C: 75 (68), n=8
Assessed with
acetate tracing and
planimetry, and
clinical assessment.
Quality
assessment
notes
Withdrawals
Randomisation
procedure
stated:
computergenerated list.
convenient, and not to be

associated with any pain
or discomfort.
No a priori
sample size
calcs. No
description of
blinding.
Randomisation
procedure not
stated.
No withdrawals.
Other notes
Mean (range) age
(years):
I: 74 (21-101)
C: 76 (25-97)
M:F ratio:
I: 1:1.4
C: 1:1.3
Mean wound size =

of surface
area (cm):
I: 4.5
C: 3.2
Complete healing
(number of
wounds):
I: 6/14
C: 1/11
No statistical
difference between the
groups for ulcer size.
Complete healing
(number of
patients):
I: 4/7
C: 1/5
Age range (years): 2957 (I), 28-59 (C)
M:F ratio: Not stated
Mean duration
No side effects reported

by patients with any of
the treatments.
Wounds measured,
photographed on
enrolment, but no
information about
further outcome
Page 40 of 219

Appendices.
Study
and
setting
Colin
(1996) [19]
Setting and
length of
treatment:
open,
multicentre,
multinationa
l, parallel
group trial.
Six different
centres
were
involved
with
approximat
ely equal
numbers of
patients in
each trial.
Assessmen
ts were
made every
7 days until
the wound
was
cleansed or
on the
completion
of 21 days.
Thomas
(1993) [20]
Setting and
length of
treatment:
2-week trial.
After 14
days those
Intervention
(I)
Dextranomer
polysaccharide
(Debrisan) paste,
n=68
Comparator
(C)
Hydrogel (Intrasite
gel), n=67
135
The two interventions

were applied in
accordance with the
manufacturers
instructions. An
absorbent plastic film
dressing (Melolin)
was used as a
standardised
secondary dressing
for both treatments.
Hydrogel dressing
(Intrasite Gel)
applied to a depth of
5 mm. Covered with
a perforated plastic
film absorbent
dressing held in
place with tape or a
bandage,
Inclusion criteria:
Male and female
patients 16 years
with pressure ulcers
present in any area
that needed
cleansing.
Exclusion criteria:
Pregnancy,
immunodeficiency,
clinical infection of the
wound, hard black
eschar covering more
than 20% of the
wound, diabetes,
inability to follow the
demands of the
protocol for any
reason, nonconsenting patients.
Where a patient had

more than one
wound only the
largest was
evaluated in the trial.
Other wounds were
treated with the
same randomised
dressing if this was
considered
appropriate by the
clinical investigator.
Dextranomer
polysaccharide
beads (Debrisan)
made into a paste
with polyethylene
glycol 600 and
water. The paste
was applied to a
depth of 10 mm
Inclusion /
exclusion criteria
Baseline
characteristics
(months): Not stated.
measurement.
Wound area:
< 4 cm2 - 18 (I), 15 (C)
4-13 cm2 - 25 (I), 5(C)
> 13 cm2 -25 (I), 27 C)
Number of wounds
completely
cleansed:
I: 14/68
C: 13/67
Non-viable tissue area:

< 3 cm2 - 18 (I), 15 (C)
3-9 cm2 - 27 (I), 24 (C)
> 9 cm2 - 23 (I), 28 (C)
Median age (years) 81
(I), 79 (C)
M:F ratio 1:1 (I), 1:1.4
(C)
Ulcer duration:
< 1 mth - 22(I), 4(C)
1-3 mths- 35(I), 28(C)
>3 mths - 11(I), 15(C)
Ulcer grade:
1 - 1 (I), 0 (C)
2 - 10 (I), 16 (C)
3 - 45 (I), 38 (C)
4 - 12 (I), 13 (C)
40
Inclusion criteria:
with grade 3 or 4
pressure ulcers. The
wounds had to be
covered or partially
covered with
yellow/brown slough.
Objective
outcome
measures /
results
Authors state groups

were well matched. All
patients gave written
consent and were
capable of
participating in the
trial.
Mean wound area
(cm2):
I: 15.6 (16.2 SD; range
1.5-68.9)
C: 22.2 (23.4 SD;
range 2.6-91.4)
% wound area covered
in slough:
Median (range) %
reduction in wound
area:
I: 7 (-340, 98), n=68
C: 35 (-185, 91),
n=67
Quality
assessment
notes
Withdrawals
A priori sample
size calcs
undertaken. No
blinding of
outcome
assessment.
Randomisation
procedure not
stated.
Withdrawals:
I: 19 lost to followup, two
died, four adverse
reactions (one related to
pain on application of the
agent, no details on the
other three).
C: 11 lost to follow-up,
two died, and one
adverse reaction.
Five adverse events were
reported, one in the C
group (hydrogel) and four
in the I group
(dextranomer
polysaccharide).
The only one considered
to be dressing related
was pain reported by one
patient in the I group.
Percentage
reduction in area of
non-viable tissue
(wound area x (%
yellow + % black
tissue) x 1/100).
Photographs were
taken at the initial
and final
assessment.
Number wounds
cleansed by 14
days:
I: 1/20
C:8/20
After 14 days all
ulcers were
reassessed.
Other notes
C was found to be easier

to apply and remove than
the I. C was also found to
be associated with less
pain.
No a priori
sample size
calcs. No
description of
blinding.
Randomisation
procedure:
computergenerated list.
Withdrawals:
Up to 14 days:
I: three because of
difficulty in applying the
dressing.
Classed as failures in the
results.
C: one patient because
the case report forms
Page 41 of 219

Appendices.
Study
and
setting
wounds
showing no
improveme
nt were
withdrawn
while the
remaining
wounds
were
followed for
a further
14 days.
Intervention
(I)
over a layer of
polyamide net,
n = 20.
Comparator
(C)
n = 20.
Inclusion /
exclusion criteria
Exclusion criteria: Age
< 16 years, insulin
dependent diabetes,
immunosuppression,
pregnancy, cellulites
and redness of the
surrounding tissue
(indicative of
infection).
Dressings were
changed as required,
and the wound
cleansed with saline
before reapplication.
Baseline
characteristics
I: 75.3 (22.4 SD; range
20-100)
C: 73.5 (29.7 SD;
range 20-100)
Mean age (years):
81.0 (I), 83.5 (C)
M:F ratio: 1:5.7 (I),
1:3.8 (C)
Ratio of grade 3:4
ulcers 5.7:1(I), 3.8:1
(C)
Values are only given
for 39 of the 40
patients entering the
trial.
Topical agent
Traditional dressing
Ljungberg
(1998) [21]
Conventional saline
dressings, every 812 hours, n=15
Setting and
length of
treatment:
spinal cord
injury
patients,
US hospital.
Treatment
continued
for a
maximum
of 15 days.
Dextranomer
paste (Debrisan),
every 8-12 hours,
n=15
Following surgical
debridement, ulcer
was cleaned with
mild soap and
water, and rinsed
with saline. Whilst
still wet, either the
Debrisan paste or
saline-soaked
gauze was
applied, and the
ulcer then covered
with a dry sterile
dressing.
No other topical
30
ulcers
23 pts
Inclusion criteria:
spinal cord patients,
>18 years, with an
exudative pressure
ulcer.
Exclusion criteria: not
stated.
Mean (SD) ulcer size:

Not reported.
Ulcer staging (Eltorai):
Stage 2:
I: 10/15
C: 12/1
Stage 3:
I: 4/15
C: 3/15
Stage 4:
I: 1/15
C: 0/15
Objective
outcome
measures /
results
Quality
assessment
notes
Wounds showing no
evidence of
debridement were
classed as failures
and withdrawn.
The remaining
wounds were
followed for another
14 days.
Up to 28 days:
Withdrawals occurred
over the follow-up period
leaving four patients in
the C group and two
patients in the I group.
C (hydrogel) had to be
changed more frequently
than I (dextranomer
polysaccharide).
However, even with
frequent dressing the
cost of the C per patient
was less than for the I.
Mean cost per patient:
I: 44.70
C: 22.60
(NB. Only successes
costed not failures)
Wound cleansing
was determined by
measuring the % of
total wound area
covered in slough.
Assessed by
photography,
grading system.
Other notes
were mislaid.
Number wounds
cleansed by 28
days:
I: 5/20
C: 8/20
Ulcer improvement
(> 25% improved
granulation from
baseline):
I: 10/15
C: 8/15
Withdrawals
No a priori
sample size
calcs
undertaken. No
blinding of
outcome
assessment.
Randomisation
procedure not
stated.
Withdrawals not reported.

No patients reported
adverse events.
Age (years):
23-73 (both groups)
M:F ratio: 1:0 (both
groups)
Page 42 of 219

Appendices.
Study
and
setting
Nasar
(1982) [22]
Setting and
length of
treatment:
hospitalbased trial.
Assessmen
ts were
made every
3 days by
an
independen
t observer
and a
photograph
taken once
a week.
Treatment
was
continued
until the
wound
reached the
end point,
or for a
maximum
of 94 days.
Parish
(1979a) [18]
Setting and
length of
treatment:
Community
(nursing
home) 4week trial.
Intervention
(I)
treatment was
permitted.
Dextranomer
polysaccharide
(Debrisan) applied
as a stiff paste
twice daily for the
first 3 days and
daily thereafter,
n = 9.
Prior to initiation of
the trial all
hardened sloughs
were cut off and all
patients were
nursed on a large
cell ripple
mattress. The only
concurrent therapy
was ultraviolet
light applied to 12
square inches of
skin to produce
first degree
erythema with the
ulcer masked from
the ultraviolet rays.
Dextranomer
polysaccharide
beads (Debrisan)
applied to a depth
of at least 3 mm
covered with a dry
dressing. Changed
1-3 times daily
depending on
exudate, n = 14
wounds from
seven patients.
Comparator
(C)
Eusol and paraffin

packs were applied
to the wound and
dressings were
changed three times
daily for the first
three days and
thereafter twice daily.
Melolin dressings
were used
throughout held in
place by micropore
tape. A
savlon sachet was
used each time the
dressing was
changed, n = 9.
18
Inclusion /
exclusion criteria
Inclusion criteria:
Patients with deep
pressure ulcers of
approximately similar
size.
Exclusion criteria:
Urinary tract infection.
Baseline
characteristics
Mean wound size:

Not stated.
Mean age (years):
83.2 (I), 77.4 (C)
Mean duration
(months): Not stated
Anaemia,
hypoalbuminaemia,
hypovitaminosis, and
high blood urea were
corrected if present.
Scrupulous control of
diabetic patients was
ensured. Patients with
urinary incontinence
were catheterised.
Pressure ulcers were
mostly on the foot or
heel in both groups.
Sugar and egg white

applied after a saline
wash. Changed four
times a day. Allowed
to dry and not
covered, n = 9
wounds from five
patients.
23
ulcers
Inclusion criteria:
nursing home.
Mean wound size =

of surface area (cm):
I: 4.5
C: 2.4

stated.
No statistical
Age range (years): 2957(I), 32-70 (C)
Objective
outcome
measures /
results
Quality
assessment
notes
Withdrawals
Wounds healed (=
cleansed and <25%
original size):
I: 6/9
C: 5/9
No a priori
sample size
calcs. Blinded
outcome
assessment.
Randomisation
procedure not
stated.
Withdrawals:
I: Three wounds.
Two due to patient death;
one as a result of patient
discomfort.
C: Four wounds.
One due to patient death;
three switched to
dextranomer (two after
16 days and one after 48
days).
Mean time to wound

healing (days):
I: 39.3, n=9
C: 62.0, n=9 (no
measure of
precision)
Wounds treated with C

(Eusol) were observed to
be associated with a rise
in blood urea to 11
mmol/l.
Wound area was

measured using
celluloid squares
and the entire
wound
photographed.
End point was
reached when the
wound was clean
and granulating and
appeared to be less
than 25% its original
size (= healed).
Complete healing
(number of
wounds):
I: 6/14
C: 0/9
Complete healing
(number of
patients):
I: 4/7
C: 0/5
Other notes
Cost of materials
calculated for each
treatment for average
treatment time in that
group. C treatment was
1.6 times more costly
than I.
No a priori
sample size
calcs. No
description of
blinding.
Randomisation
procedure not
stated.
No withdrawals.
the treatments.
Wounds measured
and photographed
on enrolment, but
Page 43 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
Mean duration
Parish
(1979b) [18]
Setting and
length of
treatment:
Community
(nursing
home) 4week trial.
Collagenase
enzyme
preparation
(Santyl) applied
daily after a saline
wash and covered
with a dry
dressing, n=11
wounds from five
patients.
Sugar and egg white

applied after a saline
wash. Changed four
times a day. Allowed
to dry and not
covered, n = 9
wounds from five
patients.
20
ulcers
Inclusion criteria:
nursing home.
Mean wound size =

of surface area (cm):
I: 3.2
C: 2.4

stated.
No statistical
Age range (years): 2859 (I), 32-70 (C)
Mean duration
Moberg
(1983) [23]
Setting and
length of
treatment:
hospitalised
patients. 3week trial.
Cadexomer iodine
polysaccharide
powder (Iodosorb)
applied daily to a
depth of 3 mm.
Removed by
running water
saline or wet
swab, n = 19.
Standard treatment
was variable. It
included: saline
dressings, enzymebased debriding
agents, and nonadhesive dressings,
n = 19.
All patients were
subject to: attention
to nutrition;
improvement of
hygiene; removal of
pressure by using
decubitus
mattresses, turning
the patient every 2 or
3 hrs, and optimal
mobilisation.
38
Inclusion criteria:
with pressure ulcers.
Exclusion criteria:
Confirmed or
suspected
malignancies,
moribund, iodine
sensitivity, psychiatric
illness, severe
psoriasis, any other
criteria that might
make a patient
unsuitable for a
clinical trial or unable
to give informed
consent.
Mean wound area

(cm2):
I: 9.6 (1.8 SEM)
C: 12.4 (4.3 SEM)
Mean age (years):
72.6 (I), 80.1 (C)
M:F ratio: 1:4.3 (I),
1:2.6 (C)
Mean duration (mths):
6.2 (I), 6.2 (C)
Values are only
available for the
patients not withdrawn
from the study.
Objective
outcome
measures /
results
no information about
outcome
measurement
during the trial.
Complete healing
(number of
wounds):
I: 1/11
C: 0/9
Complete healing
(number of
patients):
I: 1/5
C: 0/5
Wounds measured
and photographed
on enrolment, but
no information about
outcome
measurement
during the trial.
Mean (SD) wound
area reduction at 3
wks (cm2):
I: 2.9 (5.2), n=16
C: 2.5 (4.7), n=18
Mean (SD) %
wound area
reduction at 3 wks:
I: 30.9 (46.0), n=16
C: 19.6 (31.4), n=18
Number ulcers
reduced by >50% at
3 wks:
I: 8/16
C: 1/18
Mean (SD) wound
area reduction at 8
wks (cm2):
I: 7.0 (5.2), n=14
C: 5.3 (7.6), n=13
Mean (SD) %
wound area
reduction at 8 wks:
Quality
assessment
notes
Withdrawals
Other notes
No a priori
sample size
calcs. No
description of
blinding.
Randomisation
procedure not
stated.
No withdrawals.
No a priori
sample size
calcs. Blinded
outcome
assessment.
Randomisation
procedure not
stated.
Withdrawals:
I: Three withdrawals. Two
patients felt they were
getting worse and one
had skin irritation and
oedema around a sacral
ulcer and chose not to
continue.
C: One withdrawal where
the wound had grown
and the patient was
moved to another
hospital.

the treatments.
I caused three patients to

experience smarting after
application, one patient
had minor skin irritation
and another had an
exacerbation of psoriasis.
Overall pain as a result of
the wound was
Page 44 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
Objective
outcome
measures /
results
Quality
assessment
notes
I: 76.2 (30.7), n=14

C: 57.4 (33.9), n=13
Number ulcers
reduced by >50% at
8 wks:
I: 6/14
C: 1/13
Withdrawals
Other notes
significantly less in
patients treated with I.
I was easy to apply and
remove.
Perimeter of the
wound was traced
and the area
calculated by
planimetry or
measurement of the
longest diameter.
Agren
(1985) [24]
Setting and
length of
treatment:
Single-blind
trial for
8 weeks.
One of the
authors was
responsible
for
measuring
all the
wounds at
weekly
intervals.
An
independen
t surgeon
from
another
hospital
assessed
the
photograph
s.
Streptokinase/stre
ptodornase
enzyme
preparation
(Varidase
Topical) applied to
a sterile gauze
compress.
Dressings
changed twice
daily, n = 14.
Zinc oxide (400 mg

ZnO/cm2) applied to
a sterile gauze
compress. Dressings
changed once daily,
n = 14.
All dressings were
secured with porous
acrylic-based tapes.
Where multiple
wounds existed they
were all treated
uniformly, but only
the largest was
monitored.
Prior to treatment
loosely attached
necrotic material was
removed, but no
surgical debridement
was performed
thereafter.
No patients received
antibiotics.
Nursing care
28
Inclusion criteria:
Elderly inpatients and
outpatients with one
or more necrotic
pressure ulcers.
Median wound area

(cm2):
I: 4.2 (range 1.2-18.2)
C: 5.8 (range 1.2-26.0)

stated.
Median age (years):

86 (I), 81 (C)
M:F ratio: 1:3.7 (I),
1:1.8 (C)
Diabetes mellitus (n): 4
(I), 5 (C)
Complete
debridement
(disappearance of
necrotic tissue):
I: 6/14
C: 7/14
Median (range) time
to debridement
(days):
I: 21 (7-42)
C: 23 (7-56)
Median % change in
No a priori
sample size
calcs. No
blinding of
outcome
assessment
reported.
Randomisation
procedure
stated: block
randomisation
with block size
2 in matched
pairs.
Withdrawals:
I: Three patients were
withdrawn because of
unsuccessful treatment.
In one of these patients a
skin reaction occurred on
the heel after 3 weeks of
treatment. In another
patient necrosis
developed to 8x its
original size. In the third
patient Pseudomonas
Aeruginosa infection
developed after 6 weeks.
C: No withdrawals
All withdrawals were
included in the analysis.
wound area:
I: +18.7
C: -2.4% (no
precision measure)
Wound area was
traced and the size
measured by
planimetry. A
photograph was
taken at each
assessment.
I (enzyme) was
associated with an
increase in wound size.
This may be due to
excessive wound
debridement, or inhibition
of tissue growth by the
enzyme.
Page 45 of 219

Appendices.
Study
and
setting
Mulder
(1993) [25]
Setting and
length of
treatment:
A
multicentre
trial (three
independen
t sites).
Assessmen
ts of ulcer
size made
weekly for 8
weeks or
until the
ulcer was
healed.
Where
possible,
each
patient
evaluated
by same
investigator
throughout
the trial.
Intervention
(I)
Hydrogel
(Clearsite),
changed twice a
week, n=23
Comparator
(C)
followed its usual
procedure.
Saline solution and
44
moistened gauze,
changed three times
a day, n = 21.
Topical agent
Modern dressing
Brod (1990)
[26]
Hydrocolloid
dressing (DuoDerm,
Granuflex) applied as
a sheet with
adhesive backing, n
= 16.
Setting and
length of
treatment:
Academic
skilled
nursing
facility
caring for
the elderly.
Treatment
Surgical debridement
took place before
randomisation in
three patients.
Dressings were
Inclusion criteria:
Grade 2 and 3
pressure ulcers
>1.5 cm x 0.5 cm, but
<10 cm x 10 cm. All
patients had to be
>18 years and have a
life expectancy of at
least two months.
Exclusion criteria:
Grade 4 wounds or
those with tendon,
bone, capsule, or
fascia exposure;
pregnancy;
chemotherapy; prior
wound infection;
extensive
undermining of the
ulcer
(> 1 cm); AIDS;
patients receiving >
10 mg of
corticosteroids.
Dressings were
changed either by
the patient or the
care giver, after they
had received
appropriate
instructions.
Polyhydroxyethyl
methacrylate
(Poly-hema)
dissolved in
polyethylene
glycol, applied as
a paste which
solidified to a
flexible dressing, n
= 27.
Inclusion /
exclusion criteria
43
Inclusion criteria:
Grade 2 or 3 pressure
ulcers as assessed by
inspection, and
estimated life
expectancy of >6
months. Normal
marrow, hepatic and
renal functioning.
Exclusion criteria:
Not stated.
Baseline
characteristics
Area of wound (cm2):

Not stated.
Mean age (years):
56.7 (I), 57.2 (C)
M:F 1:3.6 (I), 1:9.5 (C)
Ulcer stage:
Grade 2 - 8 (I), 5 (C)
Grade 3 - 4 (I), 18 (C)
Race (patients):
Black - 4 (I), 6 (C)
White - 17 (I), 14 (C)
Hispanic - 1 (I), 0 (C)
Objective
outcome
measures /
results
Mean (SD) % ulcer
area reduction:
I: 8.0 (14.8), n=20
C: 5.1 (14.8), n=20
Perimeter of ulcer
traced on to a
transparency and
area determined by
computer. Largest
length, width and
depth of the wound
was measured and
a photograph was
taken at each
assessment.
Quality
assessment
notes
Withdrawals
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure:
computer
generated
scheme.
Withdrawals:
I: 3 patients were omitted
from the final analysis.
No reasons are given for
these withdrawals.
C: no withdrawals.
There were no adverse

reactions to C treatment.
Median area of wound

(cm2):
I: 2.5
C: 1.9 (p = 0.09)
Complete healing
rates:
I: 13/25
C: 10/16
Median
time
to
complete
healing
(days):
M:F Not stated

Wound duration
Three patients were not

evaluable and their data
are not presented in the
baseline characteristics.
One case of inflammation
occurred in the I group,
and another patient had
excoriation, which was
possibly related to I
treatment.
No statistically
between the groups.
All groups
Mean age (years):
84.5
Other notes
I: 32
C: 42 (no measure
of precision)
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure not
stated, but
patients were
randomised in
60:40 ratio,
stratified by
Withdrawals:
I: Two deaths.
C: One death (due to
concurrent illness); two
patients (7.4%)
discontinued treatment
because of adverse
effects or poor response.
DuoDerm easier to apply,
being a paste.
Complications were
Page 46 of 219

Appendices.
Study
and
setting
Intervention
(I)
continued
to complete
ulcer
healing
(maximum
treatment
length
approx. 100
days)
Brown-Etris
(1996) [27]
Setting and
length of
treatment:
hospital,
long-term
care, home
or
outpatients.
Medical
centres (no
other
details).
Trial
participation
was until 10
weeks, or
treatment
change was
indicated or
the wound
healed,
whichever
came first.
Comparator
(C)
Inclusion /
exclusion criteria
changed routinely
twice weekly, with
additional dressings
if dressing came off
or became
contaminated or
disrupted.
Baseline
characteristics
Objective
outcome
measures /
results
Absolute healing
rate to wk 6
(cm2/wk):
I: 0.18
C: 0.10 (no measure
of precision)
Quality
assessment
notes
Withdrawals
Other notes
lesion stage.
uncommon, but no data

presented.
No a priori
sample size
calcs. Blinded
outcome
assessment.
Randomisation
procedure not
stated, but
stratified by
surface area
and stage.
Withdrawals: 19
randomised patients
were not included in the
analysis as they did not
complete the first three
weeks of the study, or
missed two or more
sequential weekly visits.
Methods of
measurement not
stated.
I1: Topical
hydrogel
(Transorbent)
n=66
I2: Hydrocolloid
dressing (Duoderm
CGF, Granuflex
CGF), n = 55
Evaluation took place
weekly, dressing
changes occurred
every 7 days or more
frequently.
121
Inclusion criteria:
Patients > 18 years
with one or more
pressure ulcers.
Grade 2, 3 or 4 only.
Wound size between
2 and 80 cm2 and < 1
cm deep, clinically
noninfected, eschar
free, with >75%
granulation base with
fixed wound margins.
Adequate nutritional
intake by mouth, tube
or hyperalimentation.
Mean surface area of

wound:
Not stated.
Exclusion criteria:
Grade 1 ulcers or
grade 4 ulcers with
exposed tendon or
bone; wound size < 2
cm2 or > 80 cm2, or
> 1 cm deep; wounds
covered with necrotic
eschar or necrotic
wound base
containing > 25%
slough; diagnosis or
712 13% (I1), 2% (I2)

> 12 16% (I1), 4% (I2)
All groups
Mean age (years): 70
M:F 1:1
Duration (months):
< 1 23% (I1), 31% (I2)
13 38% (I1), 49% (I2)
46 10% (I1), 14% (I2)
Location:
Sacrum 33% (I1), 37%
(I2)
Trochanter 17% (I1),
26% (I2)
Heel 16% (I1), 8% (I2)
Ischium 16% (I1), 13%
(I2)
Malleolus 10% (I1),
Wound surface area

reduction:
data presented as
?mean wound
surface area
reductions by initial
stage and size of
ulcer, but no
measures of
precision (SD)
given, therefore no
data available for
meta-analysis. No
statistically
significant difference
between treatment
groups reported.
Withdrawals reported but

not by treatment group or
reasons given.
No significant differences
in clinical wound
infection, odour, or
dressing changes/week.
Area reduction
assessed by
gravimetric
planimetry with
wound tracing onto
plastic film and
photography.
Independent
analysis by
biostatistical
Page 47 of 219

Appendices.
Study
and
setting
Darkovitch
(1990) [28]
Intervention
(I)
I1: Hydrogel
(Biofilm), n=62
Setting and
length of
treatment:
maximum
60-day trial
unless
wound
healed,
patient
discharged
or
withdrawn
by clinician.
Measureme
nts taken at
each
dressing
change or
at least
weekly
intervals.
Mulder
(1993) [25]
Setting and
length of
treatment: a
multicentre
Comparator
(C)
I2: Hydrocolloid
dressing (DuoDerm,
Granuflex), n=67
90 pts
129
ulcers
All wounds were

initially cleansed with
hydrogen peroxide
and saline.
Patients with an oily
skin were degreased
to allow for a 1.25
inch adhesion belt
around the wound.
Although this was not
maintained where
the wound was > 20
cm2, instead utilizing
4 x 4 inch dressings.
Inclusion /
exclusion criteria
suspicion of
osteomyelitis at study
wound site;
carcinomatosis, or
signs or symptoms of
wound clinical
infection; inadequate
nutritional intake;
sinus tract, tunneling
or > 0.5 cm of wound
margin undermining.
Inclusion criteria:
Patients in acute care
facilities and nursing
homes with grade 1 or
2 pressure ulcers,
ulcers (size > 2 cm2).
Exclusion criteria:
Receiving radiation
therapy; infection,
sinus tracts or fistulae
in the wound; a blood
sugar level > 180
mg/dl; no improved
nutritional status.
Dressings were
usually changed
every 3-4 days and
washed in saline
before reapplication.
All patients lay on
pressure-reducing
mattresses.
Hydrogel
(Clearsite),
changed twice a
week, n=23
Hydrocolloid
dressing (DuoDerm,
Granuflex) changed
twice a week,
n = 20.
Baseline
characteristics
4% (I2)
Spine 6% (I1), 2% (I2)
Knee 2% (I1), 0% (I2)
analysis firm.
Change in level of
wound margin
undermining
assessed.
Mean area of wound

(cm2):
I1: 11.0 (range, 0.2100)
I2: 9.2 (range, 0.4-64)
Complete healing at
All groups
M:F 1:1.6
Ratio of grade
I:II ulcers: 1:1.3 (I1),
1:1.6 (I2)
Serum albumin
(g/dl): 2.8 (I1), 2.7 (I2)
No. grade I wounds:
27 (I1), 31 (I2)
No. grade II wounds:
35 (I1), 67 (I2)
Complete healing or
There was a significant

age of patients in the
acute care setting (69
years) and the
extended care facilities
(83 years).
43
Inclusion criteria:
Grade 2 and 3
pressure ulcers
>1.5 cm x 0.5 cm, but
<10 cm x 10 cm. All
patients had to be
Objective
outcome
measures /
results

Not stated.
60 days:
I: 24/60
C: 12/67
improved at 60
Quality
assessment
notes
Withdrawals
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure not
stated.
Withdrawals: Six extreme

results were exempt from
the analysis to make it
more meaningful. Three
patients in the I1 group
and one in the I2 group
had wounds that
enlarged by > 10% per
day. One patient in each
group was excluded
because their wounds
decreased by more than
25% per day.
Hydrogels such as
Biofilm (I1) offered the
ability to absorb excess
fluid without degradation
and maintain a moist
environment. Patients
appeared to prefer I1 too
because of the lack of
odour, cushioning and
lightness. The gel layer in
I2 was found to degrade
easily, which
necessitated mechanical
cleansing of the wound,
which damaged the
healing tissue layers.
Withdrawals:
I: 3 patients were omitted
from the final analysis.
No reasons are given for
these withdrawals.
C: 0 withdrawals
days:
I: 56/62
C: 52/67
Mean reduction in
wound area at 60
days (cm2):
I: 7.5
C: 3.7 (no measure
of precision given)
Perimeter of ulcer
traced and in some
cases photographed
to determine the
size of the ulcer.
Mean (SD) % ulcer

area reduction:
I: 8.0 (14.8), n=20
C: 3.3 (32.7), n=21
Mean age (years):
Perimeter of ulcer
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Other notes
Page 48 of 219

Appendices.
Study
and
setting
trial (three
independen
t sites).
Assessmen
ts of ulcer
size made
weekly for 8
weeks or
until the
ulcer was
healed.
Where
possible,
each
patient
evaluated
by same
investigator
throughout
the trial.
Palmieri
(1992) [29]
Setting and
length of
treatment:
Wound
clinic.
Treatment
was
continued
until
all
wounds had
healed.
Sayag
(1996) [30]
Setting and
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
least two months.
Exclusion criteria:
Grade 4 wounds or
those with tendon,
bone, capsule, or
fascia exposure;
pregnancy;
chemotherapy; prior
wound infection;
extensive
undermining of the
ulcer
(> 1 cm); AIDS;
10 mg of
corticosteroids.
Polysaccharide
beads (Debrisan)
were applied
directly to the
wound bead and
replaced daily, n =
24, in total in trial,
n for pressure
ulcers only
unknown.
All wounds were
sharp debrided
prior to
randomisation.
In addition all
wounds were
treated to ensure
negative bacterial
cultures at
baseline.
Polysaccharide
beads (Debrisan
paste) applied to a
depth of 3 mm
Collagen sponge
applied directly to the
wound after saline
nebulisation.
The dressing was
checked every day
and, if the collagen
sponge was swollen
or partially
reabsorbed, more
sponge was applied
without removing the
previous one. Greasy
sponge and regular
non-allergenic tape
completed the
dressing, n = 24 in
total, n for pressure
ulcers only unknown.
12
pressu
re
ulcers
only
Calcium
alginate
dressings (Algosteril)
applied directly on to
wound to cover the
92
Inclusion criteria:
Venous leg ulcers;
pressure ulcers;
diabetic gangrene;
pressure ulcers; posttraumatic wounds;
burns and radioactive
ulcers.
Note: Data are only
given here for
pressure ulcers.
Exclusion criteria:
Additional treatments
with drugs (with the
exception of digitalis).
Inclusion criteria:
Patients aged >60
years hospitalised for
> 8 weeks, with a
Baseline
characteristics
56.7(I), 63.1 (C)
M:F 1:3.6 (I), 1:5.6 (C)
Ulcer stage:
Grade 2 - 8 (I), 9 (C)
Grade 3 - 14 (I), 13 (C)
Race (patients):
Black - 4 (I), 3 (C)
White - 17 (I), 16 (C)
Objective
outcome
measures /
results
Quality
assessment
notes
traced on to a
transparency and
area determined by
computer. Largest
length, width and
depth of the wound
was measured and
a photograph was
taken at each
assessment.
Randomisation
procedure:
computer
generated
scheme.
?Mean (average)
(days):
Mean area of wound

(cm2):
I: 16.1 12.5 SD
C: 20.1 12.9 SD

One case of inflammation

occurred in the I group,
and another patient had
excoriation, which was
possibly related to I
treatment.
Wound area:
Not stated.
Wound type:
Leg ulcers -12
Diabetic gangrene -12
Pressure ulcers -12
Post traumatic - 12
Other notes
One patient treated with

C had mild irritation,
another showed minor
sensitivity.
No statistically
between the groups.
All groups
Age range (years): 5875
M:F 1:0.6
Withdrawals
time to healing
I: 47
C: 20 (measure of
precision not noted,
?SEM, ?SD)
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure not
stated.
No withdrawals.
A priori
sample size
calcs. No
blinded
Withdrawals:
I: 22
C: 10
Needed to read results

off graph, no primary
data given in the text. No
information re numbers
allocated to each group
for pressure ulcer
patients only.
Grading by clinical
assessment only.
Mean (SD) wound

area reduction per
wk (cm2):
Page 49 of 219

Appendices.
Study
and
setting
length of
treatment:
a
multicentre
trial based
at 20
centres
(17
specialising
in the care
of elderly
people and
three in
dermatolog
y).
Assessmen
ts were
made on a
weekly
basis by the
same
assessor.
Burgos
(2000b) [31]
Setting and
length of
treatment:
multicentre
trial at
seven
Spanish
hospitals.
Treatment
was for 12
weeks or
Intervention
(I)
over the wound
surface, n = 45.
Comparator
(C)
entire area, n=47.
Inclusion /
exclusion criteria
pressure ulcer graded
3 or 4 and surface
area from 5-100 cm2..
Ulcers were located
on the sacrum,
ischium, trochanters
and heels.
In both groups a
sterile gauze was
applied as a
secondary dressing.
No other local
treatments were
used except for
saline solution, the
use of which was not
restricted. Dressings
were inspected and
changed daily or at
least every four days
depending on the
degree of exudate.
Exclusion criteria:
More than half the
total ulcer area had
granulating tissue;
ulcer covered by
necrotic plaque;
active infection
requiring local or
systemic antibiotic
therapy; severe renal
failure.
Baseline
characteristics
Mean age (years):
80.4 (SD 9.1) (I), 81.9
(SD 8.9) (C)
M:F 1:2.8 (I), 1:2.9 (C)
Mean (SD) duration
(months): 3.0 (3.2) (I),
3.5 (3.8) (C)
Wound grade:
III - 30 (I), 33 (C)
IV - 15 (I), 14 (C)
No significant
two groups.
Where patients had
multiple wounds only
one was selected for
study.
Collagenase
ointment (Iruxol),
applied daily in 1-2
mm thick layer,
n=18
Hydrocolloid
dressing
(Varihesive),
changed every 3
days, n=19.
43
ulcers
37 pts
Inclusion criteria:
aged >55 years,
stage 3 ulcer for <1
year.
Exclusion criteria:
end-stage organ
disease, localised or
systemic signs and/or
symptoms of
infection, or
hypersensitivity to
collagenase.
Mean (SD) ulcer size:

Not reported.
Mean (SD) ulcer
staging score (Arnell):
I: 17.7 (3.4)
C: 20.2 (5.9)
Ulcer age (months)
(range):
I: 3.2 (2.0)
C: 2.6 (1.9)
Objective
outcome
measures /
results
Quality
assessment
notes
Withdrawals
I: 0.27 (3.21), n=45

C: 2.39 (3.54), n=47
outcome
assessment.
Randomisation
procedure
stated: sealed
envelopes.
All withdrawals were

included in the analysis
and few were considered
to have improved at the
last evaluation.
End point data were not
available for one patient
in the C group due to
admission to a special
care unit.
Number wounds
with >75% area
reduction:
I: 6/45
C: 15/47
Number wounds
with >40% area
reduction:
I: 19/45
C: 35/47
Reasons for withdrawals:

I: death (6); adverse
event (1); deterioration or
stagnation of ulcer after
4 weeks (15).
C: death (5); transfer (2);
deterioration of health
(1); deterioration or
stagnation of ulcer after
4 weeks (2).
Area of ulcer
measured by
planimetry, digitised
twice and the area
calculated by
computer. The
mean of the two
values was used to
determine individual
ulcer area. A
photograph was
taken of each
wound at every
evaluation.
Mean (SD) ulcer

area change (cm2):
I: -9.1 (12.7), n=18
C: -6.2 (9.8), n=19
Mean % ulcer area
reduction::
I: 44.2
C: 27.9 (no measure
of precision)
Complete healing:
I: 3/18
C: 3/19
Other notes
On average the number

of dressing changes per
week was similar: 4.28
(1.49 SD) for C and 4.52
(1.42 SD) for I.
8% of C and 33% of I
patients experienced
adverse effects.
No a priori
sample size
calcs. No
blinding.
Randomisation
procedure
stated:
block
randomisation
(size=4).
Withdrawals (n=8):
I: 8 (death, n=3,
discharge n=3, transfer
n=3)
C: 6 (death n=1,
deterioration n=1,
discharge n=1, protocol
violation n=2, lack of
efficacy n=1)
Costing data:
Significantly reduced
nursing time for
Page 50 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
until ulcer
healing,
whichever
occurred
first.
Baseline
characteristics
Age + range (years):

I: 81.9 + 12.7
C: 78.6 + 10.4
M:F ratio:
I: 1:1.2
C: 1:1.25
Modern dressing
Traditional dressing
Mulder
(1993) [25]
Saline solution and

moistened gauze,
changed three times
a day, n = 21.
Dressings were
changed either by
the patient or the
care giver, after they
had received
appropriate
instructions.
Setting and
length of
treatment:
A
multicentre
trial (three
independen
t sites).
Assessmen
ts of ulcer
size made
weekly for
eight weeks
or until the
ulcer was
healed.
Where
possible,
each
patient
evaluated
by same
investigator
throughout
the trial.
Alm (1989)
[32]
Setting and
length of
treatment:
Hydrocolloid
dressing
(DuoDerm,
Granuflex)
changed twice a
week,
n = 20.
Hydrocolloid
dressing
(Comfeel)
changed when
necessary. This
included Comfeel
Wet saline gauze

changed routinely
twice daily
n=31 ulcers.
50 patients with 56
41
Inclusion criteria:
Grade 2 and 3
pressure ulcers
>1.5 cm x 0.5 cm, but
<10 cm x 10 cm. All
patients had to be
least two months.
Exclusion criteria:
Grade 4 wounds or
those with tendon,
bone, capsule, or
fascia exposure;
pregnancy;
chemotherapy; prior
wound infection;
extensive
undermining of the
ulcer
(> 1 cm); AIDS;
10 mg of
corticosteroids.
56
Inclusion criteria:
Patients on long-term
wards with pressure
ulcers.
Exclusion criteria:

Not stated.
Mean age (years):
63.1 (I), 57.2 (C)
M:F 1:5.6 (I), 1:9.5 (C)
Ulcer stage:
Grade II - 9 (I), 5 (C)
Grade III - 13 (I), 18
(C)
Race (patients):
Black - 3 (I), 6 (C)
White - 16 (I), 14 (C)
Objective
outcome
measures /
results
Quality
assessment
notes
Perimeter of ulcer
traced on to a
transparency and
area determined by
computer. Largest
length, width and
depth of the wound
was measured and
a photograph was
taken at each
assessment.
Other notes
hydrocolloid dressing 4.6
mins/patient/day vs 8.6
for collagenase.
Assessed via
measurement,
photography,
acetate tracing and
planimetry.
Mean (SD) % ulcer

area reduction:
I: 3.3 (32.7), n=21
C: 5.1 (14.8), n=20
Withdrawals
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure:
computer
generated
scheme.
No withdrawals in either
group.
One patient treated with
I had mild irritation,
another showed minor
sensitivity.
There were no adverse
reactions to C treatment.
No statistically
between the groups.
Wound size:
Median depth (mm):
1.75 (I), 2.00 (I),
Median area (cm2):
2.02 (I), 2.44 (C)
Complete healing at
6 weeks:
I: 11/25
C: 5/31
No a priori
sample size
calcs. Blinded
outcome
assessment.
Randomisation
Withdrawals:
I: 2
C: 3
Drop-outs occurred
because of death for
Page 51 of 219

Appendices.
Study
and
setting
Intervention
(I)
long-stay
wards
(multicentre
).
Treatment
was initially
for 6 weeks;
if healing
not
complete,
treatment
continued
for 3-6
weeks.
Ulcus sheet, paste

and powder.
Sheet: sodium
carboxymethylcell
ulose particles
embedded in an
adhesive elastic
mass.
Paste: sodium
carboxymethylcell
ulose, guar
cellulose and
xanthan cellulose
n=25 ulcers
pressure ulcers were

randomised.
Barrois
(1992) [33,
34]
Hydrocolloid
dressing
(Granuflex
standard), n=38
Standard dressing
(tulle gauze)
impregnated with
povidone-iodine
antiseptic, n=38
Setting and
length of
treatment:
56 days or
earlier if
ulcer
healed.
Cleansing was
carried out with
saline, and
debridement with
forceps if
necessary.
Comparator
(C)
Inclusion /
exclusion criteria
Patients with a Norton
score < 7.
Baseline
characteristics
Other characteristics
(I), 83 (C)
M:F approx. 1:3 (all
groups)
Duration (months): 4.6
(I), 4.8 (C)
Norton score: 12 (I),
13 (C)
Body weight (kg): 50
(I), 50 (C)
Objective
outcome
measures /
results
Median remaining
ulcer area at 6
weeks:
I: 0%
C: 31% (no
measure of
precision)
Quality
assessment
notes
procedure not
stated, but
stratified by
Norton score,
ulcers rather
than patients
randomised.
Inclusion criteria:
Patients with open
necrotic pressure
ulcers or ulceration.
stated.

wound:
15 cm2 (all patients).
Surface area of ulcers
reported as
comparable between
treatment groups, no
details presented.
Complete healing at
8 weeks:
I: 10/38
C: 9/38
Overall
improvement at 8
weeks:
No other baseline
details of patients.
I: 32/38
C:27/38
Mean % reduction in
Other notes
reasons unrelated to
treatment, or violation of
protocol or unknown
reasons. One patient was
lost because data were
incomplete.
Patients in the
hydrocolloid (I1) group
were reported to have the
most favourable healing
distribution function,
though the overall
difference was
non-significant. No
difference in pain at
dressing changes.
Assessed by weekly
photography of
ulcer, evaluated by
dermatologist
blinded to treatment.
About one-third of
ulcers were on the
heel, and one third on
the sacral region.
76
Withdrawals
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure not
stated.
Withdrawals:
I: Two patients due to
deterioration in pressure
ulcer.
C: Five patients due to
deterioration in pressure
ulcer.
No adverse effects
observed, but no data are
reported.
Mean dressings used:
Granuflex: 2.4/week
Standard: 5.1/week
(p < 0.0001).
surface area:
I: 10%/week
C: 7%/week (no
measure of
precision)
Healing assessed
as ulcers improved
(totally or partially
healed). Tracing
took place every
seven days,
photographs at days
Page 52 of 219

Appendices.
Study
and
setting
Colwell
(1993) [35]
Setting and
length of
treatment:
academic
tertiary care
centre.
Average
length of
time in
study = 17
days, range
6-56 days.
Intervention
(I)
Hydrocolloid
dressing
(DuoDerm;
Granuflex)
extending at least
2.5 cm beyond
ulcer margins,
changed every
four days or as
needed, n = 33.
All patients were
placed on
pressure-reducing
surface (foam
overlay or low air
loss bed), and in
both groups ulcers
and surrounding
skin were
cleansed with
warm tap water
and dried.
Comparator
(C)
Moist gauze
dressings with 0.9%
sodium chloride
solution, loosely
applied and covered
with sterile dry gauze
dressing and a
secondary dressing
to keep inner
dressing moist,
secured with
hypoallergenic tape.
Changed every
Six hours, or as
needed, n = 37.
94 pts
157
ulcers
Inclusion /
exclusion criteria
Baseline
characteristics
Inclusion criteria:
ulcers.
No. of ulcers:
C: 48 (49%)
I: 49 (51%)
Exclusion criteria:
Underlying condition
or treatment likely to
affect healing.
Clinically infected
ulcers, grade 1 or 4
pressure ulcers, or
pressure ulcer that
could not be
accurately graded.
Ulcer location:
Sacrum/coccyx
C: 29 (60%)
I: 27 (55%)
Other
C: 19 (40%)
I: 22 (45%)
Objective
outcome
measures /
results
0, 28, 56.
Number of ulcers
with complete
healing at 8 weeks:
Patients were
excluded if they did
not remain in the
study for > 8 days, or
were receiving other
ulcer therapy likely to
confound results
(e.g. hydrotherapy).
Duration of ulcer:
< 1 month
C: 25 (60%)
I: 27 (59%)
1-3 months
C: 21 (45%)
I: 19 (41%)
Ulcer grade II:
C: 33 (69%)
I: 21 (44%)
Ulcer grade III:
C: 15 (31%)
I: 28 (56%)
Initial ulcer length
(cm):
C: 1-21
I: 1-12
Initial ulcer width (cm):
C: 0.4-10
I: 1-10
Initial ulcer area (cm):
C: 2.3
I: 2.4
Total : 70 patients with
97 pressure ulcers
(C), 68 (I)
M:F 1:1.1 (all groups)
No significant
differences in
continence or general
I: 11/48
C: 1/49
Reported no
statistically
significant difference
between groups in
total ulcer surface
area at end of study,
stage of ulcer,
length of time in
study, change in
ulcer length or
width, but no
primary data
presented.
Measured by tracing
every 4th day on
acetate film and
measuring with
electronic
planimeter. Width
and length
recorded. % of
pressure ulcers
completely healed
calculated.
Quality
assessment
notes
Withdrawals
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure not
stated.
Withdrawals: of 94
patients initially enrolled,
24 did not complete eight
days of treatment for
reasons not given, five
were discharged prior to
completion of eight days
of treatment, 12 died of
unrelated causes, five
were lost to follow up.
Two dropped out
because of colonization
with methicillinresistant
Staphylococcus aureus,
one because ulcer
progressed to grade 4.
Other notes
No other outcomes
reported, though a major
focus of the paper was
cost-effectiveness.
Total cost per case was
much lower with I than C.
Page 53 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
Objective
outcome
measures /
results
Quality
assessment
notes
Withdrawals
Other notes
health; typical patient

had poor health,
nutritional status, and
was confused and
debilitated.
Significantly more
grade 2 ulcers in I
group, hence groups
were stratified by ulcer
grade for analysis.
Significantly fewer I
patients with diabetes.
Kraft (1993)
[36]
Setting and
length of
treatment:
tertiary care
veterans
hospital.
Patients
treated for
24 weeks.
Non-adherent
semiocclusive
foam wound
dressing with an
adhesive cover
(Epi-Lock), n = 24.
Saline-moistened
gauze, changed
once every 8 hours,
n = 14.
38
Inclusion criteria:
ulcers.
Exclusions criteria:
Grade 1 and 4
pressure ulcers;
infected ulcers;
patients on special
beds; unstable
insulin-dependent
diabetes; serum
albumin < 2 g;
haemoglobin < 12 g;
Class IV congestive
heart failure; chronic
renal failure; severe
peripheral vascular
disease; severe
chronic obstructive
pulmonary disease.
Standardised
dressing procedures
applied in both
groups.
Wound area: Not

stated.
Number of patients
by week 12:
Mean age: 56 years

(all groups). Geriatric
but mainly spinal cord
injured patients.
with healed ulcers

I: 10/24
C: 2/14
Number of patients
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure not
stated.
with healed ulcers

Duration of ulcers:
ranged from new to 5
years. Ulcers in
existence two months
or less in 53% of
subjects.
Previous
hospitalisation for
pressure ulcer
treatment (usually
saline) reported in
53% of patients.
by week 24:
I: 10/24
C: 3/14
Polyurethane
sterile dressing
(moisture vapour
Wet-to-dry gauze
dressing, with saline
on the contact layer,
48 pts
77
Inclusion criteria:
Patients with grade 2
or grade 3 pressure
Median area of wound

(cm2):
Grade 2I:
I: 11 (five where staff

requested removal, and
four because of reactions
to treatment)
C: Six (two deaths, one
reaction to saline, three
other reasons).
Grade 2I ulcers showed
most healing by six
weeks.
Grade 3 ulcers healed
more slowly.
Assessed at weeks
3, 6, 12, and 24 by
same rater using
staging system.
Epi-lock (I) dressing

required fewer dressings
per week and less
nursing time, so that the
overall weekly dressing
cost for Epi-lock was
US$21 vs.
US$75 for saline.
Grade 2 ulcers were

present on 22 patients
and grade 3 were
found on 16 patients.
Sebern
(1986) [37,
38]
Withdrawals:
I: 10/24 (42%)
C: 3/14 (21%)
(p = 0.26)
Complete healing
for grade 2 ulcers at
No a priori
sample size
calcs. No
Withdrawals:
23 drop-outs in less than
three weeks; most
Page 54 of 219

Appendices.
Study
and
setting
Setting and
length of
treatment:
home care
setting.
Treatment
continued
for 8 weeks.
Xakellis
(1992) [39]
Setting and
length of
treatment:
Intermediat
e-level
long-term
Intervention
(I)
permeable).
Changed daily to
three times a week
depending on
adherence of
dressing, n = 100
ulcers.
Study protocol
included a turning
schedule and
wheelchair pushups. Wheelchairdependent
patients were
given a silicone
gel pad or dense
foam cushion, or
an alternating
pressure pad for
patients in bed.
The same protocol
for pressure relief
and wound
irrigation was used
in both groups.
Hydrocolloid
dressing rimmed
with tape, changed
if non-occlusive
and changed twice
weekly to allow
wound
assessment.
Cleaned with
Comparator
(C)
covered with dry
gauze and pad.
Changed every 24
hours, with saline
used to loosen
dressing, and
irrigation with halfstrength hydrogen
peroxide and saline.
If wound was
contaminated,
povidone iodine was
applied for two
minutes and rinsed
away with saline,
n = 100 ulcers.
Saline gauze
(nonsterile 8-ply 4 x
4-inch gauze
dressing moistened
with saline covered
with two non-sterile
gauze dressing
rimmed with tape), n
= 21.
ulcers
Inclusion /
exclusion criteria
ulcers receiving visits
from nursing service.
Exclusion criteria:
Wound containing
eschar, grade 1 or 4
ulcers, patient had
terminal illness, white
cell count < 4000, or
patient had three or
more existing ulcers;
necrotic ulcers;
pressure ulcers > 50
cm2.
39
Inclusion criteria:
Patients with skin
break over a bony
prominence.
Exclusion criteria:
ulcers; rapidly fatal
disease, or
Baseline
characteristics
Objective
outcome
measures /
results
I: 1.9
C: 3.4
Grade 3:
eight weeks:
I: 6.1
C: 4.5
Median % decrease
Grade 2 ulcers:
Mean age (years):

76.3 (I), 72.4 (C)
Grade 2: 59%(I), 30%
(C)
Grade 3: 41%(I) 70%
(C)
No statistically
significant group
differences in height,
weight and
PULSES score.
All participants had a
chronic illness, and
according to PULSES
score were very
severely disabled. All
patients had chronic
illness (mostly focal
cerebral disorders,
spinal cord disorders,
neurological disorders,
and miscellaneous
chronic conditions, e.g.
cardiac causes) and
poor nutrition.
5-9% of ulcers were on
the foot.
Median wound surface
area (cm2):
I: 0.66
C: 0.38 (NS)
I: 14/22
C: 0/12
in wound area,
I: 100%, n=22
C: 52%, n=12 (no
measure of
precision)
Withdrawals
Other notes
blinded
outcome
assessment.
Randomisation
procedure
stated: random
number list
used to assign
ulcer
treatments.
frequently due to death,

hospitalisation, and
inability to comply with
the study protocol for
pressure relief.
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure not
stated.
Withdrawals:
I: Two withdrawals
C: Three deaths.
No differences in supply
costs, but costs of
treatment (including
nursing visits) for grade 2
ulcers significantly lower
with I (p < 0.05).
Less pain with I, though
no data presented.
Median % decrease
in wound area,
Grade 3 ulcers:
I: 67%, n=15
C: 44%, n=28 (no
measure of
precision)
Wound area
measured with a
clear plastic
measuring card and
the area calculated
by assuming an
elliptical shape.
Complete healing at
6 months:
I: 16/18
C: 18/21
Median time to
Age (years): 77(I), 84
(C)
Quality
assessment
notes
healing (days):
Median nursing cost

(including cost of nursing
time) was significantly
lower for the hydrocolloid
group (I), though total
Page 55 of 219

Appendices.
Study
and
setting
care facility.
Treatment
period six
months
maximum.
Chang
(1998) [40]
Setting and
length of
treatment:
hospital,
Malaysia.
Treatment
period was
eight weeks
or less if
ulcer
healed.
Matzen
(1999) [41]
Setting and
Intervention
(I)
normal saline at
this time, n = 18.
Hydrocolloid
dressing
(DuoDerm),
changed every
seven days or
earlier if leaking,
n=17
Comparator
(C)
anticipated discharge
within one week; skin
ulcers from cause
other than pressure
e.g. venous stasis
ulcers.
Routine care to all

participants
included
repositioning every
two hours and
cleaning of
incontinence with
warm water as
required. Necrotic
tissue was debrided
using sharp
debridement at
enrolment and during
treatment as
necessary. All
patients were placed
on an air mattress
and an air-filled
wheelchair cushion.
Saline soaked gauze

dressing, changed
daily, n=17
Inclusion /
exclusion criteria
34
Inclusion criteria:
stage 2 or 3 pressure
ulcer, >18 years age.
Only one pressure
ulcer per patient was
eligible for study
entry.
Exclusion criteria:
immunocompromised,
infected ulcers, known
sensitivity to study
dressings.
Hydrocolloid
dressing
(hydrogel,
Coloplast),
Saline soaked gauze

dressing, changed
daily, n=15
32
Inclusion criteria:
stage 3 or 4 noninfected pressure
ulcers.
Baseline
characteristics
Objective
outcome
measures /
results
M:F 1:12 (all groups)

Norton score: 11 (I),
13 (C)
I: 9
C: 11 (no measure
of precision)
No statistically
significant group
differences in other
baseline measures,
including comorbidities
(diabetes, stroke,
cancer, dementia,
urinary tract infection,
Foley catheterisation,
other mobility-limiting
condition),
incontinence,
nutritional status, %
with exudate,
erythema, necrotic
tissue, maceration,
ulcer grade 2 or 3,
location of ulcer, or
history of ulcer at
same site.
Ulcer area: Not stated.
Time to 75% healing
Mean (range) age:

57.6 (20-85) years - all
patients.
Mean duration of ulcer:
33 days (range 2-274)
- all patients.
Stage 2 ulcers:
I: 11/17
C: 7/17
Ulcer area: Not stated.

Median (range) age:
I: 82 (32-97) years
Quality
assessment
notes
Withdrawals
Other notes
nursing costs using local
nursing wages were not
significantly different,
though at national wage
rates hydrocolloid
treatment was cheaper.
(days):
I: 14
C: 26 (no measure
of precision)
Assessed number of
wounds healed i.e.
with epithelial
covering by
inspection and
absence of moist
surface by
palpation.
Change in mean
surface area from
baseline:
I: -34%, n=17
C: +9%, n=17 (no
measure of
precision)
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure not
stated.
wound volume (%)

at 12 weeks:
Performance data all

favour DuoDerm for
dressing adherence,
exudate handling ability,
comfort, pain, ease of
use.
No difference in costs
(using nursing time data)
between the two
treatments.
Assessed with
acetate tracings,
colour photography.
Relative mean (SD)
No a priori
sample size
calcs. No
blinded
Adverse events:
I: 0
C: 1, wound infection
Sponsored by ConvaTec.
Withdrawals:
I: 9 (illness n=5, death
n=2, missing schedule
n=1, patient withdrew
Page 56 of 219

Appendices.
Study
and
setting
Intervention
(I)
length of
treatment:
hospital
patients,
Denmark.
Followed
for 12
weeks or
until ulcer
healed,
including at
home.
changed daily,
n=17
Thomas
(1998) [42]
Hydrogel dressing,
one eighth inch
thick layer,
changed daily,
n=22
Setting and
length of
treatment:
nursing
homes and
home care
services.
Treatment
was for 10
weeks.
Comparator
(C)
Baseline
characteristics
C: 84 (46-89) years
Exclusion criteria:
diseases or drugs
known to impair
healing.
Surgical
debridement
carried out on all
patients prior to
randomisation. All
ulcers were
dressed with
Comfeel
transparent
dressing.
Ulcer cleansed
with saline,
treatment dressing
applied, then
covered with dry
sterile nonwoven
gauze, held in
place with thick
dressing.
Inclusion /
exclusion criteria

Not stated.
Median (range) ulcer
stage:
I: 4 (3-4)
C: 4 (3-4)
M:F ratio:
I: 1:7.5
C: 1:4.0
Saline soaked
gauze, changed
daily, n=19
41
Concomitant use of
other topical
medications to the
study ulcer was not
permitted.
Inclusion criteria:
aged > 18 years,
stage 2-4 pressure
ulcers >1 cm2. Only
one pressure ulcer
per patient was
evaluated.
Mean (SD) ulcer area

(cm2):
I: 8.9 (9.3)
C: 5.9 (6.0)
Exclusion criteria:
ulcers of nonpressure
aetiology, wounds
with sinus tracts
and/or undermining
>1cm, clinically
infected wounds,
severe illness, life
expectancy < 6
months, those HIV
positive, or alcohol or
drug dependent,
pregnant or breastfeeding, diagnosis of
cancer or on
chemotherapy.
Ulcer stage II:

I: 8/16
C: 6/14
Ulcer stage III:
I: 6/16
C: 7/14
Ulcer stage IV:
I: 2/16
C: 1/14

Not stated.
Objective
outcome
measures /
results
I: 26 (20), n=17
C: 64 (16), n=15
Complete wound
healing:
Quality
assessment
notes
outcome
assessment.
group.
Randomisation
procedure not
stated.
I: 5/17
C: 0/15
Withdrawals
Other notes
n=1)
C: 11 (treatment failure
n=6, other illness n=3,
death n=1, patient
withdrew n=1)
No difference in odour,
pain, comfort or length of
time dressing required.
Ulcer volume
measured by
amount of water
needed to fill cavity.
Assessed weekly.
Complete wound
healing at 10 weeks:
I: 10/16
C: 9/14
Mean (?SD ?SEM)
healing time
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure not
stated.
Withdrawals (n=11):
I; 6 (death n=4, ulcer
worsening n=1,
hospitalised n=1)
C: 5 (death n=2, ulcer
worsening n=1,
hospitalised n=1, protocol
violation n=1)
No a priori
sample size
calcs. No
Withdrawals (n=13):
death or deterioration
n=10, non-compliant n=3.
(weeks):
I: 5.3 (2.3), n=10
C: 5.2 (2.4), n=9
Assessed weekly by
ulcer tracings and
photographs.
Mean (SD) age:
I: 79 (9) years
C: 72 (13) years
M:F ratio:
I: 1:1.3
C: 1:0.6
Kloth
(2002) [43]
Noncontact
normothermic
wound therapy,
Standard wound
care, n=22. This
involved daily
53 pts
56
Inclusion criteria:
Inpatients with stage
3 and 4 pressure
Mean (SD?) ulcer area

(cm2):
I: 5.4 (1.7)
Wound closure by
12 weeks:
I: 10/21
Page 57 of 219

Appendices.
Study
and
setting
Intervention
(I)
Setting and
length of
treatment:
seven USA
long-term
care
facilities.
Treatment
was for 12
weeks.
(Warm-Up), n=21.
This involved
wearing a sterile,
noncontact wound
dressing (cover)
24 hours per day,
7 days per week
for 12 weeks or
until wound
closure. The
radiant heat
element was
inserted into the
wound cover and
activated for three
separate one-hour
periods, with at
least two hours
between warming
sessions.
removal of moisture
retentive dressing
(hydrofibers,
alginates, hydrogels,
hydrocolloids, salinemoistened gauze,
saline-impregnated
gauze), irrigation with
saline, and
application of fresh
dressing. All other
enzymes, pastes and
other impregnated
dressing were
prohibited.
Noncontact
normothermic
wound therapy
(Warm-Up Active
Wound Therapy),
n=15. This
involved a
dressing with an
open cell foam
border and a
noncontact
transparent film
cover that lies
above the wound
surface and
contains a pocket.
An infrared
warming card
connected to a
temperature
control unit was
inserted three
times daily for
Standard wound
care, n=14. standard
wound care, n=22.
This involved
reapplication of a
moisture-retentive
dressing
(hydrofibers,
alginates, hydrogels,
hydrocolloids, salinemoistened gauze,
saline-impregnated
gauze), every 8-24
hours.
Whitney
(2001) [44]
Setting and
length of
treatment:
Variety of
USA care
settings:
primary
care, home
care, acute
care, and
long-term
care
facilities.
Treatment
was for
eight weeks
or until
ulcer
healed
whichever
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
Objective
outcome
measures /
results
ulcers
ulcers.
C: 4.1 (0.8)
C: 8/22
43
analys
ed
Exclusion criteria:
poorly controlled
diabetes, terminal
illness, wound
undermining >1cm,
clinical signs of
infection, >50%
wound covered with
necrotic tissue after
debridement, allergy
to adhesives.
Mean (SD?) age of

ulcer (days):
I: 106.3 (22)
C: 151.0 (36)
Change in wound
Mean (SD?) age
(years):
I: 78.1 (3)
C: 77.9 (4)
M:F ratio:
I: 1:1.3
C: 1:2.1
All patients were on

2-hourly turning
schedules and
mattresses.
40
Inclusion criteria: >18

years age, stage 3 or
4 pressure ulcer,
English speaking.

(cm2):
I: 10 (10)
C: 7 (9)
Exclusion criteria:
wound infection,
existing dermatitis,
recurrent ulcer,
sensitivity to
adhesives,
corticosteroids, endstage disease with <3
months life
expectancy.
Wound duration <1yr:

I: 11/15
C: 7/14
Wound duration >1yr:
I: 2/15
C: 7/14
Wound stage III:
I: 7/15
C: 11/15
Wound stage IV:
I: 8/15
C: 3/14
surface area per

week treated (cm2):
I: 0.52 + 0.11, n=21
C: 0.23 + 0.03, n=22
(measure of
precision not noted,
?SD, ?SEM)
Quality
assessment
notes
Withdrawals
Other notes
blinded
outcome
assessment.
Randomisation
procedure
stated: random
number
generator. Unit
of
randomisation
was ulcers.
Not noted in which

treatment group these
withdrawals occurred.
No a priori
sample size
calcs. No
blinded
outcome
assessment.
group (n=11).
Randomisation
procedure not
stated, but
used block
randomisation
with varied
block sizes.
Withdrawals (n=11):
I: nonadherence to
protocol / withdrawal n=2,
C: nonadherence to
protocol / withdrawal n=6,
infection n=1, clinician
decision to change
treatment n=1, periwound maceration n=1.
Assessed by wound
tracings, digital
imagery with 3D
stereophotogramme
try.
Complete wound
healing by eight
weeks:
I: 8/15
C: 6/14
Mean (SD) rate of
wound healing
(cm/day):
I: 0.012 (0.008),
n=15
C: 0.004 (0.006),
n=14
Assessed by
acetate tracings,
planimetry, digital
and Polaroid
photography, and
Pressure Ulcer
Status Tool
evaluations.
Page 58 of 219

Appendices.
Study
and
setting
occurred
first.
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
one-hour
treatments.
Baseline
characteristics
Objective
outcome
measures /
results
Quality
assessment
notes
Withdrawals
A priori sample
size calcs
stated. No
blinded
outcome
assessment.
Randomisation
procedure not
stated, but was
stratified by
centre and
used block
randomisation,
size=4.
Withdrawals (n=44):
I: death n=11, transfer
n=1, worsening health
n=1, local adverse event
n=1, pressure ulcer
impariment.
C: death n=8, transfer
n=2, local adverse event
n=3, pressure ulcer
impairment n=3.
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure
stated:
computergenerated
sequence.
Withdrawals (n=20, I: 9
C: 11):
I: wound infection n=7,
surrounding skin
ulcerness n=1, cavity
wound requiring different
treatment n=1.
C: death n=1, lack of
efficacy n=1, wound
infections n=4, heart
failure n=1, chest
infection n=1, logistic
problems n=1, skin
maceration n=1,
antibiotics for UTI n=1.
Other notes
Mean (SD) age

(years):
I: 63 (21)
C: 53 (19)
M:F ratio:
I: 1:0.9
C: 1:0.4
Modern dressing
Modern dressing
Belmin
(2002) [45]
Calcium alginate
dressing for four
weeks (UrgoSorb),
then hydrocolloid
dressing for four
weeks (Algoplaque),
n=57
If patients had deep
ulcers, a hydrocolloid
paste could be
applied to the
hydrocolloid
dressing. No paste
could be added to
the calcium alginate
dressing.
Setting and
length of
treatment:
geriatric
hospital
wards.
Treatment
was for
eight weeks
or until
ulcer
healed
whichever
occurred
first.
Banks
(1997) [46]
Setting and
length of
treatment:
community
patients.
Treatment
was for six
weeks or
until ulcer
ligthly
exudating
whichever
Hydrocolloid
dressing for eight
weeks
(DuodermE),
n=53.
If patients had
deep ulcers, a
hydrocolloid paste
could be applied to
the hydrocolloid
dressing.
Hydrocellular
dressing (Allevyn),
n=10
Polyurethane foam
dressing (Lyofoam
Extra), n=10
110
20
Mean (SD) ulcer
Inclusion criteria:
Pressure ulcer on
sacrum, pelvic girdle
or heel; surface area
less than 50 cm2;
granulation tissue
area not covering
more than 50% ulcer
surface; no clinical
evidence of active
local infection.

(cm2):
I: 14.7 (10.4)
C: 12.6 (8.0)
Exclusion criteria: Se
albumin below 25 g/L;
if being treated with
radiotherapy,
cytotoxic drugs, or
cortocosteroids; or if
surgical or palliative
care needed.
Inclusion criteria:
adult patients with
moderate to heavily
exuding wounds.
Mean (SD) age

(years):
I: 84.8 (7.1)
C: 82.2 (7.9)
Mean (SD) change
M:F ratio:
I: 1:2.8
C: 1:2.1
(cm2): not reported.
I: -5.2 (7.2), n=53

C: -9.7 (7.1), n=57
Exclusion criteria:
patients with necrotic
wounds, pregnant or
breastfeeding
mothers, patients with
ulcers, patients
already enrolled in
this or another clinical
trial within the past
Mean (SD) age of

ulcer (weeks):
I: 7.2 (6.8)
C: 7.7 (6.6)
Mean (range) age of

ulcer (weeks):
I: 17.8 (4 weeks-1
year)
C: 17.9 (1 week-2
years)
Mean age (years):
I: 76.69
C: 74.95
surface area at eight

wks (cm2):
I: 7.4 (10.2), n=53
C: 5.0 (8.2), n=57
Surface area
reduction > 40% at
eight wks:
I: 31/53
C: 43/57
in surface area at
eight wks (cm2):
Ulcer healing by six

weeks:
results given for all
enrolled patients,
including those with
leg ulcers and other
wounds. Data not
presented for
pressure ulcer
patients separately.
Some performance data

reported: ease of use,
pain, odour, number of
dressings. No cost data
reported.
Page 59 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
occurred
first.
Seeley
(1999) [47]
Setting and
length of
treatment:
communitybased trial
with
patients
followed
until wound
healed, up
to
maximum
of eight
weeks.
Baseline
characteristics
Objective
outcome
measures /
results
Quality
assessment
notes
Withdrawals
Other notes
month.
Hydrocellular
dressing (Allevyn),
n=20
Setting and
length of
treatment:
USA, longterm
facilities
and wound
centre
outpatient
clinic.
Treatment
was for
eight weeks
or until
ulcer
healed
whichever
occurred
first.
Bale
(1998a) [48,
49]
Inclusion /
exclusion criteria
Hydrocolloid
dressing
(Duoderm CGF
Border Dressing),
n=20
40
Inclusion criteria:
adults with stage 2 or
3 pressure ulcers.
Exclusion criteria:
ulcers smaller than
1cm2 or larger than
50cm2; patients with
infected ulcers;
patients with
uncontrolled diabetes,
known history of poor
compliance with
medical treatment.
M:F ratio:
I: 1:1.6
C: 1:6.5
(cm2):
I: 6.84 (8.19)
C: 4.61 (5.56)
Mean (SD) age of
ulcer (weeks):
I: 11.8 (7.4)
C: 23.1 (38.9)
Mean (SD) age
(years):
I: 75.7 (18.6)
C: 76.7 (19.5)
M:F ratio:
I: 1:1.2
C: 1:1.1
Hydrocellular
dressing (Allevyn),
n=17
Dressings were
only changed if
there was leakage
or specific
indication, such as
wound pain
investigation.
Hydrocolloid
dressing (Granuflex),
n=15
32
Inclusion criteria:
Pressure ulcers, leg
ulcers and other
wounds were
included. Included
stage 2 and 3
pressure ulcers.

wound: Not stated for
pressure ulcer patients
only.
Wound closure at
eight weeks:
I: 8/20
C: 6/19
Wound appearance
improved by eight
weeks:
I: 12/20
C: 11/19
?Mean % reduction
in ulcer area by
eight weeks:
I: 50
C: 52 (no measure
of precision)
Complete wound
healing by eight
weeks:
I: 10/17
C: 4/15
Exclusion criteria:
Pregnant or lactating
women, patients with
ulcers, wounds too
large to be covered by
one dressing, wounds
expected to heal
within one week,
wounds with sloughly
or necrotic tissue, or
Patient comfort and ease

of use results reported.
(I), 78 (C)
Assessment made
by visual inspection.
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure
stated:
computer
generated list,
stratified by
initial ulcer
size.
Withdrawals (n=14, I: 8
C: 6):
I: patient request n=1,
lost n=3, adverse event
n=2, death n=1, other
n=1.
C: adverse event n=2,
death n=1, other n=3.
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure not
stated, used
block
randomisation,
size=4.
Withdrawals only
reported for all 100
enrolled patients, not
stated for pressure ulcer
patients only:
14 patients withdrawn
due to adverse incidents,
of which seven
(maceration,
overgranulation and pain)
were related to
dressings. Four patients
excluded from analysis:
one due to lost case
report forms, two patients
spent < 7 days in study,
so insufficient data; and
one protocol violation.

pain, odour, number of
dressings. No cost data
reported.
Page 60 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
Objective
outcome
measures /
results
Quality
assessment
notes
grossly infected
wounds.
Setting and
length of
treatment:
Community
setting.
Length of
treatment
up to 4-6
weeks
(pressure
ulcers).
Thomas
(1997) [51]
Setting and
length of
treatment:
Community
setting with
Hydropolymer
dressing (Tielle),
n=50
Hydrocolloid
dressing
(Granuflex, improved
formulation), n=49
99
Dressings were
changed
every seventh day.
Inclusion criteria:
Patients with grade 2
and 3 pressure ulcers,
or venous leg ulcers.

wound (mm2):
C: 286.24.7
I: 263.6

stated.
Only data for pressure

ulcers reported here,
not additional 100
patients with leg
ulcers.
Hydropolymer
dressing (Tielle),
n=50
Hydrocolloid
dressing
(Granuflex), n=49
In both groups
wounds were
cleansed with sterile
normal saline and
99
Inclusion criteria:
ulcers; wound less
than 10mm deep and
maximum diameter of
8cm.
Exclusion criteria:
Other notes
Patient-assessed comfort
of dressings was also
analysed. Hydrocellular
dressings (I) were more
comfortable, but results
not stratified by wound
type.
Only data for pressure

ulcers reported here.
Banks
(1996) [50]
Withdrawals
Mean age 78.6 (C),

80.1 (I)
No significant
differences in ulcer
duration, wound area,
ulcer grade
distribution, visual
appearance, exudate,
odour, or pain at
baseline.
Approximately half of
the pressure ulcers in
each group were on
the heels.
Wounds were free of
clinical infection, and
had a maximum
dimension of 8 cm.
(cm2): not reported.
Age of ulcer (months):
<1 month
I: 8
C: 9
Complete wound
healing by 4-6
weeks:
I: 12/50
C: 15/49
Wound appearance
improved by 4-6
weeks:
I: 39/50
C: 39/49
Number with
reduced wound
size:
I: 35/46
C: 35/45
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure not
stated.
Funding from Smith &

Nephew Ltd.
Withdrawals:
C: 4
I: 4
(both groups of patients)
No difference in comfort
or ease of removal
between the two
treatments.
Method of wound
assessment not
noted.
Complete wound
healing by six
weeks:
I: 10/50
C: 16/49
Mean % reduction in
ulcer area by six
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure
pain, odour, mean time
dressings in place. No
cost data reported.
Page 61 of 219

Appendices.
Study
and
setting
Intervention
(I)
patients
followed
until wound
healed, up
to
maximum
of six
weeks.
Banks
(1994a) [52]
Setting and
length of
treatment:
hospital
based.
Final
assessment
was after
six weeks
of treatment
or sooner if
wound
healed.
Comparator
(C)
both groups had

access to
appropriate
pressure-relieving
support surfaces.
Polyurethane
dressing
(Spyrosorb), n=13
Hydrocolloid
dressing (Granuflex
E), n=16
Inclusion /
exclusion criteria
under 16 years age;
known history of poor
compliance with
medical treatment;
considered unlikely to
survive the study
period; previous
adverse reaction to
the materials under
test; clinically infected
wounds.
29
Inclusion criteria:
Aged > 16 years, with
shallow, moist ulcers
of grade 2 or 3 that
could be covered
adequately with a
single 10 cm x 10 cm
dressing, who could
be managed to
prevent further lesions
developing.
Exclusion criteria:
Patients with lesions
involving tissues other
than skin &
subcutaneous fat; dry
or necrotic lesions
(included once
debrided); patients
taking systemic
corticosteroids;
patients whose ulcers
had been dressed
with either treatment
in past two weeks, or
who had previously
shown sensitivity to
either dressing;
Baseline
characteristics
1-3 months
I: 21
C: 18
Objective
outcome
measures /
results
Quality
assessment
notes
stated: sealed
envelopes.
Seven patients in the

group and 10 in the
hydropolymer group
reported adverse events
that were thought to
relate to the dressing.
Trauma or erythema on
removal, skin maceration,
bleeding, excess
granulation tisse and
wound dehydration.
Complete wound
healing by six
weeks:
I: 10/13
C: 11/16
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Withdrawals
and reasons
reported by
treatment
group.
Randomisation
procedure not
stated.
Withdrawals:
C: Four all due to woundor dressing-related
problems.
I: Three withdrawals (two
due to wound- or
dressing-related
problems).
Mean (SD) age
(years):
I: 80.1 (10.2)
C: 78.6 (14.3)
Median time to
Median age (years):
74 (C), 73 (I)
Median duration
(days): 6.5 (C), 7 (I)
Wound location:
Buttock - 56% (C),
62% (I)
Sacrum - 38% (C),
31% (I)
Other - 6% (C), 8% (I)
Other notes
weeks:
I: 75
C: 55 (no measure
of precision)
>1 months
I: 20
C: 21
M:F ratio:
I: 1:1.2
C: 1:1.1
Mean wound area
(cm2):
C: 2.4
I: 1.4
Withdrawals
wound healing
(days):
I: 13.36, n=10
C:12.69, n=11 (no
measure of
precision)
Wounds traced an
acetate sheets at
each dressing
change.
No differences in comfort,
or length of time
dressings remained in
situ.
Spyrosorb significantly
easier to remove and
associated with
significantly less pain at
dressing changes
(p < 0.005).
No difference in
appearance or odour.
Trial sponsored by C.V.
Laboratories and Calgon
Vestal Laboratories.
Page 62 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
Objective
outcome
measures /
results
Quality
assessment
notes
Complete wound
healing by six
weeks:
I: 12/20
C: 10/20
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure not
stated.
Withdrawals
Other notes
infected ulcers;
patients incapable of
giving an opinion
about the dressing;
patients incontinent of
urine or faeces with
sacral pressure ulcers
or site likely to be
soiled.
Banks
(1994b) [53,
54]
Polyurethane
dressing
(Spyrosorb), n=20
Setting and
length of
treatment:
patients
resident in
the
community
treated for
six weeks
unless the
pressure
ulcer had
healed.
Patients in both
groups were
provided with
pressure-relieving
mattresses and
cushions.
Dressings were
changed when the
area discoloured
by exudate was <
1cm from edge.
Cleansing with
warmed saline
was undertaken if
necessary.
No topical
applications were
allowed.
Hydrocolloid
dressing (Granuflex
E), n=20
40
Inclusion criteria:
Aged > 16 years, with
shallow, moist ulcers
of grade 2 or 3 that
could be covered
adequately with a
single 10 cm x 10 cm
dressing, who could
be managed to
prevent further lesions
developing.
Exclusion criteria:
Patients with lesions
involving tissues other
than skin and SC fat,
grade 1, 4 or 5
pressure ulcers, dry
or necrotic lesions
(included once
debrided); patients
taking systemic
corticosteroids;
patients whose ulcers
had been
dressed with either of
the treatments in the
previous two weeks,
or who had previously
reacted to either
dressing; infected
pressure ulcers;
patients incapable of
giving an opinion
about the dressing;
patients incontinent of
Mean wound area

(cm2):
C: 1.51
I: 1.47
Other characteristics
I1 I2
Median age (years):
73 (C), 71 (I)
Median duration
(days): 21 (C), 56 (I)
Wound location:
Buttock - 45%(C),
50%(I)
Sacrum - 5%(C),
20%(I)
Other - 50%(C),
30%(I)
Wound improved
(healed or greatly
improved) by six
weeks:
I: 18/20
C: 10/20
Wound size
measurements
carried out using a
structured light
method to measure
the area of the
wound tracings.
Withdrawals:
I: Two withdrawals for
reasons unrelated to
wound
C: Two for wound
deterioration; two for
overgranulation; two for
discomfort; four for
reasons unrelated to the
wound.
Spyrosorb (I) reported to
be easier to remove
(p < 0.005). No
significant differences in
reported pain on removal,
or comfort, or mean
number of days which
dressing remained in
place.
Page 63 of 219

Appendices.
Study
and
setting
Bale (1997)
[55]
Intervention
(I)
Polyurethane foam
dressing, n=29
Comparator
(C)
Hydrocolloid
dressing, n=31
61
Setting and
length of
treatment:
hospital
setting, five
UK centres.
Treatment
was for 30
days or until
ulcer
healed
whichever
occurred
first.
Inclusion /
exclusion criteria
urine or faeces with
sacral pressure ulcers
or site likely to be
soiled.
Inclusion criteria:
aged 18 years or
over, able to
undestand and
consent to the trial;
ulcers with largest
diameter <11cm and
no signs of wound
infection.
Exclusion criteria:
history of poor
compliance; previous
involvement in the
study; pregnant.
Baseline
characteristics
Ulcer area:
<5 cm2
I: 14
C: 10
Objective
outcome
measures /
results
Quality
assessment
notes
Withdrawals
Complete wound
healing by four
weeks:
I: 7/29
C: 5/31
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure
described as
open
randomisation
list, stratified by
centre.
Withdrawals (n=40, I: 18,

62% C: 22, 71%):
I: patient discharged n=5,
death n=6, adverse event
n=3, patient request n=2,
dressing unsuitable n=1,
wound deteriorated n=1.
C: patient discharged
n=8, death n=2, adverse
event n=2, patient
request n=2, dressing
unsuitable n=3, wound
deteriorated n=2, lack of
progress n=1, dressing
rolling n=2.
Large withdrawal rate
(40/61=66%).
5-<10 cm2
I: 6
C: 6
10-<20cm2
I: 4
C: 9
>20cm2
I: 5
C: 6
Mean (SD) age of
ulcer (weeks): not
reported.
Other notes

wear time, absorbency,
pain on removal. No cost
data reported.
Median age (years):
I: 73
C: 74
Banks
(1994c) [56]
Setting and
length of
treatment:
hospital and
community.
12 weeks,
or until
wound
Polyurethane foam
dressing (Lyofoam
A), n=26
Low-adherence
dressing secured
with
vapourpermeable
film (Tegaderm),
n = 24.
Dressing changed
when necessary.
Patients also had
50
Inclusion criteria:
ulcers.
Exclusion criteria:
Terminal illness,
necrotic or infected
ulcers, ulcers > 6-7cm
in any direction, or
patient unavailable for
full 12 weeks.
M:F ratio:
I: 1:1.4
C: 1:1.1
Mean area of wound
(no. of patients):
< 1 cm2: 11 (I), 12 (C)
> 1 cm2, 2 (I), 2 (C)
< 2.5 cm2: 0 (I), 0 (C)
> 2.5 cm2: 6 (I), 1 (C)
68% of patients aged
Complete wound
healing by 12
weeks:
I: 19/26
C: 15/24
Assessed by weekly
visits of trial
coordinator.
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure
stated:
independent
statistician
Withdrawals:
I: 7
C: 9
12 withdrawals (no other
information) and four
patients died.
No significant group
differences in pain on
removal or comfort, nurse
assessed ease of
Page 64 of 219

Appendices.
Study
and
setting
Intervention
(I)
healed.
Comparator
(C)
Inclusion /
exclusion criteria
access to pressurerelieving equipment.
Baseline
characteristics
Objective
outcome
measures /
results
> 75 years
M:F 1:1.8
36% had body mass
index < 19 kg/m2.
Quality
assessment
notes
Withdrawals
Other notes
prepared
sealed
envelopes.
application or removal.
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure
stated:
computer
generated list
prepared by
company
making
intervention
product,
stratified by
initial wound
depth.
Withdrawals reported but

not by treatment group or
reasons (n=2).
Withdrawn patients
included in the analyses
(intention-to-treat
analysis).
A priori sample
size calcs.
Blinded
outcome
assessment.
Randomisation
procedure
stated:
Withdrawals (n=11, I:6,

C:5).
I: withdrew n=1, died
n=3, hospitalised n=2.
C: dies n=2, hospitalised
n=1, lost to follow-up
n=2.
Most common wound

was sacral site (53%)
followed by buttocks
(32%), trochanter and
foot, not heels (both
6%), and heels (3%).
Duration of ulcer not
known for 28% of
patients. Not reported
by group.
Seaman
(2000) [57]
Change indicator
dressing (SIG),
n=17
Setting and
length of
treatment:
home and
long-term
care
facilities in
the US.
Treatment
was for five
dressing
changes, or
until wound
healed.
Graumlich
(2003) [58]
Setting and
length of
treatment:
11 USA
nursing
Hydrocolloid
dressing (Comfeel),
n=18
35
The investigator did

the initial 1-3
dressing changes
while teaching the
caregiver. The
caregiver then
performed at least
two dressing
changes under
supervision.
Collagen dressing
(Medifil), once
daily, n=35
Hydrocolloid
dressing (DuoDerm)
twice weekly, n= 30
Inclusion criteria:
stage 2, 3 or 4
pressure ulcers, aged
18 years or over.
Patients caregiver
must also be willing to
consent.
Exclusion criteria:
pressure ulcer greater
than 6cm x 6cm at
maximum length and
width; patients
undergoing radiation
treatment to the area,
who had known
hypersensitivity to any
of the test products or
who were in involved
in any concomitant
research.
65

(cm2):
I: 4.2 (6.1)
C: 4.9 (4.1)
Mean (SD) age of
ulcer (weeks): not
reported.
Mean age (years):
I: 78
C: 66
Complete wound
healing by ~2
weeks:
I: 6/17
C: 1/18
?Mean % wound
surface area
reduction:
I: 60
C: 22 (no measure
of precision)
M:F ratio:
I: 1:2.4
C: 1:1
Inclusion criteria: 18
years of age or older;
at least one stage 2 or
3 pressure ulcer.
Median (IQR) ulcer

area (mm2):
I: 121 (63, 338)
C: 174 (50, 436)
Exclusion criteria:
Hypersensitivity to
collagen or bovine
Median (IQR) age of

ulcer (weeks):
I: 3.0 (1.6, 8.0)
Complete wound
healing by eight
weeks:
I: 18/35
C: 15/30
Mean (SD) wound
area healed per day
Sponsored by company
making intervention
product (SIG, ConvaTec).
Page 65 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
homes.
Treatment
was for
eight
weeks, or
until wound
healed
whichever
occurred
first.
Honde
(1994) [59]
Setting and
length of
treatment:
hospital,
multicentre.
Either eight
weeks or
until ulcer
healing,
whichever
occurred
first.
Amino acid
copolymer
membrane
dressing (Inerpan),
n=80
Hydrocolloid
dressing (Comfeel),
n=88
168
Inclusion /
exclusion criteria
Baseline
characteristics
products, concomitant
investigational
therapy, previous
enrolment in the trial;
osteomyelitis,
cellulitis; malnutrition;
ulcers covered by
eschar or necrotic
material; ulcers
covered by orthopedic
casts or support
surfaces; burn
ulcers;diabetic foot
ulcers distal to
tarsals;life expectancy
less than eight weeks;
anticipated transfer to
acute care within
eight weeks.
Inclusion criteria:
> 65 years old, with
grade 2 to 4 pressure
ulcer < 10 cm
diameter.
C: 6.5 (2.0, 12.0)
Exclusion criteria:
Signs and symptoms
of clinical infection
(treated before entry);
necrotic pressure
ulcers with black crust
(removed before
entry); pressure
ulcers on irradiated
skin; ulcers requiring
surgery; deep ulcers
extending to bone
with risk of
osteomyelitis
complications;
patients on
airfluidised beds.
Age (years): 80 (I), 84

(C)
Objective
outcome
measures /
results
Quality
assessment
notes
(cm2/day):
I: 0.6 (1.9), n=35
C: 0.6 (1.6), n=30
computer
generated list
prepared
independently,
stratified by
diabetes
status, block
randomisation
(variable size
blocks: 4-10),
central
telephone
allocation.
Withdrawn patients
included in the analyses
(intention-to-treat
analysis).
Complete wound
healing by eight
weeks:
I: 31/80
C: 23/88
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure
stated:
computer
generated list
prepared
independently.
Withdrawals: n=38
I: Four for emergent
reasons (mainly
necrosis); ten for reasons
unrelated to treatment
(mainly death, transfer or
discharge).
C: Six for emergent
reasons (mainly
necrosis); 18 for reasons
unrelated to treatment
(mainly death, transfer or
discharge).
Mean (SD) age

(years):
I: 82.0 (9.9)
C: 80.6 (12.2)
M:F ratio:
I: 1:1.7
C: 1:1.7
Mean surface area

(cm2):
I: 8.99
C: 6.85 (NS)
Grade distribution:
Grade 2 - 64%(I), 54%
(C)
Grade 3 - 30%(I), 40%
(C)
Grade 4 - 6% (I), 6%
(C)
No significant
differences in weight,
height, systolic or
diastolic blood
pressure, Norton score
or range of plasma
measures assessing
nutritional status.
Median (range)
eight healing time at
8 weeks (days):
I: 32 (13-59), n=80
C: 38 (11-63), n=88
Analysis adjusted
for initial wound
depth found
difference in
favour of Inerpan
(p = 0.044).
% change in area
from baseline:
reported to be
higher with Inerpan
(p = 0.09) but no
data presented.
Wounds assessed
Withdrawals
Other notes
Investigators unblended
assessment at
completion of study
favoured Inerpan.
Unclear what this
assessment was based
on.
Ease of care similar in
each group.
Sponsored by company
making Inerpan.
Page 66 of 219

Appendices.
Study
and
setting
Intervention
(I)
Comparator
(C)
Inclusion /
exclusion criteria
Baseline
characteristics
Objective
outcome
measures /
results
Quality
assessment
notes
Withdrawals
No a priori
sample size
calcs. No
blinded
outcome
assessment.
Randomisation
procedure
stated:
computergenerated
randomisation
list, stratified by
centre, block
size unknown
to
investigators,
sealed
envelopes.
A priori sample
size calcs.
Blinded
outcome
assessment.
Randomisation
Withdrawals & reasons

reported by treatment
group (n=12, I: 5, C: 7).
I: died n=3, lost to followup n=1, patient requested
withdrawal n=1.
Other notes
by tracings,
planimetry and
colour photography
at each visit.
Meaume
(2003) [60]
Setting and
length of
treatment:
three
nursing
homes in
France,
Belgium
and Italy.
Treatment
was for
eight weeks
or until
ulcers
healed.
Bale 1998b
[61]
Setting and
length of
treatment:
Self-adherent soft
silicone dressing
(Mepilex Border),
changed at least
once weekly, n=18
Self-adherent
hydropolymer
dressing (Tielle),
changed at least
once weekly, n=20
38
Extra fixation or
hydrating gel
(Normlgel) could
be used if needed.
Inclusion criteria: age

65 years or older;
stage 2 pressure
ulcers; a Modified
Norton Scale score of
11 or above; a
red/yellow wound
(according to the RedYellow-Black system);
ulcer had not shown
signs of improvement
in the previous four
weeks.
Exclusion criteria:
underlying disease
that might interfere
with the treatment of
the pressure ulcer (as
determined by the
investigator); food
and/or fluid intake
score of two or below
on the Modified
Norton Scale;
allergic/hypersensitivit
y problem with any
materials in the
dressings; wound
larger than 11cm x
11cm; wound with
black necrotic tissue
or clinical signs of
local infection.
amorphous
hydrogel
(Sterigel), daily,
n=24
amorphous hydrogel
(Intrasite), daily,
n=22
A low-adherence
dressing (Telfa) and
50
Inclusion criteria;
patients with necrotic
pressure ulcers.
Exclusion criteria:
wounds >8am in
Mean (range) ulcer

area (cm2):
I: 4.9 (0.7-25.3)
C: 5.4 (0.2-26.0)
Mean (range) age of
ulcer (weeks):
I: 8.3 (1-24)
C: 13.0 (1-52)
Mean (range) age
(years):
I: 83.8 (74.9-95.1)
C: 82.5 (66.4-91.9)
Complete wound
healing by eight
weeks:
I: 8/18
C: 10/20
Wound healed or
improved by eight
weeks:
I: 15/20
C: 19/20
M:F ratio:
I: 1:8
C: 1:4
Mean (range) ulcer

area (cm2):
I: 14.7 (6.6-49)
C: 9.4 (1.0-36)
Mean (range) age of
Complete wound
debridement by 4
weeks:
I: 14/26
C: 9/24
Adverse events report:

I: hypergranulation tissue
development n=1, other unrelated to support
surface n=3.
C: hypergranulation
tissue development n=1,
surrounding skin trauma
n=1, skin redness n=1,
other - unrelated to
support surface n=2.
reported: number of
dressing changes, ease
of use, leakage, odour,
surrounding tissue
damage. No cost data
reported.
Page 67 of 219

Appendices.
Study
and
setting
Intervention
(I)
Hospital
and
community
settings.
Treatment
was for 4
weeks or
until wound
debridemen
t, whichever
was sooner.
Price
(2000) [62]
Setting and
length of
treatment:
hospital
setting.
Treatment
was for six
weeks or
until wound
healing,
whichever
was sooner.
Comparator
(C)
a semipermeable film
(Tegaderm) were
used as secondary
dressings in both
groups.
Radiant heat
dressing (WarmUp), changed
daily, heated twice
daily for one hour
(morning and
evening), n=25
Alginate dressings,
changed as
indicated, n=25
Inclusion /
exclusion criteria
diameter (because of
the size of the
secondary dressing
use); disease
resulting in
immunosupression;
pregnant or nursing
mothers; participation
in any other clinical
trial less than one
month prior to this
study; already
enrolled in the trial.
58
Inclusion criteria:
stage 3 or 4 noninfected pressure
ulcers.
Exclusion criteria:
existing dermatitis;
history of
hypersensitivity to
adhesive products;
oral corticosteroids.
Baseline
characteristics
ulcer (months):
I: 5.1 (5 days-4 years)
C: 4.7 (11 days-4
years)
Objective
outcome
measures /
results
Outcomes were
assessed every 7
days.
Quality
assessment
notes
Mean (SD) age of

ulcer (months): not
reported.
Mean (SD) age
(years):
I: 75.72 (16.8)
C: 69.76 (16.2)
M:F ratio:
I: 1:2.1
C: 1:1.5
Complete wound
healing by six
weeks:
I: 3/25
C: 2/25
Mean (SD) change
in ulcer area by six
weeks (cm2):
I: -4.03 (4.3), n=25
C: -3.89 (8.1), n=25
Mean (SD) change
in ulcer area by six
weeks (%):
I: -54.62 (39.9),
n=25
C: -22.84 (75), n=25
Other notes
procedure
stated:
computergenerated
random
number list.
C: died n=4, wound

infection n=3.
No a priori
sample size
calcs. No
blinded
outcome
assessment,
but blinded
data analysis.
Randomisation
procedure
stated:
allocation
concealment
by opaque
envelopes.
Withdrawals (n=8, I: 7, C:
1): died n=3, condition
deterioration n=3,
support surface-related
deterioration n=1, patient
request to withdraw n=1.
No a priori
sample size
calcs. Blinded
outcome
assessment.
Randomisation
procedure not
No reporting of
withdrawals.
Mean (range) age

(years):
I: 78 (20-93)
C: 77 (38-99)
M:F ratio:
I: 1:1.9
C: 1:1.4
(cm2):
I: 7.3 (7.0)
C: 9.8 (12.0)
Withdrawals

reported: pain,
maceration, patient
comfort, odour. No cost
data reported.

reported: pain,
maceration. No cost data
reported.
Outcomes were
assessed weekly.
Modern dressing
Placebo
Ritz (2002)
[63]
Placebo: standard
care plus twice daily
treatment with a
Provant support
surface transparently
modified so that no
treatment was given,
Setting and
length of
treatment:
high-risk
Provant wound
closure system
(uses
radiofrequency
stimuli to induce
fibroblast and
epithelial cell
49
Inclusion criteria:
ulcers, >18 years age,
Exclusion criteria:
change in Norton Risk
Assessment score >7
?Mean wound area

(cm2):
Stage 2 ulcers:
I: 3.0
C: 4.4
Stage 3 ulcers:
I: 11.3
Wound closure at
six weeks for stage
2 ulcers:
I: 8/8
C: 4/11
Wound closure at
Page 68 of 219

Appendices.
Study
and
setting
patients,
setting not
stated.
Treatment
was for 12
weeks or
until ulcer
closure or
until
discharge
home,
whichever
occurred
first.
Intervention
(I)
proliferation),
active, twice daily
plus standard
care, n=16.
Comparator
(C)
n=18.
Inclusion /
exclusion criteria
within 30 days,
osteomyelitis, immune
dysfunction or
repeated systemic
infection, cancer,
concurrent treatment
with other woundhealing support
surfaces (e.g.
hyperbaric
oxygenation, electrical
stimulation).
Baseline
characteristics
C: 4.4
?Mean age (years):
Stage 2 ulcers:
I: 72
C: 69
Stage 3 ulcers:
I: 75
C: 63
Objective
outcome
measures /
results
12 weeks for stage
3 ulcers:
I: 4/8
C: 1/7
Quality
assessment
notes
Withdrawals
Other notes
stated.
?Mean (SD?)
wound closure
(cm2/day):
I: 1.192 (0.20), n=8
C: 0.68 (0.17), n=11
?Mean (SD?)
wound closure
(cm2/day):
I: 1.29 (0.41), n=8
C: 0.36 (0.22), n=7
Not stated how
measurements were
assessed.
Page 69 of 219

Appendices.
Table of included studies: nutrition

Study
Methods
Participants
Interventions
Outcomes
Chernoff (1990)
RCT. Method of
randomisation not
described.
Blinding method
not described.
12 institutionalised tube-fed
ulcers.
A) High protein (16%

of calories) (n=6)
B) Very high protein
(25% of calories)
dietary formula (n=6)
Monitoring for eight
weeks.
Pressure ulcer healing

measured in % of
decreasing surface.
Norris (1971)
RCT double-blind
crossover study.
14 patients with a pressure

ulcer.
Exclusion: neoplastic
disease, terminal phase of
illness, superficial pressure
ulcers, deep ulcer with
sinus tract.
Setting: chronic disease
hospital, Baltimore.
A) 3 capsules of
Zinc sulphate
(200 mg) (n=7)
B) 3 placebo
capsules per
day (n=7) for a
period of 24
hours.
After 12 weeks
patients switched
groups.
Volume of pressure ulcer

(crater)(Pories method)
Taylor (1974)
RCT double blind
20 surgical patients with

pressure ulcers,
baseline groups
comparable.
A) 500 mg
ascorbic acid
twice daily.
B) Inert placebo
twice daily
All patients had
standard hospital
bed and mattresses,
the same basic
hospital diet and
similar local therapy
Areas of the pressure ulcers

assessed weekly
subjectively, by pressure
area tracings and by
photography assessment.
Comments
Methodological quality
B
Only three of the 14

patients completed the
study. Volume
measured at four-week
intervals.
Page 70 of 219

Appendices.
to the pressure
ulcers.
Ter Riet (1995)
RCT multi-centre.
Investigators
blinded to
treatment
allocation.
Intention-to-treat
analysis and
sensitivity analysis.
88 patients with pressure

ulcers (partial thickness
skin loss or worse)
Exclusion:
Difficulty with swallowing,
frequent vomiting,
osteomyelitis, in the ulcer
area,
idiopathic
haemochromatosis,
thalassemis major, cushing
syndrome or disease,
pregnancy, radiotherapy in
the ulcer area, use of
antineoplastic agents, or
systemic
glucocorticosteroids,
terminally ill patients,
patients for whom surgical
treatment of the ulcer (other
than debridement) had
been planned, patients
already taking over 50 mg
vitamin C per day.
Patients with grade 2 ulcers
could be included if deepithelialisation had
persisted for at least seven
days without interruption.
Setting: 11 nursing homes
and one hospital in south
Netherlands.
Baseline: good for 5 of 8
cluster variables.
A) 500mg ascorbic
acid twice daily
and ultrasound
or 500mg
ascorbic acid
twice daily with
sham
ultrasound
(n=43)
B) 10mg of
ascorbic acid
twice daily with
ultrasound or
10 mg of
ascorbic acid
with sham
ultrasound(N=4
5) for 12-week
period
Ulcer volumes, surface area,

healing velocity, overall
visual mark, wound survival
time, wound closure,
probabilities per unit time.
Most patients had

nutrition deficiencies on
admission.
Page 71 of 219

Appendices.
Table of included studies: surgery

Study
Objective
Design/methods
Measurement
/intervention/procedure
Patients/
population
Findings /results
Comments
Akguner M et al.
(1998), Turkey
To investigate 18
chronic, wide and
deep pressure
ulcers in 14 patients
between 1990 and
1996.
Case series.
Gracilis myocutaneous flap.

Patients with ulcers > 3cm and
present for 3 months or > were
included.
4 bilateral 10 unilateral.
14 SCI patients
5 female 9 male.
10 with unreported
complications, 4 with reported
complications.
Limited baseline data.

Follow up time not stated.
Sutures removed on 15th
day and pressure on site
allowed on 21st day which
wound indicate healing
time. Healing time not
stated co-interventions not
described.
Akan IM et al.
(2001), Turkey.
To report on the use

of a modified
bilateral V-Y
advancement flap
(pac man flap) in
the repair of sacral
and trochanteric
pressure ulcers.
Case series.
Modified bilateral V-Y

advancement flap (pac man
flap).
Sacral ulcer 10
Trochanteric 3
Jan 1998-May 2000. All
wounds debrided. Follow-up
range 3-14 months (7.84)
13 patients, 8
male, 5 female.
Age range 15-55
(31). Ulcer size
range 10-22 cm
(15.84cm).
All wounds healed. No

breakdown or recurrence in the
follow-up period observed.
Time to heal?
Co-interventions?
Bocchi A et al.
(2002), Spain.
To report on the
treatment of
decubitus ulcers in
patients with spina
bifida.
Case series.
Debridement and removal of

bony prominence if
appropriate.
Ischial:
G M M rotation flap.
Gracile Muscle M
advancement flap.
Sacral:
G M F rotation flap
G M M R Flap
G M T flap
G M M V-Y advancement flap.
Fasciocutaneus
thoracolumbar-sacral rotation
flap.
52 patients spina
bifida. Age range
5-18.
20 surgical treatment.
4 recurrence.
All conservatives healed (32).
Baseline data?
Time to heal?
Follow-up?
Page 72 of 219

Appendices.
Chan J et al. (2003),

USA
To identify clinical
features of patients
undergoing
hemipelvectomy for
life-threatening
septic complications
of decubitus ulcers.
Retrospective chart
review.
Paravertabral osteomuscular
flap
Trochanteric:
F rotation/Transposition Thigh
flap.
Advancement bipedical thigh
skin flap
G M M R Flap
Broad latera muscle flap.
M F L tensor flap
Heel:
Cutaneous
rotation/transposition skin flaps
Lateral calcaneal skin flap
Fasciocutaneous plantar flap
Short toe flexor muscle flap
Malleolar:
Reverse fasciosubcutaneous
flap
Island sural flap
Short allux abductor muscle
flap
Plantar:
Rotation/transposition/V-Y adv
Flap
Plantar fasciocutaneous flap.
Co- interventions:
2-hrly position change
water mattress
ROHO air mattress
air fluidised mattress
Hemipelvectomy for decubitus
ulcers. 8 patients from 19891998.
Osteomyelitis in seven
patients.
Necrotising fascititis in one
patient.
4 standard hemipelvectomy.
4 modified hemipelvectomy.
Type of closure:
Standard flap-7
8 patients. All
male, mean age
51. 5 caucasian, 3
african. All SCI all
with pressure
ulcers with pelvic
osteomyelitis or
life-threatening
soft-tissue
infection. Those
with SCI not due to
Re-operations 3
Soft tissue resection 2
Bone resection 1
Post op complications 2
MOF 1 SCI (L1)
Resp Ar 1 SCI (C5)
30 ay mortality.
25% (2 0f 6).
No details of healing rate

of ulcers.
Follow up of ulcer?
Baseline data for ulcers?
Page 73 of 219

Appendices.
Wound left open 1
trauma or with
incomplete cord
injury were
excluded. Mean of
2.5 comorbid
conditions.
Eshaque D et al.
(1994), Bangladesh
To evaluate the
treatment of sacral
pressure ulcers
using
myocutaneous
flaps.
Case series.
Conservative treatment 10
patients (which includes
excision of the ulcer).
Surgical treatment including
excision and primary closure,
myocutaneous flap (10
patients), skin graft and
transposition.
25 patients 24
male, 1 female.
mean age 43.56
years.
10 conservative treatment, 9
healed, 1 loss to follow up.
15 surgical primary healing in
6, complications in 4 of which 3
went on to heal after infection
control and 1 required a skin
graft.
Very limited baseline data.

Interventions need
clarifying. Conservative
treatment inclusive of
surgical excision?
Esposito G et al.
(1992), Italy
To evaluate the use

of skin expansion in
reconstruction of
pressure ulcers.
Case series.
680ml skin expanders. Repair

of ischial ulcers.
10 patients (8
paraplegic) 1
medullar section
and 1 spina-bifida.
7 previous ops, 4 2
or more previous
ops. Age range 2166.
No ulcer recurrence in median

follow-up time of 12 months.
No recurrence of ulcers in
median follow-up period.
Healing rate?
Baseline data?
Foster R et al.
(1997), USA
To evaluate the
treatment of
pressure ulcers
using surgery.
Case series
Debridement and flap

coverage in single stage in
75%. Co-interventions include
bed rest and air fluidised bed
for 10-14 days.
Healing defined as: a healed
wound within one month post
op.
Failure defined as: non healed
wound.
Follow up one month nine
years. (10.7m)
Average wound size post
debridement = 75cm2
Flap selection:
Inferior GMIs 34
Gluteal thigh 27
87 patients(64
male, 23 female).
Mean age 49
range 16-90yrs.
Chronic wound
(present for >3
months) 52% of
the 112 ulcers.
89% paraplegic,
4% quadriplegic,
7% ambulatory.
Results (primary healing)%

Overall 83%
89% of single stage cases
Inferior GMIs 94
Gluteal thigh 93
Gracilis 75
V-Y hamstring 58
Tensor Fascia lata 50
Anterior thigh 100
Rectus abdominis 100
Time to heal averaged 38 days.
Average length of stay 21 days
and 16.5 for those without prior
complications.
Page 74 of 219

Appendices.
Gracilis 16
V-Y hamstring 12
Tensor Fascia lata 12
Anterior thigh 6
Rectus abdominis 5
Complications.
37% of reconstruction.
60% of ulcers had previous flap
surgery. No significant
difference between the flap
success of those with and
without prior flap repair.
Analysis gave statistical
significance that smaller
defects of and average of 59.6
cm2 were less likely to heal
(p=0.0089). Healed wounds
averaged 82.9cm2.
Subset analysis of patients
with small wounds 0-75cm2
showed that 71% had more
than one risk factor for wound
healing.
Geoffrey G and
Hallock MD (1994),
PA?
To evaluate the
random posterior
thigh
fasciocutaneous
flap in the treatment
of ischial pressure
ulcer.
Case series.
Hiroyuki O et al
(1995), Japan
To describe the
closing of a sacral
ulcer using a
modified gluteus
maximus V-Y
advancement flap
for sacral ulcers: the
gluteal
fasciocutaneous
flap method.
Case series.
To descibe
experience with the
Case series.
Hovius SER et al.

(1988), Netherlands
2 recurrences in the follow-up

period of 5 years.
Baseline data not

available
Recurrence in 6 week post op.

5 year follow up patient
developed new pressure ulcer.
Healing time not available.
24 patients.
19 sacral ulcers
(5 radiation ulcers
sacrum)
18 patients
ambulatory.
Ulcer size. 5-15cm.
All wounds healed without

necrosis.
Complications in 3 patients.
Time to heal?
Co-interventions?
7 patients 7 flaps.
Age range 21-83.
4 patients developed
complications. Longest follow
Random posterior thigh

fasciocutaneous flap. 10-year
period.
7 patients with
ischial sores.
The gluteal fasciocutaneous

flap.
1988-1995.
Ulcers with average
6.7x7.6cm treated with
unilateral gluteal
fasciocutaneous flaps.
Ulcers with average 11.1x11.2
treated with bilateral gluteal
fasciocutaneous flaps.
Lateral calcaneal artery flap.
From 1974- 1986.
Follow up 2-60 months (24.3).

Blood loss 250ml
Baseline data for ulcer

size and severity not
Page 75 of 219

lateral calcaneal
artery flap in
patients with chronic
ulcers of the heel or
lateral ankle.
up 12 years patient developed

hyperkeratosis.
10 patients (11
ulcers)
Healing achieved in all

patients.
No recurrence reported during
follow up.
Healing not clear, report in 1
case as 8 months.
Appendices.
available. Healing time?
Co-interventions?
To evaluate 10 year
experience using
the modified
hamstring
musculaocutaneous
flap for the
coverage of ischial
pressure ulcer.
Case series.
Klein NE et al.
(1988), Canada
Presentation of a
philosophy and
technique using
proximal femoral
resection (modified
girdlestone
technique) for
dealing with defects
from pressure
ulcers in paraplegic
patients.
Case series.
Proximal femoral resection

and vastus lateralis muscle
flap.
10 SCI patients.
Inclusion criteria
included other
pressure ulcers
had to be healed. 8
male 3 female. Age
range 25-69. 3-9
years post SCI. All
infected
trochanteric and or
ischial pressure
ulcers over a
diseased hip. 4
previous
resections.
Number of
debridements
ranged from 1-6, 6
requiring only 1
debridement.
Complications in 6 of 10.
3 lost to follow up, 5 healed
and sitting. 2 healed but
developed new ulcer. Follow up
2- 26 months.
Average time to discharge 9.5
weeks (7.5-12)
Baseline data?
Co-interventions?
Time to heal?
Little J W et al.
(1982), USA
To report on an
alternative flap
Case series.
Gluteus medius-tensor fasciae

latae flap. 8 flaps over 2 years.
8 patients. All
paraplegic. Age
All healed without

complications or recurrences.
Baseline data limited.

Co-interventions?
Josvay J and
Donath A (1998),
Hungary
Modified hamstring
musculaocutaneous flap.
10 year period.
average. 47.14. 5
male 2 female.
No flexion of the affected joint

for 3 weeks.
No loading for 2 months.
Follow-up ambiguous.
Suggestion of last op 6 months
prior to reporting.
Page 76 of 219

Appendices.
Margara A et al
(2002), Italy
repair for
uncomplicated
defects of the
trochanter, the
gluteus mediustensor fasciae latae
flap.
A proposed protocol
for the surgical
treatment of
pressure ulcers
based on 15 years
of experience with
337 cases.
range 32-81 years.

Defects up to
8x12cm.
Not clear from

reporting if data were
collected
prospectively or
retrospectively and
from what.
Total ulcer 337 treated

throughout study period 19852000.
Sacral ulcers 149
Ischial ulcers 121
Trochanteric 67.
Protocol adopted in 1992.
Outcomes before this period
were compared.
Group A (140) group.
Ischial 57
Island gluteus major muscle
flap 23
Gracilis rotation flap 18
V-Y advancement hamstring
flap 10
Advancement local
fasciocutaneous 6
297 patients all

SCI 271 male 26
female. 337
pressure ulcers.
Grade 3,4
(NPUAP)
Group A (140)
male 129, female
11 age 42+/-11.94.
Group b (157)
male 142, female
15 age 41+/11.44.
Healing time?
Follow-up?
Significantly better results with

group B for repair of ishial
ulcers (p=,0.005)
Significantly better results
found for sacral ulcers in group
B (p=<0.005)
Recurrence rates for the 2
groups.
A 24.79%
B 9.80%
Sacral ulcers 68
Gluteus maximus island flap
34
V-Y gluteus maximus
advancement myocutaneous
flap 29
Local fasciocutaneous flap 5
Trochanteric ulcers 29
Rotation tensor fasciae latae
10
Island tensor F L 17
Local F flap 2
Group B (157) protocol
Page 77 of 219

Appendices.
group.
Ischial
V-Y thigh posterior
compartment 64
Sacral
V-Y gluteus maximus muscle
81
Trochanteric
Rotation tensor muscle fasciae
latae 38.
Success defined as intact
without infection, haematoma
and pain at 60days. Or failure.
Recurrence determined if
failure post 6months.
Co-intervention
Vacuum assisted closure.
Oral fluids 30ml/kg 24 hrs.
Vitamins/minerals
No smoking nutrition of 3035kcal/kg BW
Protein of 1-2g/kg 24hrs
physiotherapy; muscles
stretching and electrical
stimulation of antagonist
muscles, muscle relaxants
dantrolene, baclofen, zanidia.
Psychosocial interventions to
assess compliance.
Support surfaces. Air fluidised
for 10-15 days then DUO
deteq.
Maruyama Yu et al.
(1980), Japan
To report on the use

of a gluteus
maximus
myocutaneous
island flap for repair
of sacral ulcers.
Case series?
Gluteus maximus
myocutaneous island flap
Longest follow-up 1 year.
8 patients.
All healed, no recurrence in

follow-up period.
Demographics limited.
Baseline data?
Co-interventions?
Time to heal?
Page 78 of 219

Appendices.
Baseline data?
Co-interventions?
Follow-up?
Not clear if patients or
ulcers?
Norman H and
Schulman MD
(1980), USA
Report on use of
bipedicle tensor
fascia lata
musculocutaneous
flap to close
trochanteric
pressure ulcers.
Case series.
Bipedicle tensor fascia lata

musculocutaneous flap.
Weight on flaps 10days +
6 trochanter
pressure ulcers.
Defects up to 17cm
diameter.
All 6 wounds healed primarily.
Rollin D and
Faibisoff B (1982),
Canada
Evaluation of the
role of
myocutaneous
flaps.
Case series.
Myocutaneous flaps
1 year follow-up (min)
4 trochanteric
2 ischial
1 sacral ulcer
7 patients (11 flap

repairs)
No recurrances reported.
Pressure damage reported.
Atrophy of muscle flap resulting
in localised depression.
Baseline data?
Co-interventions?
Atrophy not reported in
other studies?
Rubayi S (1999),
USA
The efficacy of
single-stage
surgical
management of
pressure ulcers
compared to
multistage
Retrospective
review.
10 year period. 1986-1996.

Included: those with grade 4
ulcers near pelvic girdle and
proximal lower extremities not
responsive to conservative
treatment.
Flaps used:
Gluteus maximusMR flap.
V-Y advancement tensor
fascialata musculocutaneous
flap.
V-Y hamstring Mflap.
Girdlestone procedure for
those with hip joint
involvement.
Vastus lateralis
Gracilis muscle flap.
Ulcers:
Ischial 220
Trochanteric 150
Sacral 50.
120 patients.
SCI. Age range 1581 (37.5) male
113, female 7.
Average ulcers per
patient 3.5.
Hospital stay.
Multi 19
Single 9.5
Op time
Multi 2.5 each surgery
Single 4.7
Ave ulcers /patient
Multi 3.5
Single 3.5
Blood loss
Multi 575
Single 980
Baseline data?
49 patients (52
38 of 52 ulcers healed without
Co-interventions
Air fluidised bed.
Physiotherapy at 4 weeks.
Sitting programme at 6 weeks.
Schessel ES and
To report on the
Case series.
Excisional debridement and
Page 79 of 219

Ger R (2001), USA.
management of
contant-tension
approximation.
Tavakoli K et al.
(1999)
Evaluation of 8
years study using
hamstring flaps, V-Y
musculocutaneous
flap for the repair of
ischial pressure
ulcers.
Follow-up study.
contant-tention approximation.
5 year period
Ulcers:
sacral 21
ischial 13
heel 16
9 patients died within 1 month
of treatment (with closed
wounds)
5 lost to follow-up, 3 of which
had closed wounds.
ulcers) Average
age 75. 22 male 27
female.
recurrence.
Time to heal 2-48 months.
Sacral ulcers healed 15 of 23
Time of closure 5.21days
Average follow-up 12.46
months.
3 died. 2 recurrences.
Trochanteric ulcer healed 10
of 12.
Average time of closure 13.1
days
Average follow-up 15.4
months.
7 died.
Heel ulcers healed 13 of 14.
Average time to closure 14.46
days
Average follow-up 25.6 months
1 died.
1 complication
Hamstring V-Y
musculocutaneuos flap.
Initial op 1988-1993.
Initial follow up mean (20
months)
2nd follow-up period 18-90
months. Mean 62 months.
4 patients lost to follow-up,
4 patients died at follow-up.
Living patients 19.
Initially 27 patients
(37 ulcers).
This follow-up
study 19 (29
ulcers). Mean age
43.7, 13 male, 10
female.SCI.
Initial follow-up 1993.

33% recurrence
14.8% re-advancement
14% non-healing ulcers.
Appendices.
Co-interventions.
Baseline data (to fine

initial study output)
Co-interventions?
Time to heal?
2nd follow-up 1997.

Recurrence rates 41.4 (47.8)%
period 0.5-70 months.
89.5% have intact flaps at time
of follow up.
Pelvic osteomyelitis reported
as cause of death in 1 patient.
Tellioglu AT el al.
(1999), Turkey.
Report on ischial
pressure ulcers
treated with sensate
gracilis
myocutaneous flap.
Case series.
Sensate gracilis
myocutaneous flap
Period 1995-1997.
Mean follow up 8 months
range 1.5-14 months.
12 patients all
ischial ulcers.
Median age 32.5
years, ten male 2
female. All SCI
under L3.
All healed, no recurrence in

follow-up period.
Baseline data?
Co-intervention?
Page 80 of 219

Tizian C et al.
(1986), Germany.
Report on onestage treatment of

multilocated
pressure ulcers
using
myocutaneous
island flaps.
Case series.
Gluteus maximus island flap

and biceps femoris flap.
Period 1982-1986.
Previous ops in 7.
Follow-up (12 of 14 patients 260 months).
Co-interventions:
Nutrition
Pressure relief
Watier E et al.
(1999), France.
William D et al.
(1989) USA.
Report on
experience of ischial
pressure ulcers.
To report on
hemipelvectomy for
end-stage pressure
ulcers.
Retrospective
review.
Case series.
Grffith fasciocutaneous flap +

Biceps
Semitendinous
Hamstring
Gluteusmaximus
Alon
Fasceocutaneous
Gluteus maximus
Musculocutaneus island
10 year period.
Co-interventions:
Air- fluidised bed.
Internal hemipelvectomy.
Multiple previous ops.
Follow-up 4-30 months.
32 patients. Single
ulcer 18 (sacral)
multi 14 all
paraplegic. All
grade 5-6
(campbell)
age range 19-63
(38)
ulcers defect size:
ischial 2.5-12cm
sacral and
trochanter 7-17cm
Healing achieved in all cases.

One report of complication.
34 patients mean
age 41 +/- 15.2
years range 22-74.
27 male 7 female.
All paraplegic or
tetraplegic. 61
procedures.
Recurrence rate in first two

years in 85% of cases.
5 patients.
Paraplegic
2 reported cases
17 ops in 10 years
and 15 ops in 5
years.
Healed ulcers without

recurrence (follow-up 2 years in
reported cases).
Left hospital at 6 weeks.
Appendices.
Only appears to give
results for those with multi
ulcers although consistent
with title.
Baseline data?
Co-interventions?
Time to heal?
Baseline data?
Co-interventions?
Time to heal?
No significance in early
complications of those with or
without recurrences rates.
Baseline data?
Co-interventions?
Time to heal?
Page 81 of 219

Appendices.
Table of included studies: mobility and positioning
Study
Objective
Design/Method Population/Setting Intervention/

Measurements
Results/Findings
Authors
conclusions
Bates-Jensen
BM et al.
(2003)
USA
To examine the
skin health
outcomes of an
exercise and
incontinence
intervention.
Randomised
controlled trial with
blinded assessments
of outcomes at 3
points over 8
months.
Ethics approval.
Consent obtained
from individual
patients or carers.
Blinded assessment.
Skin health outcomes:

Skin health total score
includes 8 skin conditions:
(maceration,
papules,macules,oedema,
scaling, blanchable
erythema, non pressure
related ulcers and pressure
ulcers (grade 1-4).
Incontinence and exercise

interventions led to
improvements in four
major risk factors relating
to skin health.
Effects were limited
primarily to back distal
perineal region.
4 nursing homes.
190 incontinent residents
Recruited from same
population community, all
meeting inclusion criteria:
not acutely ill and
receiving care in those
care areas, not terminally
ill with life expectancy of <
3 months, incontinent of
urine, free of catheter and
able to follow on-step
instructions.
Intervention group:
Research staff
provided exercise
and incontinence
care every 2 hours
from 8:00 a.m. to
4:30.p.m. (4 daily
care episodes) 5
days per week for 32
weeks.
Control group:
Received usual care
from nursing home
staff.
Comments
Pressure ulcer area.

Mean Sd.
Intervention group:
Baseline.
All regions 0.24+/- 0.82
Back distal 0.15+/- 0.6
Post 2 assessment.
Control group:
Baseline.
Post 2 assessment.
All regions o.5+/- 1.9
p-values:
All regions .319
Back distal .059
Covariate Analysis p-value:
0.73.
Page 82 of 219

Appendices.
DATA EXTRACTION TABLES ECONOMIC EVALUATION: DRESSINGS AND DEBRIDEMENT

1
Authors: Aguilo Sanchez et al. (2001)*
Setting/Perspective of the analysis: Hospital, Spain
Type of economic evaluation: Cost-consequence analysis
Interventions: (I) Hydrocolloid dressing. (C) Saline moistened gauze
Funding: Coloplast Products Medicos SA and Abbott Laboratories
METHOD
RESULTS
OVERVIEW
Design: RCT, patients were randomised at the moment

of hospitalisation.
Cost:
Average cost of materials: (I) Pta 11,323.63 (+/-10,828.45) vs. (C) Pta7,577.99 (+/-53.334.46)
Average cost of nursing time: (I) Pta 2,658.96 (+/-2,549.68) vs. (C) Pta 5,264.33 (+/-2,957.63)
Total daily cost of treatment: (I)= Pta 180.50 vs. (C) Pta 209.36
Conclusions: (I) was

more cost-effective
than (C). The total
costs were lower due
to a higher success
rate and less nursing
time required.
However, the unit
cost of (I) treatment
material was higher.
Sample: (I) sample of patients n=35. (C) sample of

patients n=35. Analysis of treatment completers
Level of effectiveness evidence: Level 1
Inclusion: PU of diameter no greater than 12cm. Grade 2
and 3 PU
Exclusion: Those patients with systemic infection, active
vasculitis, lupus erythematosus or cryoglobulinemia.
Those who were allergic to the products or those having
immunosuppressive therapies. PU were not linked to
muscle or tendon
Outcome/s: Complete heal
Resource use: Materials & nursing time
Currency: Spanish Pesetas (Pta), price year not stated
Follow-up: NS
Effectiveness:
Complete heal: (I)=20 patients PU vs. 10 in group (C)
For (I) treatment quality was excellent for 40% of patients (n=14) vs. 23% for (C) patients
(n=8)
For (I) treatment quality was good for 31% of patients (n=11) vs. 20% for (C) patients (n=7)
For (I) treatment quality was bad for 17% of patients (n=6) vs. 54% for (C) patients (n=19)
Four patients did not respond in group (I) vs. 1 non-responder in group (C)
Cost-effectiveness:
Cost and outcomes not synthesised. More PU healed in (I) and the daily cost of treatment was
lower, therefore (I) appears to be the more cost-effective option, dominating (C).
Uncertainty assessed:
Costs were reported as means with SD. However, no statistical analysis of total costs was
performed.
Comment: It is not
clear what the total
cost of treatment was
or how the total daily
cost of treatment was
calculated. The length
of follow-up was not
stated. The loss to
follow-up was high.
No statistical analysis
to compare total costs
was performed.
Assessments: Nurses
*NB Taken from an abstract written in English
Page 83 of 219

Appendices.
2
Authors: Bale et al. (1998)
Setting/Perspective of the analysis: National Health Service, UK
Interventions: (I) Hydrocellular dressing. (C) Hydrocolloid dressing
Funding: Smith and Nephew Limited
METHOD
RESULTS
OVERVIEW
Design: Open, prospective randomised parallel group trial. Patients were randomised in blocks of 4
Resources: (I) changed every 3.6 days vs.

(C) changed every 4.1 days, (P=0.15)
Conclusions: (I) more costeffective than (C).
Cost: Cost of treatment per patient,

whether PU healed or not, was 50 in the
(I) group and 76 in the (C) group
Comment: The cost of labour

time to change dressings was
omitted. Some patients were
withdrawn from the study (the
authors do not say which
wound group they are in).
More patients were withdrawn
from the (C) group and this
could bias results in favour of
this group. Across all wounds,
at 7 weeks the number of
wounds healed was very
similar across groups but data
were not presented on PU 7week comparisons.
Sample: 100 patients, 32 of which had PU. (I) = 15 PU, (C)=17 PU. If a patient had >1 PU, the
largest was entered into the study. At admission, in group (I) 65% of PU were grade 2, 35% were
grade 3 PU. In group (C) 40% of PU were grade 2, 60% were grade 3 PU. Analysis of treatment
completers
Effectiveness: 59% of PU healed in the (I)

group, 27% in the (C) group
Inclusion: Grade 2 or 3 PU
Exclusion: Pregnant and lactating women, grade 1 or 4 PU, wounds which were too large to be
covered by one dressing, PU expected to heal within one week, PU with sloughy or necrotic tissue
or grossly infected wounds, patients in the trial for at least one week
Outcome/s: Wounds completely healed at 8 weeks
Resource use: Materials used as recorded by nurses and costed using unit costs from the published
literature
Currency: UK Sterling, 1994 values
Follow-up: Maximum of 8 weeks
Cost-effectiveness:
Cost and outcomes not synthesised. More
PU healed in (I) and the daily cost of
treatment was lower, therefore (I) appears
to be the more cost-effective option,
dominating (C).
Uncertainty assessed: A number of oneway sensitivity analyses were undertaken,
including varying the costs applied if
withdrawn prior to 8 weeks, but did not
alter the findings. Statistical analysis to
compare average dressing wear time
across interventions.
Assessments: Nurses assessing PU at every dressing change
Page 84 of 219

Appendices.
3
Authors: Bergemann et al. (1999)
Setting/Perspective of the analysis: Hospital, Germany
Interventions: (I1) Gauze, (I2) Impregnated gauze, (I3) Calcium alginate, (I4) Hydroactive 1 (hydroactive wound dressing in combination with enzymatic wound cleaning
(collagenese), (I5) Hydroactive 2 (hydroactive wound dressing in combination with enzymatic wound cleaning (collagenese) during the first seven days of treatment
Funding: Beiersdorf AG and Knoll AG
METHOD
RESULTS
OVERVIEW
Design: A spreadsheet model using data from four hospitals. An expert panel
was consulted to help structure the model. Care of four sizes of PU were
considered i.e. PU of 5cm x 8 cm, 8cm x 12 cm, 10cm x 15cm, 12cm x 20cm.
It was assumed that the bigger the wound, the longer the treatment duration
required
Resource use:
Varied across wound surface area and informed by the
expert panel
Conclusions: Despite the higher
Sample: 120 patients in total but this included patients with venous leg ulcers
too
Level of effectiveness evidence: Level 3 and 4
Inclusion/exclusion: As for design
material costs of (I4) and (I5), the

reduced labour costs, due to
Cost:
Cost savings of between DM1,138 (DM538 to 1739) for (I4)
vs. (I2) and DM8,234 (DM4610 to DM 11,858) for (I4) vs.
(I1) were estimated
Effectiveness:
Equal efficacy assumed or a decrease in the length of
hospital stay of 10% for (I4) and/or (I5)
quicker time to heal and reduced

duration of treatment or time to
inpatient discharge, that were
assumed resulted in lower total
costs relative to the three
comparators.
Effect/s: Not compared to costs. However, in order to calculate total costs the
number of wound dressing changes until PU healing or discharge from
hospital was required
Resource use: Use of material and personnel time
Currency: German Mark DM, 1997 values
Follow-up: Between 22 days and 50 days depending on size of wound and
type of treatment applied
Assessments: Nurses
Cost-effectiveness:
Outcomes were incorporated with cost estimates
Two-way sensitivity analysis was undertaken on the total
costs associated with each intervention as well as the
following parameters used to calculate costs; personnel
costs per minute, time required to change a dressing, total
number of wound dressing changes, and results remained
fairly robust. Monte Carlo simulation was used to estimate
the variation in inputs into the model (95% CI).
Comment: The model assumed that

use of (I4) and (I5) reduced
inpatient stays by 10%. PU were
followed in the model not only until
PU heal but sometimes instead until
inpatient discharge: hence the PU
may remain unhealed and does not
fully take into account effectiveness.
It is unlikely that all treatments are
equally efficacious.
Page 85 of 219

Appendices.
4
Authors: Burgos et al. (2000)
Setting/Perspective of the analysis: Hospitals, Spain
Type of economic evaluation: Cost-effectiveness analysis
Interventions: (I) Collagenese ointment. (C) Hydrocolloid occlusive dressing
Funding: Laboratories Knoll, SA
METHOD
RESULTS
OVERVIEW
Design: Multi-centre, non-blind parallel group study. Randomisation by

computer-generated randomisation list into blocks of 4 patients
Resource use:
(I)=1/day, (C)=0.42/day. Staff time per patient/day in minutes was 8.6 (+/-5.3) in
the (I) group and 4.6 (+/-2.8 in the (C) group
Conclusions: NSS
difference in costs
or effects across
treatments.
However, there
was a trend
towards lower costs
and better effects
associated with (I)
making it the more
cost-effective
option.
Sample: (I) n=18 patients/PU. (C) n=19, patients/PU

Level of effectiveness analysis: Level 1
Cost: Total costs:

(I)=Pta 41,488 (95%CI: Pta 26,191-Pta 56,784)
(C)=Pta 32,963 (95%CI: Pta 23,389-Pta 42,538), NSS
Inclusion: Grade 3 PU for <1 year

Exclusion: End-grade organ disease, localised or systemic signs &/or
symptoms of infection (fever, local erythema, regional lymph node
swelling) of hypersensitivity to (I)
Effectiveness:
Mean (SD) reduction in PU area in (I) group was 9.1 (1.2) cm2 vs. 6.2 (9.8) cm2 in
group (C), an area reduction of 44% & 28% respectively
PU area decreased in 83% of (I) group vs. 74% in (C) group after 12 weeks (NSS)
Complete PU heal 3 patients in each group, NSS
Intention to treat: No
Outcome/s: Reduction of PU area
Resource use: Nurse time and treatment supply including ancillary
supplies
Currency: Spanish Pesetas Pta, price year 1998
Follow-up: 12 weeks or until complete heal, whichever occurred first.
Duration of study 1 year.
Cost-effectiveness:
Total cost/1 cm2 reduction in PU was Pta 4,559 for (I) & Pta 5,310 for (C)
2
If only pharmaceutical costs were considered, the cost/1cm reduction in PU was
Pta 2,290 for (I) and Pta 3,382 for (C), NSS. The cost per reduction in PU area was
lower for (I) & on this basis (I) is the more cost-effective option, dominating (C).
Appropriate statistical tests applied and variance reported. However no uncertainty
around the cost-effectiveness estimate was presented. No sensitivity analyses
were conducted.
Comment: Material
costs very similar
but total cost of (I)
tended to be higher
than (C) due to
greater staff input.
Cost per 1cm2
reduction were
lower for (I) but not
NSS. No allowance
for across site
differences.
Assessments: Weekly by nurses
Page 86 of 219

Appendices.
5
Authors: Capillas Perez et al, 2000*
Setting/Perspective of the analysis: District Health Authority, Spain
Interventions: (I) Moist environment dressings (Hydrocolloid Comfeel), n=15 PU, (C) Traditional dressings (saline gauze), n=14 PU
Funding: None stated
METHOD
RESULTS
OVERVIEW
Design: Randomised clinical trial with study

analysts blinded to allocation of patients to
study groups. Analysis of treatment
completers
Resource use:
2
Median nurse time required to cicatrise an initial 1cm PU: (I)= 67.5 (32.24 to 135) minutes
Median nurse time required to cicatrise an initial 1cm2 PU: (C)= 400 (129.9 to 2,041) minutes, p<0.018 (SS)
2
Median number of treatments required to cicatrise an initial 1cm PU: (I)=1.86 (0.71 to 2.29)
Median number of treatments required to cicatrise an initial 1cm2 PU: (C)=12.1 (5.71 to 29.86), P<0.05 (SS)
Median frequency of treatments: (I)=every 5 (3.46 to 5.86) days
Median frequency of treatments: (C)=every 1 (1.0 to 1.01) day, p<0.05 (SS)
Conclusions:
(I) was more
cost-effective
than (C).
Sample: (I) n=15 PU, (C) n=14 PU

Level of effectiveness analysis: Level 1/2
Exclusion: Patients with infected PU
Outcome/s:
Time required to cicatrise an initial 1cm2
wound
% of surface healed daily
Resource use: Materials and nurse time
Currency: Spanish pesetas (Pta), price year
not reported
Effectiveness:
2
Median nurse time required to cicatrise an initial 1cm PU: (I)=7.12 (5.33 to 11) days
Median nurse time required to cicatrise an initial 1cm2 PU: (C)=12.18 (5.85 to 39.38) days, NSS
Median % of surface healed daily: (I)=1.42% (0.56% to 2.5%)
Median % of surface healed daily: (C)=1.19% (0.59% to 1.55%), NSS
Cost-effectiveness:
st
rd
2
Median (1 and 3 percentiles) cost of the cicatrisation of an initial 1cm PU: (I)= Pta 4,388 (1,808 to 7,539) vs. (C)=
Pta 17,983 (6,521 to 87,798), SS
Nurses times for cicatrisation of an initial 1cm2 PU cost: (I)= Pta 2,610 (1,247 to 5,221) vs. (C)= Pta 15,490 (5,027 to
78,971), SS
Material cost for cicatrisation of an initial 1cm2 PU: (I)= Pta 1,230 (338 to 2,754) vs. (C)= Pta 2,619 (1,351 to 12,086),
SS
Median % of surface area healed daily was faster for (I) and median cost of cicatrisation was lower, therefore (I)
appears to be the more cost-effective option, dominating (C).
Follow-up: Not stated explicitly

Assessment: Not clear
Standard statistical analyses conducted
Comment:
Sequential
randomisatio
n to groups
not truly
random.
Reduced
time to
cicatrise PU
with (I) may
have
beneficial
quality of life
impacts and
benefits for
caregivers
too. Reported
median costs
that are
difficult to
interpret.
*NB Taken from an abstract written in English
Page 87 of 219

Appendices.
6
Authors: Colwell et al. (1993)
Setting/Perspective of the analysis: Hospital, US
Interventions: (I) Hydrocolloid wafer dressing, (C) Sterile moist gauze dressings
Funding: Convatec, division of Bristol-Myers Squibb Company
METHOD
RESULTS
OVERVIEW
Design: RCT, PU randomly assigned. More grade 2 PU randomised

to (I) (SS) & more grade 3 PU in (C) (SS)
Resource use:
(I) 0.42 dressing changes/ day (over 17 days), took 7.30
minutes/dressing change and spent 3.07 minutes/PU/day
(C) 4.1 dressing changes/ day (over 17 days), 7.95
minutes/dressing change and spent 32.60 minutes/PU/day
Conclusions: (I) more cost-effective

when all costs considered. Cost of (I)
dressing was higher than cost of (C)
though. Greater proportion of PU
healed in group (I) vs. group (C).
Cost:
Average supply cost/dressing change= $6.15 for (I) & $0.47 for
(C)
Average labour cost/dressing change = $2.31 for (I) & $2.52 for
(C)
Total cost/dressing change = $8.46 for (I) vs. $2.99 for (C)
Total daily cost of (I)=$3.55 vs. $12.26 for the (C) group
Total average cost per case = $53.68 (I) vs. $176.90 (C)
Comment: Authors randomised by PU

instead of by patient and that can
introduce bias. Variance around cost
estimates not reported. Not clear what
measure of central tendency was used.
No statistical tests of costs undertaken.
There were SS more grade 2 PU
randomised to (I) than (C) and grade 2
PU tend to have better healing
characteristics than grade 3 PU.
Sample: 70 patients; (I): n=33, (C): n=37. 97 PU; (I): n=48 PU, (C):
n=49 PU
Level of effectiveness evidence: Level 1/2
Inclusion: Grade 2 & 3 PU
Exclusion: Grade 1 or 4 PU, if factors present that could adversely
influence wound healing e.g. uncontrolled diabetes mellitus, clinical
infection, PU that could not be accurately graded, if left study within
8 days of initial enrolment, if patients receiving other therapies that
could confound the results.
Outcome/s: Number of PU completely healed. Decrease in PU size
and area, total wound healing.
Effectiveness:
22% (n=11) PU healed n the (I) group vs. 2% (n=1) in the (C)
group
Resource use: Nurse time and treatment supply (including tape,

dressings, underpad, gauze pads). Activity data based on
observation of dressing changes over a fortnight. Nurses completed
supply usage forms for first 50 PU redressed.
Cost-effectiveness:
Not presented. Costs associated with (I) were lower and more
PU healed and on this basis (I) is the more cost-effective option,
dominating (C).
Currency: US$, no price date
Uncertainty assessed: Indication of variance and significance

testing. Robustness of results tested using different wage costs.
Follow-up: 17 days on average (range 6-56 days)

Assessments: Assessed every 4 days
Page 88 of 219

Appendices.
7
Authors: Gorse et al. (1987)
Interventions: (I) Hydrocolloid dressings. (C) Dakins solution (chloramines-T)-soaked wet-to-dry dressings
Funding: Not stated
METHOD
RESULTS
Design: Prospective selection of patients. Allocation to intervention was
determined on the basis of admission to a particular ward. Wards were chosen
which included medical and surgical patients.
Resource use: (I) was changed approximately every 4 days per week,
five minutes per dressing change was assumed
(C) was changed approximately every 8 hours or 3 times per day, 21
times per week. 20 minutes per dressing change was assumed
Sample: (I) 27 patients & 76 PU. (C) 25 patients with 52 PU

Inclusion: grade 2 & 3 PU and grade 4 PU that extended only into the muscle
Exclusion: Adjacent osteomyelitis or extension of PU into fascia, bone &/or a joint
space, venous stasis, ischaemic ulcers of the extremities, rapidly fatal underlying
disease, planned hospital discharge within 7 days of initiating treatment
Outcome/s: Rate of healing for each healed PU (initial surface area divided by
number of days until complete healing). If patients died/were discharged prior to
complete healing, the surface area at the last examination was subtracted from
the initial surface area and the results divided by the number of treatment days.
Resource use: Nurse time & treatment supply but only the cost of supplies were
calculated
Follow-up: From initiation of conservative treatment until healing, hospital
discharge or failure of the initial intervention
Cost: Based on intervention costs only, a cost of $6.20 per week was
estimated for (I) vs. $52.50 per week for (C)
Effectiveness: (I) 86.8% of PU improved vs. (C) 69.2%. The number of
days to complete heal for those PU that did heal was 10.0 (+/-10.5) for
(I) vs. 8.7 (+/-6.2) for (C). The rate of decrease (cm2 per day) for PU
that healed was 0.72 (+/-1.22) for (I) vs. 0.55 (+/-0.59) for (C). NSS
Among incompletely healed PU the duration of follow-up was SS for (C)
vs. (I) but the rate of decrease in surface area was not significantly
different.
Among PU that worsened, a SS higher rate of increase in surface area
in (I) resulted compared to (C).
Cost-effectiveness: Not presented. Costs associated with (I) were lower
and more PU healed and on this basis (I) is the more cost-effective
option, dominating (C).
Appropriate statistical tests were applied to the effects. Cost differences
across groups were not compared statistically.
OVERVIEW
Conclusions: (I)
resulted in a large
proportion of PU
completely healed
or healing vs. (C).
The weekly cost of
the interventions
alone was lower for
(I) vs. (C).
Comment: The cost
was not examined
until time to heal or
according to any
other effectiveness
measure. Some
patients had more
than one PU that
was entered into
the trial. Allocation
of patients to
interventions not
random. The cost
of nursing time was
not assessed.
Assessments: Nurses
Page 89 of 219

Appendices.
8
Authors: Graumlich et al (2003)
Setting/Perspective of the analysis: Nursing homes, US
Interventions: (I) Topical collagen. (C) Hydrocolloid
Funding: Glaxo, Smith, Kline Inc, BioCore Medical Technologies, Retirement Research Foundation
METHOD
RESULTS
OVERVIEW
Design: Multi-centre, randomized (by computerized random number generator), allocation concealed,
single (outcome assessor) blind, controlled trial. Stratified, blocked design with diabetes mellitus as the
stratification variable. One PU per/patient. Analysis according to intention to treat.
Resource use: (I)=1/day, (C)=0.29/day or

2/week. Average time/dressing change=15
minutes
Sample: (I) n=35, (C) n=30, drop-out rate= 17% (n=6) for (I) and 17% (n=3) for (C), NSS
Cost: Average cost/patient for grade 2 or 3 PU

for 8 weeks = $627.56 for (I) & $222.36 for (C)
Conclusions:
NSS differences
in healing
outcome across
groups. (I) was
considerably
more expensive
and offered no
major benefits to
patients
otherwise eligible
for (C)

Inclusion: Grade 2 or 3 PU, 18+ years old
Exclusion: Hypersensitivity to collagen or bovine products, concomitant investigational therapy, previous
enrolment in the trial, osteomyelitis, cellulitis, malnutrition, PU covered by eschar or necrotic material, PU
covered by orthopaedic casts, burn ulcers, diabetic foot ulcers distal to tarsals, life expectancy <8 weeks,
anticipated transfer to acute care within 8 weeks.
Outcome/s: % of PU completely healed within 8 weeks. Secondary outcomes, time to heal, ulcer area
healed per day, linear healing of wound edge
Resource use: Nurse time & treatment supply including ancillary supplies
Follow-up: 8 weeks (median=5 weeks)
Effectiveness: Complete PU healing within 8

weeks for 51% of (I) and 50% of (C) (95% CI:
26% to 29%), NSS
Mean healing time (I)=5 weeks (95% CI: 4 to 6
weeks), (C)=6 weeks (95% CI: 5 to 7 weeks),
NSS
2
Mean area healed/day = 6mm /day in both
groups
Mean linear healing of wound edge was 3mm
both groups
Cost-effectiveness: Not presented. Costs
associated with (I) were higher and more PU
healed but NSS
Uncertainty assessed: Appropriate statistical
tests were applied
Comment: The
rationale for
using an 8 week
follow-up period
was not
provided. Little
exploration of the
uncertainty
associated with
the cost data was
provided
Assessments: Weekly nurse assessments
Page 90 of 219

Appendices.
9
Authors: Harding et al. (2000, 2001)
Setting/perspective of the analysis: Health care, UK
Interventions: (I1) Saline moistened gauze, (I2) Hydrocolloid Comfeel dressing, (I3) Hydrocolloid Granuflex dressing
Funding: ConvaTec
METHOD
RESULTS
OVERVIEW
Design: Probability based decision model
Resource use:
Frequency of doctor visits = 0. Nursing time to change dressing &
assess PU = 20 minutes/PU. Dressing changes/week: (I1)=14, (I2)
& (I3)=2. Surgical debridement by a doctor was estimated to be
required in 25% of PU and subsequent debridement in 13% of PU.
Non-surgical debridement by a nurse was assumed to be required
in 50% of all PU. In case of PU infection, a course of antibiotics
was assumed: 500mg Amoxycillin, 3/day for 10 days.
Conclusions: (I3) was the

most cost-effective option.
The cost of (I2) & (I3) were
lower per patient PU healed
compared to (I1)
Sample: Initially (I1) PU n=102, (I2) PU n=136, (I3) PU=281. Total sample of
PU, n=519. Hypothetical managed care plan with a population of 100,000
individuals.
Level of effectiveness evidence: Not clear but use of evidence on levels 1 to
4 possible
Inclusion: Effectiveness data derived from review of published studies and
validated by expert panel. 15 studies of 3 PU protocols qualified for inclusion.
Exclusion: Those studies that did not include information on patient
demographics by treatment modality, wound healing assessments or
methods of care, grade 1 PU, studies that did not report the % of PU healed
between 4 and 12 weeks, and studies with a pooled total of <100 PU.
Outcome/s: Average (weighted) proportions of PU completely healed at
different time frames. Number of patients healed/not healed after 12 weeks. If
no healing data was available, the % of PU healed was estimated based on
available data and linear growth interpolation.
Resource use: Dressing materials, ancillary supplies, nursing and doctor
debridement. A PU care questionnaire was developed to validate resource
use and treatment patterns, based on existing guidelines and the published
literature. 4 European experts completed the questionnaire and the data from
each used to obtain parameter estimates.
Cost:
Average cost for (12) weeks per healed PU were:
(I1)=115 for dressing materials, 2,548 for nursing
(I2)= 189 for dressing materials, 453 for nursing
(I3)= 124 for dressing materials, 298 for nursing
Effectiveness:
Proportion of PU healed at 12 weeks: (I1)=51%, (I2)=48%,
(I3)=61%
Cost-effectiveness:
Not reported. Instead the average cost per effect (i.e.) total
cost/patient healed after 12 weeks of treatment was calculated:
(I1)=2,663, (I2)=642, (I3)=422
No
Comment: (I1) dressings

were cheaper than (I2) and
(I3) dressings. However, due
to increased nurse input
associated with higher
frequency of dressing
changes, the total cost per
healed PU at 12 weeks was
lower for groups (I2) & (I3).
Difficult to compare primary
study samples in terms of %
of PU healed according to
ulcer grade and location.
Testing for statistical
significance not applied. To
compare across treatments,
the average costeffectiveness ratio was
calculated rather than the
incremental costeffectiveness ratio.
Currency: UK sterling , price date 1999

Follow-up: 12 weeks
Page 91 of 219

Appendices.
10
Authors: Kerstein et al. (2001)
Setting/Perspective of the analysis: Hypothetical managed care plan, US
Interventions: (I1) Saline moistened gauze (I2) Hydrocolloid Comfeel dressing (I3): Hydrocolloid DuoDERM dressing
Funding: Convatec, division of Bristol-Myers Squibb Company
METHOD
RESULTS
Design: Probability based decision model
Sample: Hypothetical managed-care plan with a population of 100,000 lives
Level of effectiveness evidence: Not clear but use of evidence on levels 1 to 4
possible
Inclusion: Effectiveness data derived from review of published studies and validated
by expert panel.
Exclusion: Those studies that did not include information on patient demographics
by treatment modality, wound healing assessments or methods of care, grade 1 PU,
studies that did not report the % of PU healed in at least one of a number of specific
timeframes (4, 6, 8 and 12 weeks of PU) and studies with a pooled total of <100 PU.
Outcome/s: Average (weighted) proportions of PU completely healed at different
time frames. Number of patients healed/not healed after 12 weeks. If no healing
data was available, the % of PU healed was estimated based on available data and
linear growth interpolation and extrapolation.
Resource use: Dressing materials, nursing and doctor debridement. A PU care
questionnaire was developed to validate resource use and treatment patterns,
based on existing guidelines and the published literature. 4 US experts completed
the questionnaire and the data from each used to obtain parameter estimates
Resource use:
Frequency of doctor visits was 0.25/week (15 to 30 minutes
for the first visit and 15 minutes for follow-up visits)
Nursing time to change dressing and assess PU was 15
minutes/PU.
Dressing changes/week were 14.41 (7 to 21) for I1, 2.47
(1.8 to 7) for I2, 2.19 (1.0 to 3.4) for I3
Cost: Average cost for 12 weeks were:
(I1)=$92.43 for dressing materials, $996.05 for nursing,
$338.87 for doctor debridement
Effectiveness:
After 12 weeks 511 patients with PU were healed with I1,
358 with I2, 696 with I3
Proportion of PU healed at 12 weeks: (I1)=51% (0-100),
(I2)=48% (29-80), (I3)=61% (33-100)
Currency: US$ 2000
Cost-effectiveness: Not reported. Instead the average cost

per effect (i.e.) total cost /patient healed after 12 weeks of
treatment was calculated: (I1)=$2,179, (I2)=$1,267,
(I3)=$910
Follow-up: 12 weeks
Uncertainty assessed: No
OVERVIEW
most cost-effective option.
The cost of (I2) and (I3)
were lower per patient PU
healed compared to (I1).
Comment: (I1) dressings
were cheaper than (I2) and
(I3) dressings. However, due
to increased nurse input
associated with higher
frequency of dressing
changes, the total cost per
healed PU at 12 weeks was
lower for groups (I2) & (I3). It
was difficult to compare
primary study samples in
terms of % of PU healed
according to PU grade and
location. Testing for
statistical significance not
applied. To compare across
treatments, the average
cost-effectiveness ratio was
calculated rather than the
incremental costeffectiveness ratio.
Page 92 of 219

Appendices.
11
Authors: Kim et al. (1996)
Setting/Perspective of the analysis: Health care system, Korea
Interventions: (I) Hydrocolloid occlusive dressing. (C) Wet-to-dry gauze dressing
Funding: Not stated
METHOD
RESULTS
OVERVIEW
Design: RCT
Resource use:
(I) changed every 4 to 5 days
(C) changed 3 times per day
Medical staff time was 20.4 minutes per day for (I) vs. 201.7 minutes per
day for (C)
Conclusions: (I) may be

more cost-effective than
(C)
Sample: (I) 26 PU. (C) 18 PU

Inclusion: Grade 1 and 2 PU
Exclusion: Patients with systemic infections, with endocrinological
disorders, with difficulty in keeping pressure-relieving positions or with
aggravated general conditions due to other factors.
Outcome/s: Complete heal, time to heal, PU healing rate
Resource use: Number of dressing changes per day and medical staff
time
Costs: Only costs of the interventions were considered
Currency: Korean Won, price date not specified
Follow-up: Not stated
Assessment: Every 4 days
Cost: The average cost of the interventions was Won 8,204 (+/-2,664) for (I)
vs. Won 14,571 (+/-6,700) for (C) (P<0.05). These costs did not take the
cost of staff into account.
Comment: The method of

allocation to treatment
was not described fully.
The length of follow up
was not stated.
Effectiveness:
80.8% of (I) and 77.8% of (C) healed completely (NSS).
Time to complete heal was 18.9 days for (I) vs. 24.3 days for (C)
2
2
PU healing speed was 9.1mm per day for (I) vs. 7.9 mm /day for (C)
3 (11.5%) of PU in (I) developed hypergranulation and they were treated
with povidine-iodine gauze until complete healing was achieved.
Cost-effectiveness:
Cost and outcomes not synthesised. More PU healed in (I) and the daily
cost of treatment was lower, therefore (I) appears to be the more costeffective option, dominating (C). However the difference in outcomes was
NSS.
Uncertainty assessed: Statistical analysis was undertaken to compare costs
and outcomes across groups.
Page 93 of 219

Appendices.
12
Authors: Kraft et al. (1993)
Setting/Perspective of the analysis: Long-term hospital care at a spinal cord injury centre, US
Interventions: (I) semi-permeable polyurethane foam dressing, (C) Moist saline gauze dressings
Funding: Calgon Vestal Laboratories
METHOD
RESULTS
OVERVIEW
Design: RCT. Treatment completers
Resource use:
(I) changed once per week or until leakage of exudates, an
average of 2.5 dressings/week or 25 minutes nursing time
(C) 3/day, an average of 21 dressing changes/week or 210 minutes
of nursing time
Conclusions: (I)
more cost-effective
when all costs
considered. Cost of
(I) dressing was
higher than cost of
(C) though. Greater
proportion of PU
healed in group (I)
vs. group (C).
Sample: Initial sample size: (I): n=24 PU, (C): n=14 PU. Final sample size: (I): n=11
PU, (C): n=6 PU
Exclusion: Grade 1 or 4 PU, clinically infected patients, patients on special beds,
unstable insulin-dependent diabetes, serum albumin <2gm, haemoglobin<12gm, class
4 congestive heart failure, chronic renal insufficiency, documented severe peripheral
vascular disease, documented severe COPD
Outcome/s: Complete heal within 24 weeks
Resource use: Nurse time and treatment supply. Nurses assumed to spend an
average of 10 minutes per dressing.
Currency: US$ 1990
Cost: Average supply weekly cost of (I)=$12.18 vs. $5.25 for (C)
group
Average cost of nursing time/week (I)= $8.30, (C)=$69.72
Total average cost/week (I)=$20.48, (C)=$74.97
Effectiveness: At 24 weeks, in the (I) group 42% (n=10) of PU were
healed vs. 21% (n=3) in the (C) group
Cost-effectiveness:
Cost and outcomes not synthesised. More PU healed in (I) and the
daily cost of treatment was lower, therefore (I) appears to be the
more cost-effective option, dominating (C). However the difference
in outcomes was NSS.
Follow-up: 24 weeks
Assessments: Nurse assessed at 6, 12 and 24 weeks
Comment: Not
clear what measure
of central tendency
average was. No
statistical tests
undertaken. 2/24 (I)
patients withdrawn
and the reason for
this was not given.
Uncertainty assessed: Indication of variance and significance

testing. Robustness of results tested using different wage costs.
Page 94 of 219

Appendices.
13
Authors: Mosher et al. (1999)
Setting/Perspective of the analysis: Long-term care, Third party payer (Medicare), US
Interventions: (I1) Autolysis (autolytic debridement) (I2) Wet to dry saline (mechanical debridement) (I3) Collagenase (enzymatic debridement) (I4) Fibrinolysin (enzymatic
debridement)
Funding: Knoll Pharmaceutical Company
METHOD
RESULTS
OVERVIEW
Design: Decision analytic model. Effectiveness evidence synthesised data from the literature and
expert opinion. Initial surgical debridement of the wound was not entered into the model. Median
values of experts gained were used as probabilities in the decision model. A modified Delphi
approach was used to reach consensus on critical treatment choices and possible outcomes.
Cost:
Total cost per patient for 28 days: (I3)=$610.96,
(I1)=$920.73, (I4)=$986.38, (I2)=$1008.72

most cost-effective
treatment for the
management of PU in
elderly long-term care
residents. (I) remained the
most cost-effective option
when probability estimates
were varied between +/10%.
Sample: Hypothetical 78-yr-old female in a long-term care facility who had not been hospitalised
in the prior 12 months. She has a new full-thickness PU on her trochanter with 50% necrotic
tissue (eschar) covering the PU, mild odour, minimal draining, no undermining and intact periulcer skin.
Effectiveness:
Probability of a clean wound bed: (I3)=0.887,
(I1)=0.641, (I2)=0.376, (I4)=0.449
Cost-effectiveness:
(I3) dominant over all other alternatives
Level of effectiveness evidence: Not clear but use of evidence on levels 1 to 4 possible
Outcome/s: Probability of obtaining a clean wound bed for each 28-day treatment of the
hypothetical treatment
Resource use: Drugs, dressing and irrigation supply, doctor visits, ancillary services (e.g.
outpatient laboratory tests), hospitalisation and associated resource use, surgical debridement.
Currency: US$ 1995
Expected costs were probability weighted costs.
Probabilistic sensitivity analysis conducted to
investigate parameter uncertainty. All parameter
inputs were varied by 5% and +5% and results
remained robust.
Comment: The quality of

the review process and
the elicitation of expert
opinion was not clear. The
authors note that the
probability data was nonnormally distributed and
non-random.
Follow-up: 28 day treatment
Page 95 of 219

Appendices.
14
Authors: Motta et al. (1999)
Setting/Perspective of the analysis: Home healthcare patients, US
Interventions: (I) Synthetic polymer dressing. (C) Hydrocolloid dressing
Funding: AcryMed educational grant, Portland
METHOD
RESULTS
OVERVIEW
Design: RCT
Resources:
On average 3.38 dressings were used and labour time per dressing
change was 9 minutes for (I) vs. 8 dressings and a labour time per
dressing change of 13 minutes for (C)
Conclusions: (I) may be

more cost-effective than
(C) with a lower
associated cost and
similar effectiveness. The
lower cost of treatment
using (I) was due to the
use of significantly fewer
dressings by that group.
Sample: (I) n=5 PU. (C) n=5 PU

Inclusion: Grade 2 and 3 PU
Exclusion: Those with an underlying medical condition such as long-term
use of steroids or uncontrolled diabetes
Outcome/s: Healing rate, adverse reaction, product performance (based on
exudate performance, whether dressing maintains moist environment,
promotes autolytic debridement and its overall clinical performance marked
out of 1 to 5 with 1 being most favourable and 5 being least favourable)
Resource use: Treatment (dressings and ancillary supplies) and labour
(nursing time)
Currency: US$, price year not stated
Follow-up: 8 week pilot study
Assessment: Weekly
Cost:
Total cost of treatment over 8 weeks was $57.76 for (I) and $9l.48 for
(C)
Effectiveness:
2 PU in each group completely healed and all other PU demonstrated
substantial reductions in size. The overall healing rates were not SS
different.
No adverse reactions occurred.
The overall performance of the interventions was assessed based on
the average score obtained during dressing change for each parameter.
No SS differences were noted.
Comment: Randomisation
process was not
described. This was a pilot
study and the sample size
was small.
Cost-effectiveness:
The same number of PU healed in (I) and (C). The daily cost of
treatment using (I) was lower therefore it may be the more costeffective option.
Statistical analysis to compare costs and effects but tests used were
not reported
Page 96 of 219

Appendices.
15
Authors: Muller et al. (2001)
Setting/Perspective of the analysis: Hospital, The Netherlands
Interventions: (I): Collagenese-containing ointment. (C): Hydrocolloid dressing (Duoderm)
Funding: Knoll AG
METHOD
RESULTS
OVERVIEW
Design: RCT. Following autolytic debridement patients were

allocated to the interventions. Treatment completers since
one patient in (C) failed to comply with the weekly PU
inspection and was dropped from the study.
Resource use:
(I) treated 1 /day
(C) treated 0.29 /day
Nurse time to change dressing = 15 minutes for both groups
Doctor time per visit = 30 minutes for both groups
Conclusions: (I) was more

cost-effective and that the
amount of time needed for
wound healing was
shorter.
Cost:
Average cost / patient of (I) = NLG1,615.8 vs. (C) NLG1,692.7
Comment: Average costeffectiveness rather than

incremental costeffectiveness reported.
Sensitivity analysis
revealed that even under
extreme conditions (I)
remained more costeffective than (C). Two
patients, one in each
group had two PU on the
heel but it was not
mentioned which PU was
included in the study.
Sample: (I) n=12 PU, (C) n=12

Inclusion: Grade 4 PU on the heel following orthopaedic
surgery due to hip fracture or total hip replacement
Exclusion: Patients with a life expectancy < 6 months
Outcome/s: Complete wound heal meant that the patient was
successfully treated. Rate of complete wound healing.
Average number of weeks required until PU healing was
achieved
Effectiveness:
(I): 91.7% (11/12) patients successfully treated
(C): 63.6% (7/11) patients successfully treated, SS (p<0.005)
Time to PU heal was shorter for (I) at, on average, 10 weeks compared to 14 weeks
for (C), P<0.005)
Cost-effectiveness:
Cost per successfully treated patient (i.e. complete wound heal): (I)=NLG1,762.0 vs.
NLG2,661.4 for (C). (I) cost less and was associated with better effects and therefore
dominated (C).
Resource use: Materials and labour time

Currency: Dutch Guilders NLG 1998
Follow-up: To complete heal
Uncertainty assessed: Statistical tests were undertaken. A deterministic model and

one-way sensitivity analysis and a probabilistic model using Monte Carlo simulation
were conducted. In all scenarios, (I) remained the more cost-effective treatment. The
independency of the model parameters was assumed.
Assessments: Once per week by the doctor
Page 97 of 219

Appendices.
16
Authors: Nasar et al. (1982)
Setting/Perspective of the analysis: Hospital, UK
Interventions: (I): Debrisan, n=10 PU. (C): Eusol and paraffin dressings, n=8. Total of 12 patients, 18 PU
Funding: Not stated
METHOD
RESULTS
OVERVIEW
Design: RCT
Resource use:
(I) was applied 2/day for the first 3 days and once per day thereafter.
(C) were changed 3 times per day for the first 3 days and then twice daily until
the PU was healed.
Conclusions: (I) appears to be more

cost-effective than (C), costing less
and time to heal was faster for those
PU that healed.
Cost: Average cost for PU that healed was 1053.05 for (I) vs. 1667.00 for
(C)
Comment: Some patients had more

than one PU entered into the trial.
Randomisation procedure to allocate
patients to interventions was not
described. Length of follow-up not
clear. Costs only relate to those
whose PU healed.
Sample: (I) n=10 PU, (C) n=8 PU. Total of 12 patients,

18 PU.
Exclusion: Those with urinary tract infections
Outcome/s: Complete heal, time to heal
Resource use: Materials and ancillary supplies and
hospital stay
Currency: UK Sterling , price year not stated
Follow-up: Endpoint was when the PU was clean and
granulating and appeared to be less than 25% of its
original surface area
Effectiveness:
For (I), 6 out of 8 PU healed in approximately 39.3 days. One other patient
died and one patient withdrew from treatment.
For (C), 5 out of 8 PU healed in approximately 62 days. Three patients were
switched to (I).
Cost-effectiveness:
(I) was lower cost and was associated with a higher number of PU healed
compared to (C).
No
Assessment: Every three days by an independent

observer
Page 98 of 219

Appendices.
17
Authors: Ohura et al. (2004)
Setting/Perspective of the analysis: Hospital, Japan
Interventions: (I1) Hydrocolloid DuoDERM dressing with a standardized wound management algorithm (I2) Traditional care of ointment and gauze with a standardized wound
management algorithm (I3) Traditional care of ointment and gauze without a standardized wound management algorithm
Funding: ConvaTec, a division of ER Squibb & Co
METHOD
RESULTS
OVERVIEW
Design: Multi-centre, comparative, prospective study. Successive patients

were assigned to one of the three groups. The dressings and ointments to be
used for each PU grade were grouped for use in different grades of wound
healing.
Cost:
(I1): Average total cost per patient = Yen 87,715 vs. Yen
131,283 for (I2) & Yen 200,584 for (I3). Difference in cost of
(I1) vs. (I3) was SS as well as when materials and total labour
costs were analysed separately.
Similar trends existed but were NSS when comparisons made
for patients with grade 2 PU only.
For grade 3 PU, the total cost of care, the cost of labour and
the cost of materials was SS different for (I1) vs. (I3) groups
(p=0.003, 0.005, 0.005 respectively).
Conclusions: (I1) was the most

cost-effective option. The total
costs were lower due to a higher
success rate and less nursing
time required. However, the unit
cost of (I) treatment material was
higher.
Sample: Total number of patients enrolled = 91, 83 patient in final analysis

(9% dropped out). (I1) 35% of patients (n=29), (I2) 41% of patients (n=34),
(I3) 24% of patients (n=20)
Outcome/s: Change in Pressure Ulcer Status Tool (PSST) score calculated
by subtracting end score by enrolment score
Resource use: Materials and labour time of nurses, doctors, nurses, nurse
assistants, care-workers. Wound management materials and time spent were
recorded daily on an activity record form.
Currency: Japanese Yen, 2001
Effectiveness: (I1)= 11.1 point reduction in PSST vs. 6.9 point

reduction for I2 group & 9.0 for I3.
Reduction in PSST was SS different for (I1) vs. (I2). If groups
compared by grade of PU, (I1) was more effective than (I2)
and (I3) but NSS.
Comment: Non-random
allocation to groups. Statistical
tests applied to compare costs
across groups were not stated.
Doctors were involved in wound
management, a high cost input.
Cost-effectiveness:
Across all PU, PSST units difference/Yen: (I1) = 0.127 was
more cost-effective than (I3) = (0.045) and SS more costeffective than (I2) = 0.052 (p=0.044). Average effect per unit of
cost rather than incremental cost per effect was calculated.
Follow-up: Maximum period of 12 weeks

Assessments: Not clear who did or when
Uncertainty assessed: Statistical tests applied to compare

costs across groups. No sensitivity analyses conducted.
Page 99 of 219

Appendices.
18
Authors: Robson et al. (1999)
Interventions: Recombinant human platelet-derived growth factor-BB. (I1) 100 g rhPDGF-BB per day. (I2) 300 g rhPDGF-BB per day. (I3) 100 grhPDGF-BB twice daily. (I4)
Placebo.
Funding: The R.W Johnson Pharmaceutical Research Institute. Statistical support by Ortho-McNeil Pharmaceuticals Inc
METHOD
RESULTS
OVERVIEW
Design: Multi-centre (n=14) clinical trial sites. A double blind, randomised, placebo
controlled trial.
Cost: At the beginning of the trial, the mean and median

cost of closure was estimated at $8,000 per PU as they
were rated as requiring a somewhat easy pedicle flap
procedure to close the wound. At the end of the trial, (I)
required (according to the raters) a difficult direct wound
application costing $800 to $1,000 (a cost saving of $7,000
to $7,200), vs. an easy skin graft for (I2) and (I3) costing
$1,200 (a cost saving of $6,800) and for (I4) a slightly more
difficult procedure was required costing $1,700 (a cost
saving of $6,300). The cost savings were SS even though
100% wound closure was not routinely achieved.

dominant treatment being
cheaper and showing
signs of higher ease of
wound closure compared
to (I2), (I3) and I4).
Sample: (I1) n=21 patients. (I2) n=22 patients. (I3) n=23 patients. (I4) n=17 patients.
Total patients, n=124 and of these 83 had photographs of sufficient quality to rate for
ease of closure.
Outcome/s: Wound volume decrease over time. Changes in ease of surgical closure
on a scale from 0 (no need to close, healed) to 13 (not possible to close) based on
photographs of PU at a set focal distance obtained weekly and as assessed by 4 rater
blinded surgeons.
Cost: The change in difficulty of wound closure was studied in relation to the
composite cost including surgeons fee, anaesthesia fee and operating room cost.
Costs were arrived at from charges to patients at two university centres. The range of
costs was $100 for a single-buttressed suture placed at the patients bedside to
$12,000 for a difficult musculocutaneous or free flap.
Currency: US $, no price date
Follow-up: 16-week treatment trial
Assessments: From day 0 and weekly for 16 weeks by independent observers
Effectiveness: 94% of the possible maximum number of

photographs were available for rating. At the end of the trial,
(I1) patients PU improved 6 points on the scale from
beginning to end of treatment. For (I2) and (I3) patients had
a mean of 5 points on the scale and for (I4) the score was 4
points. All outcomes were SS improved from their respective
starting ease of closure scores of 10 (p<0.0001).
Comment: The analysis

assumes that PU would
have otherwise been
closed via surgical
techniques. The authors
tested the correlation
between the ease of
closure scale and the
wound area as
photographs are only 2dimensional. Results of
clinical trial are provided in
another paper.
Cost-effectiveness: Not synthesised. It appears that (I) was

more cost-effective than (I2) & (I3) which, in turn, were more
cost-effective than (I4).
Uncertainty assessed: Statistical tests regarding
effectiveness and costs (but cost test results not reported)
Page 100 of 219

Appendices.
19
Authors: Robson et al. (2000)
Interventions: (I1) Cytokine growth factors (2.0 g/cm2 GM-CSF) therapy topically applied daily for 35 days. (I2) 5.0 g/cm2 bFGF therapy applied daily for 35 days. (I3) 2.0 g/cm2
2
GM-CSF applied for 10 days followed sequentially by 25 days of topically applied 5.0 g/cm bFGF. (I4) Placebo applied daily for 35 days.
Funding: National Institutes of Health. Schering-Plough Research Institute and Scios Inc provided the cytokines
METHOD
RESULTS
OVERVIEW
Design: A double blind, randomised, placebo controlled trial Sample: (I1) n=15 patients. (I2)
n=15 patients. (I3) n=16 patients. (I4) n=15 patients. Total patients, n=61
Inclusion: Grade 3 and 4 PU. All patients were denervated in the area of ulceration because
3
of acquired spinal cord pathology. PU measuring 10 to 200cm for at least 8 weeks .
Exclusion: Significant diabetes mellitus, renal insufficiency, vasculitis, or hepatic,
immunologic, cardiac, or haemorrhagic disease, malignant or neoplastic disease (except for
adequately treated skin cancers), significant malnutrition, systemic steroidal therapy,
immunotherapy, or chemotherapy, cytokine therapy within 90 days or investigational drug
study within 30 days.
Outcome/s: Wound volume decrease over time. Changes in ease of surgical closure on a
scale from 0 (no need to close, healed) to (13) (not possible to close) based on photographs
of PU at a set focal distance. An arbitrary response rate of at least 85% wound closure
during 35 days of follow-up was chosen as indicative of a responder.
Resource use: The amount of topical substance each week of treatment was based on
volumetrically determined surface area at baseline and on study days 7, 14, 21, 28
Cost: Change in difficulty of PU closure in relation to total cost (surgeons fee, anaesthesia
fee, operating room cost)
Follow-up: 35 days (5 weeks)
Cost: At the beginning of the trial, the median cost of

closure was estimated at $10,000 per PU. At the end of
the trial, (I2) patients PU could be healed by a difficult
wound approximation costing $800 to $1,000 (a cost
saving of $9,000 to $9,200). For (I3) patients would
require a somewhat easy skin graft costing $1,700 (cost
saving of 8,300). For (I1) a somewhat difficult procedure
was required costing $2,200 (cost saving of $7,800).
For (I4) PU could be closed for $3,000 (cost-saving of
$7,000).
Effectiveness: No differences in mean % of initial PU
volume remaining on day 36 across all interventions.
However, (I2) had a trend toward greater PU closure.
The % of patients responding was SS higher for all
cytokine therapies compared to (I4) (p=0.03) with (I2)
patients doing best. The median ease of closure for all
4 groups was 11 on day 0. (I2) patients PU improved 7
points on the ease of closure scale. (I3) patients
improved 5 points, (I1) patients improved 4 points and
(I4) patients improved 3 points.

dominant treatment being
cheaper and showing signs
of higher ease of wound
closure compared to (I1),
(I3) and I4). Delaying the
onset of (I2) appeared to
decrease its response.
Comment: Little detail was
provided on costs. The
analysis assumes that PU
would have otherwise been
closed via surgical
techniques. Inter-rater
reliability using the ease of
closure scale was not
undertaken.
Cost-effectiveness: Not undertaken. It appears that (I)

was more cost-effective than (I2) & (I3) which, in turn,
were more cost-effective than (I4).
Uncertainty assessed: Statistical tests regarding
effectiveness estimates
Assessments: From day 0 and weekly for 5 weeks as assessed by 2 blinded surgeons
Page 101 of 219

Appendices.
20
Authors: Sebern et al. (1986, 1989)
Setting/Perspective of the analysis: Home-care population served by a metropolitan visiting nurse association, US
Interventions: (I) Transparent moisture vapour permeable (MVP) dressing. (C) Gauze and tape
Funding: Sigma Theta Tau research grant and 3M Medical Division, St Paul
METHOD
RESULTS
Design: RCT, PU randomly assigned using sequential list of
100 random numbers. Treatment completers.
Sample: Initial sample size; (I) n=50 PU, (C): n=50 PU. Final
sample size: 77 PU, 48 patients; (I): n=37 PU, (C): n=40 PU
Inclusion: Grade 2 and 3 PU using a visiting nurse
association service
Exclusion: PU contained eschar, grade 1 or 4 PU, patient was
terminal, patients white count <4,000 or patient had >3
existing PU
Outcome/s: Healing status at 8 weeks: healed, progress
toward healing, no change, discontinued or deteriorated.
Healing rates. Comfort.
Resource use: Nurse time and treatment supply (asepto
syringe, hydrogen peroxide, physiologic saline, povidone
iodine, sterile gloves, dressings)
Follow up: 8 weeks
Assessments: Nurse. Weekly
Resource use:
(I) Change daily to 3 times per week, (C) 1/day
Cost:
Mean supply costs for grade 2 PU mean cost: I=$97, C=$99. Mean supply costs for grade
3 PU mean cost: I=$179, C=$140 (NSS, Wilcoxon)
Mean 8 weeks cost per grade 2 PU: (I)=$845, (C)=$1359 (p<0.05) (Wilcoxon, nonparametric). The cost of treatments was NSS across groups.
Mean 8 week treatment costs per grade 3 PU was $1470 for (I) group and $1412 for (C)
group (NSS across groups).
Effectiveness:
Grade 2 PU, (I) 64% (n=14) healed, C: 0% (n=0) healed. Grade 3 PU not significantly
different between the 2 groups and no further details were provided. Healing rates: grade
2 PU in the (I) group had a 52% median decrease in area of the wound vs. 100% median
decrease in the (C) group (P<0.01, Wilcoxon). Grade 3 PU in the (I) group 67% median
decrease in PU size vs. 44% in (C) group (not statistically significant). Subjects who had
intact sensory input from their PU reported less pain when (I) (MVP or MVP and pouch)
was used.
Cost-effectiveness:
Not undertaken. (I) cost slightly more per PU than (C). Effects differed depending on
grade of PU.
OVERVIEW
Conclusions: (I) more
cost-effective for
grade 2 PU. (C) less
costly for grade 3 PU
and NSS different
effectiveness.
Overall, (I) cheaper.
Comment: No
difference in
outcome for grade 3
PU, however,
possible type 2 error.
Authors incorrectly regraded PU at the end
of the study. Authors
randomised by PU
rather than by patient
and this can introduce
bias. Variance around
cost estimates not
reported. Statistical
tests applied to costs
were non-parametric.
Significance testing to compare effects and costs across interventions
Page 102 of 219

Appendices.
21
Authors: Xakellis et al. (1992)
Setting/Perspective of the analysis: Long-term care, US
Interventions: (I) Hydrocolloid dressings vs. (C) Non sterile saline gauze dressings
Funding: Family Heart Foundation of America & Convatec
METHOD
RESULTS
OVERVIEW
Design: RCT, only one PU included in the analysis. If >1 PU,

PU chosen by toss of a coin. Intention to treat.
Resource use:
(I) changed daily to 2 times per week, (C) 3/day.
Median nurse time for dressing change (I)= 4.4 minutes, (C)=3.3 minutes. (C) saline
remoistening median time of 1.4 minutes.
Total median nursing time for dressing changes/remoistening: (I)=15.4 minutes, (C) =
127 minutes
Conclusions: (I) could

be cost saving because,
although materials
significantly more
expensive, nursing time
cost was significantly
lower.
Sample: (I) n=18 PU, (C): n=21 PU

Exclusion: Grade 1 or 4 PU, patient was terminal or an
anticipated discharge within one week
Outcome/s: Complete heal. Time to healing. Healing rates.
Resource use: Nurse time and treatment supply (syringe, tape,
dressings, gauze pads, saline) for 10 randomly chosen patients
in each group. Two dressing change times measured and
median used.
Currency: US$ 1990
Follow up: Study period was 21 months. The study endpoints
included PU heal, progression to grade IV, doubling in PU
surface area, systemic infection from the PU, no decrease in
PU size in 2 months or 6 months of treatment, subject death of
subject discharge.
Cost:
Median total cost was $15.58 for (I) group and $22.65 for the (C) group (NSS) if local
nurse wages used. If national nurse wages used, median total cost was $15.90 for (I)
group and $25.31 for (C) group. (p=0.04).
Effectiveness:
Complete heal of PU in 89% (n=16) if (I) group and 86% of (C) group. Median time to
healing after randomisation was 9 days for the (I) group and 11 days for (C) group
(NSS). (I) 75% of PU healed within 14 days vs. 26 days for (C). After adjusting for
exudates present at baseline, healing rates NSS different across groups although a
trend towards slower healing for (C) group
Comment: Healing rates

appeared to be faster in
the (I) group but this
was not statistically
significant. Reported
median costs that are
difficult to interpret.
Statistical tests applied
to costs were nonparametric.
Cost-effectiveness:
Not undertaken. (I) was a lower cost and was associated with a slightly higher
number of PU healed compared to (C).
Uncertainty assessed: Indication of variance and significance testing. Robustness of
results tested using different wage costs.
Assessments: Nurse assessed twice weekly
Page 103 of 219

Appendices.
DATA EXTRACTION TABLES: ADJUNCT THERAPIES

22
Authors: Macario et al. (2002)
Setting/Perspective of the analysis: Long-term medical care, health care payer perspective, USA
Type of economic evaluation: Cost-utility analysis
Interventions: (I) Noncontact normo-thermic wound therapy in combination with the use of pressure-reducing surfaces and repositioning vs. (C) Current standard care, that is
moisture retentive dressings, a pressure-reducing surface, repositioning and debridement
Funding: Augustine Medical Inc
METHOD
RESULTS
OVERVIEW
Design: Markov model. Rates of healing, complications associated with healing and mortality
rates were obtained from the literature. Incidences of progressing through health states were
estimated, based on the literature and converted to bimonthly transition probabilities. Where
no empirical data on base transition probabilities were available, estimates were based on
available data. Age specific death rates were obtained from national statistics. The model
comprised 6 mutually exclusive health states: grade 3 PU, grade 4 PU, healing wound,
closed wound healed back to normal, complications requiring hospitalisation and death.
Sample: The base case involved analysis of a hypothetical, 72 year old patient living in a
nursing home with a 2-month-old grade 3 ischial PU. Secondary analysis involved a grade 4
PU. Monte Carlo simulation was undertaken to estimate results for 10,000 hypothetical
patients for use in the probabilistic sensitivity analysis.
Level of effectiveness evidence: Levels 1 to 4
Inclusion: Data from literature used to populate the model based on controlled trials of over 4
weeks duration and appropriate outcome measures
Outcome/s: Quality-Adjusted Life Years (QALYs) were calculated based on author
assumption using the Rosser Index to form quality of life weights (utilities) for each state in
the model. Levels of distress and disability were assigned to each health state. The change in
health status was combined with the life expectancy of patients to form QALYs..
Resource use: Nurse time, use of supplies and equipment, costs of complications and
doctors.
Currency: US $ 2000
Follow-up: Patient progression divided into 8-week cycles over 40 months. Discounting at 3%
per year.
Effectiveness: RCT based evidence to suggest

that (I) reduces the surface area of grade 3
and 4 PU by 2.5 fold (SD 9%) vs. (C) An RCT
found that that the 8-week healing rate of
grade 3 PU = 71% for (I) and 54% for (C). At
these healing rates, for grade 3 PU the 40month timeframe increases QALYs for (I) of
0.10 (SE=0.0005) life years relative to (C). For
grade 4 PU there was an increase in QALYs
for (I) of 0.14 (SE=0.001) relative to (C).
Cost: Total expected cost of (C) for a grade 3
PU was $20,874. For grade 3 PU, there was a
cost saving of $6,3340 (SE $98) for a 40month time frame. For grade 4 PU (I) saved
$15,216 (SE $186) relative to (C)
Conclusions: (I) is less costly and

more effective than (C) for 75%
(SE=0.4%) of patients with grade
3 PU. (I) is less costly than (C) for
81% (SE 0.4%) of patients with
grade 4 PU.
Comment: More rapid reduction
in PU area does not necessarily
translate to a higher probability of
complete PU healing. Quality of
life assessments were gained
indirectly.
Cost-effectiveness: (I) dominates for grade 3

and 4 PU. However this result was associated
with substantial uncertainty.
Uncertainty: Probabilistic sensitivity analysis.
Triangular distributions were used for
parameter values When the cost of (I) was
increased to >$421, the use of (I) increased
the overall cost to society. The variables that
had the biggest impact on modelling were the
daily treatment costs and the probability of
healing to a normal closed PU.
Page 104 of 219

Appendices.
23
Authors: Philbeck et al. (1999)
Setting/Perspective of the analysis: Medicare home health care (I), Nursing home residents (C), US
Interventions: (I) negative pressure wound therapy in patients who had failed previous interventions. Although PU n=566, for the purposes of comparison with (C), records of
patients who were treated on a low air loss surface were observed, n=43 (i.e. 8% of PU all PU in the study. (C) Saline soaked gauze dressing applied to patients placed on a low
air loss surface (based on data from Ferrell et al. 1993 (see Ferrell table)).
Funding: Kinetic Concepts Inc
METHOD
RESULTS
OVERVIEW
Design: Compared retrospective review of Medicare observational data for group (I)
with a historical control (C) reported in Ferrell et al. (1993) (see Ferrell et al. 1993,
1995 table)
Cost:
(I) = material costs and nursing visit costs/day = $107.46
and $42.50 (n=43 patients) respectively
(C) = material costs and nursing visit costs/day = $10.00
and $85.00
Conclusions: (I) more costeffective due to faster healing

time expected. However
material costs higher for (I) per
day.
Total cost / day, (I) = $149.96 vs. (C) = $95.00

Expected total cost to treat: (I)=$14,546 vs. $23,465 for
(C)
Comment: Data was taken

from two different sources
where the study designs and
settings were different. The
initial surface area of PU
across groups was very
different for (I) vs. (C) (22.2 cm
2
vs. 4.3cm2.respectively)
potentially favouring (C). It is
not known what % of PU were
grade 3 and 4 PU and (C)
included grade 2 PU also. No
assessment of uncertainty
associated with the estimates.
Sample: There were 566 PU for (I) and 43 PU for (C) (i.e. 8% of all PU in the study
(C))
Inclusion: Grade 3 and 4 PU treated on the trochanter or trunk
Exclusion: Patient whose notes were not eligible or that did not have the basic data
set
Outcome/s: Reduction in wound area and volume after 30 days of treatment
(healing rates)
Resource use: Nurse time and materials
Currency: US$, price year not stated
Effectiveness:
Area reduction rate (cm2 /day), (I) = 0.230 vs. (C) = 0.090
Time to heal based on wound healing reduction rates, (I)
= 97 days expected to complete heal vs. (C) = 247 days
to complete heal.
Cost-effectiveness:
(I) dominates (C) for grade 3 and 4 PU
No
Follow-up: 180 days for (I). Median follow-up for (C) was 33 days
Page 105 of 219

Appendices.
DATA EXTRACTION TABLES: PRESSURE-RELIEVING SUPPORT SURFACES

24
Authors: Branom et al. (2001)
Setting/Perspective of the analysis: Hospital, USA
Interventions: (I) Constant force technology mattress, (C) Low air loss mattress
Funding: Span-America Medical Systems Inc
METHOD
RESULTS
OVERVIEW
Design: Clinical trial, patients allocated alternately to either mattress. Treatment completers.
Cost:
Purchase price for mattress (I) = $1,080.00, 55% of
cost of (C) over 8 weeks
Daily rental cost for (C) mattress = $35.00/day or
$1,960.00/8 weeks
Conclusions: (I) was more

cost-effective than (C) and
further cost savings could
be realised because the
mattress (I) could be
available for further use.
Sample: (I) patients/PU n=10, (C) patients/PU n=8

Inclusion: Grade 3 or 4 PU on the trunk or pelvis. For patients with >1 PU, only the deepest
one was followed in the study. All patients had to be bedridden.
Exclusion: Patients with infected PU
Outcome/s:
Goal for wound healing. The wound care team established a goal for wound healing from
progressive closure, maintenance or preparation for flap surgery. At the end of the study
patients were rated as having achieved their goal, not having achieved their goal, or having
exceeded their goal.
Average rate of PH closure/week
Average % PU closed
Effectiveness: The goals set for PU healing were

achieved of exceeded for all 100% (n=10) patients in
the (I) group vs. 63% (n=5) in the (C) group
Average size at discharge from the study was 6.6cm3
for group (I) vs. 24.6cm3 for group (C)
Average amount closed at discharge from study =
25.8cm3 for group (I) & 22.2cm3 for group (C)
Average rate of closure/week at discharge from study
= 3.5cm3 for group (I) & 2.8cm3 for group (C)
Average % closed = 60.0% for group (I) & 39.6% for
group (C)
Average % closed/week = 9.0% (+/-4.8) for group (I)
vs. 5.0% (+/-3.7) for group (C)
Comment: Sequential
randomisation to groups
not truly random. A narrow
cost focus was adopted.
The cost savings achieved
by the (I) mattress was
heavily dependent on the
prices of the two
mattresses and the time to
heal. Small sample size.
Resource use: Mattress

Currency: US $, price year not stated
Follow-up: Maximum of 8 weeks. Study exit criteria also included death, discharge from
inpatient status, flap surgery.
Cost-effectiveness:
(I) dominates (C) for grade 3 and 4 PU
Limited statistical analysis undertaken comparing
outcomes.
Page 106 of 219

Appendices.
25
Authors: Ferrell et al. (1995)
Setting/Perspective of the analysis: Nursing home, US
Type of economic evaluation Cost-effectiveness analysis
Interventions: (I) Low air loss beds (C) Conventional foam mattress (four inch corrugated foam mattress overlying a conventional foam mattress)
Funding: UCLA Older American Independence Centre. Sepulveda VAMC GRECC, RAND. Jewish homes for the Aging of Greater Los Angeles, Kinetic Concepts International
provided some support for data collection
METHOD
RESULTS
OVERVIEW
Design: Retrospective analysis of an RCT to describe the rate of healing as a function of

patient and PU characteristics and to provide data on variation in healing across patients.
The result of the statistical model of healing produced was used in a simulation model to
calculate the expected days to cure, death or end of the first year for patients with
particular characteristics for the two interventions.
Effectiveness:
SS decrease in surface area of PU for (I) for
2
grade 3 and 4 PU. 9.9 mm /day vs. 0.7
2
mm /day, p<0.02
2
Grade 2 PU (I)=9.0mm /day vs.
2
3.2mm /day, p<0.004 resulted in a higher
probability of cure using (I)
The overall cure-probability ratio was 2.66,
p<0.004.
PU took an average of 75 days to cure for
group (I) and 172 days for group (C)
Conclusions: On average, the costeffectiveness of (I) was $26 per

additional day without a PU in the first
year. (I) was more cost-effective for
patients with good healing
characteristics and mild PU (i.e.
smaller diameter, with pink
granulating tissue present, no
necrotic tissue and minimal drainage,
sessing grade 3 and no contractures).
Sample: (I) n=43 (patients), (C) n=41 patients

Inclusion: Grade 2 or more PU on trunk or trochanter
Outcome/s: Added day free of PU in one year. Change in diameter of PU over time to
estimate number of additional days free of PU. Took number of days with (C) and
subtracted number of days until cure with (I).
Resource use: Based on two studies. Nurse time and treatment use and cost.
Costs: Additional cost of (I)
Cost-effectiveness:
(I) = $26 per added day free of PU
Comment: No assessment of utility

based on patient preferences
One-way sensitivity analysis was conducted
and results were sensitive to the lease cost
of (I) and patient and PU healing
characteristics
Currency: US $, price year 1992

Follow-up: Until complete heal, death or transfer to another faculty. Median days of care
(I)=33, (C)=40 days (p=0.56)
Assessments: Two per week by nurses
Page 107 of 219

Appendices.
26
Authors: Strauss et al. (1991)
Setting/Perspective of the analysis: Health care sector and home funded by the patient or private insurer, Medicare programme, US
Type of economic evaluation Cost-consequence analysis
Interventions: (I) Home air fluidised bed including the services of a visiting nurse specialist so long as the patient had a grade 3 or 4 PU. (C) Conventional therapy on a patient
specific basis including alternating pressure pads, air support mattresses, water mattresses, high density foam pads.
Funding: Support systems International
METHOD
RESULTS
OVERVIEW
Design: RCT. Randomisation was by a random-number generating system
Sample: (I) n=58 patients or 47 when excluding patients who were completely dropped from the study. (C) n=54 patients or 50
when excluding patients who were completely dropped from the study
Inclusion: Grade 3 or 4 PU, had an attending doctor who believed the patient would probably require future hospitalisation for PU
related care, had severely limited mobility, adequate social support to use (I), likely to comply with the care regimen, likely to live
at least one year, 16+ years old, out of hospital for at least 3 weeks, had a personal doctor who was willing to closely manage
care in the patients home
Exclusion: Febrile or septic or otherwise required immediate hospitalisation, radiated skin
Outcome/s: Heal to grade 2 PU or better. Clinical reviews of interpretable photographs for patients who had completed the 36
week follow-up period. Reviews by two nurses blinded to intervention type. PU were categorised as improved (ulcer that
progressed to a lower grade or if the grade was unchanged showed a smaller surface area, reduced inflammation or less eschar),
unchanged (no obvious changes), worse (PU that progressed to a higher grade or covered a greater surface or showed more
inflammation or more eschar) or not accessible.
Resource use: Hospital and doctor visits, nursing home admissions, home visits by nurse or home health care aide and outpatient
services
Effectiveness: Compared to
(C), a higher % of (I) PU
were classified as improved,
NSS for those patients who
completed the 36-week
regimen.
Conclusions:
(I) cost less
and a higher %
PU were
improved but
this was NSS.
Resource use: Days in

hospital was 11.4 day (I) vs.
25.5 days for (C), (p<0.05)
Comment: The
drop out rate
was high with
only 50% of (I)
patients
completing the
study and 56%
of (C)
completing the
study.
Cost: (I) use of inpatient and

outpatient resources based
on charges was $29,016 for
(I) vs. $34,747 for (C), NSS
For Medicare DRG & doctor
payments (I) cost $16,415
vs. $16,800, NSS
Cost-effectiveness: (I)
dominates (C) but difference
in outcomes NSS
Statistical tests applied
Follow-up: 36 weeks
Assessments: Weekly assessments for first four weeks then biweekly telephone calls for data on resource use for as long as
patients remained on the bed for (I) or regarding resource use for (C). The health care co-ordinator (nurse) measured the PU at
the beginning of the study, after each hospital discharge and during the final visit at the end of the 36-week study period.
Page 108 of 219

Appendices.
KEY
PU = pressure ulcer
SS = statistically significant
NSS = not statistically significantly different
NS = not stated
NA = not applicable
CI = confidence interval
SD = standard deviation
Level of evidence relates to questions of effectiveness only.
Eccles M and Mason J (2001) How to develop cost conscious guidelines. Health Technology
Assessment,5,16
Page 109 of 219

Appendices.
Appendix B: Search strategies

Clinical effectiveness search strategies for Question A
Medline & Medline In-Process Citations strategy (OVID interface)
1. Skin Ulcer/
2. decubitus ulcer/
3. (decubitus or decubital or skin breakdown$).tw.
4. (bedulcer$ or bed-ulcer$).mp. [mp=title, abstract, subject headings, drug trade name,
original title, support surface manufacturer, drug manufacturer name]
5. ((pressure or bed) adj ulcer$).mp. [mp=title, abstract, subject headings, drug trade name,
6. (pressure adj (ulcer$ or wound$ or damag$ or injur$)).mp. [mp=title, abstract, subject
headings, drug trade name, original title, support surface manufacturer, drug manufacturer
name]
7. or/1-6
8. limit 7 to english language
9. animal/
10. human/
11. 9 not (9 and 10)
12. 8 not 11 not (letter or editorial or comment).pt.
13. NUTRITION ASSESSMENT/ or Monitoring, Physiologic/
14. GERIATRIC ASSESSMENT/
15. (evaluat$ or assessment$).ti,ab.
16. (nutrition$ adj (exam$ or survey$ or assess$ or eval$ or status or condition$ or situation$
or score$)).mp. [mp=title, abstract, subject headings, drug trade name, original title, support
surface manufacturer, drug manufacturer name]
17. (pain adj (exam$ or survey$ or assess$ or eval$ or status or condition$ or situation$ or
score$)).mp. [mp=title, abstract, subject headings, drug trade name, original title, support
18. (psychosocial$ adj (exam$ or survey$ or assess$ or eval$ or status or condition$ or
situation$ or score$)).mp. [mp=title, abstract, subject headings, drug trade name, original title,
support surface manufacturer, drug manufacturer name]
19. (psycho-social$ adj (exam$ or survey$ or assess$ or eval$ or status or condition$ or
20. (mobile or mobility or exercis$ or mobilis$ or mobiliz$).mp. [mp=title, abstract, subject
name]
21. or/13-20
22. 12 and 21
Embase strategy (OVID interface)
1. Skin Ulcer/
2. Decubitus/
3. (decubitus or decubital or skin breakdown$).mp. [mp=title, abstract, subject headings, drug
trade name, original title, support surface manufacturer, drug manufacturer name]
name]
7. or/1-6
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Appendices.
9. (cat or cats or dog or dogs or animal or animals or rat or rats or hamster or hamsters or
feline or ovine or bovine or canine or sheep).ti,ab,de.
10. exp ANIMAL/
11. Animal Experiment/
12. Nonhuman/
13. Human/
14. Human Experiment/
15. or/9-12
16. 13 or 14
17. 15 not (15 and 16)
18. 8 not 17
19. 18 not (editorial or letter or note).pt.
20. Nutritional Status/
21. (geriatric assess$ or physiolog$ assess$ or physiologi$ exam$ or physiolog$
monitor$).mp. [mp=title, abstract, subject headings, drug trade name, original title, support
or score$)).mp. [mp=title, abstract, subject headings, drug trade name, original title, support
24. (pain$ adj (exam$ or survey$ or assess$ or eval$ or status or condition$ or situation$ or
score$)).mp. [mp=title, abstract, subject headings, drug trade name, original title, support
25. (psycho?social$ adj (exam$ or survey$ or assess$ or eval$ or status or condition$ or
27. (mobile or mobility or exercis$ or mobilis$ or mobiliz$).mp. [mp=title, abstract, subject
name]
28. or/20-27
29. 19 and 28
Cinahl strategy (OVID interface)
1. skin ulcer/ or pressure ulcer/
2. (decubitus or decubital or skin breakdown$).mp. [mp=title, cinahl subject headings,
abstract, instrumentation]
3. (bedulcer$ or bed-ulcer$).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
4. ((pressure or bed) adj ulcer$).mp. [mp=title, cinahl subject headings, abstract,
instrumentation]
5. (pressure adj (ulcer$ or wound$ or damag$ or injur$)).mp. [mp=title, cinahl subject
headings, abstract, instrumentation]
6. or/1-5
7. limit 6 to english
8. 7 not (editorial or letter or anecdote or commentary).pt.
9. geriatric assessment/ or geriatric functional assessment/ or monitoring, physiologic/ or
nursing assessment/ or nutritional assessment/ or patient assessment/
or score$)).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
score$)).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
situation$ or score$)).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
15. (mobile or mobility or exercis$ or mobilis$ or mobiliz$).mp. [mp=title, cinahl subject
Page 111 of 219

Appendices.
16. or/9-15
17. 8 and 16
SIGLE (SilverPlatter interface)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
decubitus or decubital or skin breakdown*

bedulcer* or bed-ulcer*
(pressure or bed) adj ulcer*
pressure adj (ulcer* or wound* or damag* or injur*)
#1 or #2 or #3 or #4
evaluat* or assessment*
nutrition* adj (exam* or survey* or assess* or eval* or status or condition* or situation* or
score*)
pain* adj (exam* or survey* or assess* or eval* or status or condition* or situation* or
score*)
psychosocial* adj (exam* or survey* or assess* or eval* or status or condition* or
situation* or score*)
psycho-social* adj (exam* or survey* or assess* or eval* or status or condition* or
situation* or score*)
mobile or mobility or exercis* or mobilis* or mobiliz*
#6 or #7 or #8 or #9 or #10 or #11
#5 and #12
#13 and (LA = "ENGLISH")
British Nursing Index strategy (OVID interface)

1. pressure ulcers/
2. (decubitus or decubital or skin breakdown$).mp. [mp=heading words, title]
3. (bedulcer$ or bed-ulcer$).mp. [mp=heading words, title]
4. ((pressure or bed) adj ulcer$).mp. [mp=heading words, title]
5. (pressure adj (ulcer$ or wound$ or damag$ or injur$)).mp. [mp=heading words, title]
6. or/1-5
7. patient assessment/ or elderly screening/
8. physiologic$ monitoring.mp.
or score$)).mp. [mp=heading words, title]
score$)).mp. [mp=heading words, title]
situation$ or score$)).mp. [mp=heading words, title]
situation$ or score$)).mp. [mp=heading words, title]
14. (mobile or mobility or mobilz$ or mobilis$ or exercis$).mp. [mp=heading words, title]
15. or/7-14
16. 6 and 15
Cochrane Library strategy (internet interface)
#1. SKIN ULCER single term (MeSH)
#2. DECUBITUS ULCER single term (MeSH)
#3. (decubitus or decubital or (skin next breakdown*))
#4. (bedulcer* or bed-ulcer*)
#5. ((pressure near ulcer*) or (bed near ulcer*))
#6. ((pressure next ulcer*) or (pressure next wound*) or (pressure next damag*) or (pressure
next injur*))
#7. (#1 or #2 or #3 or #4 or #5 or #6)
#8. (evaluat*:ti or assessment*:ti or evaluat*:ab or assessment*:ab)
#9. ((nutrition* next exam*) or (nutrition next survey*) or (nutrition next assess*) or (nutrition
next eval*) or (nutrition next status) or (nutrition next condition*) or (nutrition next situation*) or
(nutrition next score*))
Page 112 of 219

Appendices.
#10. ((pain* next exam*) or (pain* next survey*) or (pain* next assess*) or (pain* next eval*) or
(pain* next status) or (pain* next condition*) or (pain* next situation*) or (pain* next score*))
#11. ((psychosocial* next eval*) or (psychosocial* next status) or (psychosocial* next
condition*) or (psychosocial* next situation*) or (psychosocial* next score*))
#12. ((psycho-social* next eval*) or (psycho-social* next status) or (psycho-social* next
condition*) or (psycho-social* next situation*) or (psycho-social* next score*))
#13. (mobile or mobility or exercis* or mobilis* or mobiliz*)
#14. (#8 or #9 or #10 or #11 or #12 or #13)
#15. (#7 and #14)
DARE & HTA strategy (internal CRD Cairs interface)
1.
2.
3.
4.
5.
6.
7.
S decubitus or decubital or skin breakdown$

S (bedulcer$ or bed(w1)ulcer$)
S (pressure or bed)(w3)ulcer$
S (pressure)(w3)(ulcer$ or wound$ or damag$ or injur$)
S s1 or s2 or s3 or s4
S (evaluat$ or assessment$)/til,abs
S (nutrition$)(w3)(exam$ or survey$ or assess$ or eval$ or status or condition$ or situation$
or score$)
8. S (pain$)(w3)(exam$ or survey$ or assess$ or eval$ or status or condition$ or situation$ or
score$)
9. S (psychosocial$)(w3)(exam$ or survey$ or assess$ or eval$ or status or condition$ or
situation$ or score$)
10. S psycho(w1)social$)(w3)(exam$ or survey$ or assess$ or eval$ or status or condition$ or
situation$ or score$)
11.S (mobile or mobility or exercis$ or mobilis$ or mobiliz$)
12. S s6 or s7 or s8 or s9 or s10 or s11
13. S s5 and s12
14. s (French or spanish or italian or dutch or german or russian)/lan
15. s s13 andnot s14
PsycInfo strategy (SilverPlatter interface)
1.
2.
3.
4.

(bedulcer* or bed-ulcer*)
( pressure adj (ulcer* or wound* or damag* or injur*) )or( (pressure or bed) adj ulcer* )
(( pressure adj (ulcer* or wound* or damag* or injur*) )or( (pressure or bed) adj ulcer* )) or
((bedulcer* or bed-ulcer*)) or (decubitus or decubital or skin breakdown*)
5. ( nutrition* adj (exam* or survey* or assess* or eval* or status or condition* or situation* or
score*) )or( pain* adj (exam* or survey* or assess* or eval* or status or condition* or situation*
or score*) )or( psychosocial* adj (exam* or survey* or assess* or eval* or status or condition*
or situation* or score*) )
6. ( ((evaluat* or assessment*)) in AB )or( ((evaluat* or assessment*)) in TI )
7. ( psycho-social* adj (exam* or survey* or assess* or eval* or status or condition* or situation*
or score*) )and( (mobile or mobility or exercis* or mobilis* or mobiliz*) )
8. (( nutrition* adj (exam* or survey* or assess* or eval* or status or condition* or situation* or
score*) )or( pain* adj (exam* or survey* or assess* or eval* or status or condition* or situation*
or score*) )or( psychosocial* adj (exam* or survey* or assess* or eval* or status or condition*
or situation* or score*) )) or (( psycho-social* adj (exam* or survey* or assess* or eval* or
status or condition* or situation* or score*) )and( (mobile or mobility or exercis* or mobilis* or
mobiliz*) )) or (( ((evaluat* or assessment*)) in AB )or( ((evaluat* or assessment*)) in TI ))
9. ((( pressure adj (ulcer* or wound* or damag* or injur*) )or( (pressure or bed) adj ulcer* )) or
((bedulcer* or bed-ulcer*)) or (decubitus or decubital or skin breakdown*)) and ((( nutrition* adj
(exam* or survey* or assess* or eval* or status or condition* or situation* or score*) )or( pain*
adj (exam* or survey* or assess* or eval* or status or condition* or situation* or score*) )or(
psychosocial* adj (exam* or survey* or assess* or eval* or status or condition* or situation* or
score*) )) or (( psycho-social* adj (exam* or survey* or assess* or eval* or status or condition*
or situation* or score*) )and( (mobile or mobility or exercis* or mobilis* or mobiliz*) )) or ((
((evaluat* or assessment*)) in AB )or( ((evaluat* or assessment*)) in TI )))
10. ((( pressure adj (ulcer* or wound* or damag* or injur*) )or( (pressure or bed) adj ulcer* )) or
((bedulcer* or bed-ulcer*)) or (decubitus or decubital or skin breakdown*)) and ((( nutrition* adj
(exam* or survey* or assess* or eval* or status or condition* or situation* or score*) )or( pain*
Page 113 of 219

Appendices.
adj (exam* or survey* or assess* or eval* or status or condition* or situation* or score*) )or(
psychosocial* adj (exam* or survey* or assess* or eval* or status or condition* or situation* or
score*) )) or (( psycho-social* adj (exam* or survey* or assess* or eval* or status or condition*
or situation* or score*) )and( (mobile or mobility or exercis* or mobilis* or mobiliz*) )) or ((
((evaluat* or assessment*)) in AB )or( ((evaluat* or assessment*)) in TI ))) and (LA:PY =
ENGLISH)
AMED strategy (OVID interface)
1. skin ulcer/ or decubitus ulcer/
2. (decubitis or decubital or skin breakdown$).mp. [mp=title, cinahl subject headings, abstract,
instrumentation]
4. ((bed or pressure) adj ulcer$).mp. [mp=title, cinahl subject headings, abstract,
instrumentation]
6. or/1-5
8. 7 not (commentary or editorial or notes or letter).pt.
9. patient assessment/ or geriatric assessment/ or pain measurement/
10. nutritional status/
11. physiologic$ monitoring.mp.
or score$)).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
score$)).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
17. (mobile or mobility or mobils$ or mobilz$ or exercis$).mp. [mp=title, cinahl subject
18. or/9-17
19. 6 and 18
Health Management Information Consortium (up to 2003/07) (OVID)
1. pressure ulcers/
2. skin ulcers/
3. (decubitus or decubital or skin breakdown$).mp. [mp=title, other title, abstract, heading
words]
4. (bedulcer$ or bed-ulcer$).mp. [mp=title, other title, abstract, heading words]
5. ((pressure or bed) adj ulcer$).mp. [mp=title, other title, abstract, heading words]
6. (pressure adj (ulcer$ or wound$ or damag$ or injur$)).mp. [mp=title, other title, abstract,
heading words]
7. or/1-6
8. individual assessment/ or nursing assessment/ or psychological assessment/ or pain
assessment/
9. (physiologic$ monitor$ or geriatric assess$).mp. [mp=title, other title, abstract, heading
words]
or score$)).mp. [mp=title, other title, abstract, heading words]
score$)).mp. [mp=title, other title, abstract, heading words]
situation$ or score$)).mp. [mp=title, other title, abstract, heading words]
situation$ or score$)).mp. [mp=title, other title, abstract, heading words]
15. (mobile or mobility or exercis$ or mobilis$ or mobiliz$).mp. [mp=title, other title, abstract,
Page 114 of 219

Appendices.
heading words]
16. or/8-15
17. 7 and 16
Cost-effectiveness search strategies for Question A

Economics terms used to search Endnote
Cost
Price
Pricing
Econom
Value
Pharmacoeconom
Pharmaco-econom
Budget
Exoen
Qualy
Utility
*Search was not limited to field and automatic truncation was used.
NHS EED strategy (internal CRD Cairs interface)

1.
2.
3.
4.
5.
6.
7.

s (French or spanish or italian or dutch or german or russian)/xla
s s5 andnot s6
HEED strategy (cd-rom interface)
decubitus or decubital or skin breakdown or bedulcer or bedulcers or bed-ulcer or bed-ulcers
OR
pressure ulcer or pressure ulcers or bed ulcers or bed ulcer or pressure ulcer
OR
pressure ulcers or pressure wound or pressure wounds or pressure damage
OR
pressure damaging or pressure injury or pressure injuries
EconLit strategy (SilverPlatter interface)
1. ( decubitus or decubital or skin breakdown* )or( bedulcer* or bed-ulcer* )or( (pressure or bed)
adj ulcer* )
2. pressure adj (ulcer* or wound* or damag* or injur*)
3. (pressure adj (ulcer* or wound* or damag* or injur*)) or (( decubitus or decubital or skin
breakdown* )or( bedulcer* or bed-ulcer* )or( (pressure or bed) adj ulcer* ))
Clinical effectiveness search strategies for Question B

1. Skin Ulcer/
2. decubitus ulcer/
Page 115 of 219

Appendices.
4. (bedulcer$ or bed-ulcer$).mp. [mp=title, abstract, cas registry/ec number word, mesh
subject heading]
5. ((pressure or bed) adj ulcer$).mp. [mp=title, abstract, cas registry/ec number word, mesh
subject heading]
6. (pressure adj (ulcer$ or wound$ or damag$ or injur$)).mp. [mp=title, abstract, cas
registry/ec number word, mesh subject heading]
7. or/1-6
9. animal/
10. human/
11. 9 not (9 and 10)
13. Nursing Assessment/ or nurs$ assess$.tw.
14. Decubitus Ulcer/cl [Classification]
15. Skin Ulcer/cl [Classification]
16. Photography/du [Diagnostic Use]
17. (wound$ assess$ adj (tool$ or score$ or scoring or scale$ or instrument$ or equipment$ or
support surface$)).mp. [mp=title, abstract, cas registry/ec number word, mesh subject
heading]
18. (pressure ulcer$ adj assess$ adj (tool$ or score$ or scoring or scale$ or instrument$ or
equipment$ or support surface$)).mp. [mp=title, abstract, cas registry/ec number word, mesh
subject heading]
subject heading]
20. (decubit$ adj assess$ adj (tool$ or score$ or scoring or scale$ or instrument$ or
subject heading]
21. ((bedulcer$ or bed-ulcer$) adj assess$ adj (tool$ or score$ or scoring or scale$ or
instrument$ or equipment$ or support surface$)).mp. [mp=title, abstract, cas registry/ec
number word, mesh subject heading]
22. (pressure wound$ adj assess$ adj (tool$ or score$ or scoring or scale$ or instrument$ or
subject heading]
23. (pressure injur$ adj assess$ adj (tool$ or score$ or scoring or scale$ or instrument$ or
subject heading]
24. (probe$ or tape measure$ or measur$ tape$ or rule or ruler or rulers or trace or traced or
tracing$).mp. [mp=title, abstract, cas registry/ec number word, mesh subject heading]
25. (photograph$ or ultrasound$ or ultra-sound$ or ultrasonog$ or ultra-sonog$).mp. [mp=title,
abstract, cas registry/ec number word, mesh subject heading]
26. (sonogra$ or echogra$).mp. [mp=title, abstract, cas registry/ec number word, mesh
subject heading]
27. Ultrasonography/
28. or/13-27
29. 12 and 28
1. Skin Ulcer/
2. Decubitus/
name]
7. or/1-6
Page 116 of 219

Appendices.
10. exp ANIMAL/
12. Nonhuman/
13. Human/
15. or/9-12
16. 13 or 14
17. 15 not (15 and 16)
18. 8 not 17
20. examination/ or clinical examination/
21. nurs$ assess$.mp. [mp=title, abstract, subject headings, drug trade name, original title,
22. photography/ or medical photography/
23. (wound$ assess$ adj (tool$ or score$ or scoring or scale$ or instrument$ r quipment$ or
support surface$)).mp. [mp=title, abstract, subject headings, drug trade name, original title,
equipment$ or support surface$)).mp. [mp=title, abstract, subject headings, drug trade name,
26. (decubi$ adj assess$ adj (tool$ or score$ or scoring or scale$ or instrument$ or
instrument$ or equipment$ or support surface$)).mp. [mp=title, abstract, subject headings,
drug trade name, original title, support surface manufacturer, drug manufacturer name]
30. (probe$ or tape measure$ or measur tape$ or rule or ruler or rulers or trace or traced or
tracing$).mp. [mp=title, abstract, subject headings, drug trade name, original title, support
abstract, subject headings, drug trade name, original title, support surface manufacturer, drug
manufacturer name]
33. (sonogra$ or echogra$).mp. [mp=title, abstract, subject headings, drug trade name,
34. echography/
35. ULTRASOUND/
36. or/20-35
37. 19 and 36
instrumentation]
Page 117 of 219

Appendices.
6. or/1-5
9. Nursing Assessment/
10. nurs$ assess$.tw.
11. Pressure Ulcer/cl [Classification]
13. Leg Ulcer/cl [Classification]
support surface$)).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
equipment$ or support surface$)).mp. [mp=title, cinahl subject headings, abstract,
instrumentation]
instrumentation]
instrumentation]
instrument$ or equipment$ or support surface$)).mp. [mp=title, cinahl subject headings,
instrumentation]
instrumentation]
instrumentation]
tracing$).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
cinahl subject headings, abstract, instrumentation]
25. (sonogra$ or echogra$).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
27. or/9-26
28. 8 and 27
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.

(pressure or bed) adj ulcer*
pressure adj (ulcer* or wound* or damag* or injur*)
#1 or #2 or #3 or #4
#5 and (LA = "ENGLISH")
nurs* assess*
wound* assess* near (tool* or score* or scoring or scale* or instrument* or equipment* or
support surface*)
pressure ulcer* near assess* near (tool* or score* or scoring or scale* or instrument* or
equipment* or support surface*)
pressure ulcer* near assess* near (tool* or score* or scoring or scale* or instrument* or
decubit* near assess* near (tool* or score* or scoring or scale* or instrument* or equipment*
or support surface*)
(bedulcer* or bed-ulcer*) near assess* near (tool* or score* or scoring or scale* or instrument*
or equipment* or support surface*)
Page 118 of 219

Appendices.
13. pressure wound* near assess* near (tool* or score* or scoring or scale* or instrument* or
14. pressure injur* near assess* near (tool* or score* or scoring or scale* or instrument* or
15. probe* or tape measure* or measur* tape* or rule or ruler or rulers or trace or traced or
tracing*
16. photograph* or ultrasound* or ultra-sound* or ultrasonog* or ultra-sonog*
17. sonogra* or echogra*
18. #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17
19. #6 and #18

1. pressure ulcers/
6. or/1-5
7. patient assessment/
8. nurs$ assess$.mp. [mp=heading words, title]
9. photography.mp.
support surface$)).mp. [mp=heading words, title]
equipment$ or support surface$)).mp. [mp=heading words, title]
instrument$ or equipment$ or support surface$)).mp. [mp=heading words, title]
tracing$).mp. [mp=heading words, title]
18. (photograph$ or ultrasound$ or ultra-sound$ or ultrasonog$ or ultra-sonog$).mp.
[mp=heading words, title]
19. (sonogra$ or echogra$).mp. [mp=heading words, title]
20. ULTRASOUND/
21. or/7-20
22. 6 and 21
next injur*))
#7. (#1 or #2 or #3 or #4 or #5 or #6)
#8. DECUBITUS ULCER [cl] single term (MeSH)
#9. SKIN ULCER [cl] single term (MeSH)
#10. PHOTOGRAPHY [du] single term (MeSH)
#11. ULTRASONOGRAPHY single term (MeSH)
#12. (wound* next assess*)
#13. ((pressure next ulcer*) near assess*)
Page 119 of 219

Appendices.
#14. ((pressure next ulcer*) near assess*)
#15. (decubit* near assess*)
#16. (bedulcer* near assess*)
#17. (bed-ulcer* near assess*)
#18. ((pressure next wound*) near assess*)
#19. ((pressure next injur*) near assess*)
#20. (probe* or rule or ruler or rulers or trace or traced or tracing*)
#21. (photograph* or ultrasound* or ultra-sound* or ultrasonog* or ultra-sonog* or sonogra* or
echogra*)
#22. ((tape next measure*) or (measur* next tape*))
#23. (#8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or
#21 or #22)
#24. (#7 and #23)
DARE strategy (internal CRD Cairs interface)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.

s nurs$(w)assess$
s wound$(w)assess$(w3)(tool$ or score$ or scoring or scale$ or instrument$ or equipment$ or
support surface$)
s pressure(w)ulcer$(w)assess$(w3)(tool$ or score$ or scoring or scale$ or instrument$ or
equipment$ or support surface$)
s pressure(w)ulcer$(w)assess$(w3)(tool$ or score$ or scoring or scale$ or instrument$ or
s decubit$(w)assess$(w3)(tool$ or score$ or scoring or scale$ or instrument$ or equipment$
or support surface$)
s bedulcer$(w)assess$(w3)(tool$ or score$ or scoring or scale$ or instrument$ or equipment$
or support surface$)
s bed(w)ulcer$(w)assess$(w)(tool$ or score$ or scoring or scale$ or instrument$ or
s pressure(w)wound$(w)assess$(w3)(tool$ or score$ or scoring or scale$ or instrument$ or
s pressure(w)injur$(w)assess$(w3)(tool$ or score$ or scoring or scale$ or instrument$ or
s probe$ or tape(w)measure$ or measur$(w)tape$ or rule or ruler or rulers or trace or traced
or tracing$
s photograph$ or ultrasound$ or ultra(w)sound$ or ultrasonog$ or ultra(w)sonog$
s sonogra$ or echogra$
S s6 or s7 or s8 or s9 or s10 or s11 or s12 or s13 or s14 or s15 or s16 or s17
S s5 and s18
s (French or spanish or italian or dutch or german or russian)/lan
s s19 andnot s20
1.
2.
3.
4.
5.
6.
7.
8.

(pressure adj (ulcer* or wound* or damag* or injur*)) or ((pressure or bed) adj ulcer*))
((pressure adj (ulcer* or wound* or damag* or injur*)) or ((pressure or bed) adj ulcer*)) or
(nutrition* adj (exam* or survey* or assess* or eval* or status or condition* or situation* or
score*)) or (pain* adj (exam* or survey* or assess* or eval* or status or condition* or situation*
or score*)) or (psychosocial* adj (exam* or survey* or assess* or eval* or status or condition*
or situation* or score*))
(((evaluat* or assessment*)) in AB) or (((evaluat* or assessment*)) in TI)
(psycho-social* adj (exam* or survey* or assess* or eval* or status or condition* or situation*
or score*)) and ((mobile or mobility or exercise* or mobilis* or mobilz*))
((nutrition* adj (exam* or survey* or assess* or eval* or status or condition* or situation* or
Page 120 of 219

Appendices.
or situation* or score*))) or ((psycho-social* adj (exam* or survey* or assess* or eval* or status
or condition* or situation* or score*)) and ((mobile or mobility or exercise* or mobilis* or
mobilz*))) or ((((evaluat* or assessment*)) in AB) or (((evaluat* or assessment*)) in TI))
9. (((pressure adj (ulcer* or wound* or damag* or injur*)) or ((pressure or bed) adj ulcer*)) or
((bedulcer* or bed-ulcer*)) or (decubitus or decubital or skin breakdown*)) and (((nutrition* adj
(exam* or survey* or assess* or eval* or status or condition* or situation* or score*)) or (pain*
adj (exam* or survey* or assess* or eval* or status or condition* or situation* or score*)) or
(psychosocial* adj (exam* or survey* or assess* or eval* or status or condition* or situation* or
score*))) or ((psycho-social* adj (exam* or survey* or assess* or eval* or status or condition*
or situation* or score*)) and ((mobile or mobility or exercise* or mobilis* or mobilz*))) or
((((evaluat* or assessment*)) in AB) or (((evaluat* or assessment*)) in TI)))
10. (((pressure adj (ulcer* or wound* or damag* or injur*)) or ((pressure or bed) adj ulcer*)) or
((((evaluat* or assessment*)) in AB) or (((evaluat* or assessment*)) in TI))) and (LA:PY =
ENGLISH)
2. (decubitis or decubital or skin breakdown$).mp. [mp=abstract, heading words, title]
3. (bedulcer$ or bed-ulcer$).mp. [mp=abstract, heading words, title]
4. ((bed or pressure) adj ulcer$).mp. [mp=abstract, heading words, title]
5. (pressure adj (ulcer$ or wound$ or damag$ or injur$)).mp. [mp=abstract, heading words,
title]
6. or/1-5
9. nurs$ assess$.mp. [mp=abstract, heading words, title]
10. Photography/
support surface$)).mp. [mp=abstract, heading words, title]
equipment$ or support surface$)).mp. [mp=abstract, heading words, title]
instrument$ or equipment$ or support surface$)).mp. [mp=abstract, heading words, title]
tracing$).mp. [mp=abstract, heading words, title]
[mp=abstract, heading words, title]
20. (sonogra$ or echogra$).mp. [mp=abstract, heading words, title]
22. or/9-21
23. 8 and 22
Health Management Information Consortium (OVID)
1. pressure ulcers/
2. skin ulcers/
Page 121 of 219

Appendices.
3. (decubitus or decubital or skin breakdown$).mp. [mp=title, other title, abstract, heading words]
heading words]
7. or/1-6
8. exp NURSING ASSESSMENT/
9. nurs$ assess$.mp.
10. exp MEDICAL PHOTOGRAPHY/ or exp PHOTOGRAPHY/
support surface$)).mp. [mp=title, other title, abstract, heading words]
equipment$ or support surface$)).mp. [mp=title, other title, abstract, heading words]
14. (decubit$ adj assess$ adj (tool$ or score$ or scoring or scale$ or instrument$ or equipment$
or support surface$)).mp. [mp=title, other title, abstract, heading words]
15. ((bedulcer$ or bed-ulcer$) adj assess$ adj (tool$ or score$ or scoring or scale$ or instrument$
or equipment$ or support surface$)).mp. [mp=title, other title, abstract, heading words]
tracing$).mp. [mp=title, other title, abstract, heading words]
other title, abstract, heading words]
20. (sonogra$ or echogra$).mp. [mp=title, other title, abstract, heading words]
21. exp ULTRASONICS/
22. or/8-21
23. 7 and 22
Cost-effectiveness search strategies for Question B

NHS EED strategy (internal CRD Cairs interface)
8. S decubitus or decubital or skin breakdown$
9. S (bedulcer$ or bed(w1)ulcer$)
10. S (pressure or bed)(w3)ulcer$
11. S (pressure)(w3)(ulcer$ or wound$ or damag$ or injur$)
12. S s1 or s2 or s3 or s4
13. s (French or spanish or italian or dutch or german or russian)/xla
14. s s5 andnot s6
HEED strategy (cd-rom interface)
decubitus or decubital or skin breakdown or bedulcer or bedulcers or bed-ulcer or bed-ulcers
OR
pressure ulcer or pressure ulcers or bed ulcers or bed ulcer or pressure ulcer
OR
pressure ulcers or pressure wound or pressure wounds or pressure damage
OR
pressure damaging or pressure injury or pressure injuries
EconLit strategy (SilverPlatter interface)
4. ( decubitus or decubital or skin breakdown* )or( bedulcer* or bed-ulcer* )or( (pressure or bed)
adj ulcer* )
5. pressure adj (ulcer* or wound* or damag* or injur*)
Page 122 of 219

Appendices.
6. (pressure adj (ulcer* or wound* or damag* or injur*)) or (( decubitus or decubital or skin
breakdown* )or( bedulcer* or bed-ulcer* )or( (pressure or bed) adj ulcer* ))
1. outcome$ measur$.mp. [mp=ti, ab, rw, sh]
2. cost minimi?ation.ti,ab.
3. quality-adjusted life years/
4. cost utility.mp.
5. cost consequence$.mp.
6. cost saving$.mp.
7. cost-effective$.mp.
8. (cba or cma or cca or cua or cca or cea).ti,ab.
9. ECONOMICS/
10. exp "Costs and Cost Analysis"/
11. VALUE OF LIFE/ec [Economics]
12. exp ECONOMICS, HOSPITAL/
13. exp ECONOMICS, nursing/
14. exp ECONOMICS, pharmaceutical/
15. exp budgets/
16. (cost or costs or costly or costed or costing or budget$).mp.
17. (econom$ or pharmacoeconom$ or pharmaco-econom$ or price$ or pricing).mp.
18. (value adj5 money).mp.
19. (expenditure$ not energy).mp.
20. (utilit$ approach$ or health gain or (hui or hui2 or hui-2 or hui3 or hui-3)).ti,ab.
21. exp Quality-of-Life/
22. Health-Status/
23. (health measurement$ scor$ or health measurement$ scale$ or health measurement$
questionnaire$).ti,ab.
24. (time-trade-off$ or hrqol).ti,ab.
25. (time trade-off$ or index of wellbeing or index of well-being).ti,ab.
26. (time trade off$ or quality of wellbeing or quality of well-being or qwb).ti,ab.
27. (rating scale$ or multiattribute$ health ind$ or multi-attribute$ health ind$ or multi attribute$
health ind$).ti,ab.
28. (health utilit$ index or multiattribute$ theor$ or multi-attribute$ theor$ or multi attribute$
theor$).ti,ab.
29. (health utilit$ indices or multiattribute$ analys$ or multi-attribute$ analys$ or multi
attribute$ analys$).ti,ab.
30. (health utilit$ scale$ or classification of illness state$ or (15d or 15-d) or 15 dimension or
15-dimension).ti,ab.
31. (health state$ utilit$ or (12d or 12-d) or 12 dimension or 12-dimension).ti,ab.
32. (health-state$ utilit$ or euroqol).ti,ab.
33. (health-utilit$ index or well year$ or well-year$).ti,ab.
34. (health-utilit$ indices or multiattribute$ utilit$ or multi-attribute$ utilit$ or multi attribute$
utilit$).ti,ab.
35. health-utilit$ scale$.ti,ab.
36. (qol or (5d or 5-d) or 5 dimension or 5-dimension).ti,ab.
37. (quality of life or eq-5d or eq5d).ti,ab.
38. quality-of-life.ti,ab.
39. (qualy or qaly or qualys or qalys).ti,ab.
40. (quality-adjusted-life-year$ or quality adjusted life year$ or quality-adjusted life-year$ or
quality adjusted life-year$ or quality-adjusted life year$).ti,ab.
41. (life-year$ gain$ or life year$ gain$ or life-year$-gain$).ti,ab.
42. (willingness to pay or willingness-to-pay).ti,ab.
43. (person trade off$ or person-trade-off$ or person trade-off$ or person tradeoff$ or time
tradeoff$).ti,ab.
44. (Hye or hyes).ti,ab.
45. (health$ year$ equivalent$ or health$-year$-equivalent$ or health$-year$ equivalent$ or
theory utilit$).ti,ab.
46. (health state$ or health-state$).ti,ab.
47. (Qale or Quality-adjusted life expectanc$ or Quality-adjusted life-expectanc$ or Quality
adjusted life expectanc$).ti,ab.
Page 123 of 219

Appendices.
48. (daly or disability adjusted life year$ or disability-adjusted life-year$ or disability adjusted
life-year$ or disability-adjusted life year$).ti,ab.
49. (Conjoint analys$ or Contingent valuat$ or Discrete choice model$).mp.
50. healing rate$.ti,ab.
51. healing time$.ti,ab.
52. healing timing$.ti,ab.
53. pain reduc$.mp.
54. (pain ceas$ or pain cessat$).mp.
55. animal/
56. human/
57. 55 not (55 and 56)
58. Skin Ulcer/
59. decubitus ulcer/
61. (bedulcer$ or bed-ulcer$).mp. [mp=ti, ab, rw, sh]
62. ((pressure or bed) adj ulcer$).mp. [mp=ti, ab, rw, sh]
63. (pressure adj (ulcer$ or wound$ or damag$ or injur$)).mp. [mp=ti, ab, rw, sh]
64. or/58-63
65. Nursing Assessment/ or nurs$ assess$.tw.
66. Decubitus Ulcer/cl [Classification]
support surface$)).mp. [mp=ti, ab, rw, sh]
equipment$ or support surface$)).mp. [mp=ti, ab, rw, sh]
instrument$ or equipment$ or support surface$)).mp. [mp=ti, ab, rw, sh]
tracing$).mp. [mp=ti, ab, rw, sh]
77. (photograph$ or ultrasound$ or ultra-sound$ or ultrasonog$ or ultra-sonog$).mp. [mp=ti,
ab, rw, sh]
78. (sonogra$ or echogra$).mp. [mp=ti, ab, rw, sh]
80. or/65-79
81. or/1-54
82. 81 not 57
84. 83 not (letter or editorial or comment).pt.
85. 84 and 64 and 80
1. outcome$ measur$.mp.
3. Quality Adjusted Life Year/
4. quality of life/
5. exp economic evaluation/
6. cost utility.mp.
8. cost saving$.mp.
10. (cba or cma or cca or cua or cea).ti,ab.
Page 124 of 219

Appendices.
11. economics/
12. health economics/ or exp fee/ or exp health care cost/ or exp health insurance/ or exp
pharmacoeconomics/ or health care organization/ or exp health care quality/ or exp disease
management/
13. health economics/ or exp fee/ or exp health care cost/ or exp health insurance/ or exp
pharmacoeconomics/ or health care organization/ or exp health care quality/ or exp disease
management/
14. economic aspect/ or cost/
15. budget/
16. (cost or costs or costly or costing or costed or budget$).mp.
21. health status/
23. (time trade-off$ or hrqol).ti,ab.
health ind$).ti,ab.
theor$).ti,ab.
utilit$).ti,ab.
tradeoff$).ti,ab.
51. pain reduc$.mp.
53. or/1-52
55. exp ANIMAL/ or Animal Experiment/ or Nonhuman/
56. or/54-55
57. Human/ or Human Experiment/
Page 125 of 219

Appendices.
58. 56 not (57 and 56)
59. 53 not 58
62. Skin Ulcer/
63. Decubitus/
name]
68. or/62-67
69. 61 and 68
70. examination/ or clinical examination/
71. nurs$ assess$.mp. [mp=title, abstract, subject headings, drug trade name, original title,
72. photography/ or medical photography/
73. (wound$ assess$ adj (tool$ or score$ or scoring or scale$ or instrument$ r quipment$ or
support surface$)).mp. [mp=title, abstract, subject headings, drug trade name, original title,
76. (decubi$ adj assess$ adj (tool$ or score$ or scoring or scale$ or instrument$ or
instrument$ or equipment$ or support surface$)).mp. [mp=title, abstract, subject headings,
drug trade name, original title, support surface manufacturer, drug manufacturer name]
80. (probe$ or tape measure$ or measur tape$ or rule or ruler or rulers or trace or traced or
manufacturer name]
83. (sonogra$ or echogra$).mp. [mp=title, abstract, subject headings, drug trade name,
84. echography/
85. ULTRASOUND/
86. or/70-85
87. 69 and 86
Page 126 of 219

Appendices.
3. cost utility.mp.
5. cost saving$.mp.
health ind$).ti,ab.
theor$).ti,ab.
utilit$).ti,ab.
tradeoff$).ti,ab.
42. pain reduc$.mp.
44. "costs and cost analysis"/ or cost benefit analysis/ or cost control/ or health care costs/ or
health facility costs/ or nursing costs/ or economic aspects of illness/ or economic value of life/
or economics, pharmaceutical/ or "fees and charges"/ or capitation fee/ or fee for service
plans/ or health facility charges/ or "rate setting and review"/ or financial management/ or
budgets/
45. economics/
46. "acceptance: health status (iowa noc)"/ or health status/ or "status (omaha)"/ or health
status indicators/
47. Quality of Life/
48. or/1-47
Page 127 of 219

Appendices.
instrumentation]
54. or/49-53
57. 48 and 56
58. Nursing Assessment/
59. nurs$ assess$.tw.
60. Pressure Ulcer/cl [Classification]
62. Leg Ulcer/cl [Classification]
support surface$)).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
instrumentation]
instrumentation]
instrumentation]
instrument$ or equipment$ or support surface$)).mp. [mp=title, cinahl subject headings,
instrumentation]
instrumentation]
instrumentation]
tracing$).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
74. (sonogra$ or echogra$).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
76. or/58-75
77. 57 and 76
1. (( bedulcer* or bed-ulcer* )or( pressure adj (ulcer* or wound* or damag* or injur*) )or(
(Pressure or bed)adj ulcer* )) or (decubitus or decubital or skin breakdown*)
2. ( (outcome* measur*) or (cost or costs or costly or costed or costing or budget*) )or( (econom*
or pharmacoeconom* or pharmaco-econom* or price* or pricing) or (value adj money) )or(
(expenditure* not energy) )
3. utilit* approach* or health gain
4. ( utilit* approach* or health gain )or( ((hui or hui2 or hui-2 or hui3 or hui-3 or cba or cma or cca
or cua or cca or cea).) in AB )or( ((hui or hui2 or hui-2 or hui3 or hui-3 or cba or cma or cca or
cua or cca or cea).) in TI )
5. ( health stat* or hrqol or qol or hye or hyes or qualy or qaly or qualys or qalys or Qale )or(
quality of life or quality adjusted life year* )or( health utilit* or Quality adjusted life expectanc* )
Page 128 of 219

Appendices.
6. ( daly or disability adjusted life year* )or( healing rate* or healing time* or healing timing* )or(
pain reduc* or (pain ceas* or pain cessat*) )
7. (( health stat* or hrqol or qol or hye or hyes or qualy or qaly or qualys or qalys or Qale )or(
quality of life or quality adjusted life year* )or( health utilit* or Quality adjusted life expectanc* ))
or (( utilit* approach* or health gain )or( ((hui or hui2 or hui-2 or hui3 or hui-3 or cba or cma or
cca or cua or cca or cea).) in AB )or( ((hui or hui2 or hui-2 or hui3 or hui-3 or cba or cma or cca
or cua or cca or cea).) in TI )) or (utilit* approach* or health gain) or (( (outcome* measur*) or
(cost or costs or costly or costed or costing or budget*) )or( (econom* or pharmacoeconom* or
pharmaco-econom* or price* or pricing) or (value adj money) )or( (expenditure* not energy) ))
or (( daly or disability adjusted life year* )or( healing rate* or healing time* or healing timing*
)or( pain reduc* or (pain ceas* or pain cessat*) ))
8. ((( bedulcer* or bed-ulcer* )or( pressure adj (ulcer* or wound* or damag* or injur*) )or(
(Pressure or bed)adj ulcer* )) or (decubitus or decubital or skin breakdown*)) and ((( health
stat* or hrqol or qol or hye or hyes or qualy or qaly or qualys or qalys or Qale )or( quality of life
or quality adjusted life year* )or( health utilit* or Quality adjusted life expectanc* )) or (( utilit*
approach* or health gain )or( ((hui or hui2 or hui-2 or hui3 or hui-3 or cba or cma or cca or cua
or cca or cea).) in AB )or( ((hui or hui2 or hui-2 or hui3 or hui-3 or cba or cma or cca or cua or
cca or cea).) in TI )) or (utilit* approach* or health gain) or (( (outcome* measur*) or (cost or
costs or costly or costed or costing or budget*) )or( (econom* or pharmacoeconom* or
pharmaco-econom* or price* or pricing) or (value adj money) )or( (expenditure* not energy) ))
or (( daly or disability adjusted life year* )or( healing rate* or healing time* or healing timing*
)or( pain reduc* or (pain ceas* or pain cessat*) )))
3. cost utility.mp.
5. cost saving$.mp.
health ind$).ti,ab.
theor$).ti,ab.
utilit$).ti,ab.
Page 129 of 219

Appendices.
tradeoff$).ti,ab.
42. pain reduc$.mp.
44. health economics/
45. "CONTRACTS AND MARKETING"/
46. "health and quality of life"/
47. or/1-46
48. pressure ulcers/
53. or/48-52
54. 47 and 53
55. patient assessment/
56. nurs$ assess$.mp. [mp=heading words, title]
57. photography.mp.
support surface$)).mp. [mp=heading words, title]
instrument$ or equipment$ or support surface$)).mp. [mp=heading words, title]
tracing$).mp. [mp=heading words, title]
67. (sonogra$ or echogra$).mp. [mp=heading words, title]
68. ULTRASOUND/
69. or/55-68
70. 54 and 69
1.
2.
3.
4.

(pressure adj (ulcer* or wound* or damag* or injur*)) or ((pressure or bed) adj ulcer*))
((pressure adj (ulcer* or wound* or damag* or injur*)) or ((pressure or bed) adj ulcer*)) or
5. (nutrition* adj (exam* or survey* or assess* or eval* or status or condition* or situation* or
Page 130 of 219
6.
7.
8.
9.
10.
Appendices.
or situation* or score*))
(((evaluat* or assessment*)) in AB) or (((evaluat* or assessment*)) in TI)
(psycho-social* adj (exam* or survey* or assess* or eval* or status or condition* or situation*
or score*)) and ((mobile or mobility or exercise* or mobilis* or mobilz*))
((nutrition* adj (exam* or survey* or assess* or eval* or status or condition* or situation* or
or situation* or score*))) or ((psycho-social* adj (exam* or survey* or assess* or eval* or status
or condition* or situation* or score*)) and ((mobile or mobility or exercise* or mobilis* or
mobilz*))) or ((((evaluat* or assessment*)) in AB) or (((evaluat* or assessment*)) in TI))
(((pressure adj (ulcer* or wound* or damag* or injur*)) or ((pressure or bed) adj ulcer*)) or
((((evaluat* or assessment*)) in AB) or (((evaluat* or assessment*)) in TI)))
(((pressure adj (ulcer* or wound* or damag* or injur*)) or ((pressure or bed) adj ulcer*)) or
((((evaluat* or assessment*)) in AB) or (((evaluat* or assessment*)) in TI))) and (LA:PY =
ENGLISH)
3. cost utility.mp.
5. cost saving$.mp.
health ind$).ti,ab.
theor$).ti,ab.
utilit$).ti,ab.
Page 131 of 219

Appendices.
tradeoff$).ti,ab.
42. pain reduc$.mp.
45. "CONTRACTS AND MARKETING"/
46. "health and quality of life"/
47. or/1-46
53. or/48-52
54. 47 and 53
3. cost utility.mp.
5. cost saving$.mp.
health ind$).ti,ab.
theor$).ti,ab.
Page 132 of 219

Appendices.
utilit$).ti,ab.
tradeoff$).ti,ab.
42. pain reduc$.mp.
44. exp economic analysis/ or economic evaluation/ or costs/ or economic research/ or
economic models/ or economic value/ or prices/
46. quality of life/ or quality adjusted life years/
47. health status/ or health status measures/ or health outcomes/ or health measurement/ or
health status measurement/
48. or/1-47
50. skin ulcers/
words]
heading words]
55. or/49-54
56. 48 and 55
57. exp NURSING ASSESSMENT/
58. nurs$ assess$.mp.
59. exp MEDICAL PHOTOGRAPHY/ or exp PHOTOGRAPHY/
support surface$)).mp. [mp=title, other title, abstract, heading words]
instrument$ or equipment$ or support surface$)).mp. [mp=title, other title, abstract, heading
words]
Page 133 of 219

Appendices.
tracing$).mp. [mp=title, other title, abstract, heading words]
69. (sonogra$ or echogra$).mp. [mp=title, other title, abstract, heading words]
70. exp ULTRASONICS/
71. or/57-70
72. 56 and 71
Clinical effectiveness search strategies for Question C

1 Skin Ulcer/
2. decubitus ulcer/
7. or/1-6
9. animal/
10. human/
11. 9 not (9 and 10)
13. BEDS/is, nu [Instrumentation, Nursing]
14. "Bedding and Linens"/
15. Protective Support surfaces/ or posture/ or head-down tilt/ or prone position/ or supine
position/
16. (pressure relie$ or pressure-relie$ or pressure reduc$ or pressure-reduc$).mp. [mp=ti, ab,
rw, sh]
17. (bed or beds or bedding or mattress$ or couch$ or cot or cots or crib or cribs or cradle or
cradles or bolster$ or cushion$).mp. [mp=ti, ab, rw, sh]
18. ((pressure or decubit$ or bedulcer$ or bed?ulcer$) adj10 (overlay$ or over-lay$ or over
lay$)).mp. [mp=ti, ab, rw, sh]
19. (support$ pillow$ or film$).mp. [mp=ti, ab, rw, sh]
20. (pillow$ or foam wedge$ or foam block$ or gelpad$ or gel pad$ or gel-pad$ or gell pad$ or
gellpad$ or gell-pad$).mp. [mp=ti, ab, rw, sh]
21. (air?support$ or air support$ or air?fluidi?ed or air fluidi?ed or support?surface$ or support
surface$).mp. [mp=ti, ab, rw, sh]
22. (sheepskin$ or sheep-skin$ or alternat$ pressure$).mp. [mp=ti, ab, rw, sh]
23. (turning adj1 (bed$ or frame$)).mp. [mp=ti, ab, rw, sh]
24. (limb$ adj1 (protect$ or guard$ or defend$ or defenc$ or shield$ or rest$)).mp. [mp=ti, ab,
rw, sh]
25. or/13-24
26. 12 and 25
27. limit 26 to yr=2002-2004
1. Skin Ulcer/
2. Decubitus/
name]
Page 134 of 219

Appendices.
7. or/1-6
10. exp ANIMAL/
12. Nonhuman/
13. Human/
15. or/9-12
16. 13 or 14
17. 15 not (15 and 16)
18. 8 not 17
20. limit 19 to yr=2002-2004
21. (pressure relie$ or pressure-relie$ or pressure reduc$ or pressure-reduc$).mp. [mp=title,
manufacturer name]
cradles or bolster$ or cushion$).mp. [mp=title, abstract, subject headings, drug trade name,
lay$)).mp. [mp=title, abstract, subject headings, drug trade name, original title, support surface
manufacturer, drug manufacturer name]
24. (support$ pillow$ or film$).mp. [mp=title, abstract, subject headings, drug trade name,
gellpad$ or gell-pad$).mp. [mp=title, abstract, subject headings, drug trade name, original title,
surface$).mp. [mp=title, abstract, subject headings, drug trade name, original title, support
27. (sheepskin$ or sheep-skin$ or alternat$ pressure$).mp. [mp=title, abstract, subject
name]
28. (turning adj1 (bed$ or frame$)).mp. [mp=title, abstract, subject headings, drug trade name,
29. (limb$ adj1 (protect$ or guard$ or defend$ or defenc$ or shield$ or rest$)).mp. [mp=title,
manufacturer name]
30. bed/ or fluidized bed/ or hospital bed/
31. protective equipment/ or body position/ or body posture/ or recumbency/ or sitting/ or
standing/ or supine position/ or head position/
32. or/21-31
33. 20 and 32
1 . skin ulcer/ or pressure ulcer/
instrumentation]
6. or/1-5
Page 135 of 219

Appendices.
cradles or bolster$ or cushion$).mp. [mp=title, cinahl subject headings, abstract,
instrumentation]
lay$)).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
12. (support$ pillow$ or film$).mp. [mp=title, cinahl subject headings, abstract,
instrumentation]
gellpad$ or gell-pad$).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
surface$).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
15. (sheepskin$ or sheep-skin$ or alternat$ pressure$).mp. [mp=title, cinahl subject headings,
16. (turning adj1 (bed$ or frame$)).mp. [mp=title, cinahl subject headings, abstract,
instrumentation]
18. "bedding and linens"/ or "beds and mattresses"/ or cribs/ or flotation beds/ or "pillows and
cushions"/
19. Protective Support surfaces/ or patient positioning/ or prone position/ or supine position/
20. or/9-19
21. 8 and 20
22. limit 21 to yr=2002-2003
1. pressure ulcers/
6. or/1-5
7. (pressure relie$ or pressure-relie$ or pressure reduc$ or pressure-reduc$).mp.
cradles or bolster$ or cushion$).mp. [mp=heading words, title]
lay$)).mp. [mp=heading words, title]
10. patients positioning/ or (support$ pillow$ or film$).mp. [mp=heading words, title]
gellpad$ or gell-pad$).mp. [mp=heading words, title]
surface$).mp. [mp=heading words, title]
13. (sheepskin$ or sheep-skin$ or alternat$ pressure$).mp. [mp=heading words, title]
14. (turning adj1 (bed$ or frame$)).mp. [mp=heading words, title]
15. (limb$ adj1 (protect$ or guard$ or defend$ or defenc$ or shield$ or rest$)).mp.
16. or/7-15
17. 6 and 16
18. limit 17 to yr=2002-2003
#1.
SKIN ULCER single term (MeSH)
#2.
DECUBITUS ULCER single term (MeSH)
#3.
(decubitus or decubital or (skin next breakdown*))
#4.
#5.
((pressure near ulcer*) or (bed near ulcer*))
#6.
((pressure next ulcer*) or (pressure next wound*) or (pressure next damag*) or
(pressure next injur*))
#7.
(#1 or #2 or #3 or #4 or #5 or #6)
#8.
BEDS single term (MeSH)
#9.
BEDDING AND LINENS single term (MeSH)
Page 136 of 219

Appendices.
#10.
PROTECTIVE SUPPORT SURFACES single term (MeSH)
#11.
posture
#12.
POSTURE single term (MeSH)
#13.
HEAD-DOWN TILT single term (MeSH)
#14.
PRONE POSITION single term (MeSH)
#15.
SUPINE POSITION single term (MeSH)
#16.
((pressure next relie*) or pressure-relie* or (pressure next reduc*) or pressure-reduc*)
#17.
(bed or beds or bedding or mattress* or couch* or cot or cots or crib or cribs or cradle
or cradles or bolster* or cushion*)
#18.
((pressure near overlay*) or (pressure near over-lay*) or (decubit* near overlay*) or
(decubit* near over-lay*) or (bedulcer* near overlay*) or (bedulcer* near over-lay*))
#19.
((support* next pillow*) or film*)
#20.
(pillow* or (foam next wedge*) or (foam next block*) or gelpad* or (gel next pad*) or
gel-pad* or (gell next pad*) or gellpad* or gell-pad*)
#21.
((air next support*) or air-support* or air-fluidised or air-fluidised or (air next fluidized)
or air-fluidized or (support next surface*) or support-surface*)
#22.
(sheepskin* or sheep-skin* or (alternat* next pressure*))
#23.
((turning next bed*) or (turning next frame*))
#24.
((limb* next protect*) or (limb* next guard*) or (limb* next defend*) or (limb* next
defenc*) or (limb* next shield*) or (limb* next rest*))
#25.
(#8 or #9 or #10 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or
#21 or #22 or #23 or #24)
#26.
(#7 and #25)
#27.
(#7 and #25) ( 2002 to current date )
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.

s pressure(w)relie$ or pressure(w)reduc$
s (bed or beds or bedding or mattress$ or couch$ or cot or cots or crib or cribs or cradle or
cradles or bolster$ or cushion$)
s (pressure or decubit$ or bedulcer$ or bed(w1)ulcer$)(w10)(overlay$ or over(w1)lay$) s
support$(w)pillow$ or film$ or pillow$ or foam(w)wedge$ or foam(w)block$ or gelpad$ or
gel(w)pad$ or gell(w)pad$ or gellpad$
s air(w)support$ or air(w)fluidised or air(w)fluidized or support(w)surface$
s sheepskin$ or sheep(w)skin$ or alternat$(w)pressure$
s turning(w1)(bed$ or frame$)
s limb$(w1)(protect$ or guard$ or defend$ or defenc$ or shield$ or rest$)
s s6 or s7 or s8 or s9 or s10 or s11 or s12 or s13
s s5 and s14
s s15 andnot s16
s 2002:2003/dat
s s17 and s18
1 . skin ulcer/ or decubitus ulcer/
title]
6. or/1-5
Page 137 of 219

Appendices.
cradles or bolster$ or cushion$).mp. [mp=abstract, heading words, title]
lay$)).mp. [mp=abstract, heading words, title]
12. (support$ pillow$ or film$).mp. [mp=abstract, heading words, title]
gellpad$ or gell-pad$).mp. [mp=abstract, heading words, title]
surface$).mp. [mp=abstract, heading words, title]
15. (sheepskin$ or sheep-skin$ or alternat$ pressure$).mp. [mp=abstract, heading words, title]
16. (turning adj1 (bed$ or frame$)).mp. [mp=abstract, heading words, title]
18. protective support surfaces/ or pronation/ or range of motion/ or rotation/ or posture/ or
head down tilt/ or prone position/ or supine position/ or sitting/
19. or/9-18
20. limit 19 to yr=2002-2003
21. 8 and 20
1. pressure ulcers/
2. skin ulcers/
words]
heading words]
7. or/1-6
cradles or bolster$ or cushion$).mp. [mp=title, other title, abstract, heading words]
lay$)).mp. [mp=title, other title, abstract, heading words]
11. (support$ pillow$ or film$).mp. [mp=title, other title, abstract, heading words]
gellpad$ or gell-pad$).mp. [mp=title, other title, abstract, heading words]
surface$).mp. [mp=title, other title, abstract, heading words]
14. (sheepskin$ or sheep-skin$ or alternat$ pressure$).mp. [mp=title, other title, abstract,
heading words]
15. (turning adj1 (bed$ or frame$)).mp. [mp=title, other title, abstract, heading words]
17. beds/ or adjustable beds/ or bed cradles/ or cots/ or fluidised beds/ or hospital beds/ or
light duty beds/ or non adjustable beds/ or roto rest beds/ or water beds/ or back rests/ or bed
aids/ or bed blocks/ or bed centres/ or bed frames/ or bed lifts/ or bed rails/ or bed spaces/ or
bedding/ or bedside fittings/ or couches/ or hospital equipment/
18. turning frames/ or patient handling/ or pressure ulcer underpads/ or fleeces/ or bedding/ or
pressure area care.mp. [mp=title, other title, abstract, heading words]
19. patient positioning equipment/ or mattresses/ or bedding/ or foam mattresses/ or ripple
mattresses/ or sheepskin mattresses/ or water mattresses/
20. or/8-19
21. 7 and 20
22. limit 21 to yr=2002-2005
National Research Register (Issue 3:2003) (cd-rom)
1. (SKIN-ULCER:ME or DECUBITUS-ULCER:ME)
2. ((DECUBITUS or DECUBITAL) OR (SKIN next BREAKDOWN*))
Page 138 of 219

Appendices.
3. (BEDULCER* or BED-ULCER*)
4. ((PRESSURE near ULCER*) or (BED near ULCER*))
5. ((((PRESSURE next ULCER*) or (PRESSURE next WOUND*)) OR (PRESSURE NEXT
DAMAG*)) OR (PRESSURE NEXT INJUR*))
6. ((((#1 or #2) or #3) or #4) or #5)
7. ((BEDS:ME or BEDS-AND-LINENS:ME) or PROTECTIVE-SUPPORT SURFACES:ME)
8. ((POSTURE or POSTURE:ME) or HEAD-DOWN-TILT:ME)
9. (PRONE-POSITION:ME or SUPINE-POSITION:ME)
10. ((((PRESSURE next RELIE*) or PRESSURE-RELIE*) OR (PRESSURE NEXT REDUC*)) OR
PRESSURE-REDUC*)
11. ((((((((((((BED or BEDS) or BEDDING) or MATTRESS*) or COUCH*) or COT) or COTS) or
CRIB) or CRIBS) or CRADLE) or CRADLES) or BOLSTER*) or CUSHION*)
12. ((((((PRESSURE next OVERLAY*) OR (PRESSURE near OVER-LAY*)) OR (DECUBIT*
NEAR OVERLAY*)) OR (DECUBIT* NEAR OVER-LAY*)) OR (BEDULCER* NEAR
OVERLAY*)) OR (BEDULCER NEAR OVER-LAY*))
13. ((SUPPORT* next PILLOW*) or FILM*)
14. ((((((((PILLOW* or (FOAM next WEDGE*)) OR (FOAM NEXT BLOCK*)) OR GELPAD*) OR
(GEL NEXT PAD*)) OR GEL-PAD*) OR (GELL NEXT PAD*)) OR GELLPAD*) OR GELLPAD*)
15. (((((((AIR next SUPPORT*) or AIR-SUPPORT*) OR AIR-FLUIDISED) OR (AIR NEXT
FLUIDIZED)) OR AIR-FLUIDIZED) OR (SUPPORT NEXT SURFACE*)) OR SUPPORTSURFACE*)
16. ((SHEEPSKIN* or SHEEP-SKIN*) OR (ALTERNAT* next PRESSURE*))
((TURNING next BED*) or (TURNING next FRAME*))
17. ((((((LIMB* next PROTECT*) or (LIMB* next GUARD*)) OR (LIMB* NEXT DEFEND*)) OR
(LIMB NEXT DEFENC*)) OR (LIMB* NEXT SHIELD*)) OR (LIMB NEXT REST*))
18. (((((((((#8 or #9) or #10) or #11) or #12) or #13) or #14) or #15) or #16) or #17)
19. ((#18 or #19) or #21)
20. (#7 and #22)
Clinical effectiveness search strategies for Question D

1. randomized controlled trial.pt.
2. exp randomized controlled trials/
3. random allocation/
4. double blind method/
5. single blind method/
6. clinical trial.pt.
7. exp clinical trials/
8. controlled clinical trials/
9. clin$ trial$.ti,ab.
10. ((singl$ or doubl$ or trebl$ or tripl$) adj3 (blind$ or mask$)).ti,ab.
11. placebo$.ti,ab.
12. placebos/
13. random$.ti,ab.
14. exp evaluation studies/
15. follow up studies/
16. exp research design/
17. prospective studies/
18. (control$ or prospectiv$ or volunteer$).ti,ab.
19. or/1-18
20. animal/
21. human/
22. 20 not (20 and 21)
23. 19 not 22
25. 24 not (comment or letter or editorial).pt.
26. Skin Ulcer/
Page 139 of 219

Appendices.
32. or/26-31
33. biological dressings/
34. bandages/
35. occlusive dressings/
36. wound healing/
37. clothing/
38. growth substances/
39. platelet derived growth factor/
40. fibroblast growth factor/
41. iloprost/
42. alginates/
43. zinc/
44. zinc oxide/
45. ointments/
46. ointment bases/
47. dermatologic agents/
48. colloids/
49. Cellulose, Oxidized/ad, tu [Administration & Dosage, Therapeutic Use]
50. collagen/ad, tu
51. (bandag$ or stocking$ or gauze$ or tulle$ or bind$ or wrap$ or paste$ or ointment$).tw.
52. (dressing$ or compress$ or cream$ or salve$ or ointment$ or lotion$ or unguent$ or balm$
or unction$ or emollient$).tw.
53. ((growth adj factor$) or (Pressure adj relie$) or (recombinant adj protein$) or iloprost or
alginate$ or zinc or hydrocolloid$ or hydro-colloid$).tw.
54. ((compress$ adj bandag$) or vitamin$ or hydrogel$ or hydro-gel$ or hydropolymer$ or
hydro-polymer$).tw.
55. (low adheren$ layer$ or vapo?r permeable film$ or hydrofiber$ or hydro-fiber$ or
hydrofibre$ or hydro-fibre$).tw.
56. (non adheren$ layer$ or no-sting barrier$ or barrier$ film$ or cavilon or ribbon gauze$).mp.
or skin substitute$.tw. [mp=ti, ab, rw, sh]
57. (polysaccharide$ or poly-saccharide$ or foam$ or odo?r$ absorb$ or malodo?r$
absorb$).tw.
58. (odo?r$ reduc$ or malodo?r$ reduc$ or odo?r$ minimiz$ or malodo?r$ minimiz$ or odo?r$
minimis$ or malodo?r$ minimis$).tw.
59. (tissue engineer$ or biologically active$ or cellulose matrix or matrix dressing$ or protease
modulating matrix or regenerated cellulose dressing$).tw.
60. (promogran or promogram).mp. [mp=ti, ab, rw, sh]
61. (nanocrystalline silver or ionic silver or silver nitrate or silver sulphadiazine or actisorb or
aquacel or avance or silver sulfadiazine or flamazine or silver based).mp.
62. povidone/ or povidone-iodine/ or iodine/ or (iodine or inadine or iodosorb or povidoneiodine or chlorehexidrine or cadexomer iodine or betadine or iodoflex).tw.
63. (silicon$ adj1 (dressing $ or film$ or barrier$ or foam$ or layer$ or bandag$ or compress$
or bind$ or wrap$)).mp.
64. (mepitel or mepilex or NA ultra).tw.
65. (acticoat or aquacell or contreet).tw.
66. (skin substitute$ or apligraft$).tw.
67. (semi occlusive or non occlusive).tw.
68. becaplermin.tw.
69. dermagraft$.tw.
70. surgical pad$.tw.
71. xerogel$.tw.
72. (debrisan or vacutex or silicone or silastic foam$ or activated charcoal or knitted viscose$
or saline soak).tw.
73. or/33-72
74. 25 and 32 and 73
75. limit 74 to yr=1997-2004
Page 140 of 219

Appendices.
1. randomized controlled trial/
2. randomization/
3. double blind procedure/ or single blind procedure/
4. exp clinical trial/
5. controlled study/
8. placebo$.ti,ab.
9. Placebo/
10. random$.ti,ab.
11. evaluation/
12. follow up/
13. exp methodology/
14. prospective study/
16. or/1-15
19. exp ANIMAL/
21. Nonhuman/
22. Human/
24. or/18-21
25. 22 or 23
26. 24 not (24 and 25)
27. 17 not 26
29. limit 28 to yr=1997-2004
30. Skin Ulcer/
31. Decubitus/
name]
36. or/30-35
hydro-polymer$).tw.
42. (non adheren$ layer$ or no-sting barrier$ or barrier$ film$ or cavilon or ribbon gauze$ or
skin substitute$).tw.
absorb$).tw.
46. (promogran or promogram).mp. [mp=title, abstract, subject headings, drug trade name,
Page 141 of 219

Appendices.
48. (iodine or inadine or iodosorb or povidone-iodine or chlorehexidrine or cadexomer iodine
or betadine or iodoflex).tw.
54. becaplermin.tw.
55. dermagraft$.tw.
57. xerogel$.tw.
or saline soak).tw.
59. "bandages and dressings"/ or bandage/ or wound dressing/
60. protective clothing/
61. Wound Healing/
62. clothing/
63. growth factor/ or growth promotor/
64. platelet derived growth factor/ or platelet derived growth factor a/ or platelet derived growth
factor aa/ or platelet derived growth factor ab/ or platelet derived growth factor b/ or platelet
derived growth factor bb/
65. fibroblast growth factor/ or fibroblast growth factor 1/ or fibroblast growth factor 10/ or
fibroblast growth factor 2/ or fibroblast growth factor 3/ or fibroblast growth factor 4/ or
fibroblast growth factor 5/ or fibroblast growth factor 8/ or fibroblast growth factor 9/
66. Iloprost/
67. Alginic Acid/
68. Zinc/
69. Zinc Oxide/
70. ointment/
71. exp Ointment Base/
72. dermatological agent/ or topical agent/
73. exp colloid/
74. Collagen/dl, ad, cm, dt, tp, td [Intradermal Drug Administration, Drug Administration, Drug
Comparison, Drug Therapy, Topical Drug Administration, Transdermal Drug Administration]
75. Oxidized Cellulose/ad, dt, cm, tp
76. or/37-75
77. 29 and 36 and 76
2. Random Assignment/
3. double-blind studies/
4. single-blind studies/
8. placebo$.ti,ab.
9. placebos/ or placebo effect/
10. random$.ti,ab.
11. Evaluation Research/
12. Prospective Studies/
13. exp Study Design/
15. or/1-14
17. limit 16 to yr=1997-2004
Page 142 of 219

Appendices.
instrumentation]
23. or/18-22
hydro-polymer$).tw.
absorb$).tw.
34. (promogran or promogram).mp. [mp=title, cinahl subject headings, abstract,
instrumentation]
42. becaplermin.tw.
43. dermagraft$.tw.
45. xerogel$.tw.
or saline soak).tw.
47. exp "Bandages and Dressings"/
48. Wound Healing/
49. clothing/ or protective clothing/
50. growth substances/ or platelet-derived growth factor/
51. Iloprost/
52. Alginates/
53. zinc oxide/ or zinc/
54. colloids/ or emulsions/ or gels/ or creams/ or ointments/
55. Dermatologic Agents/
56. Cellulose/ad, tu [Administration and Dosage, Therapeutic use]
57. Collagen/ad, tu [Administration and Dosage, Therapeutic use]
58. or/25-57
59. 17 and 24 and 58
1. exp research methods/
2. clin$ trial$.tw.
3. ((singl$ or doubl$ or trebl$ or tripl$) adj3 (blind$ or mask$)).tw.
4. placebo$.tw.
Page 143 of 219

Appendices.
5. random$.tw.
6. (control$ or prospectiv$ or volunteer$).tw.
7. ((study or studies) adj1 design$).tw.
8. or/1-7
9. limit 8 to yr=1997-2004
15. or/10-14
hydro-polymer$).tw.
absorb$).tw.
25. (promogran or promogram).mp. [mp=heading words, title]
33. becaplermin.tw.
34. dermagraft$.tw.
36. xerogel$.tw.
or saline soak).tw.
38. dressings/
39. wounds/
40. or/16-39
41. 9 and 15 and 40
2. exp research design/ or double blind method/ or random allocation/
4. clin$ trial$.tw.
6. placebo$.tw.
7. placebos/
8. random$.tw.
Page 144 of 219

Appendices.
11. or/1-10
13. limit 12 to yr=1997-2004
title]
19. or/14-18
hydro-polymer$).tw.
absorb$).tw.
29. (promogran or promogram).mp. [mp=abstract, heading words, title]
37. becaplermin.tw.
38. dermagraft$.tw.
40. xerogel$.tw.
or saline soak).tw.
42. wound healing/
43. bandages/
44. clothing/ or protective clothing/
45. growth substances/
46. zinc/
47. dermatologic agents/
48. collagen/
49. or/20-48
50. 13 and 19 and 49
Health Management Information Consortium strategy (OVID interface)
#12 #1 and #2 and #10 and ((PY:HMIC = 1997-2099) or (PY:HQ = 1997-2010))
#11 #1 and #2 and #10
#10 #3 or #4 or #5 or #6 or #7 or #8 or #9
#9 (skin near substitute*) or apligraft* or occlusive or becaplermin or dermagraft* or (surgical
near pad*) or xerogel* or debrisan or vacutex or silicone or silastic or charcoal or viscose* or
saline
Page 145 of 219

Appendices.
#8 ( silver or sulphadiazine or actisorb or aquacel or avance or sulfadiazine or flamazine )or(
iodine or inadine or iodosorb or povidone-iodine or chlorehexidrine or betadine or iodoflex )or(
silicon* or mepitel or mepilex or (NA near ultra) or acticoat or aquacell or contreet )
#7 ( (odor* near reduc*) or (odour* near reduc*) or (malodor* near reduc*) or (malodour* near
reduce*) or (odor* near minimi*) or (malodor* near minimi*) or (odour* near minimis*) or
(malodour* near minimis*) )or( (tissue near engineer*) or (biologically near active*) or
(cellulose near matrix) or (matrix near dressing*) or (protease near modulating near matrix) or
(regenerated near cellulose near dressing*) )or( (promogran or promogram) )
#6 ( (non near adheren* near layer*) or (no-sting near barrier*) or (barrier* near film*) or
cavilon or (ribbon near gauze*) or (skin near substitute*) )or( polysaccharide* or polysaccharide* or foam* or (odor* near absorb*) or (odour* near absorb*) or (malodor* near
absorb*) or (malodour* near absorb*) )
#5 (low near adheren* near layer*) or (permeable near film*) or hydrofiber* or hydro-fiber* or
hydrofibre* or hydro-fibre*
#4 (compress* near bandag*) or vitamin* or hydrogel* or hydro-gel* or hydropolymer* or
hydro-polymer*
#3 ( bandag* or stocking* or gauze* or tulle* or bind* or wrap* or paste* or ointment* )or(
dressing* or compress* or cream* or salve* or ointment* or lotion* or unguent* or balm* or
unction* or emollient* )or( (growth near2 factor*) or (Pressure near relie*) or (recombinant near
protein*) or iloprost or alginate* or zinc or hydrocolloid* or hydro-colloid* )
#2 ((pressure near2 (ulcer* or wound* or damag* or injur*)) in ti, ab, de) or (( (decubitus or
decubital or skin breakdown*) in ti, ab, de )or( (bedulcer* or bed-ulcer*) in ti, ab, de )or(
((pressure or bed) near2 ulcer*) in ti, ab, de )) or (PRESSURE-ULCERS in DE)
#1 ( (singl* or doubl* or trebl* or tripl*) near3 (blind* or mask*) )or( (clinic* trial*) or placebo* or
random* or (control* or prospectiv* or volunteer*) )or( (study or studies) near design* )
Cochrane Controlled Trials Register strategy: Issue 1:2004 (WWW interface)
next injur*))
#7. (#1 or #2 or #3 or #4 or #5 or #6)
#8. IODINE single term (MeSH)
#9. POVIDONE single term (MeSH)
#10. POVIDONE-IODINE single term (MeSH)
#11. BANDAGES explode tree 1 (MeSH)
#12. WOUND HEALING single term (MeSH)
#13. CLOTHING single term (MeSH)
#14. GROWTH SUBSTANCES single term (MeSH)
#15. FIBROBLAST GROWTH FACTORS single term (MeSH)
#16. PLATELET-DERIVED GROWTH FACTOR single term (MeSH)
#17. ILOPROST single term (MeSH)
#18. ALGINATES single term (MeSH)
#19. ZINC single term (MeSH)
#20. ZINC OXIDE single term (MeSH)
#21. OINTMENTS single term (MeSH)
#22. OINTMENT BASES single term (MeSH)
#23. DERMATOLOGIC AGENTS single term (MeSH)
#24. COLLOIDS single term (MeSH)
#25. CELLULOSE OXIDIZED [ad] single term (MeSH)
#26. CELLULOSE OXIDIZED [tu] single term (MeSH)
#27. COLLAGEN [ad] single term (MeSH)
#28. COLLAGEN [tu] single term (MeSH)
#29. (bandag* or stocking* or gauze* or tulle* or bind* or wrap* or paste* or ointment*)
#30. ((growth next factor*) or (pressure next relie*) or (recombinant next protein*) or iloprost or
alginate* or zinc or hydrocolloid* or hydro-colloid*)
#31. ((compress* next bandag*) or vitamin* or hydrogel* or hydro-gel* or hydropolymer* or
hydro-polymer*)
Page 146 of 219

Appendices.
#32. ((adheren* next layer*) or (permeable next film*) or hydrofiber* or hydro-fiber* or
hydrofibre* or hydro-fibre*)
#33. ((no-sting next barrier*) or (barrier* next film*) or cavilon or (ribbon next gauze*) or (skin
next substitute*))
#34. (polysaccharide* or poly-saccharide* or foam* or (odor* near absorb*) or (odour* near
absorb*))
#35. ((malodor* near absorb*) or (malodour* near absorb*) or (odor* near reduc*) or (odour*
near reduce*) or (malodor* near reduc*) or (malodour* near reduce*))
#36. ((odor* near minimi*) or (malodor* near minimi*) or (odour* near minimi*) or (malodour*
near minimi*))
#37. ((tissue near engineer*) or (biologically near active*) or (cellulose near matrix) or (matrix
near dressing*) or (modulating near matrix) or (cellulose near dressing*))
#38. (promogran or promogram or silver or sulphadiazine or actisorb or aquacel or avance or
sulfadiazine or flamazine)
#39. (iodine or inadine or iodosorb or povidone-iodine or chlorehexidrine or betadine or
iodoflex or silicon*)
#40. (mepitel or mepilex or (na near ultra) or acticoat or aquacell or contreet) 18
#41. ((skin near substitute*) or apligraft* or occlusive or becaplermin or dermagraft* or
(surgical near pad*) or xerogel*)
#42. (debrisan or vacutex or silicone or silastic or charcoal or viscose* or saline)
#43. (#8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20)
#44. (#21 or #22 or #23 or #24 or #25 or #26 or #27 or #28 or #29 or #30)
#45. (#31 or #32 or #33 or #34 or #35 or #36 or #37 or #38 or #39 or #40 or #41 or #42 or #43
or #44)
#46. (#7 and #45)
#47. (#7 and #45) ( 1997 to current date )
SIGLE strategy (SilverPlatter interface)
#11 #1 and #2 and #10
#10 #3 or #4 or #5 or #6 or #7 or #8 or #9
#9 (skin near substitute*) or apligraft* or occlusive or becaplermin or dermagraft* or (surgical
near pad*) or xerogel* or debrisan or vacutex or silicone or silastic or charcoal or viscose* or
saline
#8 ( silver or sulphadiazine or actisorb or aquacel or avance or sulfadiazine or flamazine )or(
iodine or inadine or iodosorb or povidone-iodine or chlorehexidrine or betadine or iodoflex )or(
silicon* or mepitel or mepilex or (NA near ultra) or acticoat or aquacell or contreet )
#7 ( (odor* near reduc*) or (odour* near reduc*) or (malodor* near reduc*) or (malodour* near
reduce*) or (odor* near minimi*) or (malodor* near minimi*) or (odour* near minimis*) or
(malodour* near minimis*) )or( (tissue near engineer*) or (biologically near active*) or
(cellulose near matrix) or (matrix near dressing*) or (protease near modulating near matrix) or
(regenerated near cellulose near dressing*) )or( (promogran or promogram) )
#6 ( (non near adheren* near layer*) or (no-sting near barrier*) or (barrier* near film*) or
cavilon or (ribbon near gauze*) or (skin near substitute*) )or( polysaccharide* or polysaccharide* or foam* or (odor* near absorb*) or (odour* near absorb*) or (malodor* near
absorb*) or (malodour* near absorb*) )
#5 (low near adheren* near layer*) or (permeable near film*) or hydrofiber* or hydro-fiber* or
hydrofibre* or hydro-fibre*
#4 (compress* near bandag*) or vitamin* or hydrogel* or hydro-gel* or hydropolymer* or
hydro-polymer*
#3 ( bandag* or stocking* or gauze* or tulle* or bind* or wrap* or paste* or ointment* )or(
dressing* or compress* or cream* or salve* or ointment* or lotion* or unguent* or balm* or
unction* or emollient* )or( (growth near2 factor*) or (Pressure near relie*) or (recombinant near
protein*) or iloprost or alginate* or zinc or hydrocolloid* or hydro-colloid* )
Page 147 of 219

Appendices.
Clinical effectiveness search strategies for Question E

1. Skin Ulcer/
2. decubitus ulcer/
7. or/1-6
9. animal/
10. human/
11. 9 not (9 and 10)
12. 8 not 11
13. letter.pt.
14. editorial.pt.
15. comment.pt.
16. 12 not (13 or 14 or 15)
17. Debridement/
18. Debrid$.ti,ab.
19. Larva/
20. Larva$.ti,ab.
21. (maggot or maggots).ti,ab.
22. (biosurg$ or bio surg$ or bio-surg$).ti,ab.
23. (trypsin or collagenase or streptokinase or streptodornase).ti,ab.
24. (varidase adj topical).ti,ab.
25. (wet adj dry adj dress$).ti,ab.
26. (polysaccharide$ or dextranomer$ or xerogel or cadexomer iodine).ti,ab.
27. (iodoflex or iodosorb or hydrogel$ or gel$).ti,ab.
28. (intrasite gel or intrasitegel or sterigel or granugel or aquaform hydrogel or nu-gel or nu gel
or nugel or purilon gel or vigilon or 2nd skin or second skin).ti,ab.
29. pressur$ wound$ irrigat$.ti,ab.
30. whirlpool.ti,ab.
31. hypochlorite solution.ti,ab.
32. sodium hypochlorite.ti,ab.
33. dakin$ solution.ti,ab.
34. eusol.ti,ab.
35. (malic acid or benzoic acid or salicylic acid or propylene glycol).ti,ab.
36. (proteolytic$ or fibrinolytic$ or collagenase$).ti,ab.
37. (hydrocholloid$ or hydrocolloid$ or granuflex or comfeel or tegasorb or aquacel or
combiderm or duoderm).ti,ab.
38. (hydrofibre or debrisan).ti,ab.
39. (bioclusive or biocclusive or cutifilm or opsite or epiview or mefilm or opsite flexigrid or
tegaderm).ti,ab.
40. (polyurethane foam or allevyn or lyfoam or tielle or lyofoam).ti,ab.
41. (alginate$ or sorbsan or tegagel or kaltostat or kaltogel or seasorb or algisite or algosteril
or megisorb or cutinova cavity).ti,ab.
42. (tulle gras or jelonet or bactigras or chlorhexitulle or serotulle or fucidin intertulle or sofra
tulle).ti,ab.
43. (vapour permeable membrane$ or vapor permeable membrane$ or spyrosorb or flexipore
or omiderm or surfasoft or tegapore).ti,ab.
44. (enzymes or enzymatic).ti,ab.
45. (secondary dressing$ or film or films or gauze or gauzes or fibre or fiber or occlusive
dressing$).ti,ab.
46. (aquacel or aloe vera or wound gel$ or polynoxylin).ti,ab.
47. (melolin or emsol or silastic foam$ or hydrofibre$ or hydrofiber$).ti,ab.
48. (polyurethane or hydrocellular or foam elastomer or cellulose).ti,ab.
49. (medicated tulle or medicated tulles or nonmedicated tulle or non-medicated tulle or
nonmedicated tulle or non-medicated tulles).ti,ab.
50. (aserbine or paratulle or unitulle or skintact or mepore).ti,ab.
Page 148 of 219

Appendices.
51. Zinc/
52. Zinc oxide/
53. Ointments/
54. Dermatologic agents/
55. Colloids/
56. Alginates/
57. Biological dressings/
58. Occlusive dressings/
59. Papain/tu [Therapeutic Use]
60. UREA/tu [Therapeutic Use]
61. Collagenases/tu [Therapeutic Use]
62. Hydrotherapy/
63. WATER/tu [Therapeutic Use]
64. IRRIGATION/
65. Acetic Acid/tu [Therapeutic Use]
66. Potassium Permanganate/tu [Therapeutic Use]
67. IODINE/tu [Therapeutic Use]
68. POVIDONE-IODINE/tu [Therapeutic Use]
69. PROFLAVINE/tu [Therapeutic Use]
70. CHLORHEXIDINE/tu [Therapeutic Use]
71. (papain or panafil or collagenase santyl or elase or fibrinolysin).ti,ab.
72. (desoxyribonuclease or dnase or antarctic krill or bromelain or iruxol or accuzyme).ti,ab.
73. (tap water or hydrotherap$ or hydro-therap$ or lavage or irrigat$).ti,ab.
74. edinburgh university solution of lime.ti,ab.
75. (acetic acid or chloramine or chlorasol or milton or potassium permanganate or silver
sulfadiazine).ti,ab.
76. (flamazine or hydrogen peroxide or hioxyl).ti,ab.
77. (semipermeable membrane$ or semi-permeable membrane$).ti,ab.
78. (semipermeable dressing$ or semi-permeable dressinge$).ti,ab.
79. (semipermeable dressing$ or semi-permeable dressing$).ti,ab.
80. (pvp iodine or iodine or proflavine or chlorhexdine or cetrimede).ti,ab.
81. or/17-80
82. 16 and 81
83. limit 82 to yr=2000-2004
1. Skin Ulcer/
2. Decubitus/
name]
7. or/1-6
10. exp ANIMAL/
12. Nonhuman/
13. Human/
15. or/9-12
16. 13 or 14
17. 15 not (15 and 16)
18. 8 not 17
Page 149 of 219

Appendices.
20. Debrid$.ti,ab.
21. Larva$.ti,ab.
35. eusol.ti,ab.
40. (bioclusive or cutifilm or opsite or epiview or mefilm or opsite flexigrid or tegaderm).ti,ab.
tulle).ti,ab.
dressing$).ti,ab.
62. debridement/ or wound irrigation/
63. larva/
64. Trypsin/
65. Collagenase/
66. Streptokinase/
67. STREPTODORNASE PLUS STREPTOKINASE/ or STREPTODORNASE/
68. Streptodornase Plus Streptokinase/
69. Polysaccharide/
70. Dextranomer/
71. CADEXOMER IODINE/
72. HYDROGEL/
73. gel/
Page 150 of 219

Appendices.
74. wound irrigation/
75. lavage/
76. Hypochlorite Sodium/
77. Eusol/
78. Malic Acid/
79. Benzoic Acid/
80. Salicylic Acid/
81. Propylene Glycol/
82. hydrocolloid/
83. Enzyme/ae, ct, ad, an, cb, cm, cr, pe, dv, do, pd, it, dt, sc, tp [Adverse Drug Reaction,
Clinical Trial, Drug Administration, Drug Analysis, Drug Combination, Drug Comparison, Drug
Concentration, Pharmacoeconomics, Drug Development, Drug Dose, Pharmacology, Drug
Interaction, Drug Therapy, Subcutaneous Drug Administration, Topical Drug Administration]
84. ZINC OXIDE/ or ZINC/
85. gel/ or hydrogel/ or ointment/
86. dermatological agent/ or topical agent/
87. colloid/ or hydrocolloid/
88. "bandages and dressings"/ or bandage/
89. UREA/ae, ct, ad, an, cb, cm, cr, pe, dv, pk, do, pd, it, tp, dt, td, to [Adverse Drug Reaction,
Clinical Trial, Drug Administration, Drug Analysis, Drug Combination, Drug Comparison, Drug
Concentration, Pharmacoeconomics, Drug Development, Pharmacokinetics, Drug Dose,
Pharmacology, Drug Interaction, Topical Drug Administration, Drug Therapy, Transdermal
Drug Administration, Drug Toxicity]
90. PAPAIN/ae, ct, ad, an, cb, cm, cr, pe, dv, pk, do, pd, it, tp, dt, td, to
91. HYDROTHERAPY/
92. water/ or fresh water/ or mineral water/ or tap water/
93. wound irrigation/
94. Wound Dressing/
95. Acetic Acid/
96. Permanganate Potassium/
97. IODINE/ or CADEXOMER IODINE/
98. POVIDONE IODINE/
99. PROFLAVINE/
100. CHLORHEXIDINE/
101. or/20-100
102. 19 and 101
103. "200000".em.
104. "2001$".em.
105. "2002$".em.
106. "2003$".em.
107. "2004$".em.
108. or/103-107
109. 102 and 108
instrumentation]
6. or/1-5
9. Debrid$.ti,ab.
10. Larva$.ti,ab.
Page 151 of 219

Appendices.
24. eusol.ti,ab.
tegaderm).ti,ab.
tulle).ti,ab.
dressing$).ti,ab.
51. Debridement/
52. Larva/
53. Ointments/
54. zinc/
55. zinc oxide/
56. Dermatologic Agents/
57. colloids/ or gels/ or suspensions/
58. Alginates/
59. biological dressings/ or hydrocolloid dressings/ or hydrogel dressings/ or occlusive
dressings/ or transparent dressings/
60. Urea/tu [Therapeutic use]
61. Hydrotherapy/
62. Water/tu [Therapeutic use]
63. Irrigation/
64. "wound irrigation (iowa nic)"/
65. Acetic Acid/tu [Therapeutic use]
Page 152 of 219

Appendices.
66. IODINE/tu [Therapeutic use]
67. POVIDONE-IODINE/tu [Therapeutic use]
68. CHLORHEXIDINE/tu [Therapeutic use]
69. or/9-68
70. 8 and 69
71. ("200006" or "200007" or "200008" or "200009" or "200010" or "200011" or "200012").ew.
72. ("2001$" or "2002$" or "2003$" or "2004$").ew.
73. 71 or 72
74. 70 and 73
1. pressure ulcers/
6. or/1-5
7. Debrid$.ti,ab.
8. Larva$.ti,ab.
22. eusol.ti,ab.
tegaderm).ti,ab.
tulle).ti,ab.
dressing$).ti,ab.
Page 153 of 219

Appendices.
48. or/7-47
49. 6 and 48
#1.
#2.
#3.
#4.
#5.
#6.
#7.
(#1 or #2 or #3 or #4 or #5 or #6)
#8.
DEBRIDEMENT single term (MeSH)
#9.
LARVA single term (MeSH)
#10.
ZINC single term (MeSH)
#11.
zinc
#12.
OINTMENTS single term (MeSH)
#13.
DERMATOLOGIC AGENTS single term (MeSH)
#14.
COLLOIDS single term (MeSH)
#15.
ALGINATES single term (MeSH)
#16.
BIOLOGICAL DRESSINGS single term (MeSH)
#17.
OCCLUSIVE DRESSINGS single term (MeSH)
#18.
PAPAIN [tu] single term (MeSH)
#19.
UREA [tu] single term (MeSH)
#20.
COLLAGENASES [tu] single term (MeSH)
#21.
HYDROTHERAPY single term (MeSH)
#22.
WATER [tu] single term (MeSH)
#23.
IRRIGATION single term (MeSH)
#24.
ACETIC ACID [tu] single term (MeSH)
#25.
POTASSIUM PERMANGANATE [tu] single term (MeSH)
#26.
IODINE [tu] single term (MeSH)
#27.
POVIDONE-IODINE [tu] single term (MeSH)
#28.
PROFLAVINE [tu] single term (MeSH)
#29.
CHLORHEXIDINE [tu] single term (MeSH)
#30.
(debrid* or larva* or maggot or maggots or biosurg* or (bio next surg*) or bio-surg* or
trypsin or collagenase or streptokinase or streptodornase or (semipermeable next dressing*)
or (semi-permeable next dressing*) or (pvp next iodine) or iodine or proflavine or chlorhexdine
or cetrimede)
#31.
((varidase next topical) or (wet next dry next dress*) or polysaccharide* or
dextranomer* or xerogel or iodoflex or iodosorb or hydrogel* or gel*)
#32.
(intrasite or intrasitegel or sterigel or granugel or hydrogel* or nu-gel or (nu next gel)
or nugel or vigilon or (2nd next skin) or (second next skin) or irrigat* or whirlpool)
#33.
((hypochlorite next solution) or (sodium next hypochlorite) or (dakin* next solution) or
eusol or (malic next acid) or (benzoic next acid) or (salicylic next acid) or (propylene next
glycol) or proteolytic* or fibrinolytic* or collagenase*)
#34.
(hydrocholloid* or hydrocolloid* or granuflex or comfeel or tegasorb or aquacel or
combiderm or duoderm or hydrofibre or debrisan or bioclusive or biocclusive or cutifilm or
opsite or epiview or mefilm or polyurethane or allevyn or lyfoam or tielle or lyofoam)
#35.
(alginate* or sorbsan or tegagel or kaltostat or kaltogel or seasorb or algisite or
algosteril or megisorb or (cutinova next cavity) or tulle or tulles or jelonet or bactigras or
chlorhexitulle or serotulle or intertulle or (vapour next permeable next membrane*) or (vapor
next permeable next membrane*) or spyrosorb or flexipore or omiderm or surfasoft or
tegapore)
Page 154 of 219

Appendices.
#36.
(enzymes or enzymatic or (secondary next dressing*) or film or films or gauze or
gauzes or fibre or fiber or (occlusive next dressing*) or aquacel or (aloe next vera) or
polynoxylin or melolin or emsol or (silastic next foam*) or hydrofibre* or hydrofiber* or
polyurethane or hydrocellular or (foam next elastomer) or cellulose)
#37.
(aserbine or paratulle or unitulle or skintact or mepore or papain or panafil or
(collagenase next santyl) or elase or fibrinolysin or desoxyribonuclease or dnase or (antarctic
next krill) or bromelain or iruxol or accuzyme)
#38.
((tap next water) or hydrotherap* or hydro-therap* or lavage or irrigat* or (acetic next
acid) or chloramine or chlorasol or milton or (potassium next permanganate) or (silver next
sulfadiazine) or flamazine or (hydrogen next peroxide) or hioxyl or (semipermeable next
membrane*) or (semi-permeable next membrane*) or (semipermeable next dressing*) or
(semi-permeable next dressing*))
#39.
#20)
#40.
(#21 or #22 or #23 or #24 or #25 or #26 or #27 or #28 or #29 or #30)
#41.
(#31 or #32 or #33 or #34 or #35 or #36 or #37 or #38 or #39 or #40)
#42.
(#7 and #41)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.

S Debrid$ or Larva$ or maggot or maggots or biosurg$ or (bio(w)surg$) or trypsin or
collagenase or streptokinase or streptodornase
S (semipermeable(w)dressing$) or (semi(w1)permeable(w)dressing$) or pvp(w)iodine or
iodine or proflavine or chlorhexdine or cetrimede
S (varidase(w)topical) or (wet(w)dry(w)dress$) or polysaccharide$ or dextranomer$ or xerogel
or cadexomer(w)iodine or iodoflex or iodosorb or hydrogel$ or gel$
S intrasite(w)gel or intrasitegel or sterigel or granugel or aquaform(w)hydrogel or nu(w)gel or
nugel or purilon(w)gel or vigilon or 2nd(w)skin or second(w)skin or
S irrigat$ or whirlpool or hypochlorite(w)solution or sodium(w)hypochlorite or dakin$(w)solution
or eusol or malic(w)acid or benzoic(w)acid or salicylic(w)acid or propylene(w)glycol or
proteolytic$ or fibrinolytic$ or collagenase$
S hydrocholloid$ or hydrocolloid$ or granuflex or comfeel or tegasorb or aquacel or
opsite or epiview or mefilm or tegaderm or polyurethane foam or allevyn or lyfoam or tielle or
lyofoam
S alginate$ or sorbsan or tegagel or kaltostat or kaltogel or seasorb or algisite or algosteril or
megisorb or cutinova or tulle or jelonet or bactigras or chlorhexitulle or serotulle or fucidin
S (vapour(w)permeable(w)membrane$) or (vapor(w)permeable(w)membrane$) or spyrosorb
or flexipore or omiderm or surfasoft or tegapore
S enzymes or enzymatic or (secondary(w)dressing$) or film or films or gauze or gauzes or
fibre or fiber or (occlusive(w)dressing$) or aquacel or (aloe(w)vera) or wound(w)gel$ or
polynoxylin or melolin or emsol or silastic(w)foam$ or hydrofibre$ or hydrofiber$ or
polyurethane or hydrocellular or foam(w)elastomer or cellulose
S tulles or aserbine or paratulle or unitulle or skintact or mepore or papain or panafil or elase
or fibrinolysin or desoxyribonuclease or dnase or antarctic(w)krill or bromelain or iruxol or
accuzyme
S water or hydrotherap$ or hydro(w)therap$ or lavage or irrigat$ or acetic(w)acid or
chloramine or chlorasol or milton or potassium(w)permanganate or silver(w)sulfadiazine or
flamazine or hydrogen(w)peroxide or hioxyl or semipermeable(w)membrane$ or
semi(w)permeable(w)membrane$ or semipermeable(w)dressing$ or
semi(w)permeable(w)dressing$
s s6 or s7 or s8 or s9 or s10 or s11 or s12 or s13 or s14 or s15 or s16
s s5 and s17
s s18 andnot s19
Page 155 of 219

Appendices.
title]
6. or/1-5
9. Debrid$.ti,ab.
10. Larva$.ti,ab.
24. eusol.ti,ab.
tegaderm).ti,ab.
tulle).ti,ab.
dressing$).ti,ab.
Page 156 of 219

Appendices.
50. zinc/
51. urea/
52. hydrotherapy/
53. water/
54. irrigation/
55. acetic acid/
56. iodine/
57. or/9-56
58. 8 and 57
#7 #1 and #6
#6 #4 or #5
#5 (( hypochlorite solution or sodium hypochlorite or dakin* solution or eusol or malic acid or
benzoic acid or salicylic acid or propylene glycol or proteolytic* or fibrinolytic* or collagenase*
)or( hydrocholloid* or hydrocolloid* or granuflex or comfeel or tegasorb or aquacel or
opsite or epiview or mefilm or opsite flexigrid or tegaderm or polyurethane foam or allevyn or
lyfoam or tielle or lyofoam )or( alginate* or sorbsan or tegagel or kaltostat or kaltogel or
seasorb or algisite or algosteril or megisorb or cutinova cavity or tulle gras or jelonet or
bactigras or chlorhexitulle or serotulle or fucidin intertulle or sofra tulle or vapour permeable
membrane* or vapor permeable membrane* or spyrosorb or flexipore or omiderm or surfasoft
or tegapore )) or (( Debrid* or Larva* or maggot or maggots or biosurg* or bio surg* or biosurg* or trypsin or collagenase or streptokinase or streptodornase or semipermeable dressing*
or semi-permeable dressing* or pvp iodine or iodine or proflavine or chlorhexdine or cetrimede
)or( (varidase near topical) or (wet near dry near dress*) or polysaccharide* or dextranomer*
or xerogel or cadexomer iodine or iodoflex or iodosorb or hydrogel* or gel* )or( intrasite gel or
intrasitegel or sterigel or granugel or aquaform hydrogel or nu-gel or nu gel or nugel or purilon
gel or vigilon or 2nd skin or second skin or pressur* wound* irrigat* or whirlpool ))
#4 ( enzymes or enzymatic or secondary dressing* or film or films or gauze or gauzes or fibre
or fiber or occlusive dressing* or aquacel or aloe vera or wound gel* or polynoxylin or melolin
or emsol or silastic foam* or hydrofibre* or hydrofiber* or polyurethane or hydrocellular or foam
elastomer or cellulose )or( medicated tulle or medicated tulles or nonmedicated tulle or nonmedicated tulle or nonmedicated tulle or non-medicated tulles or aserbine or paratulle or
unitulle or skintact or mepore or papain or panafil or collagenase santyl or elase or fibrinolysin
or desoxyribonuclease or dnase or antarctic krill or bromelain or iruxol or accuzyme )or( tap
water or hydrotherap* or hydro-therap* or lavage or irrigat* or acetic acid or chloramine or
chlorasol or milton or potassium permanganate or silver sulfadiazine or flamazine or hydrogen
peroxide or hioxyl or semipermeable membrane* or semi-permeable membrane* or
semipermeable dressing* or semi-permeable dressing* )
#3 ( hypochlorite solution or sodium hypochlorite or dakin* solution or eusol or malic acid or
or tegapore )
#2 ( Debrid* or Larva* or maggot or maggots or biosurg* or bio surg* or bio-surg* or trypsin or
collagenase or streptokinase or streptodornase or semipermeable dressing* or semipermeable dressing* or pvp iodine or iodine or proflavine or chlorhexdine or cetrimede )or(
(varidase near topical) or (wet near dry near dress*) or polysaccharide* or dextranomer* or
xerogel or cadexomer iodine or iodoflex or iodosorb or hydrogel* or gel* )or( intrasite gel or
gel or vigilon or 2nd skin or second skin or pressur* wound* irrigat* or whirlpool )
Page 157 of 219

Appendices.
#6 #1 and #5
#5 #2 or #3 or #4
#4 ( enzymes or enzymatic or secondary dressing* or film or films or gauze or gauzes or fibre
or fiber or occlusive dressing* or aquacel or aloe vera or wound gel* or polynoxylin or melolin
or emsol or silastic foam* or hydrofibre* or hydrofiber* or polyurethane or hydrocellular or foam
elastomer or cellulose )or( medicated tulle or medicated tulles or nonmedicated tulle or nonmedicated tulle or nonmedicated tulle or non-medicated tulles or aserbine or paratulle or
unitulle or skintact or mepore or papain or panafil or collagenase santyl or elase or fibrinolysin
or desoxyribonuclease or dnase or antarctic krill or bromelain or iruxol or accuzyme )or( tap
water or hydrotherap* or hydro-therap* or lavage or irrigat* or acetic acid or chloramine or
chlorasol or milton or potassium permanganate or silver sulfadiazine or flamazine or hydrogen
peroxide or hioxyl or semipermeable membrane* or semi-permeable membrane* or
semipermeable dressing* or semi-permeable dressing* )
#3 ( hypochlorite solution or sodium hypochlorite or dakin* solution or eusol or malic acid or
or tegapore )
#2 ( Debrid* or Larva* or maggot or maggots or biosurg* or bio surg* or bio-surg* or trypsin or
collagenase or streptokinase or streptodornase or semipermeable dressing* or semipermeable dressing* or pvp iodine or iodine or proflavine or chlorhexdine or cetrimede )or(
(varidase near topical) or (wet near dry near dress*) or polysaccharide* or dextranomer* or
xerogel or cadexomer iodine or iodoflex or iodosorb or hydrogel* or gel* )or( intrasite gel or
gel or vigilon or 2nd skin or second skin or pressur* wound* irrigat* or whirlpool ) #1 (pressure
adj (ulcer* or wound* or damag* or injur*)) or (( decubitus or decubital or skin breakdown* )or(
bedulcer* or bed-ulcer* )or( (pressure or bed) adj ulcer* ))
Clinical effectiveness search strategies for Question G

11. placebo$.ti,ab.
12. placebos/
13. random$.ti,ab.
19. or/1-18
20. animal/
21. human/
22. 20 not (20 and 21)
23. 19 not 22
Page 158 of 219

Appendices.
24. Skin Ulcer/
name]
30. or/24-29
32. animal/
33. human/
34. 32 not (32 and 33)
35. 31 not 34
36. letter.pt.
37. editorial.pt.
38. comment.pt.
39. 35 not (36 or 37 or 38)
40. Electric Stimulation Therapy/
41. (electro-therap$ or electrotherap$).mp.
42. electrical stimulat$.mp.
43. ELECTROMAGNETICS/tu [Therapeutic Use]
44. Electromagnetic Fields/tu [Therapeutic Use]
45. (pulsed electromagnetic field$ or electromagnetic therap$ or electro-magnetic
therap$).mp.
46. pemf.ti,ab.
48. (therap$ ultrasound$ or therap$ ultra-sound$).mp.
49. (therap$ echograph$ or therap$ ultra-sonog$ or therap$ ultrasonog$).mp.
50. low frequency stimulat$.mp.
51. Laser Therapy, Low-Level/
52. low level laser$.mp.
53. hene laser$.mp.
54. gaas laser$.mp.
55. helium neon laser$.mp.
56. gallium arsenide laser$.mp.
57. topical negative pressure.mp.
58. SUCTION/
59. vacuum/
60. (adjunct adj3 (therap$ or treatment$ or intervention$ or regime$)).mp.
61. or/40-60
62. 23 and 39 and 61
63. limit 62 to yr=2000-2004
2. randomization/
8. placebo$.ti,ab.
9. Placebo/
10. random$.ti,ab.
11. evaluation/
12. follow up/
Page 159 of 219

Appendices.
16. or/1-15
19. exp ANIMAL/
21. Nonhuman/
22. Human/
24. or/18-21
25. 22 or 23
26. 24 not (24 and 25)
27. 17 not 26
29. Skin Ulcer/
30. Decubitus/
name]
35. or/29-34
36. electrostimulation/
37. electrostimulation therapy/
39. electrical stimulat$.mp.
40. electromagnetic field/
therap$).mp.
42. pemf.ti,ab.
43. pulsed electric field/
44. ultrasound/
45. echography/
47. (therap$ ultra-sonog$ or therap$ ultrasonog$).mp.
48. therap$ echograph$.mp.
50. low level laser therapy/
52. hene laser$.mp.
53. gaas laser$.mp.
57. pressure/
58. suction/
59. vacuum/
61. or/36-60
62. 28 and 35 and 61
63. limit 62 to yr=1997-2004
Page 160 of 219

Appendices.
8. placebo$.ti,ab.
10. random$.ti,ab.
15. or/1-14
instrumentation]
22. or/17-21
23. electrotherapy/ or electric stimulation/
25. electric$ stimulat$.mp.
26. ELECTROMAGNETICS/tu [Therapeutic use]
27. ELECTROMAGNETIC FIELDS/tu [Therapeutic use]
therap$).mp.
29. pemf.ti,ab.
34. Lasers/tu [Therapeutic use]
36. hene laser$.mp.
37. gaas laser$.mp.
41. Suction/
43. or/23-42
44. 16 and 22 and 43
46. limit 45 to yr=1999-2003

2. clin$ trial$.tw.
4. placebo$.tw.
5. random$.tw.
8. or/1-7
9. pressure ulcers/
Page 161 of 219

Appendices.
14. or/9-13
17. (ELECTROMAGNETIC$ or ELECTRO MAGNETIC).mp. [mp=heading words, title]
therap$).mp.
19. pemf.tw.
21. ultrasound/
25. lasers/
26. hene laser$.mp.
27. gaas laser$.mp.
32. (suction$ or vacuum$).mp. [mp=heading words, title]
33. or/15-32
34. 8 and 14 and 33
next injur*))
#7. (#1 or #2 or #3 or #4 or #5 or #6)
#8. ELECTRIC STIMULATION THERAPY single term (MeSH)
#9. ELECTROMAGNETICS [tu] single term (MeSH)
#10. ELECTROMAGNETIC FIELDS [tu] single term (MeSH)
#11. ULTRASONOGRAPHY single term (MeSH)
#12. LASER THERAPY LOW-LEVEL single term (MeSH)
#13. SUCTION single term (MeSH)
#14. VACUUM single term (MeSH)
#15. (electro-therap* or electrotherap*)
#16. (electrical next stimulat*)
#17. ((pulsed next electromagnetic next field*) or (electromagnetic next therapy) or
(electromagnetic next therapies))
#18. ((electro-magnetic next therapy) or (electro-magnetic next therapies))
#19. pemf:ti
#20. ((therapy next ultrasound*) or (therapies next ultra-sound*))
#21. ((therapy next ultrasound*) or (therapies next ultra-sound*))
#22. ((therapy next echograph*) or (therapy next ultra-sonog*) or (therapy next ultrasonog*))
#23. ((therapies next echograph*) or (therapies next ultra-sonog*) or (therapies next
ultrasonog*))
#24. (low next frequency next stimulat*)
#25. (low next level next laser*)
#26. (hene next laser*)
#27. (gaas next laser*)
#28. (helium next neon next laser*)
#29. (gallium next arsenide next laser*)
#30. (topical next negative next pressure)
#31. ((adjunct next therapy) or (adjunct next therapies))
Page 162 of 219

Appendices.
#32. ((adjunct next treatment) or (adjunct next treatments) or (adjunct next intervention*) or
(adjunct next regime*))
#33. (#8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20)
#34. (#21 or #22 or #23 or #24 or #25 or #26 or #27 or #28 or #29 or #30 or #31 or #32 or
#33)
#35. (#7 and #34)
4. clin$ trial$.tw.
6. placebo$.tw.
7. placebos/
8. random$.tw.
11. or/1-10
title]
18. or/13-17
19. electric stimulation/
20. electrotherapy/
21. electromagnetic fields/
22. electromagnetics/
23. ultrasonography/
24. lasers/
therap$).mp.
28. pemf.tw.
33. hene laser$.mp.
34. gaas laser$.mp.
39. (suction$ or vacuum$).mp. [mp=abstract, heading words, title]
40. or/19-39
41. 12 and 18 and 40
#6 (( (singl* or doubl* or trebl* or tripl*) near3 (blind* or mask*) )or( (clinic* trial*) or placebo* or
random* or (control* or prospectiv* or volunteer*) )or( (study or studies) near design* )) and
(((pressure near2 (ulcer* or wound* or damag* or injur*)) in ti, ab, de) or (( (decubitus or
((pressure or bed) near2 ulcer*) in ti, ab, de )) or (PRESSURE-ULCERS in DE)) and (((topical
negative pressure) or (adjunct near3 (therap* or treatment* or intervention* or regime*))) or ((
Page 163 of 219

Appendices.
electro-therap* or electrotherap* or (electric* stimulat*) or suction* or vacuum* or ultrasound*
or echograph* or ultrasonog* or ultra-sound or echo-graph* or ultra-sonog* )or( (therap*
echograph* or therap* ultra-sonog* or therap* ultrasonog*) or (low frequency stimulat*) or (low
level laser*) or laser* )or( (pulsed electromagnetic field*) or (electromagnetic therap*) or
(electro-magnetic therap*) or pemf or (therap* ultrasound* or therap* ultra-sound*) )))
#5 ((topical negative pressure) or (adjunct near3 (therap* or treatment* or intervention* or
regime*))) or (( electro-therap* or electrotherap* or (electric* stimulat*) or suction* or vacuum*
or ultrasound* or echograph* or ultrasonog* or ultra-sound or echo-graph* or ultra-sonog* )or(
(therap* echograph* or therap* ultra-sonog* or therap* ultrasonog*) or (low frequency
stimulat*) or (low level laser*) or laser* )or( (pulsed electromagnetic field*) or (electromagnetic
therap*) or (electro-magnetic therap*) or pemf or (therap* ultrasound* or therap* ultra-sound*)
))
#4 (topical negative pressure) or (adjunct near3 (therap* or treatment* or intervention* or
regime*))
#3 ( electro-therap* or electrotherap* or (electric* stimulat*) or suction* or vacuum* or
ultrasound* or echograph* or ultrasonog* or ultra-sound or echo-graph* or ultra-sonog* )or(
)
((pressure or bed) near2 ulcer*) in ti, ab, de )) or (PRESSURE-ULCERS in DE)) and (((topical
negative pressure) or (adjunct near3 (therap* or treatment* or intervention* or regime*))) or ((
electro-therap* or electrotherap* or (electric* stimulat*) or suction* or vacuum* or ultrasound*
or echograph* or ultrasonog* or ultra-sound or echo-graph* or ultra-sonog* )or( (therap*
echograph* or therap* ultra-sonog* or therap* ultrasonog*) or (low frequency stimulat*) or (low
level laser*) or laser* )or( (pulsed electromagnetic field*) or (electromagnetic therap*) or
(electro-magnetic therap*) or pemf or (therap* ultrasound* or therap* ultra-sound*) )))
#5 ((topical negative pressure) or (adjunct near3 (therap* or treatment* or intervention* or
regime*))) or (( electro-therap* or electrotherap* or (electric* stimulat*) or suction* or vacuum*
or ultrasound* or echograph* or ultrasonog* or ultra-sound or echo-graph* or ultra-sonog* )or(
))
#4 (topical negative pressure) or (adjunct near3 (therap* or treatment* or intervention* or
regime*))
#3 ( electro-therap* or electrotherap* or (electric* stimulat*) or suction* or vacuum* or
ultrasound* or echograph* or ultrasonog* or ultra-sound or echo-graph* or ultra-sonog* )or(
)
Page 164 of 219

Appendices.
Clinical effectiveness search strategies for Question H

11. placebo$.ti,ab.
12. placebos/
13. random$.ti,ab.
19. or/1-18
20. animal/
21. human/
22. 20 not (20 and 21)
23. 19 not 22
26. Skin Ulcer/
31. (pressure adj (ulcer$ or wound$ or damag$ or injur$)).mp.
32. or/26-31
33. anti-infective agents/ or anti-bacterial agents/ or antifungal agents/ or exp anti-infective
agents, local/
34. (antiseptic$ or anti-septic$ or antibiotic$ or anti-biotic$ or antimicrobial$ or anti-microbial$
or antibacterial$ or anti-bacterial$).tw.
35. povidone/ or povidone-iodine/
36. Iodine/
37. (iodine or inadine or iodosorb or povidone-iodine or chlorehexidine or cadexomer iodine or
betadine or iodoflex).tw.
38. SODIUM HYPOCHLORITE/ad, tu [Administration & Dosage, Therapeutic Use]
39. (eusol or dakins solution$ or edinburgh university solution of lime or hypochlorite$ or
hydrogen peroxide$ or mafenide or dermablend or oxyquinoline or A&D ointment$).tw.
40. Hydrogen Peroxide/
41. Mafenide/
42. Oxyquinoline/ or (skin substitute$ or apligraft$).tw.
43. (acticoat or aquacell or contreet or nanocrystalline silver or ionic silver or silver nitrate or
silver sulphadiazine or actisorb or aquacel or avance or silver sulfadiazine or flamazine or
silver based).mp. [mp=ti, ab, rw, sh]
44. or/33-43
45. 25 and 32 and 44
46. limit 45 to yr=2000-2004
2. randomization/
Page 165 of 219

Appendices.
8. placebo$.ti,ab.
9. Placebo/
10. random$.ti,ab.
11. evaluation/
12. follow up/
16. or/1-15
19. exp ANIMAL/
21. Nonhuman/
22. Human/
24. or/18-21
25. 22 or 23
26. 24 not (24 and 25)
27. 17 not 26
29. Skin Ulcer/
30. Decubitus/
name]
35. or/29-34
silver based).tw.
41. antiinfective agent/ or antifungal agent/ or fungicide/ or exp topical antiinfective agent/ or
exp disinfectant agent/
42. Povidone/
43. Povidone Iodine/
44. Iodine/
45. Hypochlorite Sodium/dt, ad, tp [Drug Therapy, Drug Administration, Topical Drug
Administration]
46. Hydrogen Peroxide/
47. Mafenide/
48. 8 Quinolinol/
49. Sulfadiazine Silver/
50. Silver Nitrate/
51. Eusol/
52. Chlorhexidine/
53. Cadexomer Iodine/
Page 166 of 219

Appendices.
54. Antibiotic Agent/
55. or/36-54
56. 28 and 35 and 55
57. limit 56 to yr=2000-2004

8. placebo$.ti,ab.
10. random$.ti,ab.
15. or/1-14
instrumentation]
22. or/17-21
silver based).tw.
29. Antibiotic Prophylaxis/
30. exp Antiinfective Agents, Local/
31. antibiotics, antifungal/ or antifungal agents/ or chlorhexidine/ or hydrogen peroxide/ or
povidone-iodine/
32. IODINE/
33. Silver Nitrate/
34. Silver Sulfadiazine/
35. or/24-34
36. 16 and 23 and 35
37. limit 36 to yr=2000-2004
2. clin$ trial$.tw.
4. placebo$.tw.
5. random$.tw.
Page 167 of 219

Appendices.
8. or/1-7
9. limit 8 to yr=2000-2004
15. or/10-14
silver based).tw.
21. or/16-20
22. 9 and 15 and 21
next injur*))
#7. (#1 or #2 or #3 or #4 or #5 or #6)
#8. ANTI-INFECTIVE AGENTS single term (MeSH)
#9. ANTI-INFECTIVE AGENTS LOCAL explode all trees (MeSH)
#10. ANTIFUNGAL AGENTS single term (MeSH)
#11. POVIDONE single term (MeSH)
#12. POVIDONE-IODINE single term (MeSH)
#13. IODINE single term (MeSH)
#14. SODIUM HYPOCHLORITE single term (MeSH)
#15. HYDROGEN PEROXIDE single term (MeSH)
#16. MAFENIDE single term (MeSH)
#17. OXYQUINOLINE single term (MeSH)
#18. (antiseptic* or anti-septic* or antibiotic* or anti-biotic* or antimicrobial* or anti-microbial*
or antibacterial* or anti-bacterial*)
#19. (iodine or inadine or iodosorb or povidone-iodine or chlorehexidine or (cadexomer next
iodine) or betadine or iodoflex)
#20. (eusol or (dakins next solution*) or (edinburgh next university next solution next lime) or
hypochlorite* or (hydrogen next peroxide*) or mafenide)
#21. dermablend
#22. ((skin next substitute*) or apligraft* or oxyquinoline)
#23. (acticoat or aquacell or contreet or (nanocrystalline next silver) or (ionic next silver))
#24. ((silver next nitrate) or (silver next sulphadiazine) or actisorb or aquacel or avance or
(silver next sulfadiazine) or flamazine or (silver next based))
#25. (#8 or #9 or #10 or #11 or #12 or #13 or #14 or #15)
#26. (#16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24 or #25)
4. clin$ trial$.tw.
Page 168 of 219

Appendices.
6. placebo$.tw.
7. placebos/
8. random$.tw.
11. or/1-10
title]
18. or/13-17
silver based).tw.
25. antiinfective agents/ or antibiotics/ or antifungal agents/
26. iodine/
27. hydrogen peroxide/
28. or/20-27
29. 12 and 19 and 28
30. limit 29 to yr=2000-2004
#7 (((pressure near2 (ulcer* or wound* or damag* or injur*)) in ti, ab, de) or (( (decubitus or
((pressure or bed) near2 ulcer*) in ti, ab, de )) or (PRESSURE-ULCERS in DE)) and (( (singl*
or doubl* or trebl* or tripl*) near3 (blind* or mask*) )or( (clinic* trial*) or placebo* or random* or
(control* or prospectiv* or volunteer*) )or( (study or studies) near design* )) and ((( antiseptic*
or anti-septic* or antibiotic* or anti-biotic* or antimicrobial* or anti-microbial* or antibacterial* or
anti-bacterial* )or( iodine or inadine or iodosorb or povidone-iodine or chlorehexidine or
cadexomer iodine or betadine or iodoflex )or( eusol or (dakins solution*) or (edinburgh
university solution of lime) or hypochlorite* or (hydrogen peroxide*) or mafenide or dermablend
or oxyquinoline or (A&D ointment*) )) or (( (skin substitute*) or apligraft* )or( acticoat or
aquacell or contreet or (nanocrystalline silver) or (ionic silver) or (silver nitrate) or (silver
sulphadiazine) or actisorb or aquacel or avance or (silver sulfadiazine) or flamazine or (silver
based) ))) and ((PY:HMIC = 2000-2004) or (PY:HQ = 1999-2010))
based) )))
Page 169 of 219

Appendices.
#5 (( antiseptic* or anti-septic* or antibiotic* or anti-biotic* or antimicrobial* or anti-microbial* or
antibacterial* or anti-bacterial* )or( iodine or inadine or iodosorb or povidone-iodine or
chlorehexidine or cadexomer iodine or betadine or iodoflex )or( eusol or (dakins solution*) or
(edinburgh university solution of lime) or hypochlorite* or (hydrogen peroxide*) or mafenide or
dermablend or oxyquinoline or (A&D ointment*) )) or (( (skin substitute*) or apligraft* )or(
acticoat or aquacell or contreet or (nanocrystalline silver) or (ionic silver) or (silver nitrate) or
(silver sulphadiazine) or actisorb or aquacel or avance or (silver sulfadiazine) or flamazine or
(silver based) ))
#4 ( (skin substitute*) or apligraft* )or( acticoat or aquacell or contreet or (nanocrystalline
silver) or (ionic silver) or (silver nitrate) or (silver sulphadiazine) or actisorb or aquacel or
avance or (silver sulfadiazine) or flamazine or (silver based) )
#3 ( antiseptic* or anti-septic* or antibiotic* or anti-biotic* or antimicrobial* or anti-microbial* or
dermablend or oxyquinoline or (A&D ointment*) )
based) )))
#5 (( antiseptic* or anti-septic* or antibiotic* or anti-biotic* or antimicrobial* or anti-microbial* or
dermablend or oxyquinoline or (A&D ointment*) )) or (( (skin substitute*) or apligraft* )or(
acticoat or aquacell or contreet or (nanocrystalline silver) or (ionic silver) or (silver nitrate) or
(silver sulphadiazine) or actisorb or aquacel or avance or (silver sulfadiazine) or flamazine or
(silver based) ))
#4 ( (skin substitute*) or apligraft* )or( acticoat or aquacell or contreet or (nanocrystalline
silver) or (ionic silver) or (silver nitrate) or (silver sulphadiazine) or actisorb or aquacel or
avance or (silver sulfadiazine) or flamazine or (silver based) )
#3 ( antiseptic* or anti-septic* or antibiotic* or anti-biotic* or antimicrobial* or anti-microbial* or
dermablend or oxyquinoline or (A&D ointment*) )
Clinical effectiveness search strategies for Question J

Page 170 of 219

Appendices.
1 Skin Ulcer/
2. decubitus ulcer/
7. or/1-6
9. animal/
10. human/
11. 9 not (9 and 10)
13. BEDS/is, nu [Instrumentation, Nursing]
14. "Bedding and Linens"/
15. Protective Support surfaces/ or posture/ or head-down tilt/ or prone position/ or supine
position/
16. (pressure relie$ or pressure-relie$ or pressure reduc$ or pressure-reduc$).mp. [mp=ti, ab,
rw, sh]
cradles or bolster$ or cushion$).mp. [mp=ti, ab, rw, sh]
lay$)).mp. [mp=ti, ab, rw, sh]
19. (support$ pillow$ or film$).mp. [mp=ti, ab, rw, sh]
gellpad$ or gell-pad$).mp. [mp=ti, ab, rw, sh]
surface$).mp. [mp=ti, ab, rw, sh]
22. (sheepskin$ or sheep-skin$ or alternat$ pressure$).mp. [mp=ti, ab, rw, sh]
23. (turning adj1 (bed$ or frame$)).mp. [mp=ti, ab, rw, sh]
24. (limb$ adj1 (protect$ or guard$ or defend$ or defenc$ or shield$ or rest$)).mp. [mp=ti, ab,
rw, sh]
25. or/13-24
26. 12 and 25
27. limit 26 to yr=2002-2004
1. Skin Ulcer/
2. Decubitus/
name]
7. or/1-6
10. exp ANIMAL/
12. Nonhuman/
13. Human/
15. or/9-12
16. 13 or 14
Page 171 of 219

Appendices.
17. 15 not (15 and 16)
18. 8 not 17
20. limit 19 to yr=2002-2004
manufacturer name]
cradles or bolster$ or cushion$).mp. [mp=title, abstract, subject headings, drug trade name,
lay$)).mp. [mp=title, abstract, subject headings, drug trade name, original title, support surface
manufacturer, drug manufacturer name]
24. (support$ pillow$ or film$).mp. [mp=title, abstract, subject headings, drug trade name,
gellpad$ or gell-pad$).mp. [mp=title, abstract, subject headings, drug trade name, original title,
surface$).mp. [mp=title, abstract, subject headings, drug trade name, original title, support
27. (sheepskin$ or sheep-skin$ or alternat$ pressure$).mp. [mp=title, abstract, subject
name]
28. (turning adj1 (bed$ or frame$)).mp. [mp=title, abstract, subject headings, drug trade name,
manufacturer name]
30. bed/ or fluidized bed/ or hospital bed/
31. protective equipment/ or body position/ or body posture/ or recumbency/ or sitting/ or
standing/ or supine position/ or head position/
32. or/21-31
33. 20 and 32
1 . skin ulcer/ or pressure ulcer/
instrumentation]
6. or/1-5
cradles or bolster$ or cushion$).mp. [mp=title, cinahl subject headings, abstract,
instrumentation]
lay$)).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
12. (support$ pillow$ or film$).mp. [mp=title, cinahl subject headings, abstract,
instrumentation]
gellpad$ or gell-pad$).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
surface$).mp. [mp=title, cinahl subject headings, abstract, instrumentation]
15. (sheepskin$ or sheep-skin$ or alternat$ pressure$).mp. [mp=title, cinahl subject headings,
Page 172 of 219

Appendices.
16. (turning adj1 (bed$ or frame$)).mp. [mp=title, cinahl subject headings, abstract,
instrumentation]
18. "bedding and linens"/ or "beds and mattresses"/ or cribs/ or flotation beds/ or "pillows and
cushions"/
19. Protective Support surfaces/ or patient positioning/ or prone position/ or supine position/
20. or/9-19
21. 8 and 20
22. limit 21 to yr=2002-2003
1. pressure ulcers/
6. or/1-5
cradles or bolster$ or cushion$).mp. [mp=heading words, title]
lay$)).mp. [mp=heading words, title]
10. patients positioning/ or (support$ pillow$ or film$).mp. [mp=heading words, title]
gellpad$ or gell-pad$).mp. [mp=heading words, title]
surface$).mp. [mp=heading words, title]
13. (sheepskin$ or sheep-skin$ or alternat$ pressure$).mp. [mp=heading words, title]
14. (turning adj1 (bed$ or frame$)).mp. [mp=heading words, title]
16. or/7-15
17. 6 and 16
18. limit 17 to yr=2002-2003
#1.
#2.
#3.
#4.
#5.
#6.
#7.
(#1 or #2 or #3 or #4 or #5 or #6)
#8.
BEDS single term (MeSH)
#9.
BEDDING AND LINENS single term (MeSH)
#10.
PROTECTIVE SUPPORT SURFACES single term (MeSH)
#11.
posture
#12.
POSTURE single term (MeSH)
#13.
HEAD-DOWN TILT single term (MeSH)
#14.
PRONE POSITION single term (MeSH)
#15.
SUPINE POSITION single term (MeSH)
#16.
((pressure next relie*) or pressure-relie* or (pressure next reduc*) or pressure-reduc*)
#17.
(bed or beds or bedding or mattress* or couch* or cot or cots or crib or cribs or cradle
or cradles or bolster* or cushion*)
#18.
((pressure near overlay*) or (pressure near over-lay*) or (decubit* near overlay*) or
(decubit* near over-lay*) or (bedulcer* near overlay*) or (bedulcer* near over-lay*))
Page 173 of 219

Appendices.
#19.
((support* next pillow*) or film*)
#20.
(pillow* or (foam next wedge*) or (foam next block*) or gelpad* or (gel next pad*) or
gel-pad* or (gell next pad*) or gellpad* or gell-pad*)
#21.
((air next support*) or air-support* or air-fluidised or air-fluidised or (air next fluidized)
or air-fluidized or (support next surface*) or support-surface*)
#22.
(sheepskin* or sheep-skin* or (alternat* next pressure*))
#23.
((turning next bed*) or (turning next frame*))
#24.
((limb* next protect*) or (limb* next guard*) or (limb* next defend*) or (limb* next
defenc*) or (limb* next shield*) or (limb* next rest*))
#25.
#21 or #22 or #23 or #24)
#26.
(#7 and #25)
#27.
(#7 and #25) ( 2002 to current date )
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.

s pressure(w)relie$ or pressure(w)reduc$
s (bed or beds or bedding or mattress$ or couch$ or cot or cots or crib or cribs or cradle or
cradles or bolster$ or cushion$)
s (pressure or decubit$ or bedulcer$ or bed(w1)ulcer$)(w10)(overlay$ or over(w1)lay$) s
support$(w)pillow$ or film$ or pillow$ or foam(w)wedge$ or foam(w)block$ or gelpad$ or
gel(w)pad$ or gell(w)pad$ or gellpad$
s air(w)support$ or air(w)fluidised or air(w)fluidized or support(w)surface$
s sheepskin$ or sheep(w)skin$ or alternat$(w)pressure$
s turning(w1)(bed$ or frame$)
s limb$(w1)(protect$ or guard$ or defend$ or defenc$ or shield$ or rest$)
s s6 or s7 or s8 or s9 or s10 or s11 or s12 or s13
s s5 and s14
s s15 andnot s16
s 2002:2003/dat
s s17 and s18
1 . skin ulcer/ or decubitus ulcer/
title]
6. or/1-5
cradles or bolster$ or cushion$).mp. [mp=abstract, heading words, title]
lay$)).mp. [mp=abstract, heading words, title]
12. (support$ pillow$ or film$).mp. [mp=abstract, heading words, title]
gellpad$ or gell-pad$).mp. [mp=abstract, heading words, title]
surface$).mp. [mp=abstract, heading words, title]
15. (sheepskin$ or sheep-skin$ or alternat$ pressure$).mp. [mp=abstract, heading words, title]
16. (turning adj1 (bed$ or frame$)).mp. [mp=abstract, heading words, title]
Page 174 of 219

Appendices.
18. protective support surfaces/ or pronation/ or range of motion/ or rotation/ or posture/ or
head down tilt/ or prone position/ or supine position/ or sitting/
19. or/9-18
20. limit 19 to yr=2002-2003
21. 8 and 20
1. pressure ulcers/
2. skin ulcers/
words]
heading words]
7. or/1-6
cradles or bolster$ or cushion$).mp. [mp=title, other title, abstract, heading words]
lay$)).mp. [mp=title, other title, abstract, heading words]
11. (support$ pillow$ or film$).mp. [mp=title, other title, abstract, heading words]
gellpad$ or gell-pad$).mp. [mp=title, other title, abstract, heading words]
surface$).mp. [mp=title, other title, abstract, heading words]
14. (sheepskin$ or sheep-skin$ or alternat$ pressure$).mp. [mp=title, other title, abstract,
heading words]
15. (turning adj1 (bed$ or frame$)).mp. [mp=title, other title, abstract, heading words]
17. beds/ or adjustable beds/ or bed cradles/ or cots/ or fluidised beds/ or hospital beds/ or
light duty beds/ or non adjustable beds/ or roto rest beds/ or water beds/ or back rests/ or bed
aids/ or bed blocks/ or bed centres/ or bed frames/ or bed lifts/ or bed rails/ or bed spaces/ or
bedding/ or bedside fittings/ or couches/ or hospital equipment/
18. turning frames/ or patient handling/ or pressure ulcer underpads/ or fleeces/ or bedding/ or
pressure area care.mp. [mp=title, other title, abstract, heading words]
19. patient positioning equipment/ or mattresses/ or bedding/ or foam mattresses/ or ripple
mattresses/ or sheepskin mattresses/ or water mattresses/
20. or/8-19
21. 7 and 20
22. limit 21 to yr=2002-2005
National Research Register (Issue 3:2003) (cd-rom)
21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
(SKIN-ULCER:ME or DECUBITUS-ULCER:ME)
((DECUBITUS or DECUBITAL) OR (SKIN next BREAKDOWN*))
(BEDULCER* or BED-ULCER*)
((PRESSURE near ULCER*) or (BED near ULCER*))
((((PRESSURE next ULCER*) or (PRESSURE next WOUND*)) OR (PRESSURE NEXT
DAMAG*)) OR (PRESSURE NEXT INJUR*))
((((#1 or #2) or #3) or #4) or #5)
((BEDS:ME or BEDS-AND-LINENS:ME) or PROTECTIVE-SUPPORT SURFACES:ME)
((POSTURE or POSTURE:ME) or HEAD-DOWN-TILT:ME)
(PRONE-POSITION:ME or SUPINE-POSITION:ME)
((((PRESSURE next RELIE*) or PRESSURE-RELIE*) OR (PRESSURE NEXT REDUC*)) OR
PRESSURE-REDUC*)
Page 175 of 219

Appendices.
31. ((((((((((((BED or BEDS) or BEDDING) or MATTRESS*) or COUCH*) or COT) or COTS) or
CRIB) or CRIBS) or CRADLE) or CRADLES) or BOLSTER*) or CUSHION*)
32. ((((((PRESSURE next OVERLAY*) OR (PRESSURE near OVER-LAY*)) OR (DECUBIT*
NEAR OVERLAY*)) OR (DECUBIT* NEAR OVER-LAY*)) OR (BEDULCER* NEAR
OVERLAY*)) OR (BEDULCER NEAR OVER-LAY*))
33. ((SUPPORT* next PILLOW*) or FILM*)
34. ((((((((PILLOW* or (FOAM next WEDGE*)) OR (FOAM NEXT BLOCK*)) OR GELPAD*) OR
(GEL NEXT PAD*)) OR GEL-PAD*) OR (GELL NEXT PAD*)) OR GELLPAD*) OR GELLPAD*)
35. (((((((AIR next SUPPORT*) or AIR-SUPPORT*) OR AIR-FLUIDISED) OR (AIR NEXT
FLUIDIZED)) OR AIR-FLUIDIZED) OR (SUPPORT NEXT SURFACE*)) OR SUPPORTSURFACE*)
36. ((SHEEPSKIN* or SHEEP-SKIN*) OR (ALTERNAT* next PRESSURE*))
((TURNING next BED*) or (TURNING next FRAME*))
37. ((((((LIMB* next PROTECT*) or (LIMB* next GUARD*)) OR (LIMB* NEXT DEFEND*)) OR
(LIMB NEXT DEFENC*)) OR (LIMB* NEXT SHIELD*)) OR (LIMB NEXT REST*))
38. (((((((((#8 or #9) or #10) or #11) or #12) or #13) or #14) or #15) or #16) or #17)
39. ((#18 or #19) or #21)
40. (#7 and #22)
41.
Clinical effectiveness search strategies for Question I

11. placebo$.ti,ab.
12. placebos/
13. random$.ti,ab.
19. or/1-18
20. animal/
21. human/
22. 20 not (20 and 21)
23. 19 not 22
26. Skin Ulcer/
32. or/26-31
33. debridement/mt and (surg$ or sharp or scalpel or blade$ or scissor$).mp.
34. Surgery/
35. surgical$ debrid$.mp. [mp=ti, ab, rw, sh]
Page 176 of 219

Appendices.
36. (surgical$ adj1 (interven$ or method$ or excis$ or remov$ or treatment$ or therap$ or
manag$ or drainage)).mp.
37. surgical$ technique$.mp. [mp=ti, ab, rw, sh]
38. (debrid$ adj2 (instrument$ or sharp or sharps or scalpel or scissors or blade$)).mp.
39. (excis$ adj2 (instrument$ or sharp or sharps or scalpel or scissors or blade$)).mp.
40. ofd.ti,ab.
41. (openflap debrid$ or open flap debrid$).mp.
42. skin graft.ti.
43. Decubitus Ulcer/su [Surgery]
44. Bone Transplantation/
45. SKIN TRANSPLANTATION/
46. surgical flaps/
47. ((skin or bone) adj1 (graft$ or transplant$)).tw.
48. ((skin or tissue$ or muscle$ or bone$) adj1 (excis$ or debrid$ or remov$)).tw.
49. or/33-48
50. 25 and 32 and 49
2. randomization/
8. placebo$.ti,ab.
9. Placebo/
10. random$.ti,ab.
11. evaluation/
12. follow up/
16. or/1-15
19. exp ANIMAL/
21. Nonhuman/
22. Human/
24. or/18-21
25. 22 or 23
26. 24 not (24 and 25)
27. 17 not 26
29. Skin Ulcer/
30. Decubitus/
name]
35. or/29-34
36. debridement/ and (surg$ or sharp or scalpel or blade$ or scissor$).mp.
37. surgery/
Page 177 of 219

Appendices.
38. surgical$ debrid$.mp.
40. surgical$ technique$.mp.
43. ofd.ti,ab.
44. Decubitus/su [Surgery]
45. exp bone transplantation/
46. exp skin graft/
47. exp skin flap/
50. or/36-49
51. 28 and 35 and 50
8. placebo$.ti,ab.
10. random$.ti,ab.
15. or/1-14
instrumentation]
23. or/18-22
24. Debridement/mt and (surg$ or sharp or scalpel or blade$ or scissor$).mp.
25. Surgery, Operative/
31. ofd.ti,ab.
32. Pressure Ulcer/su [Surgery]
33. Bone Transplantation/
34. Skin Transplantation/
35. Surgical Flaps/
38. or/24-37
39. 17 and 23 and 38
Page 178 of 219

Appendices.
2. clin$ trial$.tw.
4. placebo$.tw.
5. random$.tw.
8. or/1-7
9. pressure ulcers/
14. or/9-13
15. (debrid$ and (surg$ or sharp or scalpel or blade$ or scissor$)).mp.
21. ofd.ti.
24. ((surgical or skin) adj1 (flap or flaps)).mp.
25. surgery operative/
26. plastic surgery/
27. or/15-26
28. 8 and 14 and 27
Cochrane Controlled Trials Register strategy (internet interface)
next injur*))
#7. (#1 or #2 or #3 or #4 or #5 or #6)
#8. (surg* or sharp or scalpel or blade* or scissor*)
#9. DEBRIDEMENT [mt] single term (MeSH)
#10. (#8 and #9)
#11. SURGERY single term (MeSH)
#12. (surgical* next debrid*)
#13. ((surgical* next interven*) or (surgical* next method*) or (surgical* next excis*))
#14. ((surgical* next remov*) or (surgical* next therapy) or (surgical* next therapies) or
(surgical* next manag*) or (surgical* next drainage))
#15. ((surgical* next treatments) or (surgical* next treatment))
#16. ((surgical* next technique*) or (openflap next debrid*) or (open next flap next debrid*))
#17. (ofd:ti or ofd:ab or (skin next graft*) or (skin next transplant*) or (bone next graft*) or
(bone next transplant*))
#18. ((skin next excis*) or (skin next debrid*) or (skin next remov*) or (tissue* next excis*))
#19. ((tissue* next debrid*) or (tissue* next remov*) or (muscle* next excis*) or (muscle* next
debrid*))
#20. ((muscle* next remov*) or (bone* next excis*) or (bone* next debrid*) or (bone* next
remov*))
#21. ((debrid* near instrument*) or (debrid* near sharp) or (debrid* near sharps))
#22. ((debrid* near scalpel) or (debrid* near scissors) or (debrid* near blade*))
#23. ((excis* near instrument*) or (excis* near sharp) or (excis* near sharps))
Page 179 of 219

Appendices.
#24. ((excis* near scalpel) or (excis* near scissors) or (excis* near blade*))
#25. DECUBITUS ULCER [su] single term (MeSH)
#26. BONE TRANSPLANTATION single term (MeSH)
#27. SKIN TRANSPLANTATION single term (MeSH)
#28. SURGICAL FLAPS single term (MeSH)
#29. (#10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20)
#30. (#21 or #22 or #23 or #24 or #25 or #26 or #27 or #28 or #29)
#31. (#7 and #30)
4. clin$ trial$.tw.
6. placebo$.tw.
7. placebos/
8. random$.tw.
11. or/1-10
13. (comment or commentary or editorial or letter).pt.
14. 12 not 13
title]
20. or/15-19
21. surgery/
22. (debrid$ and (surg$ or scalpel$ or sharp or blade$ or scissor$)).mp.
28. ofd.ti,ab.
31. ((surgical or skin) adj1 (flap or flaps)).mp.
32. or/21-31
33. 12 and 20 and 32
((pressure or bed) near2 ulcer*) in ti, ab, de )) or (PRESSURE-ULCERS in DE)) and
(((surgical or skin) near1 (flap or flaps)) or (( (debrid* or excis*) near2 (instrument* or sharp or
sharps or scalpel or scissors or blade*) )or( (skin or bone) near1 (graft* or transplant*) )or(
(skin or tissue* or muscle* or bone*) near1 (excis* or debrid* or remov*) )) or (surgical* near1
(interven* or method* or excis* or remov* or treatment* or therap* or manag* or drainage)) or
(( debrid* and (surg* or scalpel* or sharp or blade* or scissor*) )or( (surgical* debrid*) or
(surgical* technique*) or ofd )))
#7 ((surgical or skin) near1 (flap or flaps)) or (( (debrid* or excis*) near2 (instrument* or sharp
or sharps or scalpel or scissors or blade*) )or( (skin or bone) near1 (graft* or transplant*) )or(
Page 180 of 219

Appendices.
(surgical* technique*) or ofd ))
#6 (surgical or skin) near1 (flap or flaps)
#5 ( (debrid* or excis*) near2 (instrument* or sharp or sharps or scalpel or scissors or blade*)
)or( (skin or bone) near1 (graft* or transplant*) )or( (skin or tissue* or muscle* or bone*) near1
(excis* or debrid* or remov*) )
#4 surgical* near1 (interven* or method* or excis* or remov* or treatment* or therap* or
manag* or drainage)
#3 ( debrid* and (surg* or scalpel* or sharp or blade* or scissor*) )or( (surgical* debrid*) or
(surgical* technique*) or ofd )
SINGLE strategy (SilverPlatter interface)
((pressure or bed) near2 ulcer*) in ti, ab, de )) or (PRESSURE-ULCERS in DE)) and
(((surgical or skin) near1 (flap or flaps)) or (( (debrid* or excis*) near2 (instrument* or sharp or
sharps or scalpel or scissors or blade*) )or( (skin or bone) near1 (graft* or transplant*) )or(
(surgical* technique*) or ofd )))
#7 ((surgical or skin) near1 (flap or flaps)) or (( (debrid* or excis*) near2 (instrument* or sharp
or sharps or scalpel or scissors or blade*) )or( (skin or bone) near1 (graft* or transplant*) )or(
(surgical* technique*) or ofd ))
#6 (surgical or skin) near1 (flap or flaps)
#5 ( (debrid* or excis*) near2 (instrument* or sharp or sharps or scalpel or scissors or blade*)
)or( (skin or bone) near1 (graft* or transplant*) )or( (skin or tissue* or muscle* or bone*) near1
(excis* or debrid* or remov*) )
#4 surgical* near1 (interven* or method* or excis* or remov* or treatment* or therap* or
manag* or drainage)
#3 ( debrid* and (surg* or scalpel* or sharp or blade* or scissor*) )or( (surgical* debrid*) or
(surgical* technique*) or ofd )
Page 181 of 219

Appendices.
Appendix C Quality assessment A I

TABLE A: Quality assessment of systematic reviews for pressure sores
Was a quality
assessment of
included studies
undertaken?
Were the
characteristics and
results of the
individual studies
appropriately
summarised?
Were data pooling

methods
appropriate?
Were sources of
heterogeneity
explored?
Total score/6
Was an adequate
search strategy
used?
Were the
inclusion
criteria
appropriate and
applied in an
unbiased way?
Bradley 1999
Bradley 1999
Cullum 2001
Evans 2001
Flemming 2000
Flemming 2000a
Flemming 2001
Langer 2003
Omeara 2001
Yes = 9 , No = 8 = not clear
Page 182 of 219

Appendices.
TABLE B: Quality assessment of cohorts pressure sores

1. Study Design
Allman 1995
2. Sample
selection
a
Reed 2003
Williams 2000
3. Participation
4. Inception
5. Exposure
status
b,c,d
6.Comparability
b,c,d
7. Outcome
status
c
8. Blind
assessment
c
9. Follow up
period
a
10.Final
analysis
b
8 = Not reported or unclear

For full description of quality criterion see Appendix E
Page 183 of 219

Appendices.
TABLE C: Quality assessment of studies for ulcer assessment

1. Is an
appropriate
test being
evaluated?
2. Is the
incremental
value of the
test being
compared to
other routine
tests?
Cutler 1993
Griffin 1993
Houghton 2000
Shubert
Plassmann
3. Were
patients
selected
consecutively?
*
*
*
*
*
4. Is the
decision to
perform the
reference
standard
independent
of the test
result?
8
8
8
8
8
8. If test has
been compared
has this been
done
independently?
9. Was the
test valid in a
second,
independent
group of
patients?
5. Was there a
valid
reference
standard?
6. Are the
tests and
reference
standard
measured
independently?
*
*
9
*
7. Are tests
measured
independent of
other clinical
and test
information?
Is the test
available,
affordable,
accurate
and precise
in setting?
9
9
9
9
9
9 = Yes, 8 = No, * Not reported or unclear

For full description of quality criterion see Appendix E
Page 184 of 219

Appendices.
TABLE D: Quality assessment of RCTs of support surfaces for treatment of pressure sores
Study
Inclusion and
exclusion criteria
stated
Overall sample size

[arms]
A priori sample size

calculation?
Appropriate
baseline
characteristics
reported*
9c
Blinded outcome
assessment
reported
Withdrawals
stated
ITT analysis
Randomisation
procedure stated,
adequate allocation
concealment
9
Allman 1987
72 [2]
9b
Caley 1994
55 [2]
9b
Clark 1999
33 [2]
9c
9a
Day 1993
83 [2]
9c
9a
Devine 1995
41 [2]
9c
9a
Evans 2000
32 [2]
9 (not achieved)
9c
9a
Ewing 1964
36 [2]
Ferrell 1993
84 [2]
9c
9a
Keogh 2001
100 [2]
9b
Groen 1999
120 [2]
9c
9a
Mulder 1994
49 [2]
9b
Munro 1989
40 [2]
9c
Russell 2000
112 [2]
9b
Russell 2003
158 [2]
Strauss 1991
112 [2]
9a
9 = Yes; 8 = No; N/A = Not Appropriate (no withdrawals)

* Baseline characteristics: 9= one or more appropriate characteristics stated (but not initial wound size); 9c = initial wound size stated
Withdrawals: 9a = reported by group and with reason; 9b = withdrawals but not reported by group or reason not given; 8 = withdrawals not reported
Page 185 of 219

Appendices.
TABLE E: Quality assessment of RCTs of dressings and topical applications for treatment of pressure sores
Study
Inclusion and
exclusion criteria
stated
Overall sample size

[arms]

calculation?
Randomisation
procedure stated
Blinded outcome
assessment
reported
Withdrawals
stated
ITT analysis
Appropriate
baseline
characteristics
reported*
9c
Brod 1990 [
43 [2]
9a
Collwell 1993
70 [2]
9c
9a
Barrios 1993
Huchon 1992
76 [2]
9c
9a
Bale 1998a
100 [2]
9a
Banks 1996
98 [2]
9c
N//A
N/A
Brown-Etris 1996
121 [2]
9b
Alm 1989
50 [2]
9c
9b
Honde 1994
168 [2]
9c
9a
Banks 1994b
40 [2]
9c
Banks 1994a
29 [2]
9c
9a
9a
Banks 1994c
50 [2]
9c
9b
Kraft 1993
38 [2]
9a
Xakellis 1992
39 [2]
9c
9a
Page 186 of 219

Appendices.
Study
Inclusion and
exclusion criteria
stated
Overall sample size

[arms]

calculation?
Randomisation
procedure stated
Blinded outcome
assessment
reported
Withdrawals
stated
ITT analysis
Appropriate
baseline
characteristics
reported*
9c
200 [2]
9b
van Ort 1976
14 [2]
N/A
N/A
Mustoe 1994
41 [3]
9c
9a
Robson 1992b
20 [4]
9c
N/A
N/A
Robson 1992a
50 [3]
9c
9a
Robson 1994
26 [4]
9b
Le Vassueur 1991
21 [2]
9c
N/A
N/A
Palmieri 1992
48 [2]
N/A
N/A
Darkovitch 1990
90 patients
129 wounds [2]
9c
9a
Sebern 1986 [37,

38]
Page 187 of 219

Appendices.
Study
Inclusion and
exclusion criteria
stated
Overall sample size

[arms]

calculation?
Randomisation
procedure stated
Blinded outcome
assessment
reported
Withdrawals
stated
ITT analysis
Appropriate
baseline
characteristics
reported*
9
Mulder 1993
67 [3]
9b
Sayag 1996
92 [2]
9c
9a
Lee 1975
28 [2]
9a
Rees 1999
124 [4]
9c
Robson 2000
61 [4]
9c
9a
Landi 2003
38 [2]
9c
9a
Burgos 2000a
92 [2]
9a
Pullen 2002
135 [2]
9c
9a
Alvarez 2002
28 [2]
9c
9a
Parish 1979(a, b)
12 patients
25 wounds [2]
9c
N/A
N/A
Page 188 of 219

Appendices.
Study
Inclusion and
exclusion criteria
stated
Overall sample size

[arms]

calculation?
Randomisation
procedure stated
Blinded outcome
assessment
reported
Withdrawals
stated
ITT analysis
Appropriate
baseline
characteristics
reported*
9c
Colin 1996
135 [2]
9a
Thomas 1993
40 [2]
9c
9a
Ljungberg 1998
23 patients
30 wounds [2]
Nasar 1982
18 [2]
9a
Moberg 1983
38 [2]
9c
9a
Agren 1985
28 [2]
9c
9a
Burgos 2000b
37 patients
43 wounds [2]
9a
Chang 1998
34 [2]
N/A
N/A
Matzen 1999
32 [2]
9a
Thomas 1998
41 [2]
9c
9a
Kloth 2002
9c
9b
Whitney 2001
53 patients
56 wounds [2]
29 [2]
9c
9a
Belmin 2002
110 [2]
9c
9a
Banks 1997
20 [2]
9a
Seeley 1999
40 [2]
9c
9a
Page 189 of 219

Appendices.
Study
Inclusion and
exclusion criteria
stated
Overall sample size

[arms]

calculation?
Randomisation
procedure stated
Appropriate
baseline
characteristics
reported*
Blinded outcome
assessment
reported
Withdrawals
stated
ITT analysis
Thomas 1997
99 [2]
N/A
N/A
Bale 1997
61 [2]
9c
9a
Seaman 2000
35 [2]
9c
9b
Graumlich 2003
65 [2]
9c
9a
Meaume 2003
38 [2]
9c
N/A
N/A
Bale 1998b
50 [2]
9c
9a
Price 2000
58 [2]
9c
9a
Ritz 2002
49 [2]
9c

Page 190 of 219

Appendices.
TABLE F: Quality assessment of RCTs of antimicrobials for the treatment of pressure sores
Study
Inclusion and
exclusion criteria
stated
Overall sample size

[arms]

calculation?
Randomisation
procedure stated,
adequate allocation
concealment
Appropriate
baseline
characteristics
reported*
Blinded outcome
assessment
reported
Withdrawals
stated
ITT analysis
40[2]
Gerding, 1992
1102[2]
Huchon, 1992
76[2]
19[2]
8
8
8
9
9
9
8
8
8
8
8
8
8
8
Della Marchina, 1997
9
Toba, 1997
Page 191 of 219

Appendices.
TABLE G: Quality assessment of RCTs of adjunct therapies for the treatment of pressure sores
Study
Inclusion and
exclusion criteria
stated
Overall sample size

[arms]

calculation?
Randomisation
procedure stated,
adequate allocation
concealment
Appropriate
baseline
characteristics
reported*
Blinded outcome
assessment
reported
Withdrawals
stated
ITT analysis
24 patients
36 wounds [2]
9c
McDiarmid 1985
40 [2]
Nussbaum 1994
20 patients
22 wounds [3]
9c
9a
ter Riet 1995
88 [2]
9b
Gentzkow 1991
49 [2]
9c
Griffin 1991
17 [2]
9c
Wood 1993
9c
Ritz 2002
71 patients
74 wounds [2]
49 [2]
9c
Comorosan 1993
30 [3]
Salzberg 1995
31 [2]
Joseph 2000

Page 192 of 219

Appendices.
TABLE H: Quality assessment of RCTs of nutrition for the treatment of pressure sores
Study
Inclusion and
exclusion criteria
stated
Overall sample size

[arms]

calculation?
Randomisation
procedure stated,
adequate allocation
concealment
Appropriate
baseline
characteristics
reported*
Blinded outcome
assessment
reported
Withdrawals
stated
ITT analysis
12[2]
9c
Norris, 1971
14[2]
Taylor, 1974
20[2]
9c
Ter Riet
88[2]
Chernoff,1990

Page 193 of 219

Appendices.
TABLE I: Quality assessment of RCTs of mobility and positioning for the treatment of pressure sores
Study
Inclusion and
exclusion criteria
stated
Overall sample size

[arms]

calculation?
Randomisation
procedure stated,
adequate allocation
concealment
Appropriate
baseline
characteristics
reported*
Blinded outcome
assessment
reported
190[2]
9c
ITT analysis
Bates-Jensen
2003
Withdrawals
stated

Page 194 of 219

Appendices.
TABLE J: Quality assessment of case series of surgery for treatment of pressure ulcer
Study
Aims of case
series clearly
stated
Case series
collected in more
than one centre
(multi-centre
trial)
Case definition
clearly reported
Explicit statement
that patients were
recruited
consecutively
Prospective data
collection
Reporting of
mortality/recurrences/complications
> 10 cases
Baseline data for

ulcers
9c
Reporting of
confidence
intervals or other
estimate of
random
variability
8
Akan 2001
9c
Bocchi 2002
9c
Eshaque 1994
9a
Esposito 1992
Forster 1997
9c
9a
Geoffrey 1994
Hayashi 1998
Hiroyuki 1995
9b
Hovius 1979
Inoue 1990
Josvay 1998
Klein 1988
Little 1982
Akguner 1998
Page 195 of 219

Appendices.
Study
Aims of case
series clearly
stated
Case series
collected in more
than one centre
(multi-centre
trial)
Case definition
clearly reported
Explicit statement
that patients were
recruited
consecutively
Prospective data
collection
Reporting of
mortality/recurrences/complications
> 10 cases
Baseline data for

ulcers
Reporting of
confidence
intervals or other
estimate of
random
variability
8
Maruyama 1980
Norman 1980
Rollin 1982
Shessel 2001
Stevenson 1986
Tellioglu 1999
Tizian 1986
William 1989
9 = Yes; 8 = No; N/A = Not Appropriate (no withdrawals);? Dont know

mortality/recurrence/complications: 9a = reported by group and with reason; 9b = not reported by group or reason not given; 8 = not reported
Page 196 of 219

Appendices.
Table K: Dressings and debridement economic evaluation checklist1

Study number (refers to reference)
6
7
8
9ab
10
The research question is stated
The economic importance of the research

question is stated
The view point(s) of the analysis are clearly
stated and justified
The rationale for choosing the alternative
programmes or interventions compared is
stated
The alternatives being compared are clearly
described
The form of economic evaluation is stated
The choice of form of economic evaluation is

justified in relation to the questions addressed
Study design
11
12
13
14
15
16
17
18
19
20ab
21
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Data collection
The source(s) of effectiveness estimates
used are stated
Details of the design and results of
effectiveness study are given (if based on
single study)
Details of methods of synthesis or metaanalysis of estimates are given (if based on
an overview of a number of effectiveness
studies)
The primary outcome measure(s) for the
economic evaluation are clearly stated
Methods to value health states and other
benefits are stated
Details of the subjects from whom valuations
were obtained are given
Productivity changes (if included) are
reported separately
The relevance of productivity changes to the
study question is discussed
Quantities of resources are reported
separately from their unit costs
Methods for the estimation of quantities and
unit cost are described
Currency and price date are recorded
Details of currency of price adjustments for
inflation or currency conversion are given
Page 197 of 219

Appendices.
Details of any model used are given
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
The choice of model used and the key

parameters on which it is based are justified
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Analysis and interpretation of results
9ab
10
11
12
13
14
15
16
17
18
19
20
21
Time horizon of costs and benefits are stated
The discount rate(s) is stated
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
The choice of rate(s) is justified
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
An explanation is given if cost or benefits are

not discounted
Details of statistical tests and confidence
intervals are given for stochastic data
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
The approach to sensitivity analysis is given
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Major outcomes are presented in a

disaggregated as well as aggregated form
NA
The answer to the study question is given
Conclusions followed from the data reported
The choice of variables for sensitivity analysis

is justified
The ranges over which the variables are
varied are stated
Relevant alternatives are compared
Incremental analysis is reported
Conclusions are accompanied by the

P
P
P
X
X
X
P
P
appropriate caveats
1.
Drummond MF, Jefferson TO (1996) Guidelines for authors and peer reviewers of economic submissions to the BMJ. British Medical Journal, 313,pp.275-283.
Yes - , NO - X, P partial, Unclear U, NA Not Applicable
Page 198 of 219

Appendices.
Dressings and debridement: study numbers

1. Aguilo Sanchez S, Figueiras Mareque L, Quintilla Gatnau A and Veiga Bogo L (2001)
Traditional dressings or cures in a moist environment? (Spanish). Revista Rol de
Enfermeria,24,pp.50-54.
2. Bale S, Hagelstein S, Banks V and Harding KG (1998) Costs of dressings in the
community. Journal of Wound Care,7,pp.327-330.
3. Bergemann R et al. (1999) Economic evaluation of the treatment of chronic wounds:
hydroactive wound dressings in combination with enzymatic ointment versus gauze dressings
in
patients
with
pressure
ulcer
and
venous
leg
ulcer
in
Germany.
PharmacoEconomics,16,pp.367-77.
4. Burgos A, Gimenez J, Moreno E, Lamberto E, Utrera M, Urraca EM et al. (2000) Cost,
efficacy, efficiency and tolerability of collagenase ointment versus hydrocolloid occlusive
dressing in the treatment of pressure ulcers. A comparative, randomised, multicentre study.
Clinical Drug Investigation,19,pp.357-365.
5. Capillas PR, Cabre AV, Gil CAM, Gaitano GAG and Torra iBJE (2000) A comparison of the
effectiveness and cost of moist environment dressings treatment as compared to traditional
dressings treatment: randomized clinical trial on patients suffering venous leg ulcers or
pressure ulcers treated by primary health care nurses. Revista Rol de Enfermeria,23,pp.1724.
6. Colwell JC, Foreman MD and Trotter JP (1993) A comparison of the efficacy and costeffectiveness of two methods of managing pressure ulcers. Decubitus,6,pp.28-36.
7. Gorse GJ and Messner RL (1987) Improved pressure sore healing with hydrocolloid
dressings. Archives of Dermatology,123,pp.766-71.
8. Graumlich JF, Blough LS, McLaughlin RG, Milbrandt JC, Calderon CL, Agha SA et al.
(2003) Healing pressure ulcers with collagen or hydrocolloid: a randomized, controlled trial.
Journal of the American Geriatrics Society,51,pp.147-154.
9a. Harding K, Cutting K and Price P (2000) The cost-effectiveness of wound management
protocols of care. British Journal of Nursing,9,S6,S8,S10-S20.
9b. Harding K, Cutting K and Price P (2001) Wound management protocols of care. British
Journal of Health Care Management,7,pp.191-197.
10. Kerstein MD, Gemmen E, Van Rijswijk L, Lyder CH, Phillips T, Xakellis G et al. (2001)
Cost and cost-effectiveness of venous and pressure ulcer protocols of care. Disease
Management & Health Outcomes,9,pp.651-663.
11. Kim YC, Shin JC, Park CI, Oh SH, Choi SM and Kim YS. (1996) Efficacy of hydrocolloid
occlusive dressing technique in decubitus ulcer treatment: a comparative study. Yonsei
Medical Journal,37,pp.181-5.
12. Kraft MR, Lawson L, Pohlmann B, Reid-Lokos C and Barder L. (1993) A comparison of
Epi-Lock and saline dressings in the treatment of pressure ulcers. Decubitus,6,pp.42-4,46,48.
13. Mosher BA, Cuddigan J, Thomas DR and Boudreau DM (1999) Outcomes of 4 methods
of debridement using a decision analysis methodology. Advances in Wound Care,9;12:81-88.
Page 199 of 219

Appendices.
14. Motta G, Dunham L, Dye T, Mentz J, O'Connell-Gifford E and Smith E (1999) Clinical
efficacy and cost-effectiveness of a new synthetic polymer sheet wound dressing.
Ostomy/Wound Management,45,pp.41-49.
15. Muller E, van Leen MWF and Bergemann R (2001) Economic evaluation collagenasecontaining ointment and hydrocolloid dressing in the treatment of pressure ulcers.
PharmacoEconomics,19,pp.1209-16.
16. Nasar MA and Morley R (1982) Cost-effectiveness in treating deep pressure sores and
ulcers. Practitioner,226,pp.307-310.
17. Ohura T, Sanada H and Mino Y (2004) Clinical activity-based cost-effectiveness of
traditional versus modern wound management in patients with pressure ulcers. Wounds a
Compendium of Clinical Research & Practice,pp.157-163.
18. Robson MC, Maggi SP, Smith PD, Wassermann RJ, Mosiello GC, Hill DP et al. (1999)
Original articles: ease of wound closure as an endpoint of treatment efficacy.[comment].
Wound Repair & Regeneration,7,pp.90-6.
19. Robson MC, Hill DP, Smith PD, Wang X, Meyer-Siegler K, Ko F et al. (2000) Sequential
cytokine therapy for pressure ulcers: clinical and mechanistic response. Annals of
Surgery,231,pp.600-11.
20a. Sebern MD (1986) Pressure ulcer management in home health care: efficacy and costeffectiveness of moisture vapor permeable dressing. Archives of Physical Medicine &
Rehabilitation,67,pp.726-9.
20b. Sebern MD (1989) Cost and efficacy of pressure ulcer management in a metropolitan
visiting nurse association. Decubitus,2,pp.58-9.
21. Xakellis GC and Chrischilles EA (1992) Hydrocolloid versus saline-gauze dressings in
treating pressure ulcers: a cost-effectiveness analysis. Archives of Physical Medicine &
Rehabilitation;73:463-9.
Page 200 of 219

Appendices.
Table L: Adjunct therapies economic evaluation checklist*1

Study design
22
23

question is stated
stated
described

justified in relation to the questions
addressed
NA
NA
NA
NA
NA
NA
NA
NA

NA
NA

not discounted
Details of statistical test and confidence
NA
NA

is justified
varied are stated
Data collection
used are stated
single study)
studies)
benefits are stated
reported separately
Page 201 of 219

Appendices.
NA

X
appropriate caveats
1.
Drummond MF, Jefferson TO (1996) Guidelines for authors and peer reviewers of economic submissions to the
BMJ. British Medical Journal, 313,pp.275-283.
Adjunct therapies: study numbers

22. Macario A and Dexter F (2002) Is noncontact normothermic wound therapy cost-effective
for the treatment of stages 3 and 4 pressure ulcers? Wounds A Compendium of Clinical
Research & Practice,14(3),pp.93-106.
23. Philbeck JTE, Whittington KT, Millsap MH, Briones RB, Wight DG and Schroeder WJ
(1999) The clinical and cost-effectiveness of externally applied negative pressure wound
therapy in the treatment of wounds in home healthcare Medicare patients. Ostomy/Wound
Management,45(11),pp.41-50.
Page 202 of 219

Appendices.
Table M: Pressure-relieving devices economic evaluation checklist1

Study design

question is stated
stated
described

justified in relation to the questions addressed
NA
NA
NA
NA
NA
NA
NA
NA
NA
Data collection
used are stated
single study)
studies)
benefits are stated
reported separately

NA
NA
NA
NA

NA
NA

NA
NA
NA
NA
NA
NA

not discounted
Details of statistical test and confidence
NA
NA
NA

is justified
Page 203 of 219

Appendices.
varied are stated
NA
NA


P
appropriate caveats
1.
Drummond MF, Jefferson TO (1996) Guidelines for authors and peer reviewers of economic submissions to the
BMJ. British Medical Journal, 313,pp.275-283.
Pressure-relieving devices: study numbers

24. Branom R and Rappl LM (2001) Constant force technology versus low-air-loss therapy in
the treatment of pressure ulcers. Ostomy Wound Management,47(9),pp.38-46.
25. Ferrell BA, Keeler E, Siu AL, Ahn SH and Osterweil D (1995) Cost-effectiveness of lowair-loss beds for treatment of pressure ulcers. Journal of Gerontology,50A:M141-M146.
26. Strauss MJ (1991) The cost of home air-fluidized therapy for pressure sores. A
randomized controlled trial. J. Family Practice,pp.52-59.
Page 204 of 219

Appendices.
Appendix D: Table of excluded studies

Study
Holistic assessment
Bianchetti et al., 1993
Reason excluded
The studys main focus is on those subjects
without ulcers but who are at risk of
developing pressure ulcers.
Clarke and Kadhom, 1988
Prevention study
Guralnik et al., 1988
Prevention study
Berlowits and Wilkin, 1989
Prevention study
Kemp et al., 1990
Prevention study
Ek et al., 1991
Prevention study
Marchette et al., 1991
Prevention study
Bergstrom et al., 1992
Prevention study
Rijswijk, 1993
Study design and methods not clear. Poor

methodology.
No multivariate analysis of risk factors.
Hoshowsky and Schramm, 1994
Prevention study
Brandeis et al., 1994
Prevention study
Bergstron et al.,1996
Prevention study
Schnelle et al., 1997
Prevention study
Nixon et al., 2000
Prevention study
Halfens et al., 2000
Prevention study
Theaker et al., 2000
Prevention study
Boyle and Green, 2001
Prevention study
Schoonhoven et al., 2002
Prevention study
Berquist, 2003
Prevention study
Baumgarten et al., 2003
Prevention study
Schoonhoven et al., 2003
Prevention study
Ulcer assessment
Melhuish et al., 1994
Not pressure ulcers
Page 205 of 219

Appendices.
Gardner et al., 2001
General chronic wound unclear what

percentage were pressure ulcers.
Pressure-relieving surfaces
Bennett et al., 1998
Prevention trial
Lazzara et al., 1991
Prevention trial
Marchand et al.
Prevention trial
Rosenthal et al., 1996
Prevention trial
Stoneberg et al., 1986
Prevention trial
Dressings and topical agents

Cheneworth, 1994
Pressure sore prevention, not treatment.
Collier, 1992
No data on healing - mentions improved.
Fowler, 1983
No outcome data.
Gorse, 1987
Not RCT. Patients allocated to wards to give

a balance of surgical and medical patients,
then one treatment used on each ward.
Isago, 2003
Not RCT. Case series.
Kloth, 2000
Not RCT. Control group was a convenience

sample.
Not RCT. Quasi randomised trial: patients
with odd admission number were allocated to
the control group, those with an even number
were assigned to the treatment group.
Lum, 1996
Maas-Irslinger, 2003
Not RCT. Controlled experiments on healthy

volunteers.
Milward, 1995
Evaluation of a skin treatment rather than

wound dressing.
Mosher, 1999
Not RCT. Decision analysis study.
Rhodes, 2001
Quasi experimental design: unit of

randomisation was physicians not patients or
ulcers.
Quasi experimental design: unit of
randomisation was nursing modules not
patients or ulcers. Patients would receive the
treatment assigned to the module.
Oleske, 1986
Pierce, 1994
Outcome data was electron microscopy

results.
Pittl, 1995
Conflicting results. Coloplast contacted for

clarification - no reply.
Page 206 of 219

Appendices.
Shutler, 1995
No data on healing.
Smith, 1996
Not RCT. A practice survey, excluded

patients with pressure sores.
Shiraishi, 1997
Not RCT. Pharmacological study.
Tytgat, 1988
Not RCT. No objective outcomes

measurement.
Vande Berg, 1995
Outcome based on histology.
Wongworawat, 2003
Not RCT. Case series.
Antimicrobials
Baker, 1981
Before-after study.
Bendy, 1964
No objective wound healing outcomes.
Gorse, 1987
Unit of allocation was wards and this

allocation was likely to produce
heterogeneous treatment groups.
Hartman, 2002
Not truly randomised. Some patients acted

as their own controls. Used essential oils as
antimicrobial agent.
Kucan, 1981
Microbiological outcomes and subjective

assessment of wounds the only outcomes
available.
Nasar, 1982
Some patients were additionally given

systemic antibiotics, but insufficient details
given regarding this co-intervention. Some
patients crossed over between treatment
groups.
Norton 1962
The unit of allocation was wards and this

allocation was likely to produce
heterogeneous treatment groups.
Robson, 1991
Growth factor and disaccharide preparation

evaluated within two double blind, placebo
controlled RCTS. For both trials, silver
sulphadiazine was allocated to any additional
ulcers in a non-randomised, un-blinded
fashion.
Subramanian, 1990
Separate data not available for chronic

wounds. No objective wound healing
outcomes.
Adjunct therapies
Page 207 of 219

Appendices.
Canedo-Dorantes, 2002
Not RCT, physiological study. Did not

address treatment of pressure ulcers but
chronic arterial and venous leg ulcers.
Elsberg, 2002
Not RCT. Case series (n=8) with stage 3-4

pressure ulcers that showed no improvement
after conventional treatment for 2 weeks.
Treatments given were topical hyperbaric
oxygen and electrical stimulation.
Rippon, 1999
Not RCT. Experimentally induced wounds

were monitored using pulse ultrasound over
21 days.
Selkowtiz, 2002
Not RCT. Description of single case (patient

with stage 3 pressure ulcer) different
treatment administered at different time
periods.
Argenta, 1997
This study utilised TNP to treat 300 wounds,

175 of which were chronic. There was no
control or comparison group therefore this is
not a prospective RCT.
Banwell, 1998
This study utilised TNP to treat 200 acute

and chronic wounds. There was no control or
comparison group therefore this is not a
prospective RCT.
Das Gupta, 1996
This study utilised TNP to treat 23 patients

with chronic wounds. There was no control or
comparison group therefore this is not a
prospective RCT.
Deva, 2000

with pressure ulcers who were judged to be
unsuitable for reconstructive surgery. The
study is not a prospective RCT, but a
prospective, consecutive case series.
Fabian, 2000
This study compared the healing of hypoxic

full thickness ear wounds in rabbits (41)
when treated with TNP or foam (not treated
with TNP) and adhesive drape, with or
without hyperbaric oxygen. This is a
prospective RCT but not in humans.
Genecov, 1998
This study compared the healing rate of

donor site wounds in pigs (4) when treated
with TNP or Opsite. It also compared the
epithelialisation rates of donor site wounds in
humans (10) when treated with TNP or
Opsite, but looking at acute wounds.
Greer, 1999
This study appeared to be a relevant RCT

looking at the effect of TNP on pressure ulcer
Page 208 of 219

Appendices.
healing. The trial was terminated
prematurely.(Personal communication
KCI,USA)
Heath, 2002
This study compared the percentage of

epithelialisation in surgical wounds in
humans (30) when treated with a skin graft
plus TNP or standard pressure dressing. This
appears to be a prospective controlled trial in
humans but in acute wounds.
Heissing, 1995
This study utilised either continous or

variable TNP to treat 120 hip replacement
patients. This is a prospective randomised
controlled trial in humans but in acute
wounds healing by primary intention.
Holmich, 1998

with acute (5) or chronic (9) wounds. There
was no control or comparison group therefore
this is not a prospective RCT.
Isago, 2003
Not an RCT. This study assessed the effect

of negative pressure dressings on 10 patients
with stage 4 pressure ulcers. There was no
control group or random allocation of
patients.
Ladin, 2000

with diabetic foot ulcers, venous stasis ulcers
or post traumatic ulcers. There was no
control or comparison group therefore this is
not a prospective RCT.
de Lange, 2000
This study utilised TNP to treat 100 patients,

23 of which had 26 stage 4 pressure ulcers.
There was no control or comparison group
therefore this is not a prospective RCT.
McCallom, 2000
This RCT assessed the effect of TPN on

patients with diabetic foot ulcers, and not on
pressure ulcers.
Mooney, 2000
This study utilised TNP to treat 27 paediatric

patients,16 of which had chronic extremity
and axial wounds. There was no control or
experimental group therefore this is not a
prospective RCT.
Morykwas, 1993
This study compared the healing rates of full

thickness dorsal wounds in pigs (5) when
treated with TNP or saline wet to moist
dressings. This appears to be a prospective
controlled trial on acute wounds and not in
humans.
Morykwas, 1995
This study retrospectively analysed the
Page 209 of 219

Appendices.
length of stay and total charges for 159
hospitalised patients with chronic wounds
treated with either TNP (35) or other
modalities (124) over a 21-month period.
Patients were not randomly allocated to the
two treatment groups.
Morykwas, 1997
This series of studies of the effect of TNP on

blood flow in the wound and adjacent tissue
(5), the rate of granulation tissue formation
(10), the clearance of bacteria from infected
wounds (5) and the measurement of nutrient
flow (5). These studies appear to be
prospective controlled trials but on acute
wounds and not in humans.
Mullner, 1997

17 of whom had sacral pressure ulcers.
There was no control or comparison group
therefore this is not a prospective RCT.
Philbeck, 1995
Retrospective analysis of wound healing, and

from this estimated the financial cost, in
1,032 home healthcare patients with 1,170
chronic wounds, when treated with TNP. This
group was compared with an historical
control group that had been treated with
saline-soaked gauze therefore this is not a
prospective RCT.
Wu, 2000

11 of whom had chronic wounds. There was
no control or comparison group therefore this
is not a prospective RCT.
Nutrition
Benati, 2001
36 patients with severe cognitive impairment

and pressure ulcers were randomised into
three intervention groups but no outcome
data were reported.
Bergstrom, 1987
129 institutionalised elderly, who were at risk

but did not have pressure ulcers at
admission, were studied to determine
whether dietary and serum zinc and copper
differ between those who developed pressure
ulcers and those who did not.
Bourdel, 1997
Retrospective case-control study with 108

patients to discover early and late tolerance
of long-term feeding with PEG for older and
frail patients. Not an RCT or CCT.
Breslow, 1990
PHD thesis. Published report see Breslow,

1991.
Page 210 of 219

Appendices.
Breslow, 1991
Comparison of nutritional status and dietary

intake of 14 tube fed nursing home patients
with pressure ulcers to 12 tube fed patients
without pressure ulcers. Not an RCT or CCT.
Breslow, 1993
28 malnourished patients with pressure sores

received 24% protein or 14% protein
supplements for a period of 8 weeks. First
RCT, then CCT justified by unbalanced
groups and high drop-out rate; effects of bed
type on results are unclear.
Burr, 1972
Not an RCT. Study assessed the leucocyte

ascorbic acid concentration of 91 paraplegic
patients on admission (33 of which had
pressure sores) and 41 controls. 10 of the
patients with pressure sores were given a
course of ascorbic acid or placebo, but
allocation to the treatments were not made at
random.
Cruse, 2000
Review of immune function, healing of

pressure ulcers and nutritional status in
patients with spinal cord injury. Not linked to
pressure ulcers laboratory study of immune
function and nutritional markers.
Gardner, 1999
Literature review and meta-analysis of

studies assessing the effect of electrical
stimulation on chronic wound healing.
Gray, 2003
Literature review article of vitamin C

supplementation to promote pressure ulcer
healing.
Gray, 2003
Literature review article of oral zinc

supplementation to promote healing of
chronic wounds.
Gray, 2003
Literature review article of supplementation of

vitamin A or E to promote healing of chronic
wounds.
Henderson, 1992
This study examined the nutritional status

and clinical outcomes including pressure
ulcers and death in 40 tube fed patients. Not
linked to pressure ulcer healing.
Jackobs, 1999
13 patients in long-term care with grade 2 or

3 pressure ulcers were included in this study
to evaluate the cost of nutrition therapy to
heal pressure ulcers. Not a randomised or
controlled clinical trial. Diet regimes were
allocated according to pressure ulcer stage.
Main outcomes reported were economic.
Page 211 of 219

Appendices.
Langkamp Henken, 2000
32 nursing home residents with pressure

ulcers received 0g, 8.5 g or 17 g arginine for
4 weeks. Not pressure ulcers but only
immune functions were measured.
Lawson, 2003
Studied the effect of unselected postoperative nutritional supplementation on

nutritional status and clinical outcome of
orthopaedic patients. Not pressure ulcers.
Larsson, 1990
501 geriatric patients received standard

hospital diet or additional nutritional
supplements for 26 weeks. Pressure ulcers
not measured.
Lewis, 1996
A literature review of protein levels and the

aetiology of pressure sores.
Myers, 1990
80 patients with pressure ulcers were treated

with wound care, with nutritional support, with
both or with standard hospital treatment for 7
days. Nutritional supplementation was not
clearly described.
North, 1999
Systematic review of studies that compared

the impact of oral or enteral supplements of
Vitamin C on the rate of healing of pressure
sores. The review included other systematic
reviews, randomised trials, quazi-exerimental
studies and nonexperimental studies.
Prescott, 2003
Expert opinion paper with literature review.

Abstract notes that five RCTs have been
conducted to assess the effect of zinc
supplementation on the healing of pressure
ulcers, but the five trials referred to all
assessed the effect of zinc supplementation
in healing venous leg ulcers.
Rypkema, 2004
298 older patients in a prospective controlled

study. Randomisation was wards. Not
pressure ulcer healing.
Senapati, 1989
Not an RCT. A physiological study assessing

plasma zinc levels in elderly patients with leg,
sacral or gluteal decubitus ulcers, and three
groups of different types of control patients.
Thomas, 2001
Literature review of nutritional interventions to

improve outcomes for people with pressure
ulcers.
Mobility and positioning

Defloor, 1999
Not RCT
Page 212 of 219

Appendices.
Defloor, 2000
Not RCT
Defloor, 2000
Prevention trial
Defloor, 2001
Interface pressure outcome
Surgery
Arregui et al., 1965
Retrospective chart review
Aydan et al., 2003
Brucks et al., 1991
Animal study
Chan et al., 2003
Gusenoff, 2002
Higins et al., 2002
Single case report
Hollis, 1979
Single case report
Inoue, 1990
2 subjects only
Patel and Kuzon, 2001
Single case report
Rubayi, 1999
Retrospective review
Thomson et al., 2001
4 subjects only
Page 213 of 219

Appendices.
Appendix E: Quality assessment for risk factor studies

All studies will fulfil the following criteria for inclusion
Eligible cohort of participants.

High participation at baseline and follow up > 70%.
Risk factors conceptually relevant.
Baseline measurement of risk factors.
Reporting of methods, explicit inclusion criteria and demographic information.
Adequate length of follow up > 6 months.
Measurement of falls as outcome.
Statistical methods detailed. Adequate reporting for data extraction. Methods of
adjustment for confounding reported: see below.
Studies then have to be assessed against these criteria:

High quality
Large sample.
High participation at baseline and follow up > 80%.
Baseline measurement of risk factors: clear methods of measurement given. Balance
between clinical tests and subjective measurement.
Methods of outcome measurement clear. Falls diaries with frequent researcher follow
up. Minimal reliance on recall of fall events.
Methods of adjustment: all factors adjusted and reported.
Medium quality
Large sample.
Participation at baseline and follow up 70-80%.
Baseline measurement of risk factors: Unclear methods of measurement given.
Subjective methods of measurement.
or
Methods of outcome measurement clear. Inadequate measurement of outcome i.e.
relying on memory at follow up alone.
Methods of adjustment: some adjustment and reporting.
Low quality
Small sample < 200.
Low participation at baseline and follow up < 70%.
Baseline measurement of risk factors: unclear methods of measurement given.
Subjective methods of measurement.
or
Methods of outcome measurement clear. Inadequate measurement of outcome i.e.
relying on memory at follow up alone.
Methods of adjustment: adjusted variables not reported.
Page 214 of 219

Appendices.
Case Series quality checklist

Case series collected in more than one centre (multi-centre study) Y/N
Aims of case series clearly stated Y/N
Case definition clearly reportedY/N
Explicit statement that patients were recruited consecutively Y/N
Prospective data collection Y/N
Reporting of confidence intervals or other estimate of random variability Y/N
Reporting of mortality/recurrences/complications Y/N
Baseline data for ulcers Y/N
Y =1
N= 0
Page 215 of 219

Appendices.
Case control studies quality assessment (generic issues)

Please circle as appropriate for each paper. The approach recommended by the Centre
for Statistics in Medicine is to describe the quality of each paper rather than consign to
the dustbin if it scores "b's" or "c's". However, you may decide that if multiple flaws,
the paper should not be included as it may be too biased.
Selection
1. How were cases selected?
a.
All eligible subjects diagnosed as cases over a defined period of
time, or in a defined catchment area, or a random or systematic
sample of such cases
b.
Unrepresentative or biased sample of cases
c.
Unclear
2. Are the case and control definitions adequate and validated?
(Cases=specific for review question, looking for validated or accepted
diagnostic criteria/outcome measure. Control=defined and shown not to be a
case.)
a.
Yes
b.
No, case definition inadequate
c.
No, control definition inadequate
d.
No, case and control definitions inadequate
e.
Unclear
3. How were controls selected?
a.
General population controls (ie, same population as cases)
b.
Hospital/clinic controls
c.
Other
d.
Unclear
4. Are the controls representative?
a.
Individually matched
b.
Frequency matched
c.
Not matched, but all non-cases over a defined period of time, or in
a defined catchment area or a random or systematic sample of
such subjects
d.
Unrepresentative
e.
Unclear
5. What percentage of selected individuals agreed to participate in the study?
Cases_______________
Controls_____________
a.
> 80% agreed in both groups
b.
> 80% cases agreed, < 80% controls
Page 216 of 219

Appendices.
c.
d.
e.
< 80% cases agreed, > 80% controls

<80% in both groups agreed
Not reported or unclear
Exposure/intervention ascertainment
6. How was exposure status ascertained (this will be specific to review
question)?
a.
Questionnaire
b.
Clinical examination
c.
Medical record review
d.
Unclear
7. Were assessors of exposure blind to outcome status? (ie, whether a case
or control)
a.
Yes
b.
No
c.
Unclear
Comparability of groups
8. Are the groups (exposed/unexposed) comparable with respect to
confounding factors? (The list in the table will be specific to the review
question)
Confounding
factors
Matched
design
Balanced by
design
Imbalance
adjusted for in
analysis
Neither or
unclear
Age
Gender
Smoking status
Etc
Outcome assessment
9. How was the outcome status ascertained? (specific to the review question)
a. Self-assessed questionnaire
b. Medical record review
c. Clinical examination
d. Type of diagnostic test
e. Unclear
10. Were outcome assessors blind to exposure status?
a. Yes
b. No
c. Unclear
Page 217 of 219

Appendices.
Analysis
11. What was the proportion of subjects included in the final analysis?
Percentage_____________
a. All participants included in analysis
b. 80% subjects included in final analysis
c. < 80% subjects included in analysis with no description of those
missing
d. < 80% subjects included in analysis with no description of those
missing
e. Based on a description of the missing subjects, bias likely to be
introduced.
Page 218 of 219

Appendices.
Quality criteria for systematic reviews (NHMRC 2001)

Include:
Yes: No:
Name of paper__________________________________
Was an adequate search strategy used?
Yes /No/Not stated
Were the inclusion criteria appropriate and applied in an unbiased way?
Yes/No/Not stated
Was a quality assessment of included studies undertaken?
Yes/No/Not stated
Were the characteristics and results of the individual studies appropriately

summarized?
Yes/No/Not stated
Were the methods for pooling the data appropriate?
Yes/No/Not stated
Were sources of heterogeneity explored?
Yes/No/Not stated
Total Score:..
Yes = 1, No = 0, Not stated = 0
Page 219 of 219

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Royal College of Nursing

20 Cavendish Square London W1G ORN

The management of pressure ulcers in

This guideline has been developed by the Royal College of

The management of pressure ulcers in primary and secondary care

Other relevant guidelines and documents:

Nutritional support in adults: oral supplements, enteral and parental feeding.Currently

National Service Framework for older people (2001) DH.

The management of pressure ulcers in primary and secondary care

local services, policies and protocols

the patients circumstances and wishes

available personnel and support surfaces

clinical experience of the practitioner, and

knowledge of more recent research findings.

When implementing evidence-based guidance it is important that all health care

The management of pressure ulcers in primary and secondary care

Guideline Development Group membership

Chartered Society of Physiotherapy

Prof Debra Bick

Acting Director, National Collaborating Centre Nursing

The management of pressure ulcers in primary and secondary care

The management of pressure ulcers in primary and secondary care

Knowsley Primary Care Trust

The management of pressure ulcers in primary and secondary care

Nightingale Care Beds Ltd

The management of pressure ulcers in primary and secondary care

absolute relative risk

Centre for Health Economics, University of York

The management of pressure ulcers in primary and secondary care

Absolute risk reduction

The difference between the observed event rates

Dressings that may cover a wound but do not create an

Influences on a study that can lead to invalid conclusions

A study in which the effects of an exposure in a group of

Detailed report on one patient (case), usually covering the

Description of several cases of a given disease or condition,

An individual who provides unpaid care as opposed to paid

A group of people sharing some common characteristics

The management of pressure ulcers in primary and secondary care

The extent to which an intervention for example a support

An international organisation in which people retrieve,

An observations study that takes a group (cohort) of patients

Interventions or treatments other than the treatment under

Co-existence of a disease or diseases in a study population

A consultation process between a health care professional

The management of pressure ulcers in primary and secondary care

A way of expressing certainty about the findings from a study

A type of economic evaluation where both costs and benefits

A type of economic evaluation that assesses the additional

A special form of cost-effectiveness analysis where benefit is

The total cost to the person, the NHS or to society.

The process of converting future pounds and future health

The removal of dead (devitalised) tissue, cell debris or

Dead tissue can present in a variety of forms. Dead

The management of pressure ulcers in primary and secondary care

A study in which neither the subject (patient) nor the

Comparative analysis of alternative courses of action in

The extent to which interventions achieve health

The extent to which medical interventions achieve health