Health Technology Assessment 2001; Vol. 5: No. 14 Rapid review

A rapid and systematic review of the clinical effectiveness and cost- effectiveness of debriding agents in treating surgical wounds healing by secondary intention

R Lewis P Whiting G ter Riet S O’Meara J Glanville

Health Technology Assessment NHS R&D HTA Programme HTA HTA

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The website also provides information about the HTA Programme and lists the membership of the various committees. A rapid and systematic review of the clinical effectiveness and cost- effectiveness of debriding agents in treating surgical wounds healing by secondary intention

R Lewis1* P Whiting1 G ter Riet1,2 S O’Meara1 J Glanville1

1 NHS Centre for Reviews and Dissemination, University of York, UK 2 Department of Epidemiology, Maastricht University, The Netherlands

* Corresponding author

Competing interests: One of the members of the advisory panel has attended symposiums and meetings organised by wound care companies for which they received lecture fees and travel expenses.Two members have received sponsorship to attend conferences from a pharmaceutical company. One member of the advisory panel was employed on a lectureship sponsored by a pharmaceutical company.

Expiry date: December 2003

Published May 2001

This report should be referenced as follows:

Lewis R,Whiting P,ter Riet G, O’Meara S, Glanville J. A rapid and systematic review of the clinical effectiveness and cost-effectiveness of debriding agents in treating surgical wounds healing by secondary intention. Health Technol Assess 2001;5(14).

Health Technology Assessment is indexed in Index Medicus/MEDLINE and Excerpta Medica/ EMBASE. Copies of the Executive Summaries are available from the NCCHTA website (see opposite). NHS R&D HTA Programme

he NHS R&D Health Technology Assessment (HTA) Programme was set up in 1993 to ensure T that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and provide care in the NHS. The research reported in this monograph was commissioned by the HTA Programme on behalf of the National Institute for Clinical Excellence (NICE). Rapid reviews are completed in a limited time to inform the appraisal and guideline development processes managed by NICE. The review brings together evidence on key aspects of the use of the technology concerned. However, appraisals and guidelines produced by NICE are informed by a wide range of sources. The research reported in this monograph was funded as project number 00/03/01. The views expressed in this publication are those of the authors and not necessarily those of the HTA Programme, NICE or the Department of Health. The editors wish to emphasise that funding and publication of this research by the NHS should not be taken as implicit support for any recommendations made by the authors.

Criteria for inclusion in the HTA monograph series Reports are published in the HTA monograph series if (1) they have resulted from work commissioned for the HTA Programme, and (2) they are of a sufficiently high scientific quality as assessed by the referees and editors. Reviews in Health Technology Assessment are termed ‘systematic’ when the account of the search, appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others.

HTA Programme Director: Professor Kent Woods Series Editors: Professor Andrew Stevens, Dr Ken Stein, Professor John Gabbay and Dr Ruairidh Milne Monograph Editorial Manager: Melanie Corris

The editors and publisher have tried to ensure the accuracy of this report but do not accept liability for damages or losses arising from material published in this report.

ISSN 1366-5278 © Queen’s Printer and Controller of HMSO 2001 This monograph may be freely reproduced for the purposes of private research and study and may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to HMSO,The Copyright Unit, St Clements House, 2–16 Colegate, Norwich, NR3 1BQ. Published by Core Research, Alton, on behalf of the NCCHTA. Printed on acid-free paper in the UK by The Basingstoke Press, Basingstoke. R Health Technology Assessment 2001; Vol. 5: No. 14

Contents

Glossary and list of abbreviations ...... i 7 Conclusions...... 47

Executive summary ...... v Acknowledgements...... 49 1 Aims ...... 1 References ...... 51 2 Background...... 3 Description of wounds ...... 3 Appendix 1 Classification of debriding Current service provision ...... 3 methods and agents ...... 59 Description of intervention ...... 5 Appendix 2 List of excluded studies ...... 63 3 Methods...... 7 Search strategy...... 7 Appendix 3 Data extraction forms...... 69 Inclusion and exclusion criteria...... 7 Data extraction strategy ...... 8 Appendix 4 Quality checklists ...... 73 Quality assessment strategy...... 8 Data synthesis...... 8 Appendix 5 Summary of included clinical trials...... 75 4 Results: clinical effectiveness ...... 11 Quantity and quality of research available .. 11 Appendix 6 Summary of included Assesment of clinical effectiveness ...... 16 economic evaluations ...... 93 Summary of clinical effectiveness data ...... 31 5 Results: cost-effectiveness ...... 35 Appendix 7 Search strategies ...... 99 Quantity and quality of research available .. 35 Assessment of cost-effectiveness ...... 38 Appendix 8 Manufacturer and sponsor Summary of cost-effectiveness data ...... 39 submissions made to NICE...... 117 6 Discussion ...... 41 Health Technology Assessment reports Main results ...... 41 published to date ...... 123 Assumptions, limitations and uncertainties ...... 42 Health Technology Assessment Need for further research...... 45 Programme ...... 129

Health Technology Assessment 2001; Vol. 5: No. 14

Glossary and list of abbreviations

Technical terms and abbreviations are used throughout this report. The meaning is usually clear from the context, but a glossary is provided for the non-specialist reader. In some cases usage differs in the literature, but the term has a constant meaning throughout this review.

Glossary Bias A tendency to produce results that analysis, different consequences are values in depart systematically from the ‘true’ results. comparison to each other, and the outcomes Unbiased results are internally valid. (e.g. life-years gained) are adjusted by assign- ing weightings. In this way, an attempt is Confidence interval (CI) The range within made to value the quality of life associated which the ‘true’ value of the effect of an with the outcome, so that life-years gained intervention is expected to lie with a given become quality-adjusted life-years gained. degree of certainty. Confidence intervals represent the distribution probability of Debridement The removal of devitalised, random errors, but not systematic necrotic tissue or fibrin from a wound.1 errors (bias). Dehiscence The splitting or bursting open Cost–benefit analysis (CBA) An attempt of a wound.2 is made to give the consequences of the Effect size/measure (treatment effect, alternative interventions a monetary value. estimate of effect) The observed relationship In this way, the consequences can be more between an intervention and an outcome. easily compared with the costs of the This could be summarised as a p value, an intervention. This can involve measuring odds ratio, a relative risk, a risk difference, individuals’ ‘willingness to pay’ for the number needed to treat or a standardised given outcomes. mean difference, or weighted mean Cost–consequence analysis (CCA) Where difference for pooled data. multiple outcome measures and costs for Family Practitioner Form (FP 10) The form each alternative are presented, clinical used for prescriptions within general practice. outcomes may vary in direction and effect. This is sometimes considered a subtype of Generalisability The extent to which cost-effectiveness analysis. the effects observed in a study truly reflect what can be expected in a target population Cost-effectiveness analysis (CEA) The con- beyond the sample recruited in that study. sequences of the alternatives are measured It refers to the applicability of the results in natural units (e.g. postoperative infections to non-study subjects. prevented, years of life gained). The con- sequences are not given a value. Granulation The outgrowth of new capillaries and connective tissue from the surface of an Cost-minimisation analysis (CMA) Where open wound.2 two alternatives are found to have equal clinical efficacy or outcomes (consequences). Healing by primary intention When the Therefore, the only difference between the edges of a clean wound are accurately held two is cost. This is considered to be a subtype together, healing occurs with the minimum of cost-effectiveness analysis. of scarring and deformity.2 Cost–utility analysis (CUA) The Healing by secondary intention When the consequences of alternatives are measured edges of a wound are not held together, the in ‘health state preferences’, which are gap is filled by granulation tissue before given a weighting score. In this type of epithelium can grow over the wound.2 continued i Glossary and list of abbreviations

Glossary contd Heterogeneity The variability or differences published. Because of this, systematic reviews between studies in key characteristics (clinical that fail to identify such studies may over- heterogeneity), quality (methodological estimate the true effect of an intervention. heterogeneity) and effects (heterogeneity p value (statistical significance) The of results). Statistical tests of heterogeneity probability of finding a treatment of this may be used to assess whether the observed magnitude or larger given that the null variability in study results (effect sizes) is hypothesis is correct, in an unbiased study. greater than that expected to occur Put simply, the probability that the observed by chance. results in a study could have occurred Meta-analysis The use of statistical techniques by chance. A p value of less than 5% to combine the results of studies addressing (i.e. p < 0.05) is generally regarded as the same question into a summary measure. statistically significant. Modern dressings A collective term used in Quality-adjusted life-year (QALY) An index this review to represent the different types of of survival that is weighted or adjusted by dressings evaluated by the included trials (i.e. the patient’s quality of life during the foam, alginate, hydrofibre, hydrocolloid and survival period. dextranomer beads dressings). It is, however, Relative risk (RR) The ratio of risk in the acknowledged that these dressings cannot intervention group to the risk in the control be categorised as one type as they all have group. A relative risk of one indicates no different properties and functions. difference between comparison groups. Moist wound healing Healing achieved by the For undesirable outcomes a relative risk application of an occlusive, semi-permeable that is less than one indicates that the inter- dressing, which permits the exudate to collect vention was effective in reducing the risk under the film2 and therefore maintains a of that outcome. moist interface with the wound surface. Secondary care Medical interventions Primary care Basic, general healthcare intended to prevent a worsening of a con- services that are intended to prevent disease, dition or the development of complications detect illness at an early stage, and to treat in a patients suffering from illness or injury. routine, uncomplicated conditions. Primary Secondary care is often rendered by a care is usually the patient’s initial contact specialist after referral from a primary point with the healthcare system. care provider. Systematic review A review of the evidence Primary research Studies in which data are on a clearly formulated question. It uses first collected. systematic and explicit methods to identify, Publication bias A bias in the research select and critically appraise relevant primary literature where the likelihood of publication research, and to extract and analyse data of a study is influenced by the significance from the studies that are to be included in of its results. Studies in which an intervention the review. Statistical methods (meta-analysis) is found to be ineffective, or where there may or may not be used to pool data from are no clear results, may be less likely to be individual studies.

ii Health Technology Assessment 2001; Vol. 5: No. 14

List of abbreviations

ANOVA one-way analysis of variance ITT intention to treat

ARC Academic Reference Centre MD mean difference CCTR Cochrane Controlled Trials MRSA methicillin-resistant Register Staphylococcus aureus CBA cost–benefit analysis* * NHS EED NHS Economic Evaluation CCA cost–consequence analysis Database CEA cost-effectiveness analysis* NICE National Institute for CI confidence interval Clinical Excellence CMA cost-minimisation analysis* NRR National Research Register CUA cost–utility analysis* QALY quality-adjusted life-year* CRD NHS Centre for Reviews and Dissemination RCT randomised controlled trial

DARE Database of Abstracts of Reviews RR relative risk of Effectiveness FP 10 Family Practitioner Form 10 SD standard deviation HEED Health Economic Evaluations VAS visual analogue scale* Database HMIC Health Management Information Consortium * Used only in tables

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Health Technology Assessment 2001; Vol. 5: No. 14

Executive summary

Background wounds healing by secondary intention at specialised wound care clinics as compared Most surgically sutured wounds heal without any to conventional care. complication. However, in some cases wound healing can be delayed due to the presence of The review incorporated all debriding methods infection or wound breakdown. This can result and any agent that is considered to have a in the wounds becoming cavity wounds and thus debriding property. necessitate healing by secondary intention. Other surgical wounds that are not sutured but left to heal by secondary intention include abscess cavities Methods such as perianal abscesses or breast abscesses. The following databases were searched using Surgical wounds healing by secondary intention strategies designed specifically for each database: are thought to heal more slowly than wounds MEDLINE, EMBASE, CINAHL, HMIC (Health healing by primary intention, especially if infection Management Information Consortium), CCTR is present or healing is compromised by factors via the Cochrane Library, the National Research such as decreased blood supply, poor nutritional Register (NRR), the NHS Economic Evaluation status or a general suppression of the immune Database (NHS EED), and the Health Economic response. Such wounds may contain dead tissue Evaluations Database (HEED). Additional refer- and have a moderate or high level of exudate. ences were identified through reviewing manu- facturer and sponsor submissions made to NICE, Debridement involves the removal of devitalised, the bibliographies of retrieved articles, and necrotic tissue or fibrin from a wound. There conferences proceedings on the Internet. are many different methods that can be used to debride a wound, which are broadly classified as Only randomised controlled trials (RCTs) surgical/sharp, biosurgical, mechanical, chemical, or non-randomised controlled trials with con- enzymatic and autolytic. Although it is generally current controls and full economic evaluations agreed that the management of surgical wounds were considered for inclusion. Only studies that which contain devitalised tissue and are healing evaluated some sort of debriding method or a by secondary intention requires debridement, it specialised wound care clinic (a nurse with is not always clear as to what is the best method specialist training in wound care; care being or agent to use. There is currently a large provided by a multidisciplinary team; a fast- selection of products with debriding properties track referral system to other professions (e.g. available on the market, which vary considerably dermatologist); or access to the latest health in cost. It is important that the choice of both technology) were included in the review. Studies debriding method and product is based on the had to include participants with surgical wounds best scientific evidence available, taking into healing by secondary intention (e.g. cavity account both cost and effectiveness data. wounds, the consequences of wound dehiscence and abscesses) and report an objective measure of wound healing. Objectives Data were extracted by one reviewer and checked The review had two main objectives: by a second. Quality assessment was conducted independently by two reviewers. Disagreements • To determine the clinical effectiveness and were resolved by consensus and, when necessary, cost-effectiveness of debriding agents in by recourse to a third reviewer. The primary out- treating surgical wounds healing by comes of interest were wound healing and cost. secondary intention. Results of data extraction and quality assessment • To evaluate the clinical effectiveness and cost- were presented in structured tables and also as a effectiveness of treating patients with surgical narrative summary. In addition, where feasible, v Executive summary

the results of individual studies were presented of included participants. The majority of trials as forest plots. Studies were grouped according that used the outcome measure ‘time to complete to the type of wound, debriding method and healing’ reported mean values instead of median outcome measure used. values. Mean healing times may not represent the healing events in an appropriate way as they are greatly affected by outliers and, unlike median Results times, cannot be calculated if some wounds fail to heal. Almost half of the included trials did Clinical effectiveness not report the results in sufficient detail to Seventeen trials met the inclusion criteria, calculate a summary estimate of the treatment all of which used the autolytic method of debride- effect, for one or more outcome measures. The ment. No studies were found that investigated statistical test used to compare the treatment sharp/surgical, biosurgical, mechanical, chemical groups was often not reported or no statistical or enzymatic debridement in the treatment of test was used. surgical wounds healing by secondary intention. No studies were found which investigated special- Overall findings of clinical effectiveness ised wound care clinics that included the provision In summary, there is a suggestion that modern of care within a clinical setting (based in either dressings have a beneficial effect on healing primary or secondary care). The type of surgical compared to traditional gauze dressings, wounds investigated by studies included in the especially for toenail avulsions, where significant review were those that had broken down post- benefits of modern dressings were found. How- operatively, perineal wounds resulting from proc- ever, these results should be interpreted with tolectomy or rectal excision, and those left open caution due to the poor quality of the studies, after pilonidal sinus excision or abscess incision, the fact that the direction of bias is unclear or wounds following a laparotomy. Four additional and the unknown effects of potential studies investigated treatment of postoperative publication bias. wounds from toenail avulsions. The debriding agents investigated included foam dressings (sili- There is some evidence to suggest a beneficial cone elastomer foam dressings and polyurethane effect of modern dressings for surgical wounds foam dressings), alginate dressings, hydrocolloid on other outcomes, such as pain, dressing perfor- dressings, and dextranomer polysaccharide bead mance and resource use, although a beneficial dressings. For the purposes of this review these effect for these outcomes was not found for studies are referred to collectively as modern dressings. of toenail avulsions. However, in addition to the Most were compared to plain or impregnated methodological problems highlighted above, these gauze dressings. However, there was a great outcome measures are very difficult to assess and variation between trials with respect to the type are particularly subject to bias, especially in of antiseptic solution that the gauze was soaked unblinded studies. in or the type of gauze-based dressing used. Three trials included a direct comparison of two In view of the lack of data and the poor methodo- types of modern dressings. One trial compared logical quality of the trials, there is no evidence to polyurethane foam with alginate dressings and support the superiority of one type of modern another trial compared it with silicone foam. The dressing over another. third trial compared dextranomer polysaccharide with silicone foam dressings. The heterogeneous Cost-effectiveness nature of the included studies precluded Four economic evaluations met the inclusion statistical pooling of results. criteria. All four studies included a cost- effectiveness analysis of an autolytic debriding Methodological quality of clinical method compared with traditional gauze effectiveness data dressings soaked in various antiseptic solutions. On the whole, included trials tended to have a The dressings investigated were silicone elas- small sample size (median = 43 participants) and tomer foam dressings, polyurethane foam the majority suffered from methodological flaws. dressings and calcium alginate dressings. No The total number of participants included in the economic evaluations that compared the cost- trials was 783. Detailed information relating to the effectiveness of two different types of modern randomisation procedure and blinding was not dressings were found. No economic evaluations reported in most trials. Many trials failed to report investigating specialised wound care clinics vi the initial wound size and baseline characteristics were found. Health Technology Assessment 2001; Vol. 5: No. 14

Conclusions • More good-quality economic evaluations of modern dressings that are based on sound The results of the cost-effectiveness data suggest scientific evidence, such as good-quality partial dominance in favour of the intervention, primary RCTs. This would mean that infor- and only the cost data support the use of the mation relating to such outcome measures intervention dressings (modern dressings were as time taken to change the dressings, number found to have lower costs than the gauze dressings, of dressing changes required and number of but with no difference in the outcome measures). nursing visits could be measured accurately. However, the quality of the clinical effectiveness Economic evaluations would also need to and cost-effectiveness analyses are poor. utilise sensitivity analyses that investigate the effect on the overall findings of adjusting Generalisability of the review findings these variables. The majority of included studies were UK based, • RCTs of other autolytic debriding methods not within the NHS setting. Two of the included trials covered by included trials, such as hydrogels. were based in a military hospital and five trials • Further research, in both clinical effectiveness were based outside the UK (Australia, USA, and cost-effectiveness, into the use of other France, Italy and Spain). Studies were published debriding methods, such as enzymatic, between 1979 and 2000, four before 1984 and biosurgical and surgical methods, in the the remainder between 1991 and 2000. treatment of surgical wounds healing by secondary intention. Implications for future research • Because there is no research available on The review identified the following areas for the organisation of care, such as the use of future research: specialist wound care clinics, research that includes studies looking at both the clinical • Large multicentre trials of good methodological effectiveness and cost-effectiveness of the use quality comparing foam, alginate, hydrofibre, of specialised wound care clinics is required. hydrocolloid or dextranomer bead dressings • Further epidemiological studies to evaluate the with standard treatment or, preferably, to each extent of the problem (i.e. the prevalence and other. It is acknowledged that it may be difficult cost to the NHS of treating surgical wounds to recruit sufficient numbers of patients with healing by secondary intention where there similar wounds from a single centre/hospital. is a delay in the healing process).

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Health Technology Assessment 2001; Vol. 5: No. 14

Chapter 1 Aims

The main objectives of the review were: primary or secondary care) with the addition of one or more of the following criteria: • to determine the clinical effectiveness and cost- effectiveness of debriding agents in treating • a nurse with specialist training in wound care surgical wounds healing by secondary intention • care provided by a multidisciplinary team, • to evaluate the clinical effectiveness and cost- or a fast-track referral system to other effectiveness of treating patients with surgical professionals (e.g. a dermatologist) wounds healing by secondary intention at • access to the latest health technology (e.g. specialised wound care clinics compared dressings not available on the drug tariff or to conventional care. not included in local formularies).

The review included all debriding methods and Conventional care included the management of any agent considered to have a debriding property wounds within the hospital or community, or (see appendix 1). shared between the two.

Specialised wound clinics included the provision of care within a clinical setting (based in either

1

Health Technology Assessment 2001; Vol. 5: No. 14

Chapter 2 Background

Description of wounds tissue defences may not be able to cope with the increase in the bacterial load, which may Most surgically sutured wounds heal without any be present in the necrotic tissue. It is therefore complication. However, in some cases wound considered that wound healing can be accelerated by debridement (i.e. the removal of any devitalised healing can be delayed due to the presence of 10,12 infection, wound dehiscence (partial or complete tissue from the wound). separation of the wound) or the presence of a foreign body.3,4 This can result in the wounds becoming cavity wounds and thus necessitate Current service provision healing by secondary intention.5 Other surgical wounds that are not sutured but left to heal Service delivery More than 6 million operations were undertaken by secondary intention include abscess cavities 13 such as perianal abscesses or breast abscesses. in the NHS in England between 1998 and 1999. Wounds healing by secondary intention will However, there is no official figure available on need to be filled with new tissue. This process how many of these operations result in surgical includes granulation, epithelialisation and wounds healing by secondary intention. Further- the contraction of the wound.6,7 more, there are no data available on how many of the resulting surgical wounds healing by secondary intention are ‘clean’ granulating Surgical wounds healing by secondary intention wounds and how many wounds would be are thought to heal more slowly than wounds deemed to require debridement due to the healing by primary intention, especially if presence of devitalised or necrotic material. infection is present. Such wounds may contain One study that included an economic evalu- dead tissue and have a moderate or high level ation of two types of dressings in the manage- of exudate, although it is acknowledged that ment of acute surgical wounds left to heal by some wounds healing by secondary intention secondary intention, calculated that an average may be clean granulating wounds. Dehisced UK district health authority with a catchment wounds usually contain devitalised necrotic 4 population of 300,000 would have potentially material. 120 patients per year with an open acute surgical wound left to heal by secondary During the inflammatory process of wound intention.14 However, this information was healing, devitalised tissue, debris and bacteria based on the theatre register data for five are removed by a process of phagocytosis medi- general surgeons at a single NHS trust hospital ated by macrophages, which are derived from with an average catchment population (190,000), monocytes and phagocytotic white blood cells.7–10 which means that the information is probably However, as the area of non-viable tissue expands an underestimation of the incidence of such it can impede the body’s natural healing process, wounds, as the figures did not include patients since it serves to stimulate ongoing inflammation from other specialities (e.g. orthopaedics and and leucocyte infiltration, which delays pro- gynaecology) with suitable wounds. gression to the formation of granulation tissue and re-epithelialisation.1 Necrotic tissue also The actual cost of treating surgical wounds provides an ideal environment for bacterial left to heal by secondary intention has not been growth11 and interferes with the mechanism of systematically evaluated. The net cost of selected wound contraction.12 There are also a number dressings (alginate, hydrocolloids, hydrogels of other local and systemic factors that can and polyurethane dressings) dispensed in the impinge upon the wound healing process and community via Family Practitioner Form 10 thus cause further delay. These include factors (FP 10) in England in 1998 was £37 million.15 such as decreased blood supply, poor nutritional However, the majority of this expenditure is status and a general suppression of the immune likely to have been in the treatment of chronic response.7 In such circumstances, the local wounds, especially venous leg ulcers, rather than 3 Background

in the treatment of surgical wounds. These Professionals working in the community may have figures give very little information about the less access to the advice of other specialists, with full cost of patient management or the cost of referral for a multidisciplinary opinion being more treating surgical wounds healing by secondary accessible within a hospital setting. Timely referral intention. In addition, many NHS trusts and protocols to other specialities (e.g. dermatologists, primary care groups purchase directly from dieticians and plastic surgeons) is very important, manufacturers and wholesalers, for which data because the older a wound becomes the longer it relating to cost are not available. The highest takes to heal.19 This means that a fast-track referral costs incurred when treating surgical wounds system has the potential to reduce the number of left to heal by secondary intention include the surgical wounds healing by secondary intention cost of hospital stay and staffing costs,14 for which that are slow to heal. there are no official figures available. Specialist practitioners, such as tissue viability Modern materials designed to provide the nurse specialists, with specific training in wound optimum conditions to promote healing, such care would potentially have greater knowledge as occlusive and semi-occlusive dressings, are and skills to treat surgical wounds where there is more expensive than traditional products such a delay in healing than would other practitioners. as gauze dressings. However, many of the newer The efficacy of wound management products products require less frequent dressing changes, depends on whether they are used appropriately and may lead to a reduction in healing time.16 (e.g. a dressing that is considered to have some This means that an expensive dressing may debriding properties that is not used correctly incur less cost than a cheaper dressing when the will not debride the wound). Therefore, know- complete episode of care is taken into account.17 ledge and skills in the use of various products is A decrease in healing time is also likely to essential. The product industry is often the only promote both social and economic advantages available source of education and advice for for patients, in terms of ensuring a shorter generic practitioners such as nurses, both in duration of pain and discomfort, as well as the community and in the private sector.19 With early mobilisation and therefore return to a growing number of products available, the work or usual activities. level of knowledge required to make the right choice of treatment is also greater. In addition, Service delivery and organisation the management of one type of wound is not of care transferable to another (e.g. the treatment of The management of patients with surgical venous leg ulcers will differ greatly from that wounds healing by secondary intention is of surgical wounds). shared by both the hospital and the community. However, due to an increase in the number of Specialised wound care clinics with access to surgical procedures being undertaken in primary the best available practices and interventions care and outpatient clinics and the general and/or a fast-track referral system to a multi- decrease in the length of hospital stay, the disciplinary team could potentially lead to a number of patients treated in the community reduction in healing time. They may also prove is increasing. Patients are also increasingly to be a more cost-effective method of wound expected to have a greater involvement in care management in terms of both labour their own care.17 and service costs.

Ideally, when patients are discharged from The implementation of specialised clinics in the acute or secondary care into the community their treatment of other chronic wound types (e.g. care should continue without interruption. For venous leg ulcers) has proceeded without robust some patients, however, ‘seamless’ care is not evidence to show that they make a difference. possible. For example, hospital staff and those This has been largely due to the fact that evalu- working in the community may not have access ations have tended to be single pre- and post- to the same range of wound care products. It audits, with only one cluster randomised trial. has been noted that secondary care has access In addition, a raft of interventions is generally to more advanced products than primary care, implemented simultaneously (e.g. clinic plus which is limited to those available on the Drug new treatment plus new referral pattern plus Tariff through prescription.18 However, hospital educational services), which means that the staff may also be restricted to products available effectiveness of individual items has not 4 on local formularies. been considered.20 Health Technology Assessment 2001; Vol. 5: No. 14

Description of intervention considered unpleasant by some people, and patient acceptability is therefore a key consider- Debridement involves the removal of devitalised, ation in its use. The enzymes that the maggots necrotic tissue or fibrin from a wound.1,7 The produce have the potential to damage keratin- effectiveness of debridement has not been ised epidermis if applied in excess, or left in confirmed by clinical research, although it is place for too long after debridement has generally agreed that wounds that contain been completed.28 devitalised and necrotic tissue require debriding.10,12 Mechanical debridement This involves the physical removal of devitalised There are many different methods that can be tissue from the wound bed by applying a mech- used to debride a wound. These are broadly anical scrubbing force or by using wet-to-dry classified as surgical/sharp, biosurgical, mech- dressings.22 Wet-to-dry debridement involves the anical, chemical, enzymatic and autolytic application of a saline-moistened gauze pad to (see appendix 1). an area of necrotic tissue presoftened with saline. As the dressing dries, necrotic tissue becomes Surgical/sharp debridement attached to the gauze and is removed along with This involves the removal of devitalised tissue the dressing. This method is generally painful to using a sharp instrument such as scissors or a the patient because patient structures that are scalpel. This method can be painful to the patient. attached to the necrotic tissue are disrupted/ Surgical/sharp debridement can be undertaken removed from the wound.22 There are other in two ways. First, the excision or wide resection methods of mechanical debridement that use of all dead or damaged tissue can be carried water to loosen necrotic debris. High-pressure out by a surgeon in theatre with general or irrigation and whirlpool baths mechanically local anaesthetic.21 This method is quick and is debride wounds using jets of water.12 The dis- essential when the presence of devitalised tissue advantage of mechanical debridement is that becomes life-threatening to the patient. However, it may damage the healthy wound bed.12 it is considered to be a non-selective method of debridement, as healthy tissue lying at the Chemical debridement margin of the wound adjacent to dead tissue is This involves the use of chemicals such as also removed.8,22 Alternatively, smaller quantities hypochlorite solutions (e.g. Eusol™) and caustic of dead tissue lying just above the level of agents (e.g. Aserbine™ and hydrogen peroxide) viable tissue can be removed by a clinician for the debridement of wounds.12,29 using sharp scissors or a blade in the ward or home environment.21 This method is time Enzymatic debridement consuming and requires skill and patience, This involves the topical application of enzymes but it is considered to be more specific. to devitalised tissue.12 These agents are activated in the presence of moisture and bring about the Biosurgical debridement breakdown/digestion of the unwanted tissue. Sterile maggots (greenbottle larvae) may be This method is thought to be a selective method used to debride wounds. Greenbottle (Lucilia of debridement, as healthy cells may contain sericata) larvae destroy dead tissue by liquefying enzyme inhibitors that protect the tissues from it with enzymes and ingesting it.12 Larvae are the action of these enzymes.22 Various types of about 2 mm long and are applied directly to enzymes target specific necrotic tissues such as the wound and held in place with a dressing.23 protein, fibrin and collagen.11 Enzymes commonly Maggots may also have the added benefit of used in wound debridement include streptokinase ingesting bacteria, thus reducing the risk of and streptodornase.29 clinical infection developing or proceeding in a wound.23 They have also been used to eliminate Autolytic debridement antibiotic-resistant strains of bacteria such as The body will naturally debride dead tissue with methicillin-resistant Staphylococcus aureus enzymes generated by the inflammatory and other (MRSA).24–26 It has been suggested that larval cells.22 This process can be speeded up by the therapy stimulates the production of granulation creation of a moist environment.23 Many of the tissue and thus promotes wound healing.27,28 dressings available, the main function of which However, as yet, there does not appear to be any is to provide a moist wound environment, are clinical evidence to support this in the healing of also recognised as having debriding properties surgical wounds. Maggot therapy is likely to be (e.g. occlusive and semi-occlusive dressings). 5 Background

Summary selection of products with debriding properties It is generally agreed that the management of available on the market, which vary considerably surgical wounds that contain sloughy necrotic in cost. It is important that the choice of both tissue healing by secondary intention requires debriding method and product is based on the debridement.10,12 However, this is not supported best scientific evidence available, taking into by research evidence. There is currently a large account both cost and effectiveness data.

6 Health Technology Assessment 2001; Vol. 5: No. 14

Chapter 3 Methods

Search strategy or more of the inclusion criteria were excluded and the reason for exclusion was recorded The following databases were searched: (appendices 2 and 8).

• MEDLINE (SilverPlatter), 1966 to June 2000 Surgical wounds • EMBASE (SilverPlatter), 1980 to June 2000 Studies had to evaluate the management of • CINAHL (SilverPlatter), 1982 to May 2000 surgical wounds healing by secondary intention • Health Management Information Consortium (e.g. surgical wounds that have ‘broken down’ (HMIC), 2000 disk into cavities, the consequences of wound • Cochrane Controlled Trials Register (CCTR) dehiscence and cavities following incision and (via Cochrane Library, 2000, Issue 2) drainage of abscesses). Excised pilonidal sinuses • National Research Register (NRR), that were left to heal by secondary intention Issue 1:2000 were also included. Such wounds usually con- • NHS Economic Evaluation Database tain necrotic or sloughy material and may have (NHS EED), June 2000 a high or low level of exudate. Studies of surgical • Health Economic Evaluations Database toenail avulsion that involved the destruction (HEED), June 2000. of the germinal matrix with phenol or sodium hydroxide in order to prevent the regrowth of Searches of conference paper databases and the nail were also included. These wounds are world wide web conference sites were also left to heal by secondary intention and the acid undertaken. More detailed information about burn results in the formation of slough. It is the search strategies used is presented in acknowledged, however, that the healing process appendix 7. of these wounds may differ from that of wounds treated with more radical surgical interventions. The bibliographies of all retrieved articles, Consequently, the results of these studies are including the recent Health Technology Assess- presented separately. ment reviews on the debridement and treatment of chronic wounds, were searched for any addi- Studies of patients undergoing any form of tional references that met relevance criteria. surgery, other than corneal or dental surgery, Manufacturer and sponsor submissions made were considered for inclusion in the review, and to the National Institute for Clinical Excellence information regarding the type of operation (NICE) were reviewed to identify any undertaken was recorded. additional studies. The review did not specifically investigate infected wounds, but information on the Inclusion and exclusion criteria presence or absence of infection, as well as the use of antibiotic therapy was recorded. Titles (and where possible abstracts) of studies identified from all searches and sources were Studies of chronic wounds, such as venous leg assessed independently by two reviewers for ulcers and pressure sores, and those that included relevance. If either reviewer considered the surgical wounds healing by primary intention paper to be potentially relevant, a full copy were excluded. Studies that included the donor of the manuscript was obtained. sites of skin grafts were also excluded, as they were considered to be ‘clean’ granulating Each full copy was reassessed for inclusion. Two wounds and were therefore not deemed to reviewers independently decided whether the require debridement. primary studies met each criterion and any dis- agreements were discussed to obtain a consensus. Type of intervention If no agreement was reached a third reviewer Any method or agent that can be used for the was consulted. Studies that did not meet one debridement of surgical wounds was included 7 Methods

in the review (see appendix 1). Many dressings Language restrictions have debriding properties, as any dressing that Only studies reported in English, German, maintains a moist environment will, in theory, Dutch or French were considered for the review. promote autolytic debridement.7 However, it is However, the search strategy included all very difficult to differentiate specific debriding languages, and the bibliographic details of other agents from those that have been developed non-English studies are presented in the table simply to promote healing. Therefore, as the of excluded studies (see appendix 2). review was primarily interested in wound healing, a very broad classification was used that incor- porated most types of dressings considered to Data extraction strategy have any form of debriding property (e.g. providing a moist environment for Data were extracted by one reviewer using autolytic debridement). predefined data extraction forms (appendix 3) and checked by a second reviewer. Any disagree- The review did not investigate the antimicrobial ment was resolved by consensus and, if this was treatment of surgical wounds per se. However, a not reached, a third reviewer was consulted. number of agents have both antimicrobial and debriding properties (e.g. hypochlorites, hydrogen peroxide and cadexomer iodine), and studies Quality assessment strategy investigating such agents were included in the review. Studies that included only treatment The methodological quality of each included protocols for surgical wounds other than study was assessed using a predefined checklist debridement, such as drug therapy to promote (appendix 4). Two reviewers conducted this healing, growth factors, tissue engineering and process independently. Any disagreement was ultrasound, were excluded. resolved by consensus and, if this was not obtained, a third reviewer was consulted. Study design Only randomised controlled trials (RCTs) A published checklist32 was used to assess the or non-randomised controlled trials with con- quality of studies that included an economic current controls were considered. Any relevant evaluation of either specialised wound clinics full economic evaluations where the costs and or debriding agents. consequences of two or more alternatives were considered were also included. Only human studies were included in the review. Data synthesis

Outcome measures Where sufficient data were presented, an Healing is considered to be the most important estimation of the treatment effect along with outcome measure.30 Only studies that reported the 95% confidence interval (CI) was calculated an objective measurement of wound healing for each individual study. Where possible this were included in the review. Such outcome was done on an intention-to-treat (ITT) basis. measures could include time to wound healing For dichotomous outcome measures the (or the time it takes for a certain proportion, relative risk (RR) was calculated and for say 50%, of wounds to heal), the number (pro- continuous outcomes the mean difference portion) of wounds completely healed within a (MD) was used. certain time period, healing rate, or change in wound size or volume (expressed as absolute or The results of data extraction and quality relative values). Studies in which the investigator assessment are presented in structured tables made a subjective decision on how much the and also as a narrative summary. Studies were wound had healed based on clinical experience grouped according to the type of debriding were excluded. However, all studies that investi- agent used (e.g. hydrocolloid, alginate or poly- gated complete healing were included, even urethane foam dressings). However, it is import- if the decision was made subjectively by ant to note that individual products within the the investigator. different debriding agent categories can also vary considerably in the way that they function, Information relating to other outcome and this may or may not be clinically significant. measures reported by included studies was Where sufficient data were available, the results 8 also collected. of individual studies are presented as Forest Health Technology Assessment 2001; Vol. 5: No. 14

plots. Heterogeneity was investigated statistically dominance indicates that both the effectiveness using a Q -test and visually by examination of the data and the economic data support the use of Forest plot. Due to the heterogeneity present, either the intervention or the comparator and pooling of results was deemed inappropriate. the decision on resource allocation is clear. Studies varied in terms of wound type, study When either the economic or the effectiveness design and the nature of the comparator. data support the intervention/comparator, but not both, the dominance is said to be In order to assess the economic data in terms ‘partial’ or ‘weak’ and a decision can still be of the clinical effectiveness of the intervention made. However, if no dominance is indicated, (i.e. the direction of the cost-effectiveness data further incremental cost analysis may be and the magnitude of clinical effectiveness data), required in order to estimate the incremental each study was given a summary grading (A to I) cost-effectiveness ratio. This is important to according to the level and direction of dominance help the decision-making process. The matrix (i.e. whether the intervention of interest should shown in Figure 1 was used to assign a summary be preferred over the comparator). Extended grading to each study.

Health outcomes +0 – + AB C Strong dominance for decision in either direction (i.e. in favour of the intervention or comparator) Costs 0 DE F Weak dominance for decision – GH I Non-dominance; no obvious decision

Code Implication for Direction of the cost-effectiveness data and the magnitude of the intervention clinical effectiveness data

A Trade-off Higher costs but better outcomes (incremental analysis required) B Reject Higher costs and no difference in outcomes (partial dominance in favour of the comparator) C Reject Higher costs and poorer outcomes (extended dominance in favour of the comparator) D Accept No difference in costs and improved outcomes (partial dominance in favour of the intervention) E Neutral No difference in costs and no difference in outcomes F Reject No difference in costs and poorer outcomes (partial dominance in favour of comparator) G Accept Lower costs and improved outcomes (extended dominance in favour of the intervention) H Accept Lower costs and no difference in outcomes (partial dominance in favour of the intervention) I Trade-off Lower costs but poorer outcomes (incremental analysis required)

FIGURE 1 Incremental cost of treatment compared with control 32,33

9

Health Technology Assessment 2001; Vol. 5: No. 14

Chapter 4 Results: clinical effectiveness

Quantity and quality of Four different types of debriding agents were investigated in the included studies. These in- research available cluded foam dressings (silicone elastomer foam Included studies dressings and polyurethane foam dressings), Seventeen studies met the inclusion criteria, all of alginate dressings, hydrocolloid dressings and which used autolytic methods of debridement.34–50 dextranomer polysaccharide beads dressings. No studies were included that investigated sharp/ These will be referred to as modern dressings for surgical, biosurgical, mechanical or enzymatic the purpose of this review. However, it is acknow- debridement. All studies were published studies; ledged that they all have different properties and no additional studies identified for inclusion from functions. The results are presented according to the company submission data presented to NICE the type of debriding agent used. met the inclusion criteria. Additional information for one included trial was provided by the Gauze or gauze based dressings, impregnated company submission data.41 or otherwise, were used as the comparator in 14 trials.35–49 However, there was great variation No studies were found that investigated specialised between trials with respect to the type of anti- wound care clinics, which included the provision septic solution that the gauze was soaked in or of care within a clinical setting (based in either the type of gauze-based dressing used. Gauze primary or secondary care). dressings impregnated with an antiseptic solution do not provide an environment for moist wound Fifteen of the included studies were healing unless a secondary occlusive or semi- RCTs,34,35,37–43,46–51 one was a quasi-RCT45 and occlusive dressing is used. Three trials using one was a non-randomised controlled trial.44 gauze dressings impregnated with antiseptic Information relating to three trials was derived solution used a simple dry gauze dressing as the from two publications.37,41,43,52–54 Two trials secondary dressing, which means that a moist were published as abstracts52,53 as well as full wound environment was not provided as the gauze reports,37,43 and one trial was published as a dressing can dry out.38,43,44 Five trials using gauze poster54 as well as an abstract.41 For the purpose dressings impregnated with antiseptic solution of this review these trials will be referred to as did not report what secondary dressing was used, one publication.37,41,43 and therefore it is not possible to ascertain if a moist wound environment was provided.40–42,47,48 Five of the included studies looked at surgical Gauze dressings may act as mechanical debriding wounds healing by secondary intention after agents and the antiseptic solutions in which the pilonidal abscess excision,34,37,44,47,49 one of which gauze is soaked could act as chemical debriding also included participants who had abdominal agents. However, as these were used as the surgical wounds.37 Three studies38,41,43 investigated comparators in trials rather than as the inter- healing after abscess incision followed by light vention, the effects of mechanical or chemical packing of the wound, and one study included debriding agents could not be investigated. the incision of either a sinus or abscess with the excision of granulation tissue.48 One of One trial compared polyurethane foam to these studies also included wounds healing by alginate dressings34 and another trial compared secondary intention following a laporotomy.43 it to silicone foam.37 A third study compared One study included perineal wounds resulting dextranomer polysaccharide to silicone foam.50 from procolectomy or rectal excision,42 and three studies36,40,50 included surgical wounds that had The majority of included studies were UK based, broken down postoperatively, but did not specify within an NHS setting. Two of the included trials the type of surgery that was undertaken. The were based in a military hospital41,48 and five trials remaining four studies investigated treatment were based outside the UK.36,41,44,46,47 The countries of postoperative wounds from toenail of origin for these trials were Australia,36 the USA,46 avulsions.35,39,45,46 France,41 Italy44 and Spain.47 Studies were 11 Results: clinical effectiveness

published between 1979 and 2000, four before the others received the standard dressing. 19847,40,42,49 and the remainder between 1991 Treatment allocation is therefore unlikely to and 2000. have been concealed from those conducting the procedure. Excluded studies In total, 136 studies identified by the main searches Follow-up were excluded, as they did not meet inclusion Relatively complete follow-up (≥ 80%) was criteria. The specific reason why each study was achieved in ten of the 13 trials of surgical excluded is presented in appendix 2. The reasons wounds.36–38,40,41,43,44,47,48,50 Insufficient information for exclusion of studies reported in the manu- was presented to judge the completeness of facturer and sponsor submissions made to NICE follow-up in two trials.42,49 Of these, one trial are presented separately in appendix 8. reported the number of participants that were followed to complete healing, but did not state Twenty-three studies were excluded because if this was the number of participants that were they were not reported in one of the languages randomised.49 Another trial reported that on considered for inclusion. It was not possible to completion there were 25 participants in each ascertain if they met any of the other inclusion treatment group.42 However, three participants criteria, such as the appropriate study design, in each group were reported to have died before intervention, wound type or outcome measure. the end of the trial and it was therefore assumed Fifteen of these studies were reported in Russian, that these participants were not included in the with the year of publication ranging from 1976 to final analysis. For this trial it was unclear how 1993. Three of the studies were reported in Italian many participants were initially randomised and and the year of publication ranged from 1984 to it was therefore not possible to calculate the 1992. The remaining studies were published in percentage lost to follow-up. The last trial, an Danish (1985), Japanese (1992), Portuguese RCT with a small sample size, reported a loss (1981) or Spanish (1994) and one study was to follow-up of 30% (6/20).34 from Scandinavia (1983). None of the seven trials38,40,41,44,47,48,50 of surgical The reason for exclusion for the majority of the wounds that were deemed to have no drop-outs remaining studies was that they did not investigate reported using an ITT analysis or a per protocol surgical wounds healing by secondary intention. analysis. It was therefore not possible to ascertain Most looked at either sutured wounds or chronic if non-compliers had been included in the analysis wounds such as venous leg ulcers, pressure sores correctly, or if any participants that had received and diabetic foot ulcers. the intervention for which they had not been randomised, were included in the analysis Quality of included studies according to their randomised treatment group. A summary of the quality of individual studies is presented in Tables 1 and 2. Four of the trials in surgical wounds reported having some participants lost to follow-up. Randomisation and concealment of treatment Two of these did not report the reason for allocation withdrawal.37,43 One of these trials did not Only three of the 14 trials of surgical wounds include those that were lost to follow-up in the reported information relating to the method final analysis37 and this information was unclear used to randomise participants to different inter- for the second trial.43 Two trials reported the vention groups. Two trials used cards contained in reason for withdrawal, presenting the information sealed envelopes36,40 and one trial reported using a according to the two treatment groups to which random card system, but gave no further details.50 participants had been randomised.34,36 However, There was insufficient information for all three neither of these trials reported the number trials to ascertain whether treatment allocation of participants that were included in the final had been adequately concealed from the analysis and therefore it was not possible to clinicians and participants. ascertain if an ITT or per protocol analysis had been conducted. Neither trial reported having Information relating to the randomisation conducted an ITT analysis. The study that did procedure used was only reported by one of the not achieve complete follow-up reported that four trials of toenail avulsion.45 Participants were three participants dropped out from each allocated numbers, and those with even numbers treatment group, although the reasons for 12 were treated with the intervention dressing while withdrawal do not appear to be related to the Health Technology Assessment 2001; Vol. 5: No. 14 ? ✔✘ ✘✘ ✘✘ ✘✘ stated ✘✘ ✔✔ ✘✔ ‡ d d d d ✔ ✘✘✘ ✘✘ ✘✔✘ ✘✘✔ ✔ ✘✘✔ ✔ istics ✔ ? ? ? † ✘ c c c c c c c c c / ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ istics ✔✔✔✔ ✔ ✔ ✔ ✔ ? ??? ??? ✔ ???? ✘ c, stated initial wound size ?? ? ? ? ✘ ?? ? ? ? d, including wound size ✔ * ✔ a? a?? ? ? ? a ✘✘✘ ✘ ✘ ✔ ✘ ✔ ✔ ✘ 7.5 17 N? ? ? ? 0NA?? 7 30 N? ? ? ? 0NA?? N? ? ? ? 0NA?? N? ? ? ? 0NA?? N? ? ? ? 0NA?? 0NA? ? ? ? 0NA?? 80% up (%) of with- assessors istrators blinded checked character- character- ventions ✔ ✔ ✔ ✔ ✘ ✔ ≥ ✔ ✔ ✔ ✔ ✔ ? ? ? ✔ ✔ ✔ arms) cealed12 (2) NA43 (2) ? drawals ? ? 20 (2) ? ? 20 (2) size(No. of adequate con- procedure cation up follow- comesoutcomeadmin- of of ipants blinding baseline baseline inter- analysis , partially covered; ?, not stated, or unclear; not enough information NA, trial) not appropriate (controlled (see appendix 4) 44 42 ✘ / ., 80 (2) ? ? ? ? ., 36 (3) ., 34 (2) ? ? 40 ✔ ., 38 (2) ? ? ., 75 (4) ? ? 43 34 ., 50 (2) 37 41 ., 1998 Quality assessment of included trials: secondary surgical wounds healing by intention et al et al et al , no; et al et al et al ✘ et al 48 49 36 38 47 50 ., 1992 ., 1996 , appropriate baseline characteristics One or more stated, but not initial wound size; , of the characteristics to one or more stated, According but not initial wound size; a, Numbers and reason reported group by ,Yes; ✔ ✔ ✔ McMahon, 1980 1981 Polyurethane foam versus traditional gauze dressings gauze foam versusPolyurethane traditional (2)? foam versusPolyurethane silicone foam dressings Butterworth 80 ? dressings gauze Alginate versus traditional Cannavo 1998 Study Sample Random. dressings gauze Silicone foam versus traditional Allo-Macfie and Follow-to Loss Walker Out- 50 (2) ITT ?Williams BlindingRicci Blinding Partic- ?ofMeyer, 1997 Success Appropriate Comparable Co- ?et al Correct versusPolyurethane alginate dressings ? Berry, 1996 (2)? Dawson 70 Guillotreau et al dressings gauze versus traditional Hydrocolloid ? Viciano 2000 dressings gauze polysaccharide versus traditional Dextranomer Goode, 1979 1982 ✔ * † ‡ Dextranomer polysaccharide versus silicone foam dressings Dextranomer Young 1991 1992 13 TABLE 1 TABLE Results: clinical effectiveness ? ? ✘✔ / ✘ ✘✘ stated ‡ ? ? istics † ✘ / ✘ ✔✔✘ ✔✔✔ ✔ istics ?? ???? ???? ✘ ✘✘ ✘ * b b ✔ ✔ ✘✘ N? ?0NA?? ? ? 5 7 56 80% up (%) of with- assessors istrators blinded checked character- character- ventions ✘ ✔ ✔ ≥ ✘✘✔ arms)18 (2) ?70 (2) cealed ?67 (2) ? 20 (2) ? ? drawals ? size(No. of adequate con- procedure cation up follow- comesoutcomeadmin- of of ipants blinding baseline baseline inter- analysis , partially covered; ?, not stated, or unclear; not enough information NA, trial) not appropriate (controlled (see appendix 4) ✘ / ✔ 46 ., ., ., Quality assessment of included trials: toenail avulsion surgery wounds from , no; et al ✘ et al et al 1998 35 39 45 , appropriate baseline characteristics One or more stated, but not initial wound size , of the characteristics to one or more stated, According but not initial wound size b,Withdrawals reported, not given or reason group but not by ,Yes; ✔ ✔ ✔ Smith 1992 ✔ Foley Foley 1994 Van Gils Van Study Sample Random.Bruce Allo- Follow-to Loss Out- ITT Blinding Blindinget al., Partic-of Success Appropriate* Comparable Co-† ‡ Correct 14 1991 TABLE 2 TABLE Health Technology Assessment 2001; Vol. 5: No. 14

intervention. Two participants were withdrawn Nine of the 14 trials of surgical wounds reported due to perceived discomfort at having biopsies information on baseline characteristics, which taken (one in each treatment group), three included the initial wound size.34,36,37,41–44,49,50 because of recurrent infection (one in the There was no difference in wound size or other foam group, two in the alginate group) and reported baseline characteristics for four of these one required further surgery.34 trials (this was judged using an ‘eye test’ rather than relying solely on reported p values or the Three of the four toenail avulsion studies findings of statistical tests).37,42,49,50 Three of the reported that relatively complete follow-up studies reported a greater mean baseline wound (≥ 80%) was achieved.39,45,46 There were no size in the intervention group,34,41,43 while the drop-outs in one trial,39 one trial did not report other two studies found a greater mean wound any information on participants lost to follow-up45 size in the control group.36,44 Three of these trials and the third trial did not state which treatment used the outcome measure reduction in wound group the one participant that was lost to follow- size,55–57 but only two reported the results of up was allocated to.46 Ten participants withdrew both absolute and relative values.55,57 Three from a small RCT which had an initial sample further trials reported one or more relevant size of 18 participants.35 Four participants were baseline characteristics, but did not specify reported to have failed to return for redressing, wound size.40,47,48 One of these trials reported for which the reasons could not be ascertained, no baseline differences between groups.40 It was and the treatment group was not stated. None not possible to assess the comparability of the of the trials with withdrawals conducted an ITT treatment groups for the remaining two trials, analysis, using techniques such as last observation as these were not reported per group.47,48 One carried forward or more sophisticated methods. trial merely stated that none of the patients The trial that had no drop-outs did not report were diabetic or receiving steroid treatment.38 using an ITT analysis and therefore it was not possible to ascertain if bad compliers were Two of the four trials of toenail avulsions reported correctly analysed.39 baseline data on one or more important patient characteristic for which the treatment groups were Blinding considered to be comparable.39,46 However, no trial Only one of the trials of surgical wounds reported reported any information relating to the initial the blinding of the outcome assessors to treatment wound size. allocation.36 None of the trials reported having blinded the administrators (those who adminis- Reporting of co-interventions tered the intervention) or participants to the type Only four of the 14 trials reported any other of dressings being used, although this may be co-interventions that participants were receiving, difficult to achieve in practice. One trial was such as drugs (e.g. steroids).34,37,38,40 reported as being an ‘open parallel’ study, and was therefore deemed not to be blind.37 One trial None of the trials of toenail avulsions reported reported that one of the authors supervised the whether participants were receiving any dressing changes, which was undertaken by a co-interventions. member of the nursing staff.38 It was therefore suspected that the assessor was not blinded to Appropriate analysis the intervention. Seven of the 14 trials of surgical wounds were judged to have used an appropriate statistical test None of the trials that investigated wounds relating to analyse the data.36,38,40–42,47,50 Three trials did not to toenail avulsions reported on the blinding of report what statistical test was used, and therefore outcome assessors or participants to the type of it was not possible to assess the appropriateness intervention used. One trial reported that the of the test.37,43,48 Eleven34,35,37,39,40,42,44,45,48–50 of authors conducted all the nail surgery as well as 1334,35,37,39,40,42,44–50 trials summarised healing times administering the dressing protocols.46 It was using mean values instead of survival analysis or therefore considered that blinding of the admin- medians. Eight trials of surgical wounds did not istrators had not been undertaken for this trial. report the results in sufficient detail to calculate a summary estimate of the treatment effect, for one Baseline characteristics or more outcome measures.34,38,40,41,43,44,47,48 The types of baseline characteristics most frequently reported by included studies were Eight trials of surgical wounds used the outcome age, sex, wound type and wound measurements. measure ‘time to complete healing’,34,37,42,44,47–50 15 Results: clinical effectiveness

seven of which reported mean values rather reported in most trials. Many trials failed to report than medians.34,37,42,44,48–50 Mean values are greatly the initial wound size and baseline characteristics affected by outliers and, unlike the median, of included participants. The majority of trials cannot be calculated if some wounds fail to heal. that used time to complete healing as the outcome One trial reported the rate of full epithelialisation, measure reported mean instead of median values. which was calculated from the initial wound Mean healing times may not represent the healing volume divided by the number of days required events in an appropriate way, as they are greatly to achieve each end-point.58 None of the included affected by outliers, and unlike median values trials of surgical wounds used survival analysis cannot be calculated if some wounds fail to heal. (where survival includes wounds not healed Almost half of the included trials did not report at any point of time during follow-up) or their results in sufficient detail to calculate a reported hazard ratios. summary estimate of the treatment effect, for one or more outcome measures. The statistical test The change in wound area or volume can be used to compare the treatment groups was often expressed as either the percentage change or the not reported or no test was used. absolute change. The absolute measure of change over time is dependent on the initial wound size. However, any change in wound area or volume Assessment of clinical presented as a percentage takes into account the effectiveness initial wound size but is dependent on the length of follow-up. It is therefore important that studies Included trials were considered to be hetero- that report incompatibility with regard to initial geneous with regard to type of wounds, type of wound size should present the results on a change dressing, comparator used and results presented, in wound area as both the percentage change and and so it was not possible to formally assess the absolute change. Of the nine trials of surgical heterogeneity across trials. As statistical pooling wounds that reported baseline wound measure- of results was not feasible, and was considered ments,34,36,41–44,49,50,59 five reported incomparability inappropriate, the results are presented according with regard to initial wound size.34,36,41,43,44 Four to dressing type, with the results of studies of toe- of these trials reported on the outcome measure nail avulsions presented separately within each reduction in wound size,36,41,43,44 of which only dressing type. The results of outcomes relating to two trials reported both the absolute and the wound healing are presented first, and results of percentage change.43,56 other outcomes investigated are presented in a separate section. Where the text states that a Only one of the four trials of toenail avulsions ‘significant’ difference was found this refers was deemed to have used an appropriate statis- to statistical, not clinical, significance. tical test.46 However, this trial used mean values to summarise healing times.46 Two trials did not Measures of healing report the statistical test used to compare data,35,39 Foam dressings and in one trial no statistical analysis was per- Two types of foam dressings were investigated by formed.45 One trial of toenail avulsions did not included studies. The first was silicone elastomer report the results in sufficient detail to calculate foam, which is prepared by mixing a base material a summary estimate of the treatment effect for and a catalyst in different proportions to form one or more outcomes.45 liquid foam. This is poured into the wound where it expands to 3–4 times its original volume and Four trials of toenail avulsions reported on the forms a soft pliable foam stent that conforms to the outcome measure time to complete healing.35,39,45,46 contour of the wound cavity.60 The foam stent can However, only one of these used median values.46 be removed, disinfected and reinserted. However, None of the included trials of toenail avulsions the foam stent needs to be remodelled when the used survival analysis or reported hazard ratios. wound changes shape, usually about once a week.61 The alternative foam dressing was a contoured Overall quality of included studies honeycomb polymer membrane filled with hydro- On the whole, included trials tended to have a cellular chips.37 This pliable polyurethane foam small sample size (median 43 participants) and comes in various preformed shapes that can be the majority suffered from methodological flaws. moulded and inserted into a cavity wound. The total number of participants included in the Unlike silicone foam, these are disposable trials was 783. Detailed information relating to the and the dressings are replaced rather than 16 randomisation procedure and blinding were not disinfected and reused. Health Technology Assessment 2001; Vol. 5: No. 14

Silicone foam dressings versus traditional volume by the number of days required to achieve gauze dressings each end-point (full epithelialisation and dry Surgical wounds healing by secondary intention dressing). No significant differences were found Four included studies investigated the use of between the treatment groups. These measures silicone elastomer foam versus traditional moist are more appropriate as they take into account gauze dressings.42,44,48,49 These included three the initial wound volume, which will affect RCTs, two of which looked at pilonidal wounds48,49 healing time. (one of which also included incised abscess wounds48), and one looked at perineal wounds.42 The controlled trial reported both a longer mean The fourth study was a controlled trial that cavity filling time and time to complete healing looked at excised pilonidal sinus wounds.44 The among participants in the iodine and dry gauze comparator gauze dressing was soaked in a differ- dressings group as compared to silicone foam ent solution for each trial. The antiseptic solution (4.3 weeks versus 9.5 weeks, and 33.5 days included Eusol,48 0.5% chlorhexidine,49 mercuric versus 73 days, respectively) (see Table 3 and chloride42 and povidone iodine solution.44 appendix 5).44 The trial also reported that the All four studies followed participants until reduction in wound volume after 15 days was complete wound healing. higher in the silicone group than in the gauze group (46% versus 22%). No data on statistical Results for the two RCTs that presented mean variability were provided, precluding the and variance data are presented in Figure 2.42,49 calculation of a CI. Both trials found no significant difference between the two groups with regard to the mean Summary time to healing, although both point estimates There was no significant difference in the healing favour silicone foam. The third RCT did not time between silicone foam elastomer dressing provide a measure of variance and so could not and conventional gauze dressing. All three trials be included in the Forest plot. This study stated included a relatively small sample size ranging that no significant difference with respect to from 50 to 80 participants (205 participants mean time to wound healing was found.48 One in total) (see Table 4). RCT also reported on the outcome of ‘number of days packed’ and found there was no significant Polyurethane foam dressings versus traditional difference between the two groups.49 One trial gauze dressings reported on time to dry dressing, which was found Surgical wounds healing by secondary intention to be significantly shorter in the foam group.42 One RCT compared the use of polyurethane This study also reported the rates of healing. foam to moist gauze after abdominal surgery or This was calculated by dividing the initial wound surgical incision of an abscess.43 No information

Study MD (95% CI) Macfie, 198042 – 9.2 (– 24.7 to 6.3) Silicone foam vs gauze Williams, 198149 8.5 (– 1.8 to 18.8) Butterworth, 199237 – 10.5 (– 22.3 to 1.3) Polyurethane foam vs silicone foam Butterworth, 199237 4.7 (– 31.9 to 22.5) Young, 198250 – 4.0 (– 14.0 to 6.0) Dextranomer vs silicone foam Foley, 199439 – 8.6 (– 12.9 to – 4.3) Alginate vs gauze Van Gils, 199846 – 11.4 (– 20.9 to – 1.9) Bruce, 199135 – 15.9 (– 33.4 to 1.6) Hydrocolloid vs gauze

–40 – 20 0 20 40

Favours intervention Favours control

FIGURE 2 Forest plot illustrating the mean difference in time to complete healing (days) between intervention and control groups ( , perineal; , pilonidal; , abdominal; , broken down surgical; , toenail avulsion) 17 Results: clinical effectiveness continued 0.04; – 18.8 to 1.8) 24.7 to 6.3) 10.79 to 10.19) 1.34) < 0.05) shorter – – – – p : no significant 28.6 to – : no significant difference 8.5; 95% CI, 9.2; 95% CI, 0.3; 95% CI, – – – : no significant differences : shorter in silicone group : ( significantly : no significant difference : no significant difference : no significant difference : higher in the gauze group : (1.24 in no significant difference 15.10; 95% CI, – 0.31 to 0.23) – > 0.05) between the groups (30 days in foam group, in foam (30 days the groups > 0.05) between group, in foam (39.8 days the groups > 0.05) between group, in foam (66.2 days the groups > 0.05) between group, in foam (41.5 days groups > 0.05) between 0.19 to 0.53) p p p p differences between the groups (60.3 days in foam group, in foam (60.3 days the groups between differences 95% CI, Rate to full epithelialisation group,(0.94 in foam 0.98 in gauze group; MD = Rate to dry dressing group,foam 1.07 in gauze group; MD = 0.17; 95% CI, ( in gauze group;33 days of variance) no measure Mean time to healing ( ( in gauze group;57.7 days MD = packed of days Mean number ( to fill cavity Mean time for (9.5 weeks); than gauze group (4.3 weeks) of no measure Mean time to full epithelialisation 69.5 days in gauze group;69.5 days MD = Mean time to dry dressing – Mean time to healing in gauze group;39.6 days of variance) no measure Mean time to healing in gauze group;41.8 days MD = variance or significance in the foam group (47.5 days in foam group, in foam (47.5 days group in the foam in 62.6 days gauze group; MD = : higher in the silicone group (33.5 days); than in the silicone group (73 days) of no measure 15 days (22%);(46%) than the gauze group no of variance or significance measure variance or significance Reduction in cavity volume after volume Reduction in cavity Mean time to healing number of wounds of wounds number volume wound time to dry dressing closed surgically) wounds wounds wounds wounds Pilonidal sinus Pilonidal sinus Until healing 42 ., Pilonidal sinus Until healing Results for measures of healing measures Results for ., Pilonidal sinus Until healing et al., et al et al 48 49 44 McMahon, 1980 Macfie and wounds Perineal Until healing Controlled trial Controlled RCT Incised abscesses Until healing RCT Study Condition Duration healed (including Proportion reduction; area cent wound Per Time to complete healing (days); Silicone foam versus traditional gauze dressings gauze Silicone foam versus traditional 1991 1981 Walker Walker Williams 18 RCT Ricci 1998 TABLE 3 TABLE Health Technology Assessment 2001; Vol. 5: No. 14 10.5; 4.7; – – continued : no significant differences : group, in foam 56.7 days : no significant differences 22.3 to 1.3) 31.9 to 22.5) – – = 0.05) between groups (51.4 days in polyurethane in polyurethane (51.4 days groups = 0.05) between = 0.05) between groups (51.9 days in polyurethane (51.9 days groups = 0.05) between p p Mean time to healing ( group,foam group; in silicone foam 61.9 days MD = Mean time to healing in gauze group;65.5 days of variance no measure or significance ( group,foam group; in silicone foam 56.6 days MD = 95% CI, 95% CI, Mean time to healing : : < 0.05) in p : no significant difference Reduction in wound volume Reduction in wound volume groups of the three any between Reduction in wound area and area Reduction in wound > 0.05); p : significantly : no significant : significantly group, faster in Cutinova also earlier = 0.01) in the Cutinova = 0.01) in the Cutinova of fibrinous coats reduction = 0.04) in Cutinova ( greater significantly p p closed surgically) ( greater (67%) than in gauze group group (27%); RR = 2.44 (95% CI, 1.23 (18%); RR = 2.6 (95% CI, 1.0 to 7.1) (50.1%); group of variance no measure healing (total healed or Overall Epithelialisation and granulation Proportion healed Proportion healed Proportion number of wounds of wounds number volume wound time to dry dressing closed surgically) to 5.31) ( groups between difference 75% in alginate review at 2 week healed at 4 weeks;wounds RR = 1.0 (95% CI, 0.8 to 1.2) or abscess incision ( greater Pilonidal wounds Until healing excision Abdominal surgery 4 weeks Pilonidal sinus Until healing abdominal wounds Abscess incision 4 weeks Results for measures of healing measures Results for 34 ., Dehisced surgical Until healing 43 37 ., 1996 et al et al., et al 1992 36 38 RCT (48%) than in gauze group group (75.6%) than in gauze group Cutinova RCT Dawson 1992 Alginate versus traditional gauze dressings gauze Alginate versus traditional Cannavo Study Condition Duration healed (including Proportion reduction; area cent wound Per Time to complete healing (days); RCT 1998 RCT Polyurethane foam versusPolyurethane alginate dressings Berry Polyurethane foam versus traditional gauze dressings gauze foam versusPolyurethane traditional Meyer, 1997 healing wounds Until foam versus silicone foam dressings Polyurethane Abdominal Butterworth et al., RCT19 group, group; 72% in control all TABLE 3 contd TABLE Results: clinical effectiveness 1.9) – continued = 0.03) 33.4 p – 20.9 to – 4.3) – > 0.05) differ- < 0.05) less in p p 15.9; 95% CI, 12.9 to : ( significantly – – 11.4; 95% CI, – : shorter in Sorbsan treatment : group, in hydrocolloid 49.3 days : ( significantly : no significant ( 8.6; 95% CI, – < 0.05) for total nail avulsions (45 days versus 69 days), versus (45 days total nail avulsions < 0.05) for p Mean time to healing (52 days);Anaflex group than (43 days) significant group ( on Sorbsan, (40 days partialbut not for nail avulsion group, in hydrocolloid (65 days the groups ences between in gauze group;68 days of variance) no measure Mean time to healing (MD = in gauze group 65.2 days alginate-treated group (25.8 days) than in gauze group than in gauze group (25.8 days) group alginate-treated (MD = (34.4 days) on control);39 days of variance no measure Median healing time Median/mean time to healing to 1.6) Mean time to healing : significantly < 0.05) higher in alginate group than < 0.05) higher in alginate group p Wound area reduction area Wound :no : one patient in : no significant > 0.05) between > 0.05) between p Proportion healed Proportion number of wounds of wounds number volume wound time to dry dressing groups (RR = 1.9;groups 95% CI, 0.9 filled Proportion 1, at weeks gauze group 2 and 3; no ( differences (59% in alginate group, groups 48% in gauze group; RR = 1.2; 95% CI, 0.8 to 1.9) closed surgically) epithelialised Proportion betweensignificant differences ( had not healed at end group control of follow-up to compared (26/24.4 days) group less in Fibracol-treated (MD = (42/35.8 days) control contd Toenail avulsionToenail Until healing wounds avulsionToenail Until healing Results for measures of healing measures Results for ., avulsion Toenail 8 weeks ., Pilonidal sinus Until healing 35 45 41 et al et al 1996 39 46 47 Quasi-RCT RCT Bruce, 1991 2000 Hydrocolloid versus traditional gauze dressings gauze versus traditional Hydrocolloid Viciano RCT Gils Van 1998 Study Condition Duration healed (including Proportion reduction; area cent wound Per Time to complete healing (days); RCT RCTAllen, and Foley avulsion Toenail Until healing to 4.5) of variance measure Guillotreau Abscess incision3 weeks incision3 dressings gauze Alginate versus traditional Abscess Guillotreau et al., 1994 20 RCT Smith, 1992 TABLE 3 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14 > 0.05) 14.0 to 6.0) – p : significantly 4.0; 95% CI, – : no significant ( < 0.05) less in beads group (8.1 days) than gauze (8.1 days) < 0.05) less in beads group p differences between the groups (41 days on beads, (41 days the groups between differences on control;37 days MD = Mean time to healing Mean time to secondary closure : no significant > 0.05) differences between> 0.05) differences ( p number of wounds of wounds number volume wound time to dry dressing Proportion healed Proportion closed surgically) groups; healed in each 1 wound group; (11.6 days) of variance and therefore no measure surgical wounds or suturesurgical wounds ( Broken downBroken Until healing Results for measures of healing measures Results for 50 et al., 40 RCT Wheeler, 1982 Study ConditionRCT Duration polysaccharide versus silicone foam dressings Dextranomer and Young healed (including Proportion reduction; area cent wound Per down Broken Time to complete healing (days); Until healing (RR = 1.0; group 95% CI, 0.1 to 8.8) unable to check this calculation 1979 Dextranomer polysaccharide versus traditional gauze dressings gauze polysaccharide versus traditional Dextranomer Goode 21 TABLE 3 contd TABLE Results: clinical effectiveness = 3: shorter significantly = 1: no significant difference mean time to healing in alginate group in hydrocolloid group in hydrocolloid N in mean time to healing, shorter N = 1: mean time to = 1: no significant dextranomer group dextranomer N in mean time to differences healing, longer in slightly dextranomer group wounds N secondary closure less in significantly = 1: no significant = 1: no significant N N = 1: healed in proportion greater significantly = 2: no significant = 1: no difference epithelialised or healed; of suggestion in favour in mean time groups alginate. of No measure to healing variance: significantly reduc- area wound greater N N in proportion difference the between difference greater reduction in wound volume in wound reduction greater tion in alginate group N = 1: no significant N = 3: no significant = 1: of no measure = 1: no significant = 1: no significant N excision of foamin favour of foam in favour groupfoam N group healing in foam healing time group in foam variance or significance; shorter mean time to N in mean time todifferences healing, although shorter in N in mean time to differences healing, although shorter difference in median difference differences in mean time differences in to healing or reduction in mean time differences size,cavity in to healing or reduction small suggestion size, cavity small suggestion treatment two between in mean time groups to healing Results for measures of healing according to intervention of healing according measures and wound type* Results for ,The number of trials reporting on this intervention and wound type Studies which show significant benefits of the intervention compared to the control are highlighted in bold are of the intervention to the control benefits compared significant Studies which show versus gauzeversus group, than gauze group foam also significantly Dextranomer Dextranomer silicone versus foam N Intervention Pilonidal sinus wound Perineal Abscess incisions Abdominal wounds surgical down Broken avulsion Toenail * versus gauze versus Silicone foam Silicone foam gauze Dextranomer Polyurethane foam Polyurethane foam Polyurethane Alginate versus versus alginate versus foam Polyurethane Polyurethane silicone versus Hydrocolloid versus gauze versus 22 gauze versus TABLE 4 TABLE Health Technology Assessment 2001; Vol. 5: No. 14

was presented as to whether the gauze had been The mean healing time for the alginate group was moistened with saline or an antiseptic solution. found to be slightly higher than that of the foam The duration of follow-up for this trial was 4 weeks. group (65.5 days versus 56.7 days). However, no During this time period the proportion of wounds measure of variance or of the significance of the healed completely was found to be significantly difference was provided. When wounds became higher in the foam group than in the gauze superficial or had no significant depth, the dress- dressing group. The results are presented in ing protocols were changed. Wounds that were Figure 3 (see also Table 3 and appendix 5). The previously dressed with polyurethane foam were reduction in wound volume was also reported to treated with polyurethane sheets (Allevyn™) and be greater for participants who were in the foam those in the alginate group were dressed with a group compared to gauze, and baseline wound different type of polyurethane sheet dressing volume was greater in the foam group. However, (Lyofoam™). The time at which dressing the authors did not report the standard deviation protocols were changed was not reported. or give an exact p value, and therefore the CI could not be calculated. The authors also failed Summary to present the statistical test used to compare No conclusions could be drawn, with regard to the treatment groups. the wound dressings used initially, from the results of a single trial comparing polyurethane foam Summary and calcium sodium alginate dressings. Wounds According to a single RCT, the number of wounds in both groups were treated with polyurethane healed at 4 weeks was significantly higher for those sheet dressings when they became superficial or treated with polyurethane foam compared to moist had no significant depth (see Table 4). gauze dressings. However, this trial included a very small sample. In addition, the initial mean wound Polyurethane foam dressings versus silicone volume was significantly greater in the foam foam dressings group (27.9 cm3) compared to the gauze group Surgical wounds healing by secondary intention (21.0 cm3) (see Table 4). One RCT compared the use of polyurethane foam to silicone foam dressings.37 Participants had cavity Polyurethane foam dressings versus wounds that had resulted from either pilonidal alginate dressings surgery excision or abdominal surgery. Participants Surgical wounds healing by secondary intention were followed up until complete healing had One RCT compared the use of polyurethane occurred. There was no significant difference in foam with a calcium sodium alginate dressing.34 mean time to complete healing between the two The type of operation was pilonidal sinus groups for either abdominal or pilonidal surgery excision and participants were followed up wounds. The results are presented in Figure 2 until complete healing had been achieved. (see also Table 3 and appendix 5).

Study RR (95% CI) Meyer, 199743 2.6 (1.0 to 7.1) Polyurethane foam vs gauze (4 weeks) Dawson, 199238 1.0 (0.8 to 1.2) (4 weeks) Guiltreau, 199641 1.9 (0.9 to 4.5) Alginate vs gauze (3 weeks) Goode, 197940 1.0 (0.1 to 8.8) (not stated) Van Gils, 199846 1.1 (0.7 to 1.5) (8 weeks)

0.1 0.20.5 1510 2

Favours intervention Favours control

FIGURE 3 Forest plot illustrating the relative risk for the number of wounds healed between intervention and control groups ( , abscess; , pilonidal; , broken down surgical wounds; , toenail avulsion) 23 Results: clinical effectiveness

Summary All three trials reported that for participants who According to a single open RCT (n = 80), there had received a total nail avulsion, as opposed to was no significant difference in the mean healing partial nail avulsion, time to complete healing was time for wounds treated with either polyurethane significantly less in the alginate group compared to foam or silicone foam dressings. However, the CIs the traditional gauze dressing group (see Table 3 were relatively large and thus the study may have and appendix 5). Two of the three trials provided lacked the power to detect differences between sufficient information to calculate a mean differ- the two treatment groups (see Table 4). ence and the 95% CI (see Figure 2).39,50 Both trials found a significantly shorter mean time to healing Alginate dressings versus traditional in the alginate compared to the gauze group. One gauze dressings trial reported the median healing time, but did Surgical wounds healing by secondary intention not report a measure of variance (median healing Two RCTs compared the use of calcium alginate time of 26 days in the alginate group versus 42 in to traditional moist gauze dressings in the packing the control group).46 This trial also reported on of wounds following the incision and drainage of the number of wounds healed at 8 weeks.46 All abscesses.38,41 The follow-up periods were 3 weeks41 wounds, except that of one participant in the and 4 weeks.38 The comparator gauze dressing was control group, had healed at 8 weeks. soaked in saline for one trial38 and povidone iodine in the other.41 There was no significant difference Summary in outcome between the two dressing protocols There was no significant difference, in terms of for the proportion of wounds healed at either the proportion of wounds healed at 3 or 4 weeks 3 or 4 weeks, although one of the trials tended between surgical wounds packed with calcium to favour alginate. The results are presented in alginate and those dressed using the conventional Figure 3 (see also Table 3 and appendix 5). One gauze dressings. The trials included only small trial also reported that the percentage reduction sample sizes, ranging from 20 to 70 (152 partic- in the mean wound surface area was significantly ipants in total). No initial wound size or any higher at weeks 1, 2 and 3 in the alginate group other baseline characteristics were reported compared to those dressed with gauze.41 One RCT (see Table 4). compared the performance of three dressings in the management of dehisced surgical abdominal Time to complete healing for wounds resulting wounds.36 The three dressing protocols included from total nail avulsion surgery was found to be calcium alginate dressings and a Combine dressing significantly shorter in the alginate dressings group pad (an absorbent wound dressing that consists compared to traditional gauze dressings. The trials of cotton wool and gauze) with or without a included only small sample sizes, ranging from 0.05% sodium hypochlorite solution moistened 20 to 70 (157 participants in total). No baseline gauze. Participants were followed up until com- wound area was reported. Two trials reported plete healing had been achieved. There was no only age and sex as baseline characteristics39,45,46 significant difference between any of the groups (see Table 4). with regard to the reduction in wound area and volume. Hydrocolloid versus traditional gauze dressings Surgical wounds healing by secondary intention Wounds resulting from toenail avulsion surgery One RCT compared the use of hydrocolloid Three RCTs compared the use of alginate dressings with traditional gauze dressings soaked dressings to conventional treatment on wounds in povidone iodine in the treatment of excised produced by toenail avulsion followed by pilonidal wounds.47 Two types of hydrocolloid chemical destruction of the germinal matrix dressings were investigated, Comfeel™ and and nailbed.39,45,46 The comparator treatment Varihesive™. Participants were followed up until used in the trials included a cotton and acrylic complete healing had occurred. There was no fibre pad bonded to a low-adherent polyester film significant difference in median healing time (Melolin™),39 Melolin dressing with Anaflex™ between the hydrocolloid groups combined powder46 and no additional wound dressing (all and the gauze treatment group (65 days wounds were dressed with a thin layer of sulfa- versus 68 days). diazine silver cream and covered with sterile compressive gauze).45 The length of follow-up Wounds resulting from toenail avulsion surgery was 8 weeks in one trial,46 and participants were One RCT compared the use of hydrocolloid followed up until complete healing had been dressings with chlorohexidine acetate impregnated 24 achieved in the other two trials.39,45 dressing (Serotulle™) for the treatment of wounds Health Technology Assessment 2001; Vol. 5: No. 14

produced by toenail avulsion followed by the dressings in the treatment of surgical wounds phenolisation of the germinal matrix and nailbed.35 that had either broken down or been left open Participants were followed up until their wounds postoperatively.50 The type of surgery undertaken had completely healed. The sample size was very was not specified. Participants were followed up small (n = 11) and there was no significant differ- until complete healing had occurred. There was ence in the mean healing time between wounds no significant difference in the mean time to treated with hydrocolloid dressing and those complete healing between the two dressings. dressed with Serotulle. The results are presented The results are presented in Figure 2 (see also in Figure 2 (see also Table 3 and appendix 5). Table 3 and appendix 5).

The trial reported the reason for withdrawal Summary according to the intervention group, which According to a single trial (n = 50), there was included pain (n = 1), developed allergies (n = 3) no significant difference in the mean healing and the decision of the chiropodist (n = 2). time for wounds treated with either dextranomer polysaccharide beads or silicone foam dressings Summary (see Table 4). One trial reported no significant difference in median healing time between excised pilonidal Other outcomes wounds dressed with hydrocolloid dressings and The results for outcome measures other than those treated with conventional gauze soaked healing reported by the included studies are pre- with povidone iodine. No baseline wound size sented below. These results should be interpreted was reported and the trial had a very small with extreme caution for two reasons. To be in- sample size (n = 38) (see Table 4). cluded in the review studies had to report an objec- tive measure of healing, and thus any trial which The findings of a very small single RCT (n = 11) reported on other outcome measures but did not showed no significant difference in mean healing report an objective healing measure was not in- time for wounds resulting from toenail avulsion cluded in the review. The results below are there- surgery treated with hydrocolloid dressing com- fore derived from a subset of studies looking at pared to traditional gauze dressings. No baseline these outcomes. The second problem with these characteristics were reported (see Table 4). results relates to the quality of the study. As high- lighted above, the methodological quality of the Dextranomer polysaccharide beads versus included studies is low, with very few studies blind- traditional gauze dressings ing investigators or participants. This is a particular Surgical wounds healing by secondary intention problem for the outcome measures presented One small RCT (n = 20) compared the use of dex- below, which are generally very subjective, difficult tranomer polysaccharide beads to that of traditional to assess and subject to bias. Results for these out- gauze dressings soaked in Eusol, in the treatment of comes are presented in Table 5 and appendix 5. contaminated or infected wounds following bowel surgery or appendectomy.40 When the wounds were Silicone foam dressings versus traditional deemed to be ‘clean’ (see appendix 5) wounds were gauze dressings closed by secondary suture. One wound in each Surgical wounds healing by secondary intention group healed by granulation and therefore did not Three RCTs and one controlled trial compared require suturing. The time to complete healing of silicone foam dressings to traditional gauze these two wounds was not reported. There was no dressings. Other outcome measures reported significant difference in the mean time to wound on by the RCTs were pain,42 duration of hospital closure by secondary suture between the two stay,42,48,49 number of visits by the district nurse,42,49 intervention groups. work lost49 and level of discomfort on dressing removal.49 One study found a significantly greater Summary number of visits by the district nurse in the gauze No conclusions could be drawn from the results group compared to the foam group, and a signifi- of a single small RCT (n = 20) (see Table 4). cantly greater requirement for analgesia in the gauze group.42 Another study also found a signifi- Dextranomer polysaccharide beads versus cantly greater number of home nursing visits in silicone dressings the gauze group compared to the foam group, as Surgical wounds healing by secondary intention well as significantly greater discomfort on dressing One RCT (n = 50) compared dextranomer change in the gauze group.49 No significant differ- polysaccharide beads and silicone foam elastomer ences were found for any of the other outcomes 25 Results: clinical effectiveness : continued 16.8 to 3.2) – : no significant 6.8; 95% CI, – > 0.05) difference between > 0.05) difference p ( Time before return to work return Time before 1.5; 95% MD = – 0.7) – : in greater significantly group, in foam (45.4 days groups : authors reported dressing : 15 patients in gauze group 2.3 to – removal (measured using (measured removal VAS) Pain significance Pain about clinical or statistical : : : 25.3) – 45.1 < 0.001) – < 0.05) p p > 0.05) > 0.05) group and 4 patients in foam 35.7 to – 3.85 to 5.85) p p 3.22 to 5.62) CI, – – : no significant 32.8; 95% CI, – : ( significantly : ( significantly 20.5) – > 0.05) difference between between > 0.05) difference 30.5; 95% CI, p 1.2; 95% CI, greater in gauze group (35.1) in gauze group greater (4.6) (MD = group than foam – discharge groups (8.5 days in foam group, in foam (8.5 days groups (2.9) than foam gauze group (MD = in gauze group 7.3 days (1.4) (MD = group in gauze group; 38.6 days Number of home nursing Number of home nursing visits less in foam group (14.1) com- group less in foam (46.9); to gauze group pared MD = to Days to hospital discharge Days Mean time to hospital Discomfort on dressing used Number of dressings lost Work no significant ( the groups between differences analgesia (RR = 0.27; required (ex- in gauze group 22.8 days cluding convalescence); MD = 1.00; 95% CI, Number of visits by district Number of visits by nurse Number of inpatient days no measure of variance no measure cannot of variance and therefore painful and bleeding occurred, determine whether statistically to presented but no data were significant judgements to be made allow of variance measure wounds Pilonidal sinus andwounds Until healing Pilonidal sinus Until healing no significant ( Pilonidal sinus Until healing wounds (20) than group less in foam group, in foam was pain free (12 days) shorter group in foam 49 48 44 42 1991 ., 1981 Results for other outcome measures Results for ., 1998 et al et al., et al RCT ( Ricci Walker Walker RCT group, in foam (23.8 days 95% CI, 0.1 to 0.63) Study dressings gauze Silicone foam versus traditional Macfie and Condition wounds Perineal Until healing Duration use Resource comfort Dressing performance Dressing Other outcomes VAS,Visual scale analogue McMahon, 1980 Controlled trialControlled (868); gauze group no measure it was while in gauze group (23 days); than gauze group no Williams 26 RCT incised abscesses groups; between difference TABLE 5 TABLE Health Technology Assessment 2001; Vol. 5: No. 14 continued uze group uze group : 4 in Cutinova : significant reduction surgically Infection : :no : no : significantly : no difference : no significant = 0.03) easier in silicone p differences between groups between differences Ease of application well); of variance no measure significant difference between between significant difference groups performance Dressing (clinician assessed) Dressing leakage and leakage Dressing absorbency capacity to 1.33) Ease of removal (97% easily groups between in both groups;removed RR = 0.99; 95% CI, 0.97 to 1.01) Conformability (99% groups between differences and 93% in in silicone group conformed group polyurethane Necrotic tissue,Necrotic odour and and itching putrid secretion closed Number of wounds : < 0.05) greater p : significant reduction : no difference after 1 week of treatment for for of treatment after 1 week group,Cutinova for 3 weeks in gauze groupreduction of treatment after 1 week group, Cutinova for 3 weeks in gauze group reduction for Erythema : times about three ( significantly : shorter in poly- (90% painless groups between ( Mean time for dressingMean time for Comfort Number of dressing Number of dressing 4 at week (VAS) Pain change measure of variancemeasure easy) (RR = 1.25; 95% CI, 1.18 changes than foam group at weeks 3 at weeks group than foam (mean 0.28/0.69) and 4 (0.86); group (mean 0.14/0.39) no measure of variance not frequently were as they (RR = 2.1; 95% CI, 0.5 time during study at any reported to 9.15) Abdominal 4 weeks Abdominal 4 Pilonidal sinus Until healing pilonidal sinus wounds wounds (203 s) than group urethane both dressings; for RR = 0.99; (84% easy) than group foam surgery or Results for other outcome measures Results for ., Abdominal and Until healing 34 et al 43 ., 1996 et al 37 Study dressings gauze foam versusPolyurethane traditional Meyer, 1997 Condition Duration use Resource foam versusPolyurethane alginate dressings Berry comfort Dressing performance Dressing Other outcomes VAS,Visual scale analogue 1992 Polyurethane foam versus silicone foam dressings Polyurethane Butterworth RCT RCT (263 s); silicone group no 95% CI, 0.96 to 1.03) (67% group foam polyurethane RCT abscess incision in gauze group frequent more (1.82) than foam in gauze group dressings between no difference and 2 in ga group 27 TABLE 5 contd TABLE Results: clinical effectiveness :1 in :1 continued :no Postoperative infection Postoperative Bacteria cultured :no : alginate < 0.02) less than > 0.05) differences gauze group, in alginate group 0 : alginate dressing p p : no significant differences = 0.011); no further no further data provided < 0.01) easier than gauze p p Problems after operation Problems data provided during dressing changes and at during dressing other times; no statistically in satisfaction significant difference at the groups the three between last assessment visit Satisfaction during dressing change Ease of removal Ease of use : = 0.001); easier than gauze dressing groups; between difference p : significantly : less in alginate group < 0.01) less painful than ( p no further data provided ( than gauze group ( than gauze group no significant difference between between no significant difference 1; at week dressing gauze alginate and combined dressing ( significantly groups alginate and combined dressing Maximum pain Maximum removal of dressing Pain alginate dressing was significantlyalginate dressing was significantly dressing ( gauze dressing; no further data provided dressing; no further data Pain provided 0.9; 95% – : similar : no significant 1.8 to 0.0) – Number of visits (6 in alginatein both groups of variance or measure significant ( group, 86% in gauze group; RR = changes groups between differences gauze group; MD = significance 0.82; 95% CI, 0.61 to 1.09) Mean number of dressing Mean number CI, abdominal to gauze compared for greater Dehisced surgical Until healing Abscess incision 4 weeks avulsionToenail 8 weeks avulsionToenail Until healing No secondary outcomes 36 46 38 Results for other outcome measures Results for ., Abscess incision 3 weeks ., 1998 ., 1998 ., 1992 et al 45 et al et al et al 41 39 Quasi-RCT group, 7 in gauze group); no (71% in alginate groups between (RR = 0.0; 95% CI, 0.0 to 3.1) RCT (3.6 in alginate group, 4.5 in 1994 RCT Allen, and Foley avulsion Toenail Until healing Study dressings gauze Alginate versus traditional Cannavo Condition Duration use Resource comfort Dressing performance Dressing Other outcomes Dawson Dawson RCT wounds alginate or combined dressing; alginate and combined between RCT Smith, 1992 Van Gils Van 28 RCT Guillotreau 1996 TABLE 5 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14 :1 :1 1.8 – : 3 patients = 0.03; p 0.3; 95% CI, – : between no difference that grew pathogen that grew RR = 0.13; 95% CI, 0.02 discharge Serous in Debrisan group Mean time to pain-free up to 5 days after wound after wound up to 5 days closure, this did not occur days in beads (5.32 days groups group, group; in foam 5.64 days MD = to 1.2) : presence : no differences : leaked gel frequently Scar quality, of tolerance dressing, smell culture Postoperative Leakage from wound site wound from : no the gel from of the hydrated = 0.05) less to 0.75) :3 in :3 p : ( significantly Pain during group in hydrocolloid than in control first 4 weeks group; in pain median difference significant only groups between 1 during week Local intolerance comfort during andPatient satisfaction Patient after dressing change after dressing : :no : shorter in Number of dressings used Number of dressings or significance time Mean dressing Hospital stay significant differences between significant differences no measure of variance no measure to 13.2) 9 min);Comfeel no measure of variance groups the patient, along with its smell ( group control or significance wounds (68) in gauze group greater group, hydrocolloid 1 in control surgical wounds or suture median of by Debrisan group to continued in Eusol group Pilonidal sinus Pilonidal sinus Until healing avulsionsToenail Until healing downBroken Until healing surgical wounds 47 40 Results for other outcome measures Results for ., 2000 35 ., 1979 et al et al 50 Bruce, 1991 RCTRCT (23); group than hydrocolloid (RR = 2; group 95% CI, 0.3 among groups 10 min, (Serotulle groups group, in hydrocolloid 5 in between significant difference to was often offensive dressing Dextranomer polysaccharide versus silicone foam dressings Dextranomer Wheeler, and Young 1982 down Broken Until healing Study dressings gauze versus traditional Hydrocolloid Viciano Condition Duration use Resource comfort Dressing performance Dressing Other outcomes Dextranomer polysaccharide versus traditional gauze dressings gauze polysaccharide versus traditional Dextranomer Goode RCT 2.2 days; of variance no measure serious discharge for have RCT 29 TABLE 5 contd TABLE Results: clinical effectiveness

investigated. The controlled trial investigated for silicone foam than for the polyurethane the number of dressings used, level of pain on foam dressings. However, dressing times were dressing removal and time before return to work.44 recorded for clinic dressing changes only, which No statistical analysis was undertaken and variance were undertaken at a specialised wound clinic. data were not provided, and thus it is difficult to Here the equipment to make the silicone foam interpret these results. These results are presented dressing was laid out in advance, whereas a nurse in Table 5 and appendix 5. in a community setting would take additional time to prepare the foam dressing. The polyurethane Polyurethane foam dressings versus traditional foam dressing is simply removed from its packet gauze dressings and placed in the wound. Surgical wounds healing by secondary intention One RCT compared foam dressings to traditional Alginate dressings versus traditional gauze dressings. Other outcome measures reported gauze dressings by the trial included the evaluation of the level Surgical wounds healing by secondary intention of putrid secretion, odour, extent of necrosis, Two RCTs compared the use of calcium alginate erythema, infection, itching and pain, as well as to traditional gauze dressings in the packing of the rate of epithelialisation and granulation. The wounds following the incision and drainage of trial also investigated the frequency of dressing abscesses.38,41 One RCT compared the perfor- changes. The results are presented in Table 5 and mance of three dressings in the management appendix 5. Pain was found to be significantly of dehisced surgical abdominal wounds.36 The greater in the gauze group at week 4 compared three RCTs reported on other outcome measures, to that in the silicone foam group. A significant which included pain,36,38,41 patient satisfaction with reduction in the level of infection and erythema the dressing process,36 ease of dressing removal,38 was also reported to be present at the end of week ease of dressing use41 and bacterial culture.41 The 1 in the silicone elastomer foam group as com- results are presented in Table 5 and appendix 5. pared to week 3 in the conventional gauze group. All three trials reported that alginate dressings However, no actual figures were presented for were significantly less painful than conventional these results. gauze dressings. Ease of use41 and ease of removal38 were reported to be significantly better in the Polyurethane foam dressings versus alginate group compared to gauze. However, no alginate dressings actual figures were presented for either outcome. Surgical wounds healing by secondary intention One RCT compared the use of polyurethane Wounds resulting from toenail avulsion surgery foam with a calcium sodium alginate dressing.34 Three RCTs compared the use of alginate dressings The trial reported on other outcome measures, to conventional treatment on wounds produced by including ease of dressing application, ease of toenail avulsion followed by chemical destruction dressing removal, ease of dressing use, dressing of the germinal matrix and nailbed.39,45,46 Two of leakage, absorbency capacity of the dressing and the RCTs39,45 reported on other outcome measures, patient comfort. These results are presented in which included the number of dressing changes,39 Table 5 and appendix 5. No significant difference number of follow-up visits,45 any volunteered com- was found between the treatment groups for any plaints by the patients and the incidence of post- outcome measure. operative infection.45 The results are presented in Table 5 and appendix 5. The mean number of Polyurethane foam dressings versus silicone dressing changes was found to be significantly foam dressings fewer for participants in the alginate treatment Surgical wounds healing by secondary intention group compared to those treated with conven- One RCT compared the use of polyurethane foam tional gauze dressings.39 No difference was found to silicone foam dressings.37 The trial reported on between the treatment groups with regard to the other outcome measures that included ease of remaining outcome measures. dressing application, ease of dressing removal by clinical staff, patient comfort and the time taken Hydrocolloid versus traditional gauze dressings by clinical staff to change the dressing. The results Surgical wounds healing by secondary intention are presented in Table 5 and in appendix 5. A One RCT compared the use of hydrocolloid greater number of clinical staff considered the dressings with traditional gauze dressings soaked application of silicone dressing easier than poly- in povidone iodine, in the treatment of excised urethane foam. The time taken to apply the cavity pilonidal wounds.47 Two types of hydrocolloid 30 wound dressing was, on average, one minute less dressings were investigated, Comfeel and Health Technology Assessment 2001; Vol. 5: No. 14

Varihesive. The trial reported on infection rate, Summary of clinical effectiveness number of dressings used, dressing intolerance, data level of pain, level of odour, scar quality, tolerance and smell. The results are presented in Table 5 and Studies were judged as having an effect if they appendix 5. The level of pain was reported to be reported any significant difference between the significantly less during the first 4 weeks post- intervention groups for either the measures of operatively in the hydrocolloid treatment group healing or other measures. Studies were judged compared to gauze. However, there were no data as showing an overall effect if they showed a on the magnitude of the effect. There were five significant difference between treatments for postoperative cultures in the hydrocolloid group more than two outcome measures, or, if only one that grew pathogens, compared to one in the outcome measure was reported, if they showed a gauze treatment group. This difference was significant difference for that outcome. However, found to be statistically significant. There was the results presented in Table 6 may be affected no difference between the treatment groups by type I error (false-positive result), where the for any other outcome measure. conclusion that the intervention is better than the control may in fact be incorrect, and have Wounds resulting from toenail avulsion surgery occurred due to chance, especially in studies One RCT compared the use of hydrocolloid which reported a large number of outcome dressings with a chlorhexidine acetate impregnated measures. It is also important to note that some dressing (Serotulle) for the treatment of wounds of the other outcome measures are in fact related produced by toenail avulsion followed by the (i.e. not truly independent, e.g. pain, comfort, phenolisation of the germinal matrix and nail- ease of use and time taken to change the dressing). bed.35 The trial reported no difference between The results of all outcome measures should be the treatment groups with regard to the mean interpreted with caution due to the methodo- time to change of the dressing and the level of logical problems highlighted above. This is partic- patient comfort during and after the change ularly the case for the ‘other outcome measures’. of dressing. Due to the very subjective nature of the majority of these outcomes their measurement is partic- Dextranomer polysaccharide beads versus ularly susceptible to bias, especially in traditional gauze dressings unblinded studies. Surgical wounds healing by secondary intention One small RCT (n = 20) compared the use of On the whole, included trials tended to have a dextranomer polysaccharide beads to that of small sample size (median 43 participants) and traditional gauze dressings soaked in Eusol, in the the majority suffered from methodological flaws. treatment of contaminated or infected wounds The total number of participants included in the following bowel surgery or appendectomy.40 The trials was 783. Detailed information relating to trial reported on the length of hospital stay and the the randomisation procedure and blinding was level of serous wound discharge. Hospital stay was not reported in most trials. Many trials failed to reported to be shorter in the dextranomer beads report the initial wound size and baseline char- group compared to gauze. However, no measure of acteristics of included participants. The majority significance was provided. Participants in the gauze of trials that used the outcome measure of time treatment group continued to have serious dis- to complete healing reported mean values instead charge for up to 5 days after wound closure. This of median values. Mean healing times may not did not occur in the dextranomer beads group. represent the healing events in an appropriate way as they are greatly affected by outliers and, Dextranomer polysaccharide beads versus unlike median values, cannot be calculated if silicone dressings some wounds fail to heal. Almost half of the Surgical wounds healing by secondary intention included trials did not report their results in One RCT (n = 50) compared dextranomer sufficient detail to calculate a summary estimate polysaccharide beads and silicone foam elastomer of the treatment effect, for one or more outcome dressings in the treatment of surgical wounds that measures. The statistical test used to compare the had either broken down or been left open post- treatment groups was often not reported or no operatively.50 The trial also reported on the time statistical test was used. to pain-free wounds and time to the disappearance of erythema, oedema and slough. There was no Modern dressings versus gauze difference between the groups with regard to Eleven of the 13 studies of surgical wounds these outcome measures. compared modern dressings to traditional gauze 31 Results: clinical effectiveness

TABLE 6 Overall results of the assessment of effectiveness

Study Condition Healing outcomes Other outcomes

Overall effect Any effect Overall effect Any effect

Modern dressings versus gauze Surgical wounds Silicone foam versus traditional gauze dressings Macfie and McMahon, Perineal wounds –* ✔ –* ✔ 198042

Walker et al., 199148 Pilonidal wounds –* –* –* –*

Incised abscesses –* –* –* –*

Williams et al., 198149 Pilonidal wounds –* –* ✔✔

Ricci et al., 199844 Pilonidal wounds –* ✔ –* –*

Polyurethane foam versus traditional gauze dressings Meyer, 199743 Abdominal surgery or ✔✔ ✔ ✔ abscess incision

Alginate versus traditional gauze dressings Cannavo et al., 199936 Dehisced surgical –* –* –* ✔ abdominal wounds

Dawson et al., 199238 Abscess incision –* –* ✔✔

Guillotreau et al., 199641 Abscess incision –* ✔✔✔

Hydrocolloid versus traditional gauze dressings Viciano et al., 200047 Pilonidal wounds –* –* ✔✔

Dextranomer polysaccharide versus traditional gauze dressings Goode et al., 197940 Broken down –* ✔ –* –* surgical wounds

Toenail avulsion Alginate versus traditional gauze dressings Foley and Allen, 199439 ✔✔ –* –*

Smith, 199245 ✔✔ –* –*

Van Gils et al., 199846 ✔✔ None investigated

Hydrocolloid versus traditional gauze dressings Bruce, 199135 ✔✔ –* –*

Direct comparison of modern dressings Surgical wounds Polyurethane foam versus alginate dressings Berry et al., 199634 Pilonidal wounds –* –* –* –*

Polyurethane foam versus silicone foam dressings Butterworth et al., Abdominal and –* –* –* ✔ 199237 pilonidal wounds

Dextranomer polysaccharide versus silicone foam dressings Young and Wheeler, Broken down –* –* –* –* 198250 surgical wounds

✔, Positive effect of intervention (i.e. intervention shows greater benefit than control) 32 *No significant effect reported Health Technology Assessment 2001; Vol. 5: No. 14

dressings. Only one study found an overall effect In summary, there is a suggestion that modern on healing in favour of modern dressings.43 A dressings have a beneficial effect compared to further four studies found some significant benefit traditional gauze dressings, especially for toenail of the modern dressings compared to traditional avulsions, where significant benefits of modern gauze dressings.40–42,44 The study which found an dressings were found. This suggestion should be overall beneficial effect in terms of healing also seen in the context of the poor quality of the found an overall beneficial effect for the other studies, the fact that the direction of bias is outcomes investigated; this study compared poly- unclear and the unknown effects of publication urethane foam to gauze dressing.43 Two of the bias. There is some evidence to suggest a beneficial four studies which found some significant effect of effect of modern dressings on other outcomes, the modern dressing (alginate and silicone foam) such as pain, dressing performance and resource on healing outcomes also found some significant use, for surgical wounds, although a beneficial effect on other outcomes.41,42 One of these studies effect for these outcomes was not found for found an overall beneficial effect of alginate dress- studies of toenail avulsions. However, in addition ing compared to gauze for the other outcomes to the methodological problems highlighted considered.41 Three studies which did not find above, these outcome measures are very difficult any difference between treatment groups for to assess and are particularly subject to bias, healing outcomes found an overall significant especially in unblinded studies. effect of the modern dressing on the other outcomes investigated.38,47,49 These studies looked Direct comparison of modern dressings at silicone foam,49 alginate dresings38 and hydro- Only two studies compared different types of colloid dressings.47 One further study found some modern dressing. One study compared a poly- significant benefit of the modern dressing urethane foam to silicone foam37 and the second (alginate) for outcomes other than healing.36 compared polyurethane foam to alginate.34 Neither of these studies found any overall signifi- The four studies of toenail avulsions all found a cant difference in healing outcomes or other significant difference in favour of modern dress- outcomes between the two groups, although ings compared to gauze for the outcomes relating one of the studies did find a significant difference to healing but not for the other outcomes,35,39,45,46 in favour of the polyurethane foam group for although one of these studies did not investigate one of the other outcomes investigated.37 In any other outcomes.46 Three of these studies view of the lack of data, there is no evidence to compared alginate to gauze,39,45,46 and the support the superiority of one type of modern fourth compared hydrocolloid to gauze.35 dressing over another.

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Health Technology Assessment 2001; Vol. 5: No. 14

Chapter 5 Results: cost-effectiveness

Quantity and quality of interventions with regard to wound healing.36,42,48 Two trials reported no significant difference research available between the treatment groups with regard to Included studies time to hospital discharge.48,51 One trial reported Three economic evaluations that met the significantly fewer district nurse visits among inclusion criteria were identified.36,48,51,60 participants in the intervention group (silicone Information relating to one study was derived foam) compared to those in the control group.51 from two publications.51,60 For the purpose of Of the economic evaluations submitted by the this review the economic evaluation is referenced pharmaceutical companies, the effectiveness according to the latest publication.51 Two further data for one62 were based on the findings of a economic evaluations, included in the company single small RCT, one case study and a small submission data presented to NICE, met the NHS hospital survey. The RCT is included in the inclusion criteria.62,63 effectiveness section of this review; it reported a significant difference with regard to healing in There was heterogeneity between studies with favour of the intervention (polyurethane foam).43 regard to the type of debriding agent investigated, However, the decision to conduct a cost- the comparator dressing and the type of study minimisation analysis for the economic evalu- populations examined. ation was based on the findings of a published systematic review of the literature on the All included economic evaluations investigated the debriding of chronic wounds, including surgical cost-effectiveness of the autolytic debriding method wounds healing by secondary intention.30 The compared to traditional gauze dressings soaked in review concluded that, pending the availability various antiseptic solutions. The type of dressings of improved relative effectiveness data, other investigated varied, with two studies looking at considerations, such as cost minimisation, silicone elastomer foam dressings,48,51 one at may reasonably guide decisions on the use polyurethane foam dressings62 and one at of debriding agents.62 calcium alginate dressings.36 All the included economic evaluations investi- The study population included in the economic gated costs from the perspective of either a single evaluations varied. One study included patients hospital or the health service (the NHS). The from a gastrointestinal surgical unit with surgical type of direct costs considered included dressing abdominal wound breakdown,36 one study costs,36,48,51,62,63 drug costs,63 inpatient hospital stay included patients with granulating perineal (which includes nursing time),36,48,51,62,63 costs wounds following abdominal excision of the incurred after discharge (outpatient and district rectum51 and another study looked at patients nurse visits)48,51,63 and travel time (for clinic or who had received surgery for either pilonidal district nurse visits after discharge).51,63 sinus or abscess.48 Both economic evaluations submitted by pharmaceutical companies looked Most economic evaluations were set in the UK at participants with difficult to heal surgical and considered the cost in pounds sterling.36,48,62,63 wounds healing by secondary intention.62,63 One economic evaluation was carried out in Neither study provided information on Australia and presented cost data in Australian the type of surgical procedures that dollars.51 The cost years, where specified, were were undertaken. 1996,36 1989–199048 and 1982.51

All five studies were cost-effectiveness analyses. Only one study used stochastic data, which were The source of effectiveness data for three of the analysed using a one-way analysis of variance economic evaluations was a single RCT with a (ANOVA).36 small sample size.36,48,51 All three RCTs are included in the effectiveness section of this review; they Detailed information about the included economic reported no significant difference between the evaluations is presented in appendix 6. 35 Results: cost-effectiveness

Quality of included economic However, this is an intermediate outcome measure, evaluations as follow-up appointments or visits are usually still A summary of the quality assessment of the required. One economic evaluation included the economic evaluations is presented in Table 7. number of nurse visits51 and one incorporated information on the number of dressing changes.62 Question Two economic evaluations also reported on pain All included economic evaluations reported as an outcome measure36,62 and one included clear objectives, and detailed information about patient satisfaction with the dressing process.36 the alternative dressing protocols was presented. Two economic evaluations did not specify the price Accurate measurements of costs and outcomes year that was used.62,63 One economic evaluation Costs were considered to have been measured used staff costs based on 1998–1999 data and accurately in all economic evaluations. The trials dressing acquisition costs in 1996 prices and did from which the clinical effectiveness data were not describe how these were combined.62 derived suffered from validity problems (see page 12).36,42,43,48 Problems included lack of blind- Important costs ing, no information reported on the method of All economic evaluations were undertaken from randomisation and no ITT analysis. Subjective the perspective of the NHS, and therefore only decisions, such as time to discharge, means that costs relating to the NHS were considered. The proper blinding is essential. Only one trial reported economic evaluations were considered to have blinded outcome measures.36 However, wound size incorporated the relevant costs and outcome and pain were the only outcome measures blinded. measures for this perspective. None of the studies It was reported that three experienced surgical covered the patient viewpoint or conducted the nurses, who were not working in the gastro- evaluation from a societal view point. However, intestinal surgical unit, but were instructed in and one study quantified lost productivity, reporting familiar with the study protocol, conducted all that some patients who received silicone elastomer ‘blinded’ assessments. No further information was foam dressings were able to return to work provided on how the assessors were blinded and within one day of discharge, although this the success of blinding was not checked. This outcome was not costed.48,51 study also reported on the outcomes of time to discharge and patient satisfaction with dressings. Source of clinical effectiveness data The same trial measured wound depth using a The effectiveness data for four economic depth gauge at the deepest point. Wound volume evaluations were obtained from small RCTs with was then calculated from this single measurement. uncertain results, and therefore a moderate or No reliability test for measuring wound depth was high risk of bias is present.36,48,51,62 One economic conducted. The initial wound size of the treatment evaluation also incorporated clinical effectiveness groups in two trials was not comparable at base- data from a very small hospital survey (n = 5) line.36,43 One trial did not present information and one case study.62 The variation in both cost- on the baseline comparability of the intervention effectiveness and clinical effectiveness data cannot groups with regard to wound size.48 be reliably established from such small samples, and a number of assumptions would have had Prospective analysis to be made. The study also failed to present Ideally, costing should be undertaken prospec- information on how the data from the two tively (i.e. as part of the clinical trial) in order to sources were combined. ensure that all the important data relevant to the economic evaluation are collected and that appro- Outcome measures priate statistical analysis is used. Costing was Only economic evaluations that incorporated undertaken retrospectively in three of the healing as an outcome measure were included economic evaluations.48,51,62 in the review, and therefore all included studies were considered to have included important Valuation of costs outcome measures. The healing rate of one Costs were considered to have been valued credibly trial also included surgical wounds that had in all economic evaluations. been closed with secondary suture.43,62 Two trials reported time to complete healing,42,48,51 and one Sensitivity analysis trial included healing rate (reduction in wound Issues of uncertainty can be dealt with using size).36 Two studies also included the outcome sensitivity analysis. Ideally, these should be 36 measure of time to hospital discharge.48,51 multiway, include other variables and 95% CIs Health Technology Assessment 2001; Vol. 5: No. 14 ✘ / § – ✘✔ ✘✔ ✘✔ / / / § – § – ✔✔ ✔✔ ✘ ✘✔ ✘✔ § – § – NA NA NANA NA NA NA NA § – § – § – ✘✔ ✘✘✔ ✔ ✔ ✔ ✘✔ ✘ ✔ / / / § – ✘✔ ✘✔ ✘✔ / / / § identified– accurately valued timing for § of altern-atives costs/ outcomes measured effectiveinterest costing outcomes comes tive– adjusted analysis out- analysis of outcomes mental tivity all issues abilitiy § – ✔✔ ✔ ✔✔ ✘✔ ✔✔ ✔ ✔✔ ✔ ✔✔ ✔ ‡ § – † Figure 1 Figure § economic letter evaluation CEA/CMA G CEA/CCA H – CEA/CMA H 36 48 , partially covered; NA, not appropriate 62 63 ✔ / 51 ., 1988 ✔ ., 1991 Quality assessment of included economic evaluations* et al , no; et al ✔ ,Yes; Commercial in confidence data omitted Commercial in confidence CCA, Cost–consequence analysis; CEA, analysis; cost-effectiveness CMA, cost-minimisation analysis For classification of matrix classification see For score Study of Type Matrix Question Description and Culyer Important Clinically Costs/Walker CEA Prospec- Costs/ Costs/† H ‡ Incre-§ Sensi- Included Generalis- Wagstaff, 1984 *More detailed information relating to the questions used to assess quality of economic evaluations is presented in appendix 4 is presented to the questions used assess quality of economic evaluations relating detailed information *More Beiersdorf, 2000 Cannavo Cannavo ConvaTec, 2000 ✔ 37 TABLE 7 TABLE Results: cost-effectiveness

should be incorporated. However, only three reasonable approach, therefore, would have of the economic evaluations conducted such been to assume zero days difference and use, for an analysis.51,62,63 The remaining two studies example, the 3 days difference in the sensitivity used a sensitivity analysis that was limited to one- analysis. The cost year for one economic evaluation way and which included a worst-case/best-case was 1982, and both clinical practice and costs will scenario. One study recalculated the cost data have changed since this date.48,51 while doubling the frequency of the intervention dressing changes (polyurethane foam)62 and one Polyurethane foam versus traditional study presented three estimates of cost for each gauze dressings variable (high, medium and low).51 One economic evaluation investigated the cost-effectiveness of polyurethane dressings as Generalisability compared to traditional gauze dressings.62 The The setting for two studies differed from that study included patients with difficult to heal of a typical UK NHS setting and this should be surgical wounds and demonstrated that the taken into consideration when generalising the polyurethane dressing was dominant (less findings. One study was based in a naval hospital costly and more effective). where participants were mainly servicemen living far outside the immediate hospital vicinity. This However, the economic evaluation had methodo- means that participants were discharged when logical problems. The findings of a small RCT55 healing was well advanced, as regular follow-up (n = 43) was used to show that patients treated with was difficult to arrange.48 One trial was based in polyurethane foam experience more rapid wound Australia, where staffing arrangements may healing as compared to gauze. Two sources were differ from those in the UK.36 used for the cost data (a case study (n = 1) and a hospital survey (n = 5)) and no information was presented on how these were combined. Staff costs Assessment of cost-effectiveness were based on 1998–1999 data and acquisition costs were based on 1996 prices. It was not stated Silicone foam dressings versus how these were combined. Costing was undertaken traditional gauze dressings retrospectively and was not conducted on the Two economic evaluations investigated the cost- sample used in the effectiveness study, and effectiveness of silicone foam dressings as com- therefore included a number of assumptions. pared to traditional gauze dressings.48,51 One economic evaluation looked at participants who Calcium alginate dressings versus had received surgery for either pilonidal sinus traditional gauze dressings or abscess48 and the second included patients One economic evaluation investigated the with granulating perineal wounds following cost-effectiveness of three dressing types in the abdominal excision of the rectum.51 The type management of dehisced surgical abdominal of costing reported by both studies included wounds.36 Dressing protocols included calcium dressing costs, hospital stay and other costs alginate dressings, sodium hypochlorite moistened incurred after discharge, such as district nurse gauze with Combine dressing pads (an absorbent visits. One study also incorporated travel costs.51 wound dressing that consists of cotton wool and There was no significant difference between the gauze), or Combine dressing pads alone. No dressings in terms of either healing rate or time significant difference was found between the to discharge; silicone foam was found to be less interventions in terms of healing time, but both expensive than traditional gauze dressings by the alginate dressings and the Combine dressing both economic evaluations. Both studies there- pad were found to be economically advantageous. fore reported partial dominance in favour of the silicone foam dressing. The effectiveness trial had a small sample size (n = 36) as well as some validity problems, which However, there are a few important methodo- should be taken into consideration when inter- logical issues, in addition to the quality issues preting the results. The economic evaluation previously reported, that need to be considered did not include a sensitivity analysis. when interpreting these results. The cost of hosp- ital stay in one economic evaluation was calculated Modern semi-occlusive and based on participants being discharged 3 days occlusive dressings versus traditional earlier in the silicone foam group.48 This differ- gauze dressings 38 ence was not found to be significant. Another Paragraphs removed: commercially in confidence. Health Technology Assessment 2001; Vol. 5: No. 14

Summary of cost-effectiveness However, one economic study evaluated the data cost of hospital stay using a cost-minimisation analysis based on the fact that the participants The conservative assumptions made by the in the silicone foam dressing group had been economic evaluations from the effectiveness discharged from hospital 3 days earlier than those data are in agreement with the findings of in the gauze intervention group.48 This was despite the review. This assumes that publication bias the fact that there was no significant difference would not affect the results. In other words, if between the two treatment groups with regard to the economic evaluations were based on a syste- length of hospital stay. This means that the results matic review the same assumptions with regard of this study may be too optimistic. to healing outcomes and length of hospital stay (i.e. no difference between the modern The results of the cost-effectiveness data lie within dressings and traditional gauze dressings) the region of grade H on the matrix presented in would have been made. This means that the Figure 1. This represents partial dominance in decision to undertake cost-minimisation favour of the intervention. However, it is important analysis is reasonable in light of our to note that the quality of the clinical effectiveness findings. and cost-effectiveness analysis is poor.

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Chapter 6 Discussion

Main results the context of the poor quality of the studies, the fact that the direction of bias is unclear Clinical effectiveness and the unknown effects of potential publication The 17 studies that met the inclusion criteria bias. None of the included studies found all promoted autolytic debridement. No studies traditional gauze dressings to be more effective were found that investigated sharp/surgical, than modern dressings. However, this could biosurgical, mechanical or enzymatic debride- also be an indication that publication bias is ment, and no studies were found that evaluated present, especially as all the included trials the use of specialised wound clinics. The type were relatively small, or if bias is operating in of surgical wounds evaluated by the included the same direction in all trials in favour of studies were those that had broken down post- modern dressings. operatively, perineal wounds resulting from proctolectomy or rectal excision, and those left Cost-effectiveness open after pilonidal excision or abscess incision, All the included economic evaluations investi- or wounds following a laparotomy. Four studies gated the cost-effectiveness of autolytic debriding investigated treatment of postoperative wounds compared with traditional gauze dressings soaked from toenail avulsions. The debriding agents in various antiseptic solutions. The type of dress- investigated included foam dressings (silicone ings investigated varied, with two studies looking elastomer foam dressings and polyurethane at silicone elastomer foam dressings, one study foam dressings), alginate dressings, hydrocolloid investigating polyurethane dressings and one dressings and dextranomer polysaccharide study looking at calcium alginate dressings. No beads dressings. Most were compared to tradi- economic evaluations that compared the cost- tional gauze dressings, impregnated or otherwise. effectiveness of two different types of modern However, there was a great variation between dressings were found. No economic evaluations trials with respect to the type of antiseptic solu- investigating specialised wound care clinics tion with which the gauze was soaked and the were found. type of gauze dressing used. Three trials in- cluded a direct comparison of modern dressings. All four studies were cost-effectiveness analyses One trial compared polyurethane foam to and two studies went on to undertake a cost- alginate dressings, and one trial included the minimisation analysis. For three of the economic comparison of polyurethane foam and silicone evaluations the sources of effectiveness data were foam. The third trial compared dextranomer single small RCTs. polysaccharide to silicone foam. No difference between the dressings was found with regard However, the conservative assumptions made by to healing. the economic evaluations on the effectiveness data are in agreement with the findings of the As the included studies varied with respect to review, assuming that publication bias would not wound type and debriding agent used, as well affect the results. This means that the decision as the type of comparator, statistical pooling of to undertake cost-minimisation analysis is study results was deemed inappropriate. Most reasonable in the light of our findings. trials found no significant difference between modern dressings and conventional gauze The results of the cost-effectiveness data suggest dressings with regard to healing, but a number partial dominance in favour of the intervention, of studies showed modern dressings to be better with only the cost data supporting the use of the than conventional gauze. The overall findings intervention dressings (modern dressings found of the effectiveness data therefore suggest a to have lower costs compared to the gauze beneficial effect in favour of the modern dressings dressings, but with no difference in the outcome compared to gauze, especially for toenail avulsions, measures). However, the quality of the clinical where significant benefits of modern dressings effectiveness and cost-effectiveness analysis were found. This suggestion should be seen in is poor. 41 Discussion

Assumptions, limitations none of the trials reported blinding of treatment and uncertainties administrators. Blinding is very important in that it avoids observer bias, and it is therefore essential Effectiveness data for any subjective outcome measures such as the Included trials were generally very small and the assessment of the wound being completely healed majority had methodological problems. There and the exact timing of healing, pain, comfort were also problems with regard to poor reporting. and granulation. Previous research has shown It is important that trials are not only conducted that non-blinded studies can overestimate the well but are also reported adequately. Readers treatment effect.66,67 Non-blindness of adminis- should not have to infer what was probably done, trators can also result in the biased administration they should be told explicitly.64 of co-interventions.

Information relating to secondary dressings The details of the initial wound size were not used by included trials was very poorly reported, reported by almost half (47%) of the included and it was therefore difficult to ascertain if a moist trials. Information relating to the comparability wound environment had been provided in the of groups with regard to other important baseline comparator group. The interventions evaluated characteristics was also very limited. Prognostic by some included trials may not be suitable for similarity at baseline is important for drawing wound management to the end-point of complete causal differences in therapeutic effects found.68 healing. If the intervention is changed (e.g. where If there are any baseline differences between the wound becomes filled with granulation tissue treatment groups, which favour either group, or exudate levels become very low (e.g. too low for then this should be adjusted for in the analysis. the use of alginate dressings)) then the dressing Five trials reported differences between the protocol needs to be described explicitly. It was treatment groups with regard to the initial generally not clear when decisions were made to wound size. None of these trials reported change dressing protocols and to what type of making any allowances for this during dressing. In order to associate any treatment data analysis. differences with a particular product one has to assume that all patients in all treatment groups Information relating to the methods used to received identical wound management with the measure wound size were poorly reported. exception of the intervention under investigation. Only nine trials reported information on wound measurement.35–37,40–43,45,50 Eight trials reported Most included trials (76%) failed to state the using a photographic record of wounds, but none method of randomisation procedure used and none stated any further details on how the photographs of the trials reported any allocation concealment. were interpreted.35–37,40,41,43,45,50 Two trials reported Proper randomisation ensures that selection bias using tracings of the wound, but again no further is avoided by ensuring that participants have a pre- description of the method was given.35,41 Two specified (very often an equal) chance of being trials used a stick and a ruler, one trial reported assigned to the experimental or control group.65 using sterile swabs and one trial filled the wound An adequate procedure for generating a random with sterile saline, but gave no further details.36,37 number list should therefore be used. None of the One trial reported taking volumetric measure- studies reported on concealment of treatment ments using impression material (type not stated) allocation. Prior knowledge of group assignments or saline,43 but gave no further details and did leaves the allocation sequence subject to manip- not state how many wounds were measured ulation by researchers and participants.65 Concealed with each method, and one trial reported using random allocation of treatments, by an independent silicone elastomer foam dressing to measure person not responsible for determining the eligi- the volume of water displacement.42 bility of patients, is therefore essential. Previous research has demonstrated that RCTs and non- Only one trial reported testing the reliability randomised controlled trials may produce different of the wound measurements taken.36 This was results.66 RCTs that have used an inadequate conducted by correlating ruler and photographic randomisation procedure or have not clearly measurements on a sample of the wounds demonstrated allocation concealment may assessed. However, only the measurement of overestimate the treatment effect size.66 wound diameter was tested. Wound depth was measured using a depth gauge at a single point, The majority of included trials (94%) did not which was considered to be the deepest point. 42 report using blinding of outcome assessors, and The reliability of this measurement was not Health Technology Assessment 2001; Vol. 5: No. 14

assessed, but it was used to calculate the wound The majority of included trials (70%) followed volume. The results were analysed with respect to up participants until complete healing had wound volume. occurred, using the healing time as an outcome measure. All but two trials reported mean values Most other outcome measures evaluated by the for time to complete healing. Mean values are trials, such as pain, comfort and dressing perfor- greatly affected by outliers and, unlike median mance, were subjective in nature. In addition, values, cannot be calculated if some wounds fail some trials included a subjective outcome to heal. None of the included trials of surgical measure of healing (this is in addition to an wounds used survival analysis (where survival indi- objective outcome measure required for cates the proportion of wound survival, i.e. not inclusion), such as time to dry dressing and healed, at any point of time during follow-up)68 time to cavity fill. Subjective outcome measures or reported hazard ratios (the ratio of the wound are unlikely to be measured consistently between closure probabilities per unit time).68 wounds.30 None of the included studies validated the measurement of these measures or tested Four of the included trials reported number of the reliability of the measurements taken (either wounds healed over a specific time period (i.e. inter-rater or intra-rater reliability). This is likely at the end of the study). These trials included a to lead to misleading results. It is also considered relatively short follow-up period (range 3–8 weeks). that subjective measures usually overestimate It was unlikely that all participants underwent the the relative effectiveness of the experimental surgical procedure at the same time, and there- treatment compared to objective measurements fore a short follow-up period may not have been in the same trial.30 adequate. However, if the length of follow-up is too long then most wounds will have completely The change in wound area (or volume) can healed at the end of the trial. The use of a survival be expressed as either the percentage change analysis which takes into account both whether or the absolute change. The percentage change and when the wound healed would have been takes into account the initial size of the wound. a more appropriate analysis to use. None of For two wounds healing at the same linear rate the trials used a survival analysis. (as measured by the diameter reduction), the percentage area calculation will show a larger Study results should be presented in enough change for a small wound than a big wound.30 detail to enable the reader to re-analyse the data. The opposite is true when reporting the absolute For surgical wounds, only 50% of included trials change in wound area, as a bigger reduction in reported sufficient data to calculate a summary the wound radius will occur for larger wounds. estimate of the treatment effect for one or more It is therefore important that studies that report healing outcome measures, and only 15% for one incompatibility with regard to initial wound size or more other outcome measures. For toenail should present the results on a change in wound avulsion surgery, 80% of included trials reported area as both the percentage change and the sufficient data on healing outcome measures and absolute change. This will enable the reader to 33% for other outcome measures. ascertain that the change data are in the same direction for both measurements. Of the nine Twenty-eight per cent of the included trials did trials that reported baseline wound measurements, not undertake a statistical analysis to compare the five reported incomparability with regard to treatment groups and 44% did not report what initial wound size. Four of these trials used statistical test was used to analyse the data. It was reduction in wound size as an outcome measure, therefore not possible to ascertain whether the of which only two trials reported both the correct statistical test was undertaken in almost absolute and the percentage change. half of the included trials. Ideally, studies should report which statistical test they were planning on Wounds rarely heal at a linear rate, with some using to analyse the data. The reader can then be wounds enlarging prior to healing while others more confident that a significant result was initially decrease rapidly in size before experi- obtained using the planned test. encing a slower rate of healing.30 Therefore, the percentage change in wound area or volume None of the trials reported using an ITT analysis, based on a linear rate would not give an accurate where participants are analysed according to the estimate of the rate of healing. Complete healing groups to which they were initially randomly is therefore seen as the most valid outcome in allocated, regardless of whether or not they studies of wound healing.30 dropped out, fully complied with the treatment, 43 Discussion

or crossed over and received the other treatment. acknowledged that some publication bias may Such an analysis protects against attrition bias.65 therefore be present. Ignoring the findings of all withdrawals, drop- outs and non-responders means that only those Another source of publication bias is where trials who fully complied with treatment were included that do not show the intervention to be effective, in the analysis, which could lead to an over- or do not report significant findings, do not get estimation of the treatment effect. published. This may be due to the reluctance of the authors themselves or due to the editorial Some of the included trials reported a large policies of editors.70 This can be a particular number of outcome measures. Five trials reported problem with industry-sponsored studies, with on more than five outcome measures. The trial companies often only wanting to publish positive that reported the greatest number of outcomes results relating to their products. Five of the reported nine measures. If trials investigate a 17 included studies reported being sponsored sufficient number of outcome measures it becomes by a pharmaceutical company, although it is more probable that a significant result will be possible that others were industry sponsored found by chance. but did not report this.

The included trials had small sample sizes, Due to the poor reporting of outcome measures ranging from 12 to 80 participants (median 43). and the different outcome measures used by A small sample size means that the randomisation included studies it was not possible to investigate process is unlikely to ensure that initial wound the effect of publication bias either graphically measurements, as well as other important prog- or statistically. nostic factors, will be comparable at baseline. Small trials are unlikely to measure any treatment Economic evaluation effects with good precision (i.e. the CI will The valid application of a cost-minimisation be wide). analysis requires that the patient outcomes associated with each procedure are the same. Many factors affect wound healing, such as under- All four economic evaluations undertook a lying medical conditions that can impede the cost-effectiveness analysis and two went on to body’s defence system (e.g. diabetes and rheu- undertake a cost-minimisation analysis. Con- matoid arthritis), concurrent medical treatment sidering the overall findings of the effectiveness (e.g. immunosuppressant drugs and steroids), part of the review, this type of analysis is con- the risk of infection due to the type of surgery that sidered appropriate, as modern dressings were was undertaken and the nutritional status of the found to be marginally more effective than patient. This means that much larger trials, with conventional gauze dressings. careful consideration given to the type of inclusion and exclusion criteria used, are needed to show However, three of the included economic the effectiveness of specific interventions. evaluations made assumptions based on the findings of very small single RCTs that found Twenty-three studies were excluded because no significant difference between the treatment they were not reported in one of the languages groups with regard to wound healing. A non- considered for inclusion. It was not possible to significant finding does not mean that the inter- ascertain if they met inclusion criteria (appro- ventions were equivalent. For equivalence to be priate study design, intervention, wound type ‘proven’ the CIs of the summary effect have to and outcome measure). Fifteen of these studies be quite narrow. This means that small trials were reported in Russian. Three studies were showing a non-significant difference between reported in Italian and the remaining studies the interventions do not prove equivalence, were published in Danish, Japanese, Portuguese as such studies may lack the power to detect or Spanish, and one study was from Scandinavia. significant difference. Authors whose first language is not English may be more likely to publish positive findings in It is also important to remember that the poor English-language journals, because they are con- quality of effectiveness trials is reflected in the sidered to have a greater international impact.69 economic evaluations. There were also some This means that the exclusion of non-English methodological problems in the economic evalu- studies could lead to overoptimistic conclusions. ations themselves, including lack of sensitivity The language restrictions used in this review analysis, absence of statistical analysis and the 44 were due to the time constraints and it is use of retrospective costing. Health Technology Assessment 2001; Vol. 5: No. 14

Need for further research • RCTs of other autolytic debriding methods not covered by included trials, such as hydrogels. The review has identified the following areas for • Further research, on both clinical effectiveness future research: and cost-effectiveness, into the use of other debriding methods, such as enzymatic, • Large multicentre trials of good methodological biosurgical and surgical methods, in the quality comparing foam, alginate, hydrofibre, treatment of surgical wounds healing by hydrocolloid or dextranomer beads dressings to secondary intention. standard treatment or, preferably, to each other. • Because there is no research available on It is acknowledged that it may be difficult to the organisation of care, such as the use of recruit sufficient numbers with similar wounds specialist wound care clinics, research that from a single centre or hospital. includes studies looking at both the clinical • More good-quality economic evaluations of effectiveness and cost-effectiveness of the use modern dressings that are based on sound of specialised wound care clinics is required. scientific evidence, such as good-quality • Further epidemiological studies to evaluate the primary RCTs. This means that information extent of the problem (i.e. the prevalence and relating to such outcome measures as the cost to the NHS of treating surgical wounds time taken to change dressings, the number healing by secondary intention where there of dressing changes required and the number is a delay in the healing process). of nursing visits is measured accurately. Economic evaluations would also need to It is recommended that future research be utilise sensitivity analyses that investigate independently funded. It is also suggested that the the effect of adjusting these variables on association of professional organisations may take the overall findings. the responsibility of organising such research.

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Chapter 7 Conclusions

he majority of included studies were UK seen in the context of the poor quality of the T based, within the NHS setting. Two of the studies, the fact that the direction of bias is included trials were based in a military hospital unclear and the unknown effects of potential and five trials were based outside the UK. The publication bias. There are insufficient data to countries of origin for these trials were Australia, support the superiority of one type of modern the USA, France, Italy and Spain. dressing over another.

In summary, there is a suggestion that modern The results of the cost-effectiveness data suggest dressings have a beneficial effect compared to partial dominance in favour of the intervention. traditional gauze dressings, especially for toenail However, the poor quality of the clinical effective- avulsions, where significant benefits of modern ness and cost-effectiveness analysis limits the full dressings were found. This suggestion should be endorsement of this interpretation.

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Acknowledgements

External advisory panel Assistance with economics data Nicky Cullum, Reader/Co-ordinating Editor, Boyka Stoykova, Research Fellow (NHS EED Cochrane Wounds Group, Centre for Evidence Project), NHS Centre for Reviews and Based Nursing, Department of Health Studies, Dissemination, University of York, Heslington, University of York, Genesis 6, York Science Park, York YO10 5DD, UK. Heslington, York YO10 5DQ, UK. John Nixon, Research Fellow (NHS EED Project), Andrea Nelson, Research Fellow/Review Group NHS Centre for Reviews and Dissemination, Co-ordinator, Cochrane Wounds Group, Centre University of York, Heslington, York YO10 5DD, for Evidence Based Nursing, Department of UK. Health Studies, University of York, Genesis 6, York Science Park, Heslington, York YO10 5DQ, UK. Reading draft copies of the report Peter Moore, Consultant Surgeon, Scunthorpe General Hospital, Cliff Gardens, Scunthorpe Jos Kleijnen, Director, NHS Centre for Reviews DN15 7BH, UK. and Dissemination, University of York, Heslington, York YO10 5DD, UK. Liz Scanlon, Nurse Consultant – Tissue Viability, Centre for the Analysis of Nursing Practice, Leeds Community and Mental Health Trust, Mansion Conducting initial literature House, Meanwood Park Hospital, Tongue Lane, searches Leeds LS6 4QB, UK. Ruth Frankish, Information Specialist, Appraisals, Christine Moffatt, Professor of Nursing, The National Institute for Clinical Excellence, Centre for Research and Implementation of 11 Strand, London WC2N 5HR, UK. Clinical Practice (CRICP) (part of Thames Valley University), Wolfson Institute of Health Sciences, 32–38 Uxbridge Road, London W5 2BS, UK.

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165. Petrosian E. Sodium hypochlorite in the treatment 178. Ricci E, Cassino R, Carusone A, Mercanti A, of suppurative peritonitis. Vestn Khir Im I I Grek Leaper D. Actisorb Plus and infected wounds: 1993;150(Pt 5–6):18–21. successful treatment and cost reduction. In: Leaper D, editor. European Wound Management 166. Phan M, Van der Auwera P, Andry G, Aoun M, Association Spring Meeting; 1997; Milan, Italy. Chantrain G, Deraemaecker R, et al. Wound London: Macmillan Magazines; 1998. p. 147. dressing in major head and neck cancer surgery: a prospective randomized study of gauze dressing 179. Sakai Y, Iwasa M, Isonokami M, Matsumoto K, vs sterile vaseline ointment. Eur J Surg Oncol Hashimoto K, Yoshikawa K. Clinical evaluation of 1993;19(Pt 1):10–16. DuoDERM registered Extra Thin for postoperative wound. Skin Res 1992;34(Pt 4):514–21. 167. Philbeck T Jr, Whittington K, Millsap M, Briones R, Wight D, Schroeder W. The clinical and cost 180. Schmidt JM, Greenspoon JS. Aloe vera dermal effectiveness of externally applied negative pressure wound gel is associated with a delay in wound wound therapy in the treatment of wounds in home healing. Obstet Gynecol 1991;78(Pt 1):115–17. healthcare Medicare patients. Ostomy Wound 181. Schmitt M, Vergnes P, Canarelli JP, Gaillard S, Management 1999;45(Pt 11):41–50. Daoud S, Dodat H, et al. Evaluation of a hydro- colloid dressing. J Wound Care 1996;5(Pt 9):396–9. 168. Platt J, Becknall RA. An experimental evaluation of antiseptic wound irrigation. J Hosp Infect 182. Schwarz N. Enzymatic wound debridement with 1984;5:181–8. a combination of fibrinolysin and desoxyribo- nuclease. Fortschr Med 1981;99(Pt 25):978–80. 169. Plaumann L, Ketterl R, Claudi B, Machka K. Pulsating jet lavage for cleansing of contaminated 183. Shukla HS. Silastic foam elastomer wound and infected wounds. Chirurg 1985;56(Pt 11):754–5. dressing in wound management. Ind J Med Res 1983;77(Pt 1):150–3. 170. Pogosov V, Daikhes N, Iskandarov S, Komissarova A, Senkevich S. Comparative study of alginate coating 184. Soul J. A trial of Debrisan in the cleansing of and charcoal sorbent in the treatment of wounds infected surgical wounds. Br J Clin Pract in otorhinolaryngology. Vestn Otorinolaringol 1978;32:172–3. 1991;5:16–18. 185. Steed D, Donohoe D, Webster M, Lindsley L. Effect of extensive debridement and treatment on the 171. Ponnighaus JM, Kowalzick L. Polyurethane or healing of diabetic foot ulcers. J Am Coll Surg calcium alginate dressings for temporary defects 1996;183:61–4. in tumour surgery? Aktuel Dermatol 1999; 25(Pt 5):133–5. 186. Stuwe U. Enzymatic debridement of wounds. Comparison of 2 commercial preparations. 172. Ponzio HA, Ponzio TC, Kuhl ICP, Onofrio B. Fortschr Med 1983;101(Pt 41):1883–8. The topical use of collagenase on necrotic wounds. Folha Med 1981;82(Pt 1):53–6. 187. Suomalainen O. Evaluation of two enzyme preparations – Trypure and Varidase in traumatic 173. Poulsen J, Kristensen VN, Brygger HE, Delikaris P. ulcers. Ann Chir Gynaecol 1983;72(Pt 2):62–5. Treatment of infected surgical wounds with varidase. A double-blind clinical comparison 188. Sutherland MA. Case report. A team approach to with normal saline solution. Acta Chir Scand wound care in pyoderma gangrenosum. J Wound 1983;149(Pt 3):245–8. Care 1997;6(Pt 4):161–4. 189. Taranenko LD, Bondarev VI, Nefedov GP, 174. Rasmussen H, Larsen MJ, Skeie E. Surgical Shlopov VG, Verkhuletskii EI. Experience with wound dressing in outpatient paediatric surgery. SKN-1K sorbent in the treatment of purulent A randomised study. Dan Med Bull 1993; wounds. Klin Khir 1984;1:44–6. 40(Pt 2):252–4. 190. Thomas S, Banks V, Fear M, Hagelstein S, Bale S, 175. Rees RS, Hirshberg JA. Wound care centers: costs, Harding K. A study to compare two film dressings care, and strategies. Adv Wound Care 1999;12:4–7. used as secondary dressings. J Wound Care 1997; 6(Pt 7):333–6. 176. Regan MB. The use of Intrasite Gel in healing open sternal wounds. Ostomy Wound Management 191. Tolstykh PI, Gostishchev VK, Khanin AG, Iusuf M, 1992;38(Pt 3):15, 18–21. Aboiants RK. Effect of biologically active dressings of wounds on the course of the wound process. 177. Ricci E, Amione P, Nano M, Cherry GW. The Vestn Khir Im I I Grek 1987;138(Pt 3):57–60. treatment of fistulae with a hydrogel dressing. In: Cherry GW, editor. 5th European Conference on 192. Treusch J, Kohnlein HE. Treatment of granulating Advances in Wound Management; 1995; Harrogate. or epithelizing wounds with silicone rubber foam London: Macmillan Magazines; 1995. p. 21. dressing. Med Welt 1985;36(Pt 5):120–2. 57 References

193. Turner JG, Larson EL, Korniewicz D, Wible JM, 202. Wollina U. A hydropolymer dressing for chronic Baigis-Smith J, Butz A, et al. Consistency and cost wounds: clinical experiences with 478 patients of home wound management by contract nurses. in an open multicenter trial. Ann Acad Bras Cienc Public Health Nurs 1994;11(Pt 5):337–42. 1997;72(Pt 6):527–32.

194. Vogel P, Lenz J. Die Behandlung des Sinus 203. Wollina U. Topical therapy of chronic wounds with pilonidalis mittels Excision und Primarnaht unter a new hydropolymer dressing – clinical experience Verwendung eins lokalen, resorbierbaren in 478 patients. H G Z Hautkr 1997;72(Pt 7):500–6. Antibioticumtragers. Chirurg 1992;63:748–53. 204. Wood R, Hughes L. Silicone foam sponge for pilonidal sinus: a new technique for dressing 195. Wahlby L, Hedberg B. Treatment of open wounds open granulating wounds. Br Med J 1975; with silicone foam dressing. Lakartidningen 4(Pt 5989):131–3. 1983;80(Pt 18):1907–8. 205. Wood RAB, Williams RHP, Hughes LE. Foam 196. Watts C, Lee S. Comparison of Allevyn cavity wound elastomer dressing in the management of open dressing to saline moisten gauze. In: Harding KG, granulating wounds. Br J Surg 1977;64:554–7. Dealey C, Cherry G, Gottrup F, editors. 3rd 206. Doggen S. Cavity wounds in colo-rectal surgery. European Conference in Wound Management; In: 2nd National Wound Care Conference on October 1993; Harrogate. London: Macmillan Managing Wounds, Improving Patient Care; Magazines; 1994. p. 159. 1996; Harrogate. 197. Weise K, Evers K. Clinical experiences with 207. Clarke M, Oxman AD, editors. Cochrane reviewers’ tetrachlorodecaoxide in the local treatment of handbook 4.0. Oxford: Update Software; 2000. The difficult-to-heal wounds. Aktuelle Traumatol Cochrane Library [database on CD-ROM], The 1988;18(Pt 5):219–25. Cochrane Collaboration, Issue 1. 198. Wernet E, Ekkernkamp A, Jellestad H, Muhr G. 208. Cassino R, Ricci E, Carusone A, Mercanti A, Antibiotic-containing collagen sponge in therapy Leaper D. The successful treatment of hyper- of osteitis. Unfallchirurg 1992;95(Pt 5):259–64. granulating wounds using a hydrocellcular dressing. In: Leaper D, editor. European Wound 199. Westrate JT. Care of the open wound in abdominal Management Association Spring Meeting; April sepsis. J Wound Care 1996;5(Pt 7):325–8. 1997; Milan, Italy. London: Macmillan Magazines; 1998. p. 117. 200. Wikblad K, Anderson B. A comparison of three wound dressings in patients undergoing heart 209. Cassino R, Ricci E, Carusone A, Leaper D. surgery. Nurs Res 1995;44(Pt 5):312–16. The cost-effectiveness of a foam dressing for the management of cavity wounds. In: Leaper D, 201. Williams P, Howells REJ, Miller E, Foster ME. editor. European Wound Management Association A comparison of two alginate dressings used in Spring Meeting; April 1997; Milan, Italy. London: surgical wounds. J Wound Care 1995;4(Pt 4):170–2. Macmillan Magazines; 1998. p. 148.

58 Health Technology Assessment 2001; Vol. 5: No. 14

Appendix 1 Classification of debriding methods and agents

59 Appendix 1 continued 8 (Biosurgical Research Unit) (Biosurgical Research ’ LarvE ‘ sensitivity and resistance of bacteria sensitivity and resistance Two tulles are impregnated with antibiotics, impregnated tulles are Fucidin Two use of these dressings Intertulle and Sofra-Tulle.The of because of the problems is not recommended

– 71 non- or low- used not be specifically may (These dressings – on-viable tissue and removes both from the wound both from on-viable tissue and removes 12 the maggots destroy destroy the maggots – : 12 quick but imprecise – Scalpel dressings Gauze dressings Gauze-based (developed gauze derivatives adherent of adherence the problem to overcome debriding) for associated with tulle dressings): Maggot larvaeMaggot dead tissue by liquefying it with dead tissue by enzymes and ingesting it film absorbent dressingperforated knitted viscous primary dressing Melolin, Mepore, Release, iodine fabric dressing Skintact povidone dressings Tulle N-A Dressing made of open-tulles (non-medicated) are impregnated Jelonet, cotton or rayon weave Paratulle, Unitulle Inadine with soft paraffin with impregnated tulles (medicated) are either antiseptics or antibiotics The commonest type of antiseptic is chlorhexidine, in Bactigras, present Chlorhexitulle and Serotulle. Gauze dressing soaked in saline soaked dressing Gauze drying dressings debride mechanically by drying by debride mechanically dressings surface the wound taking tissue from indiscriminately using jets of water – Method of debridementSharp instrument of debriding agent/dressings Type Examples of products irrigation wound Pressurised small wounds) (for Whirlpool (large wounds) dressings Adherent * 8 Classification of debridingClassification methods and agents Selective debridement removes only necrotic tissue, only necrotic Selective debridement removes non-selective debridement whereas does not discriminate between viable and n Biosurgical Selective Biosurgery 60 ClassificationSurgical Selectiveness Mechanical Non-selective Non-selective dressing Wet-to-dry * TABLE 8 TABLE Health Technology Assessment 2001; Vol. 5: No. 14 continued 8 s solution, Eusol ’ Flat dressing sheets:Flat dressing Formulation Improved on-viable tissue and removes both from the wound both from on-viable tissue and removes hydrocolloids Granuflex, Plus,Tegasorb,Tegasorb Comfeel – acid, glycol propylene and streptodornase Streptokinase poly- (usually to a carrier and applied an or film) to form foam urethane absorbent, self-adhesive, wafer waterproof dressings: Cavity Aquacel Ribbon exudate, of wound In the presence a gel, absorb liquid and form hydrocolloids determined of which are the properties of the formulation. the nature by Some gel, a cohesive form dressings which is contained within the adhesive largely matrix; mobile, more others form less within not retained viscous gels which are structure.the dressing In the intact state impermeable to are most hydrocolloids water vapour, but as the gelling process becomes place the dressing takes permeable more progressively of powders, in the form Also available fibre and paste. also available are forms Powder as an ointment or slab of Hydrocolloids/hydrocolloid wafers Hydrocolloids/hydrocolloid dressings) (occlusive 12 moisture retention retention moisture – Method of debridement of debriding agent/dressings Type Caustic agents Examples of products Malic acid, benzoic acid, salicylic collagenase Aserbine (Goldshield) collagenase Crab collagenase, krill necrotic tissue):necrotic proteolyticsfibrinolytics form): (in powder trypsin (Lederle Laboratories) Varidase healing dressing.The body will naturally debride dead tissue with enzymes containing gel- a type of dressing are agents, forming such as sodium inflammatorygenerated by and other cells.The can be process (NaCMC) and carboxymethylcellulose of a the creation speeded up by Advanced Formulation, Foam, Cutinova Hydrocoll, gelatine.moist environment products, In many these are combined with elastomers and adhesives Thin,Thin, DuoDerm Extra Extra Hydrocoll CombiDERM (ConvaTec),Hydrocoll Basic, Ltd) Aquacel (Convatec * Classification of debridingClassification methods and agents Selective debridement removes only necrotic tissue, only necrotic Selective debridement removes non-selective debridement whereas does not discriminate between viable and n Enzymatic method Selective enzymes (target-specific Topical Classification Selectiveness * Chemical method Selective Hypochlorite solution Autolytic Sodium hypochlorite, peroxide hydrogen Dakin method selective Highly to support Dressings wound 61 TABLE 8 contd TABLE Appendix 1 2nd Skin,Vigilon – 8 a polysaccharide a polysaccharide – Filler, Sorbsan Packing, Sorbsan Ribbon (Perstrop) Spyrosorb wounds:Wound cavity Filler for Cavity Allevyn (Cavi-care),Dressing Corning Ltd) Silastic (Dow Bioclusive, Cutifilm, EpiView, Mefilm, Opsite Flexigrid, Debrisan (Pharmacia Ltd) 71 17 consist – on-viable tissue and removes both from the wound both from on-viable tissue and removes produced from from produced sheets: Flat dressing Sorbsan (Maersk), Sorbsan Plus – these allow the these allow Tegaderm,Spyrosorb, Flexipore, Omiderm, Surfasoft may be made from be made from may dressing: Flat foam (Smith & Nephew), Allevyn – – (virtually impermeable Medical Ltd), Intrasite Gel (Smith and Nephew 72 made from insoluble made from Ltd), Gel (Convatec Hydrocolloid Granugel Sterigel – 3% of a gel-forming polymer polymer 3% of a gel-forming Hydrogel, Aquaform Gel sheets – of powder or beads,of powder and gel which swell of exudatein the presence Iodosorb (Perstorp), similar to Debrisan but Hydrogels/gels to moisture) a large water content. and have polymers Ltd), (Seton Health Care a common basic structure Most share and Nu-gel (Johnson of about 2 contains an element of iodine, Iodoflex Medical Ltd), Johnson Purilon Gel (Coloplast), such as NaCMC, or modified starch sodium alginate, together with 20% as a humecant, glycol propylene and preservative.The balance (about 80%) consists of water Alginate dressings the calcium and sodium salts of alginic acid, seaweed. from derived a polymer Ltd), (3M Health Care (Maersk),Tegagen exudate wound activated by These are Kaltostat gel, a hydrophilic-like to produce which Ltd), (Convatec Ltd), Kaltogel (Convatec Comfeel SeaSorb (Coloplast), Algisite M, healing. wound to promote is believed Algosteril, Kaltogel, Meligsorb (flat in a variety of formats Available dressing, or ribbon) rope dressings: Cavity Algisite M Rope, Rope, Algosteril dressings Foam or silicone.polyurethane Absorb liquid capillaryby action (Seton),Tielle Lyfoam & Johnson), (Johnson Cavity, Cutinova Kaltostat, Megisorb Cavity, Seasorb films adhesive Vapour-permeable and membranes (Polymedia), Flexipore Extra (Seton), Lyofoam used as secondaryCommonly dressings alginates and hydrogels over passage of water vapour and oxygen,passage of water vapour but not of water or micro-organisms,Tegapore or and exudating wounds. mildly suitable for are Polysaccharide beads or paste Polysaccharide to as dextranomers,(sometimes referred bead dressing or codexomer iodine) xerogels Method of debridement of debriding agent/dressings Type Examples of products * Classification of debridingClassification methods and agents contd Selective debridement removes only necrotic tissue, only necrotic Selective debridement removes non-selective debridement whereas does not discriminate between viable and n Classification Selectiveness * 62 Autolytic TABLE 8 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14

Appendix 2 List of excluded studies

o be included in the review, studies had to a specialised wound care clinic (a nurse with T fulfil all the following criteria: specialist training in wound care; care being provided by a multidisciplinary team, or by • The study design must be an RCT, controlled trial a fast-track referral system to other professions (with concurrent control) or a full economic evalu- (e.g. dermatologist); or access to the latest ation (cost-effectiveness/cost-minimisation analysis, health technology). cost–utility analysis or cost–benefit analysis). • The study must include patients with surgical • The study must evaluate some sort of debriding wounds healing by secondary intention. method (which may include products noted to • The study must include an objective outcome have debriding properties, see appendix 1) or measure of wound healing.

63 Appendix 2

TABLE 9 Summary of excluded studies

Study Study Intervention Wound Outcome Comments design type

Abasov et al., 198273 ? ? ? ? Russian Ahmed et al., 199774 No Yes No No Catheter site wound Akesson et al., 198475 No Yes No No No control group or measure of healing; mixture of appropriate wounds and ulcers, not analysed separately Alsbjorn et al., 199076 Yes Yes No Yes Wounds left by removal of drainage tubes Anon., 199177 Yes No Yes Yes Aloe vera used as intervention, which is reported to have anti-inflammatory properties and therefore is not considered to be a debriding agent Aragona et al., 198478 ? ? ? ? Italian Arnold, 199279 No No Yes Yes Retrospective study of wound care at home Arnold and Weir, 199480 No Yes No Yes Retrospective study of enterostomal nurse versus staff nurse in the home; mixture of appropriate wounds and ulcers, not analysed separately Bale et al., 199481 Yes Yes No Yes Mixture of appropriate wounds and ulcers, not analysed separately, mainly chronic Banks et al., 199582 Yes Yes No No Chronic wounds; no measure of healing Banks et al., 199583 Yes Yes No Yes Chronic wounds Banks et al., 199784 Yes Yes No No Mixed wound types reported together; no measure of healing Bridel-Nixon et al., 199885 Yes No No No Incidence of postoperative pressure sores Briggs, 199686 Yes No No No Sutured wounds; inappropriate intervention and no measure of healing Brown et al., 199187 Yes No No Yes Epidermal growth factor investigated in ulcers Calligaro et al., 199488 No Yes No Yes No control group Cassino, 1998208 Yes Yes No Yes Chronic wounds Cassino, 1998209 Yes Yes No Yes Chronic wounds Cespa et al., 198489 No ? ? ? Italian Chalmers and Turner, 199690 No Yes Yes Yes Case study Chevretton et al., 199191 No Yes Yes No Retrospective study, control not concurrent; no measure of wound healing Church, 199592 No Yes No No Report of other studies using maggots Coerper et al., 199993 No Yes No Yes Chronic wounds Creese et al., 198694 Yes Yes No Yes Mixture of appropriate wounds and ulcers, not analysed separately Dahlstrom, 199595 Yes Yes No No Split skingraft, no measure of wound healing Davis et al., 198796 No No No Yes Animal study on aloe vera Di Maggio et al., 199497 ? ? ? ? Spanish Donnelly and Maxwell, No Yes Yes Yes Case history 199798 Drago et al., 198399 Yes Yes Yes No No information on healing (only data on pain, drainage, exudate, infection, days to wearing normal shoes presented) Efendiev et al., 1991100 ? ? ? ? Russian Eldrup, 1985101 ? ? ? ? Danish Ersh, 1984102 ? ? ? ? Russian Estienne et al., 1989103 Yes Yes Yes Yes Italian

64 continued Health Technology Assessment 2001; Vol. 5: No. 14

TABLE 9 contd Summary of excluded studies

Study Study Intervention Wound Outcome Comments design type

Flanagan, 1995104 Yes Yes No Yes Chronic and traumatic wounds Fleishmann et al., 1999105 No Yes Yes No No control group Foster et al., 2000106 Yes Yes Yes No No measure of healing Foster and Moore, 1997107 Yes Yes Yes No No measure of healing Foster and Moore, 1997108 No Yes Yes Yes Case study Foster and Moore, 1997109 Yes Yes Yes No No measure of healing Foster and Moore, 1997110 Yes Yes Yes No No measure of healing Freeman et al., 1981111 Yes Yes No No Chronic wounds; no measure of healing (bacterial growth measured) Gainant et al., 1989112 Yes No No Yes Looked at method of preventing wound dehiscence Gardezi et al., 1983113 Yes Yes No Yes Sutured wounds Gates and Holloway, 1992114 Yes Yes Yes No No objective measure of wound healing Goode et al., 1985115 Yes Yes Yes No No objective measure of wound healing Gostishchev et al., 1985116 ? ? ? ? Russian Gostishchev et al., 1985117 ? ? ? ? Russian Gostishchev et al., 1993118 ? ? ? ? Russian Gostishchev et al., 1983119 ? ? ? ? Russian Gostitshchev et al., 1985120 ? ? ? ? Russian Grabski et al., 1995121 No Yes No No Descriptive study Gupta et al., 1991122 Yes Yes Yes No No measure of healing (pain level and analgesic use presented) Hancevic et al., 1980123 No Yes No No Croatian; no control group Heng et al., 2000124 No No No Yes Feasibility study of hypertonic oxygen Hermans, 1993125 Yes Yes No Yes Sutured wounds Herzberg, 1985126 No Yes Not clear Yes No control group; not clear if wounds were of appropriate type Hien et al., 1988127 Yes Yes No Yes Clean wounds, did not require debriding Hughes, 1986128 Yes Yes Not clear No No measure of healing; not clear whether wounds were of appropriate type Hulkko et al., 1981129 Yes Yes No Yes Mixture of wounds, including venous leg ulcers, results not presented separately Ingram et al., 1998130 Yes Yes Yes No No measure of wound healing (pain assessed as primary outcome) Johnson et al., 1985131 Yes Yes No Yes Sutured wounds Johnson and Jones, 1988132 No Yes Yes Yes No control group Joshi et al., 1986133 No Yes No Yes No control; chronic wounds Kallehave et al., 1994134 No Yes Yes Yes No control group Kauer and Siodmak, 1984135 No Yes No No No control group; chronic wounds; no measure of healing Kavkalo, 1984136 ? ? ? ? Russian Krupski et al., 1991137 Yes No No Yes Platelet derived wound healing factor in chronic wounds Kubatov et al., 1984138 ? ? ? ? Russian Kulikov et al., 1983139 ? ? ? ? Russian Lang, 1981140 No ? ? ? Not an RCT or controlled trial; case studies Lees et al., 1991141 Yes Yes Yes No No measure of healing (pain used as outcome measure)

continued 65 Appendix 2

TABLE 9 contd Summary of excluded studies

Study Study Intervention Wound Outcome Comments design type

Legray and Greco, 1979142 No Yes No No Chronic wounds; no measure of healing Levine et al., 1976143 Yes Yes No No Burn wounds; no measure of healing Linke et al., 1986144 Yes Yes Yes No No measure of wound healing (assessed physician and nurse assessment of superiority, and acceptance of patients) Lippert and Zeh, 1991145 No Yes Yes No No control group or measure of healing Marks et al., 1985146 Yes No Yes Yes Antibiotic therapy, no debridement Mateev et al., 1976147 ? ? ? ? Russian McCulloch and Kemper, No No Yes Yes Case report of vacuum compression 1993148 Michie and Hugill, 1994149 Yes Yes No No Wounds sutured; no measure of healing Michiels and Christiaens, Yes Yes Yes No No measure of healing 1990150 Moore and Foster, 200014 Yes Yes Yes No No measure of healing Moore et al., 1999151 No Yes Yes Yes Case study Moore and Foster, 1996152 Yes Yes Yes No No results for an objective measure of healing presented Morgan et al., 1980153 No Yes Yes Yes No control group Moshakis et al., 1984154 Yes Yes No No Sutured wounds; no measure of healing Mosher et al., 1999155 No Yes No Yes Chronic wounds Mulder and Andrews, 1993156 Yes Yes No Yes Chronic wounds Mulder, 1995157 Yes Yes No Yes Mixture of wounds (venous, trauma and pressure) Mulder, 1995158 Yes Yes No No Chronic wounds, no measure of healing Muller et al., 1994159 No Yes Yes Yes Description of a trial to be conducted Nash et al., 1994160 No Yes Yes Yes No control group Nepi, 1992161 No ? ? ? Italian Niinkoski and Renvall, 1980162 No Yes No Yes Animal study Paul, 1990163 No Yes No Yes No control group; inappropriate wound (ulcer) Pendse et al., 1993164 Yes Yes No Yes Chronic wounds Petrosian, 1993165 ? ? ? ? Russian Phan et al., 1993166 Yes Yes Yes No No measure of healing (wound infection primary outcome) Philbeck et al., 1999167 No No No Yes Descriptive study; vacuum therapy (not a debriding agent) in chronic wounds Platt and Becknall, 1984168 No No No Yes Animal study Plaumann et al., 1985169 Yes Yes Yes No No measure of healing (bacterial counts only) Pogosov et al., 1991170 ? ? ? ? Russian Ponnighaus and Kowalzick, Yes Yes Yes No No measure of healing 1999171 Ponzio et al., 1981172 ? ? ? ? Portuguese Poulsen et al., 1983173 Yes Yes Yes No No measure of healing Rasmussen et al., 1993174 Yes Yes No No Wounds did not require debridement; no measure of wound healing Rees and Hirshberg, 1999175 No Yes No No Not a trial; chronic wounds; no measure of healing Regan, 1992176 No Yes Yes Yes Case studies; no control

66 continued Health Technology Assessment 2001; Vol. 5: No. 14

TABLE 9 contd Summary of excluded studies

Study Study Intervention Wound Outcome Comments design type

Ricci et al., 1995177 No Yes No Yes No control or surgical wound Ricci et al., 1998178 No Yes No Yes No control; chronic wounds Sakai et al., 1992179 ? ? ? ? Japanese Schmidt et al., 1991180 Yes No Yes Yes Aloe vera used as intervention, which is reported to have anti-inflammatory properties and therefore is not considered to be a debriding agent Schmitt et al., 1996181 Yes No No Yes Sutured wounds Schwarz, 1981182 No Yes Yes Yes No control group Shukla, 1983183 No Yes Yes Yes No control group Soul, 1978184 No Yes Yes Yes No control group Steed et al., 1996185 No Yes No No Not a controlled trial or RCT; chronic wounds; no measure of wound healing Stuwe, 1983186 Yes Yes Yes No No measure of wound healing Suomalainen, 1983187 Yes Yes No Yes Traumatic ulcer Sutherland, 1997188 No Yes Yes Yes Case report of gangrene after total hip replacement surgery Stuwe, 1983186 Yes Yes No Yes Not surgical wounds Taranenko et al., 1984189 ? ? ? ? Russian Thomas et al., 1997190 Yes Yes No No No measure of healing; mixture of appropriate wounds and ulcers, not analysed separately Tolstykh et al., 1987191 ? ? ? ? Russian Treusch and Kohnlein, 1985192 No Yes No No No control group; chronic wounds Turner et al., 1994193 No Yes No No Observational study of home wounds managed by contract nurses; mixture of appropriate wounds and ulcers, not analysed separately Vogel and Lenz, 1992194 Yes No Yes Yes Wounds closed surgically Wahlby and Hedberg, 1983195 ? ? ? ? Foreign language – Scandinavian Watts and Lee, 1994196 Yes Yes Yes No No measure of healing Weise and Evers, 1988197 No Yes No Yes No control group; sutured wounds Wernet et al., 1992198 No No Yes Yes No control group; intervention (collagenous sponge containing gentamicin) was not a debriding agent Westrate, 1996199 No Yes Yes No Retrospective study; no control group Wikblad and Anderson, Yes Yes No Yes Sutured wounds 1995200 Williams et al., 1995201 Yes Yes Yes No No measure of healing Wollina, 1997202,203 No Yes Yes Yes No control group Wood and Hughes, 1975204 No Yes Yes Yes Retrospective study Wood et al., 1977205 No Yes Yes Yes No control group

67

Health Technology Assessment 2001; Vol. 5: No. 14

Appendix 3 Data extraction forms

69 Appendix 3

’ (authors (limitations conclusions ’ Authors comments) own Other comments authors,by generalisability and other comments) Details of withdrawals (summary Results Statistical test used to groups compare of results) of the study, biases not reported Details of baseline (e.g. any used) Duration of follow-up of healing Measure (includes information to the method relating healing) used to measure Other outcome measures intervention andsample size) Comparator intervention groups (description of comparator(s), including Concurrent treatment (description of comparability of Bacterial growth Exclusion criteria

’ (i.e. RCT or (authors An example of a data extraction form for reports for form of trials clinicalAn example of a data extraction investigating effectiveness (if multicentre, objective) in hospital)Objective dressings additional Study and designAuthor, year Participants of operation Type Intervention details Baseline characteristics Intervention Results Withdrawals Comments 70 Country of originStudy design trial) controlled criteria Inclusion Method of randomisation (if applicable)Setting of sites,number outpatients, sample size) TABLE 10 TABLE Health Technology Assessment 2001; Vol. 5: No. 14 conclusions ’ (determine if extended Magnitude and direction of and direction Magnitude results (outcome measure (summary cost results) dominance can be established) Statistical analysis deflating cost data)) Costs Synthesis of costs andbenefits in CEA,effectiveness cost per Comments (basic (summary estimates of clinical sensitivity analysis (appropriate (including gained in CUA, QALY net (if modelling used, to data according Modelling CUA, monetary value in CBA)) (e.g. cost- incremental Estimates of cost estimate benefits/costs outcomes or benefit actual sources; consider costs, and indirect both direct benefit or cost in CBA)) will be the strongest link, will be the strongest disconnectedretrospective link))will be the weakest type of model, purpose of model and components that characteristics; appropriate chosen time frame method for expert opinion; consider estimates based on certain evidence) of cost data Source health states (e.g. in QALY used in economic evaluation completed studies or on based on primary study or (data derived from a single from (data derived (including integrated in the model) were (e.g. discounting, inflating, (health service, of link between strength chosen determined by (CEA, to classification according clinical assumptions); (objectives of (objectives study, or based on a review methods of valuation health outcome/benefits) to assess variability of results An example of a data extraction form for reports for of trials form economic outcomes evaluating An example of a data extraction Perspective societal, hospital, third-party data cost and effectiveness prospective) payer, patient)Study population (i.e. concurrent prospective statistical test (appropriate Interventions Study details of data Source Method used to Resultscomparator) Sensitivity analysis Comments CBA, analysis; cost–benefit CEA, analysis; cost-effectiveness CUA, cost–utility analysis; QALY, quality-adjusted life-year Type of economic Type CUA, CBA)which data relate) of effectiveness hierarchy or data from (literature instruments used to value evaluation Country/currency (currency data and year to data and year (currency the economic evaluation) synthesis of previously states (e.g. measurements direct in the data) Author, year of efficacy data Source clinical for Valuation Clinical outcome/benefit Sensitivity analysis Authors Objective 71 TABLE 11 TABLE

Health Technology Assessment 2001; Vol. 5: No. 14

Appendix 4 Quality checklists

Quality checklist for clinical trials such as a t -test, analysis of variance, χ2 test for categorical data, Wilcoxon, Fisher’s exact or An adaptation of the checklist presented in Mann–Whitney test. Where the authors report CRD Report 465 was used. The criteria used carrying out a statistical test but do not state for assessing the quality of clinical trials were what test was used, the study will be given a as follows: question mark. All other studies will be classified as not having carried out an • Was the method of randomisation adequate? appropriate analysis.) (Computer-generated random numbers and random number tables will be accepted as Each item was graded as follows: adequate, while inadequate approaches will include the use of alternation, case record ✔ yes numbers, birth dates or days of the week.) ✘ no • Was the randomisation of participants blinded ✔/✘ partially covered (allocation concealment)? (Concealment will be ? not stated, not enough information or deemed adequate where randomisation is unclear centralised or pharmacy-controlled, or where NA not appropriate (information relating the following are used: serially numbered to the method of randomisation in non- containers, on-site computer-based systems randomised controlled trials). where assignment is unreadable until after allocation, other methods with robust methods For ticked items under withdrawals: to prevent prior knowledge of the allocation sequence to clinicians and patients. Inadequate ✔a numbers reported by group and reason approaches will include: the use of alternation, ✔b withdrawals reported, but not by group or case record numbers, days of the week, open reason not given. random number lists and serially numbered envelopes, even if opaque.) For ticked items under appropriateness of baseline • Was a relatively complete follow-up achieved? characteristics: • Were the outcomes of people who withdrew described? ✔ one or more appropriate baseline • Was an ITT analysis conducted? characteristics stated (but not initial wound • Were those assessing outcomes blinded to the size) treatment allocation? ✔c initial wound size stated. • Were administrators (those who administered the intervention) blinded? For ticked items under comparability of baseline • Were participants blinded? characteristics: • Was success of blinding checked? • Were appropriate baseline characteristics ✔ according to one or more of the reported? characteristics stated (but not initial • Were the control and treatment groups wound size) comparable at entry? ✔d including wound size. • Was there registration of any co-interventions that may influence the outcome for each group? • Was the analysis appropriate? (Analysis will be Quality checklist for economic considered appropriate if the authors: (a) report evaluations healing times using either survival analysis or medians to summarise such data, and (b) report An adaptation of the checklist published by carrying out a statistical test and state what test Drummond and co-workers32 was used. The they used. The test must be appropriate for criteria used for assessing the quality of economic comparing the outcome measures reported, evaluations were as follows: 73 Appendix 4

• Is there a well-defined question? • Were sensitivity analyses conducted to • Is there a comprehensive description investigate uncertainty in estimates of cost of alternatives? or consequences? • Are all the important and relevant costs and • How far do study results include all issues of outcomes for each alternative identified? concern to users? • Has clinical effectiveness been established? • Are the results generalisable to the setting of • Are costs and outcomes measured accurately? interest in the review? • If economic data are from a trial, was the costing analysed either concurrently Each item was graded as: or prospectively? • Are costs and outcomes valued credibly? ✔ yes • Are costs and outcomes adjusted for ✘ no differential timing? ✔/✘ partially covered • Is there an incremental analysis of costs ? unclear or not enough information and consequences? NA not appropriate.

74 Health Technology Assessment 2001; Vol. 5: No. 14

Appendix 5 Summary of included clinical trials

75 Appendix 5 continued : both : the number : Smith and conclusions ’ dressings were easy to use, were dressings effective, and acceptable to patients and clinicians. Direct comparison in performance foam the polyurethane between and the dressing hydrophilic to in relation alginate dressing healing is limited because of the of other materials introduction became when the wounds superficial or had no significant depth Other comments of patients included in the trial was small, and thus the study to power lacked have may detect significant associations. larger at were The wounds group baseline in the foam to the alginate group, compared the confounded have which may results. No statistical analysis and the results was undertaken so it is graphically presented are conclusions difficult to draw the results.Thefrom authors was state that an ITT analysis conducted, but it is not clear whether they the results from did this Study sponsor Nephew,Allevyn who produce Authors :1 : 1 participant Foam because of perceived discomfort at having biopsies taken, 1 because of recurrent infection, 1 required further surgery Alginate participant because of perceived discomfort at having biopsies taken, 2 because of recurrent infection :foam :no : 85% foam : foam : foam : 85% foam : 86% easy; foam : as presented 106 days) 78 days); – – alginate 65.5 days alginate 65.5 days (43 Ease of application 42% easy; alginate 85% easy Ease of removal easy; alginate 92% easy Ease of use alginate 100% easy conformability Patient 86% good; alginate 79% good Absorption capacity good; alginate 86% good leakage Dressing 81% nil/slight; alginate 73% nil/slight between No differences arms for treatment the two clinician observation of dress- as (measured ing performance ease of application, conform- ability and ease of removal; both groups) > 80% for Statistical test used to groups compare was statistical analysis undertaken Results mean (range) Time to healing: 56.7 days foam (36 Wound details: Wound mean ± SD Length: foam 68.2 ± 26.4 mm; alginate 53.7 ± 19.8 mm Width: foam 22.6 ± 11.1 mm; alginate 11 ± 6.2 mm Depth: foam 28.5 ± 10.4 mm; alginate 28.0 ± 12.6 mm details: Patient Mean age: foam 26.5 years; alginate 28.1 years Gender (male/female): 7/3;foam alginate 8/2 Mean weight: foam 72.7 kg; alginate 84.2 kg Mean duration before inclusion: foam 13.2 days; alginate 9.3 days : : : time = 10) = 10) n n : calcium : polyurethane : ease of use, study details characteristics wound assessment carried wound clinic visits. out at weekly Results collected from time of surgery until had re-epithelialisation wound and cavity occurred no longer were dressings use suitable for of healing Measure to complete healing Other outcome measures and removal application (classified as easy/difficult), (good patient conformability or poor) and dressing performance none reported Duration of follow-up Intervention dressing hydrophilic foam wound cavity (Allevyn dressing), by followed sheet foam polyurethane when (Allevyn) dressing no longer had the wound significant depth ( Comparator sodium alginate dressing a by (Kaltostat) followed sheet foam polyurethane when (Lyofoam) dressing no longer had the wound significant depth ( treatment Concurrent : : : : Type of operation Type excision pilonidal sinus Inclusion criteria patients with standard excision pilonidal sinus wounds Exclusion criteria not stated Bacterial growth examined were wounds at each clinic visit to exclude the presence of infection, weekly biopsies (6 mm punch the biopsies 1 cm from edge) and regular wound bacteriological swabs were taken UK 34 : : RCT Details of the clinical trials included in the review : to compare ., 1996, : and community et al Study and design Participants Intervention and Baseline Results Withdrawals Comments Berry Study design Method of randomisation not stated Setting 76 outpatient clinic Objective protocols treatment two in the management of wounds cavity TABLE 12 TABLE Health Technology Assessment 2001; Vol. 5: No. 14 continued : the : the sample conclusions ’ trial is seen to be inconclusive because of the small sample of and the number number the from patients withdrawn trial. However, Ulcer Comfeel to be is not proven Dressing the contraindicated except for have patients who may three an allergy to the developed dressing Other comments size was very small and so the the power lacked study will have to detect significant differences the groups between Authors : s decision s decision ’ ’ : 1 participant Four patients failed to Four redressing attend for was and no reason ascertained (group not stated) Gauze reported pain, with 1 interfered dressing, 1 was a chiropodist Hydrocolloid 3 participants allergies, developed 1 patient interfered with dressing, 1 was a chiropodist : < 0.05) : not stated p > 0.05) p : hydrocolloid > 0.05) : hydrocolloid : hydrocolloid p : as presented : 1.4; hydrocolloid > 0.05) > 0.05) p p Comfort during change dressing 1.1;hydrocolloid gauze 1.1 ( Comfort 15 minutes following change dressing 1.1; gauze 1.0 ( Dressing time Dressing 9 min; gauze 10 min ( Comfort prior to dressing change gauze 1.2 ( of the hydrated The presence was the dressing gel from to the patient, often offensive as was the smell.The gel the from leaked frequently wound Statistical test used to groups compare Results mean ± SD Healing time 49.3 ± 21.5 days; gauze 65.2 ± ( 9.63 days 18 subjects randomised : : : healing : Serotulle, : Comfeel : patient comfort = 8, final number) n = 3, final number) n study details characteristics redressing and assessment redressing made were appointments 3,for 7, from 10 and 14 days date; the first procedure subsequent assessment done every and redressing until full healing or 7 days patient withdrawal of healing Measure time and an estimate of the re-epithelialisation percentage were of the wound.Wounds and traced.photographed On was 3 and 10 the wound days traced and not photographed Other outcome measures nil, of 1 to 4 for (score slight, dis- moderate and severe comfort) prior to dressing change, during dressing change, and 15 minutes change. dressing following dressing Mean time to replace irrigated with normal saline irrigated accordingly and dressed Duration of follow-up Intervention (Coloplast Ulcer Dressing Ltd), dressing a hydrocolloid ( chlorhexidine acetate impreg- (gauze deriv- nated dressing ( ative) treatment Concurrent Comparator : : : : – Type of operation Type and toenail avulsion phenolisation of the germinal matrix for 3 minutes Inclusion criteria patients aged 10 in good 60 years general health Exclusion criteria diabetes and rheumatoid arthritis, peri- severe pheral vascular disease, anticoagulant and corticosteroid therapy, pregnancy Bacterial growth not stated Details of the clinical trials included in the review : UK : RCT 35 : to compare : clinic chiropody Study and design Participants Intervention and Baseline Results Withdrawals Comments Objective the efficacy of Comfeel (hydro- Ulcer Dressing with a colloid dressing) chlorhexidine acetate dressing impregnated wounds on iatrogenic toenail by produced by followed avulsion phenolisation of the germinal matrix and nailbed not stated Setting Study design Method of randomisation Bruce, 1991, 77 TABLE 12 contd TABLE Appendix 5 continued :Allevyn : the sample conclusions ’ cavity wound dressing is similar dressing wound cavity wound cavity to Silastic foam most parameters of for dressing healing,wound and progress patient comfort, with some its disposable advantages from and ease of use by format patients Other comments size was small, so the study may to detect the power lacked have between significant differences treatments the two Authors : 1 with : 3 with Allevyn pilonidal wound, 2 with abdominal wounds Foam pilonidal wounds Reasons for not withdrawals discussed : : not stated 480 s); 263 s foam – : : mean ± SE (range) 600 s) – 138 days) 112 days); 60.8 ± foam 28.4 days 138 days) 112 days); 61.9 ± foam 26.1 days 110 days) 84 days); 56.6 ± foam 37.6 days :Allevyn 93%; 99% foam – – – – – – < 0.05 (28 All wounds: 51.5 ± Allevyn 20.5 days (14 (28 p assessed by Results of measures patients Comfort change at dressing Allevyn: 90% painless, 10% acceptable, 0.1% painful Foam: 90% painless, 9% acceptable, 1% painful Ease of application Allevyn: 67% easy, 26% acceptable, 7% difficult Foam: 84% easy, 16% acceptable, 0.6% difficult Ease of removal Allevyn: 97% came out of wound spontaneously, removed 3% easily Foam: 97% came out of wound spontaneously, removed 3% easily change dressing time for Mean (range) 203 s (60 Allevyn (120 that conformed of dressings Percentage well Statistical test used to groups compare Results Time to wound healing Pilonidal: 51.4 ± Allevyn 20.9 days (14 (28 Abdominal: 51.9 ± Allevyn 20.5 days (27 : : 148 mm); – 59 mm); 82 mm); – – 160 mm) 72 years); 76 years) – 51 mm) 65 mm) – – – – Wound details Wound mean (range) Length: Allevyn 63.0 mm (23 62.3 mm foam (25 Width: Allevyn 19.8 mm (0 18.9 mm foam (0 Depth: Allevyn 26.1 mm (8 26.6 mm foam (5 details Patient Age: 30.4 years Allevyn (16 28.2 years foam (16 = 32; n : ease = 40: n : wounds = 10) = 8) = 30; : until n n n : time to wound : foam polyurethane : (Silastic silicone foam = 40: wounds pilonidal sinus n complete healing; patients were care at the wound weekly reviewed clinic, healing their wound where was reported progress of healing Measure healing; dimensions (length, wound width, at recorded depth) were baseline examination; with measured a stick and ruler; was a photograph of each wound taken Other outcome measures and removal,of application time for change,dressing comfort, dressing leakage and pain,wound and a general patients assessment by quality-of-life and clinicians judged to be either clinically or judged to be either clinically were infected bacteriologically with systemic antibiotics treated to the usual practice of according the clinic Duration of follow-up Concurrent treatment Concurrent abdominal wall wounds abdominal wall wounds Comparator foam); cleansed and sterilised dressings twice daily; held in place with surgical with an absorbent pad covered tape ( pilonidal sinus wounds wounds pilonidal sinus abdominal wall wounds (Allevyn cavity wound dressing); wound cavity (Allevyn more used,than one dressing as appro- priate; supplied in sterile dressing and patients advised to change form with exudate when soaked dressing ( 3 days and at least every Intervention study details characteristics : : : : Type of operation Type excision pilonidal sinus or abdominal surgery Inclusion criteria into patients entered study at first visit to clinic,wound usually of within one week surgery; patients of aged 16 both sexes attending or over years clinic; wound Cardiff patients with a cavity wound; permission con- referring from sultant and patient Exclusion criteria patients with wounds obvious that showed signs of clinical infection, were if they immunosuppressed, or receiving pregnant or therapy cytotoxic radiotherapy Bacterial growth for swabbed wounds at a bacterial culture clinic; wound weekly that were wounds judged to be either or bacterio- clinically were infected logically with systemic treated antibiotics according to the usual policy of the clinic Details of the clinical trials included in the review ., : : RCT et al :to : wound UK 37 Study and design Participants Intervention and Baseline Results Withdrawals Comments Butterworth 1992, Study design Method of randomisation clinic at a university hospital Objective Allevyn compare wound cavity and silastic dressings in the treat- foam ment of surgical cavity granulating wounds 78 not stated Setting TABLE 12 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14 p :the continued :no conclusions ’ s findings would supports findings would ’ values for differences be- differences values for some for the groups tween outcomes study the for of advocates the view abandonment of the use pro- dressing hypochlorite surgical wounds,tocols for as caused more hypochlorite patients discomfort without healing rate or yielding any cost benefits.The healing to be similar rates appeared but this study did not have to detect moder- the power in healing ate differences rates.The findings regarding pad the combine dressing demonstrated that it protocol in comparison well performed with calcium alginate dressing in terms of healing time, patient comfort and cost Other comments was presented information of exudate the levels on how judged to be sufficiently were to change the dressing low protocol, and no information long how on for was given were dressings hydrocolloid size at baseline used.Wound the 3 groups, varied between confounded have which may the results. some Results for not reported outcomes were adequately, with, example, for reporting the authors only Authors :1 s wound : 2 partic- ’ wounds ’ s wound devel- s wound ’ 2 weeks prior to 2 weeks – Three participantsThree before withdrawn trial started, 1 who consent withdrew and 2 required further surgery; included 36 were in final study Alginate participant on went holiday, 1 partic- ipant that oped into sinus further required surgery, and 1 par- ticipant showed significant showed overgranulation of after 3 weeks hospital care Gauze ipants developed sinuses, developed 1 participant devel- oped a cerebral vascular accident in Minor deviations protocols dressing community by docu- were nurses two mented for participants (one in alginate and one in gauze group); these the appli- involved cation of copper sulphate crystals of to a small area overgranulation 1 healing end-point : : : < 0.03 p : alginate > 0.05) : alginate > 0.05) : alginate > 0.05) > 0.05) p p p p : alginate = 0.01 p /day; gauze /day; Combine dressing ( /day 2 2 2 /day; gauze /day; Combine dressing: ( /day 3 3 3 : mean ± SD Wound volume reduction Wound 0.57 ± 0.15 cm Maximum pain reported:Maximum Gauze vs alginate: 2.6 (95% CI, difference 0.64 to 4.6), alginate favouring Gauze vs Combine dressing: difference 2.3 (95% CI, 0.27 to 4.3), gauze favouring pain in maximum No significant difference groups alginate and Combine dressing between process: with dressing Satisfaction groups:Alginate and Combine dressing similar in the first week Gauze vs alginate: Statistical test used to compare groups Statistical test used to compare ANOVA using compared rates were Results reduction area Wound 0.55 ± 0.144 cm 0.51 ± 0.164 cm 0.79 ± 0.144 cm change in area Percentage 9.5 ± 2.8%; gauze 5.6 ± 3.2%; Combine 9.2 ±dressing 2.8% ( 0.50 ± 0.17 cm 0.90 ± 0.15 cm change in volume Percentage 4.4 ± 1.4%; gauze 3.1 ± 1.6%; Combine 6.3 ±dressing 1.4% ( Gauze vs Combine dressing: in significant difference No statistically at last groups the three satisfaction between assessment visit > 10% weight loss in 6 months to trial exit alginate 38%; gauze 37%; Combine dressing 38% trial by exit not resumed intake Usual oral alginate 23%; gauze 50%; Combine dressing 33% : : ; 2 3 3 ); 2 ; Combine ; gauze 2 3 ): alginate 2 characteristics 39 participants to trial recruited details Wound mean ± SD Initial surface area (cm 10.7 ± 3.0 cm 19.4 ± 5.7 cm Combine dressing Combine dressing 23.7 ± 6.6 cm 6.9 ± 1.2 cm Initial volume: alginate 14.9 ± 3.6 cm details Patient mean ± SD Weight: alginate 71.6 ± 3.6 kg; gauze 72.1 ± 4.5 kg; Combine dressing 78.9 ± 4.7 kg Age: alginate: 61 ± 3.4 years; gauze 72 ± 2.9 years; Combine dressing 67 ± 5.0 years gauze 9.9 ± 2.2 cm = 13) = 13) : patient n n : secondary film : until healing : healing rate; wound : 0.05% sodium hypochlorite : calcium alginate dressing wound measurement at weekly measurement wound ’ blinded ‘ = 10) n intervals, not surgical nurses three by on the unit,working until healing achieved Other outcome measures comfort (questionnaire), pain (visual analogue weekly status measured scale) and nutritional Comparator and solution moistened gauze dressing pack Combine dressing until changed 2 or 3 times daily Dressing granulation;wound solution then changed to normal saline (0.09%), 2 or 3 times daily ( treatment Concurrent end-point (up to 38 days) of healing Measure and length width of each photographed using a ruler; measured wound depth wound using a sterile depth gauge at the measured deepest point; of surface area reliability correlating was established by measurements on a measurements ruler and photograph assessed;sample of the wounds assessment also included exudate evaluation, standard and a swab; photography wound participants surgical unit to the gastrointestinal returned for Combine dressing pad (absorbent wound Combine dressing and consisting of cotton wool dressing surface; to wound gauze) applied dressing ( changed 2 or 3 times daily with 3 cm applied (Tegaderm) dressing margin; once exudate was low, study dressing (Duoderm) was ceased and hydrocolloid until healing end-point applied Duration of follow-up Intervention (Sorbsan); not changed until gelled dressing ( once daily) (approximately : type : : : Type of Type operation of operation not specified Inclusion criteria in the resident catchment area; of age 18 years or over; had a surgical abdom- line inal suture with a break- of greater down than 3 cm; no allergies known to dressings Exclusion criteria not stated Bacterial growth not stated Details of the clinical trials included in the review : : ., :to et al : Australia 36 Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Cannavo Cannavo Study design RCT Method of randomisation contained cards in sealed envelopes Setting gastrointestinal surgical unit Objective the compare performance dress- of three ings in the management of dehisced surgical abdominal wounds 1998, 79 TABLE 12 contd TABLE Appendix 5 : continued : the : calcium conclusions ’ calcium alginate dressings calcium alginate dressings to traditional preferable are gauze dressings saline-soaked of in the initial treatment and raw abscess cavities require surfaces that typically packing.There seems little place in modern surgical the continued practice for use of dry or saline soaked gauze dressings Other comments authors did not report sufficient baseline details, such as the age of patients included in the trial size.Theand initial wound sample size was small and have thus the study may to detect the power lacked in wound difference any the two healing between groups Study sponsor were alginate dressings BritCair UK by provided Authors None reported : : = 0.63, r : significantly : > 0.05) < 0.01) < 0.005) p p Statistical test used to compare groups Statistical test used to compare 4 weeks healed by All wounds removal and ease of dressing Pain ease of removal between Good correlation and pain experienced ( of dressing p statistical analysis of the scores was performed of the scores statistical analysis rank-sum test Wilcoxon using the Results Number of wounds healed at 2 week review alginate 12/16 (75%); gauze 13/18 (72%) ( than gauze group less in alginate group ( characteristics None of the patients were diabetic or steroid receiving treatment Abscess types – alginate group Perianal/pilonidal: 8 (50%) Breast: 3 (19%) Other: 5 (31%) Abscess types – group gauze Perianal/pilonidal: 14 (78%) Breast: 2 (11%) Other: 2 (11%) = 16) n : patient = 18) n : wound : outcomes : complete : in saline, gauze soaked : lightly packed wound Concurrent treatment Concurrent review;assessed at 2 week patients had not seen again if wound were healed. If required, were dressings the district nurse. by continued Final at 4 weeks follow-up of healing Measure healing at 2 weeks Other outcome measures of pain on assessed level and nurse and ease of of dressing removal removal; on a linear analogue measured scale (0, ease/no pain; great 10, great pain) difficulty/severe was covered with a gauze pad; was covered 2 Co-proxamol patients given hydrochloride (dextropropoxyphene plus paracetamol) tablets 1 hour change; dressing before dressing after operation; change on first day later up 2 weeks followed Duration of follow-up Comparator ( into wound packed lightly Intervention ( with calcium alginate dressing : : sp. : incision in the : none Bacteroides Bacteroides in the perianal abscesses and Staphylococcus pyogenes remainder Type of Type operation and drainage of abscess Inclusion criteria stated Bacterial growth abscess pus from exam- sent for ination, and culture determination of antibiotic sensitivity; it was confirmed that the principal organisms encountered coliforms were and over over of age 16 years Exclusion criteria Details of the clinical trials included in the review : : ., :to et al : UK 38 Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Dawson Dawson 1992, outpatient clinic Objective examine the use of calcium alginate as a for dressing abscess cavities to compared saline-soaked gauze packs (conventional treatment) 80 Study design RCT Method of randomisation not stated Setting TABLE 12 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14 : nail continued : : BritCair conclusions ’ avulsion and phenolisation avulsion accepted as widely now are for the best treatment onychocryptosis recurring and onychogryphosis. considerable Kaltostat offers advantages both in terms of faster healing time and in of the number reducing needed dressings Other comments baseline details on wound not reported.Thesize were of the study was main focus factors which to investigate influence the rate of healing and after toenail avulsion phenolisation; the com- types parison of dressing was a secondary objective. the affected have This may design of the study and in resulted could have biased results Study sponsor Division of CV Laboratories; the second author is an of BritCair employee Division Authors None reported : : : = 0.069) < 0.05) < 0.05) : not stated p p p : alginate < 0.05) : the additional p : mean ± SD Cost data cost of Kaltostat was dressing £1.60 and £2.20 per between patient in the study (3 or 4 per patient); alginate dressings the for presented no data were cost of Melolin dressings; the in healing time reduction of one a saving represents clinic appointments or two alginate 26.3 ± 13.2 days; gauze 32.9 ± ( 14.8 days Partial nail avulsion time to healing alginate 20.3 ± 6.7 days; gauze 43.0 ± ( 16.9 days alginate 3.6 ± 1.8; gauze 4.5 ± 2.2 ( nail avulsion time to healing Total Number of dressing changes Number of dressing Statistical test used to groups compare Results Time to healing 25.8 ± 12.9 days; gauze 34.4 ± ( 15.2 days Mean ± age: SD alginate 23.7 ± 14 years; gauze 29.8 ± 17 years Gender (male/female): alginate 23/11; gauze 20/10 Sex not recorded: alginate 1; gauze 5 Non-smokers/smokers: alginate 32/2; gauze 31/4 Smoking not recorded: alginate 1; gauze 0 Mean ± SD ischaemic index: alginate 1.08 ± 0.12; gauze 1.08 ± 0.14 groups The two all similar for were the characteristics recorded characteristics = 35: n : were wounds = 5) : in both dressings n : until complete = 32; total nail avulsion : time to re- n = 35: partial nail avulsion n : Melolin (Smith & Nephew) : Kaltostat (BritCair) (calcium = 30; total nail avulsion = 3) Concurrent treatment Concurrent healing; after the day reviewed patients were once surgery then dressed and the wound a week of healing Measure epithelialisation (complete healing) Other outcome measures signs of infection, for assessed weekly pain or the operation site,tenderness around exudate, at the inflammation or irritation swelling operation site, and whether sensation in the to normal; had returned operation area at patients were appointment each postoperative comfort, for to rate the dressings asked removal acceptability and pain on dressing n with sterile normal saline soaked were groups prior to removal, with and the site swabbed saline and blotted dry.The use of topical antiseptics was discouraged, and if these were visits the patient consecutive used on two was excluded Duration of follow-up Intervention sodium alginate flat dressing); replaced dressing with moistened Kaltostat at first outpatient review; visits could at subsequent follow-up use dry sterile gauze instead of Kaltostat if moist for was no longer sufficiently wound choice ( alginate to be an appropriate partial nail avulsion n Comparator (cotton and acrylic pad bonded to fibre film) used polyester low-adherent perforated trial ( throughout : : : : Type of operation Type partial or total nail avulsion Inclusion criteria by patients referred GP to the chiropody department for toenail surgery Exclusion criteria nail infec- mycotic tion; undergoing with treatment antibiotics, steroids or immunosuppres- sants; diabetes; pulses absent foot or peripheral neuropathy Bacterial growth none stated Details of the clinical trials included in the review : : :to : UK 39 Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Foley and Allen, and Foley 1994, Study design RCT Method of randomisation chiropody outpatient department Objective factors investigate which influence the rate of heal- ing after toenail and avulsion phenolisation, including a com- parison of an alginate wound and a dressing drynon-adherent dressing predetermined random sequence Setting 81 TABLE 12 contd TABLE Appendix 5 : continued : there conclusions ’ Debrisan was found to be Debrisan was found than Eusol in effective more the patients studied Other comments no baseline details on were size and the length wound was not stated. of follow-up incon- The authors were sistent in reporting the summary measure, as both means and medians were given. It is not clear from which the data presented is the most measure appropriate Authors Not reported Whitney – : Mann : dextranomer : the cost of Debrisan : dextranomer 1; gauze : < 0.05) -test p 3 patients in the gauze group a serous to have continued after up to 5 days discharge for closure,wound but this did not occur in the dextranomer group with Patients treated dextranomer had a shorter a median of by hospital stay of (no measure 2.2 days significance provided) Cost data Statistical test used to data compare U Results Number of wounds that healed by granulation 1 (duration of time not stated) Mean time to wound closure by secondary suture 8.1 days; gauze 11.6 days ( is £3.40 (trial published in 1979) of a dressing the twice-daily for 10 cm wound. However, the high the by cost was compensated for in the total cost of hospital saving the shorter from resulting care hospital stay : : 71 years) – 91 years); gauze – Patient details Patient Mean (range) age: dextranomer 52.9 years (24 (27 50.9 years Gender (male/female): dextranomer 7/3; gauze 6/4 details Wound Appendectomy/ paramedian (near the middle): dextranomer 6/4; gauze 7/3 primary Delayed suture: dextranomer 4; gauze 6 abscess: Wound dextranomer 6; gauze 4 characteristics = 10) n : of number 72 hours : all patients were – : not stated : to secondary time taken = 10) n : Eusol ribbon gauze ( : dextranomer polysaccharide postoperatively Duration of follow-up of healing Measure skin closure. An independent assessor decided to the was clean according when the wound criteria:following of erythema resolution and oedema, absence of pus, slough at the base, tissue. of granulation and the formation Such secondary then closed by were wounds suture. at the was photographed Each wound start, during and at the end of treatment Other outcome measures in hospital days given prophylactic antibiotic cover of antibiotic cover prophylactic given with the Cephazolin and Metronidazole 48 and for premedication Concurrent treatment Concurrent Comparator Intervention beads (Debrisan) ( : : : : and , with no Type of operation Type or appendectomy surgerybowel Inclusion criteria either wounds contaminated heavily at operation and left delayed open for primary suture, or which were wounds closed primarily, but which subsequently an abscess developed of removal requiring and drainage sutures Exclusion criteria none stated Bacterial growth bacteriological slides that the showed infec- predominant organisms were tive Escherichia coli Pseudomonas particular difference groups between Details of the clinical trials included in the review : : ., :to : hospital et al UK 40 Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Goode Study design RCT Method of randomisation from drawn cards sealed envelopes Setting and outpatients Objective examine the cost- of effectiveness dextranomer and Eusol in the of treatment surgical infected wounds 82 1979, TABLE 12 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14 : continued : the conclusions ’ these results confirm that these results is effective alginate rope in and can be used safely the management of wounds infected Other comments study was conducted in military hospitals, and thus not be may the results generalisable to the general population Authors None reported; there were no reactions adverse in either of the 2 groups treatment : : : s ’ > 0.05) p test 2 : alginate 22 χ : : alginate 13 (35%); = 0.0001) and easier = 0.011) than povidone p < 0.05). : p p -test or Wilcoxon test for Wilcoxon -test or iodine Reduction in wound area at week 3 Reduction in wound area alginate 67.1%; gauze 44.8% at week 2 Reduction in wound area alginate 58.2%; gauze 38% at week 1 Reduction in wound area alginate 32.8%; gauze 20.3% mean wound The percentage in the alginate surface reduction 1, was higher at weeks group 2 and 3 ( was The calcium alginate rope painless ( to use ( Statistical test used to groups compare for categorical data, categorical for Student t data continuous Results Number of subjects with completely healed wounds gauze 6 (18%) Number of subjects in which wound cavity completely filled (59%); gauze 16 (48%) ( : : 2 35 years) ); – 2 190 cm) ) 2 – 110 kg) 50 ml); – – 2 190 cm); gauze 25 ml) – 2314 mm 863 mm 37 years); gauze 110 kg); gauze – – – – – Height: alginate 117 cm (167 176 cm (168 gauze 269.4 mm (81 (44 Volume: alginate 7.4 ml (0.5 gauze 5.6 ml (0.6 details Patient mean (range) Age: alginate 21.2 years (18 (18 22.2 years Weight: alginate 75.5 kg (57 79.6 kg (60 Wound details Wound mean (range) Area: alginate 472.6 mm characteristics : wound : none reported : 3 weeks; wounds = 33) : healing wound n : packing with gauze soaked : calcium alginate rope = 37) n were evaluated weekly; evaluated were begun treatment after incision 1 day of healing Measure cavity using wound was evaluated volume, tracings, area photographs and clinical observation Other outcome measures using bacterial swabs;infection pain and using measured ease of use were visual analogue scales Duration of follow-up Intervention ( iodine ( in povidone treatment Concurrent Comparator : : : : Type of operation Type incision and drainage of pilonidal abscess Inclusion criteria not stated Exclusion criteria not stated Bacterial growth were bacterial swabs taken; was no there between difference the bacteria cultured groups in the two Details of the clinical trials included in the review : ., : RCT et al :to :7 :7 France 41 Study and design Participants Intervention and study details Baseline Results Withdrawals Comments 1996, Guillotreau Guillotreau Study design (multicentre) Method of randomisation general surgery departments of military hospitals Objective the effi- compare of cacy and safety calcium alginate and povi- dressing done iodine pack in the management post- of infected wounds operative not stated Setting 83 TABLE 12 contd TABLE Appendix 5 :it : foam continued : this ’ Authors conclusions study suggests that elastomer dressing foam comfortable is a more to gauze alternative pack in the management of the perineal wound and substantially the amount of reduces supervisionnursing which is required.We its routine recommend use in the management of the open perineal particularly in wounds and co- the young patient operative Other comments is unclear if patients com- who died before plete healing occurred failed or whose wounds included in to heal were the trial.The authors were noted that there no exclusions; however, the outcome measures of included the number until complete days healing and epithelialis- ation, not which would for been available have these patients Study sponsor supplied were dressings Corning Ltd Dow by s ’ :3 in in :3 : 1 partic- : 3 patients :1 Foam participant had recurrent proven and 1 carcinoma failed to heal rectal following irradi- excision for ation colitis Gauze ipant had recur- carcinoma rent and 1 had Crohn of involvement the perineum Persistent sinuses and gauze group group 1 in foam in (present otherwise healed perineum and necessitated further minor surgery) Death in each group died before complete healing of wound; com- plication of wound not thought to be a contributory factor > 0.05) p > 0.05) p : foam < 0.001) : foam p -test t s ’ : foam < 0.05) : one patient in the p : 47.5 ± foam 3.1 days; : 1.24 ± foam 0.15; gauze : 4 patients (16%) in the < 0.02) > 0.05) > 0.05) p : 29.4 ± foam 3.6; gauze : 23.8 ± foam 1.8; gauze p p : mean ± SE : Student unpaired Time to dry dressing gauze 62.6 ± ( 6.3 days 0.94 ± 0.11; gauze 0.98 ± 0.08 ( Rate to full epithelialisation (time epithelialisation/initial wound size) Results Time to full epithelialisation 60.3 ± 3.0 days; gauze 69.5 ± 7.3 ( Rate to dry dressing 1.07 ± 0.11 ( Statistical test used to compare groups Complication of treatment vaginal complained of severe group foam odour 2 months postoperatively; on stent was examination a piece of foam high in the vault of lying discovered vagina; under was removed the foam general anaesthetic Assessment of pain analgesia (all had required group foam Entonox); 15 patients (60%) in the gauze of analgesia (10 some form required group Entonox,by pethidine) intramuscular 5 by Number of inpatient days, including convalescence 29.9 ± 2.8 ( Number of inpatient days, excluding convalescence 22.8 ± 1.7 ( Number of visits by districtNumber of visits by nurse 14.1 ± 2.4; gauze 46.9 ± 5.8 ( : s disease: 5; foam ’ : 14; foam characteristics Mean ± SE initial wound 14: on day volume 55.5 ±foam 4.5 ml; gauze 61.5 ± 5.3 ml Mean ± SD age: foam 54 ± 17.0 years; gauze 59 ± 17.5 years Gender (male/female): foam: 14/11; gauze 16/9 surgeryReasons for (number of subjects) colitis: Ulcerative 8;foam gauze 6 Crohn gauze 3 Carcinoma: 10; foam gauze 14 Villous papilloma: foam 1; gauze 0 colitis:Irradiation foam 1; gauze 1 Diverticulitis: 0; foam gauze 1 Number of wounds that breakdown from resulted of attempt at primary suture gauze 16 = 25 : analgesic n : perineal : until complete : initial wound s progress was s progress ’ : in ribbon gauze soaked : elastomer silicone foam = 25 completed trial) n Intervention (Silastic, Corning Ltd) ( Dow completed trial) Comparator chloride antiseptic solution, mercuric into the perineal wound packed loosely ( healing; in weekly participants reviewed surgical outpatient department; assess- ment of participant the same person made by always of healing Measure a foam forming calculated by volume dressing, by measured and the volume displacement of water; time to dry and full epithelialisation;dressing rate of initial wound healing calculated from of days the number divided by volume each end-point to achieve required Other outcome measures the of patients to cover requirements was change and while dressing dressing in position; as inpatient, of days number either in hospital or a convalescent home; the of visits made by number from each week recorded district nurse clinic attendance the patient at weekly Concurrent treatment Concurrent in both was performed irrigation wound when necessary;groups when no cavity a dry as was applied remained dressing in both groups; the sole dressing participants instructed to remove a and take at least once daily dressings was removed salt bath while dressing Duration of follow-up : : : : Type of operation Type or procolectomy excision rectal Inclusion criteria partic-consecutive ipants with open at perineal wound 14 day postoperative Exclusion criteria none stated Bacterial growth not stated Details of the clinical trials included in the review : : RCT :to : hospital UK 42 Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Macfie and McMahon, 1980, Study design Method of randomisation and surgical out- patient department clinic; a district was arranged nurse all patients on for discharge Objective assess the value of elastomer,foam a silicone catalysed dressing,polymer in the management of the perineal wound after abdominal excision of the rectum 84 not stated; randomised on postoperative 14 day Setting TABLE 12 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14 : the continued : this study ’ Authors conclusions shows a significant shows with regard difference to the healing of deep in favour wounds cavity of the hydroactive dressing. After 4 weeks was a difference there of wound in reduction size of approximately the two 25% between dressings.There also to be a lower appears of inflammation degree during the treatment with the hydroactive dressing. Patients found dressing the hydroactive comfortable due more to the significant reduc- tion in pain. Looking at the earlier time point of and the closure wound of frequency reduced changes in the dressing group, cavity Cutinova might this treatment cost- also be more effective. However, detailed analysis more is necessary Other comments authors did not state what statistical test was the data used to analyse : 2 partic- :1 Foam participant due to no further and improvement start of a local antibiotic treatment Gauze ipants due to deterioration of and non- wound acceptance of dressing : 3 :foam : 3 : faster : 6.8 cm foam : 76%; foam gauze < 0.05) p ); gauze 10.5 cm ) 3 3 : 1, week 1.77/0.97 = 1.83; : 1 week; foam gauze 3 weeks : mean (range) : not stated : 4; foam gauze 2 < 0.05) : observed not generally at any p 10.4 cm 15.0 cm – – Reduction in wound size 50% ( Epithelialisation and granulation and also epithelialisation and granulation of fibrinous coats an earlier reduction dressing the foam reported for and in infection reduction Time to significant erythema tissue,Necrotic odour, putrid and secretion itching time during the study, so no difference groups between changes Mean number of dressing (gauze/foam) 2,week 1.20/0.56 = 2.16; 3, week 0.69/0.28 = 2.48; 4, week 0.39/0.14 = 2.76 Number of wounds completely healed 10;foam gauze 4 Number of wounds closed surgically after 4 weeks (number of patients who healing rate Overall either healed during or the 4 weeks treatment whose wounds could be secondarily closed) 0.86; gauze 1.82 ( foam 14;foam gauze 6 scale) at week 4 (visual analogue Pain Statistical test used to compare groups Results volume at 4 weeks Wound (0.0 (0.0 ) 3 3 ); 3 3 27.6 cm 54.8 cm – – Mean (range) initial volume: mean wound 27.9 cm foam gauze 21.0 cm (9.2 (11.4 Secondary healing after abdominal surgery: 15;foam gauze 16 Secondary healing after surgical incision of an abscess: 6; foam gauze 6 of pain at the Level beginning of treatment: 5.54;foam gauze 5.11 characteristics ’ none ‘ :for the :for : dressings : 4 weeks = 21) : in reduction n : moist cotton gauze : foam polyurethane was used; itching was ’ severe = 22) ‘ n Comparator a by covered (the traditional therapy) simple surgical dressing; solution used to moisten the gauze was not stated ( of healing Measure size and depth;wound healing process using photography was measured (using measurement and volumetric material or saline);impression subjective of epithelialisation and evaluation tissue of granulation formation Other outcome measures of fibrinous coats,evaluation putrid secretion, odour, extent of necrosis, erythema a scale of and infection to or not present; to be present evaluated using a visual pain was evaluated analogue scale Concurrent treatment Concurrent changed as often necessary,were but at least once a week; was the wound applied; cleansed and then the dressing topical medication no additional was allowed Duration of follow-up containing hydroactive particles containing hydroactive dressing, cavity (Cutinova Beiersdorf AG); with was covered the dressing ( a thin film dressing Intervention : : : : Type of operation Type or laparotomy surgical incision of an abscess Inclusion criteria patients with a deep secondary healing wound Exclusion criteria to allergic reactions products; the applied diabetes; immuno- deficiency; wounds consisting of a big subcutaneous cavity with a small ostium; steroids, receiving radiation or chemo- therapy Bacterial growth not stated Details of the clinical trials included in the review : UK : RCT 43 :to : hospital Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Study design Method of randomisation Objective a new compare dressing hydroactive to traditional the for therapy of treatment secondary healing after wounds abdominal surgery and abscess cavities not stated Setting Meyer, 1997, 85 TABLE 12 contd TABLE Appendix 5 : continued : this ’ Authors conclusions study indicates that the advanced dressing is easy to use (foam) in with better results wounds pilonidal sinus Other comments the sample size was very small and so the lacked have study may to detect the power significant differences the groups;between no was statistical analysis undertaken None reported : 102 days) – : 46%; foam : 12 days; foam : 33.5 days foam : 4.3 weeks; foam : mean (range) : was no statistical analysis 52 days); (38 gauze 73 days – foam 20;foam gauze 868 group, the foam For pain- were dressings free, were they while in the gauze group painful and bleeding occurred Cavity reduction after 15 days Cavity reduction gauze 22% time Cavity filling gauze 9.5 weeks to work return Time before gauze 23 days used per patient Number of dressings Statistical test used to compare groups undertaken Results Time to complete healing (21 3 ; 3 All patients were than 40 years younger of age and had no other pathologies other than pilonidal sinus volume Average cavity: of wound 91 cm foam gauze 114 cm characteristics = 6) : n : all patients : treatment : healing time : 10% iodopovidone : silicone reconstituted = 6) n was continued until wound reduction reduction until wound was continued or rupture of healing Measure Other outcome measures time,granulating comfort and infection Concurrent treatment Concurrent (Inadine, an antiseptic dressing received on the first & Johnson) Johnson day;postoperative in both groups changed if dirty, were dressings contaminated or displaced; wounds cleansed with sterile saline solution Duration of follow-up foam (CaviCare,foam Smith & Nephew); each day, with was disinfected the foam 10% chlorohexidine, rinsed with sterile ( saline solution and replaced Comparator solution and dry gauze, changed twice ( daily Intervention : : : : Type of operation Type pilonidal sinus removal Inclusion criteria not stated Exclusion criteria not stated Bacterial growth of no presence was seen infection in either group Details of the clinical trials included in the review : 44 : :to ., 1998, : hospital et al Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Ricci Italy Study design trial controlled Method of randomisation Objective the healing evaluate time of surgical healing by wounds secondary intention different using two types of dressing (traditional and advanced) 86 not applicable Setting TABLE 12 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14 : : ’ continued : conclusions ’ the results of the study the results indicate that Sorbsan, used after nail matrix phenolisation, reduced median healing time and of patient the number complaints when com- with the control pared treatment. As a result, the visits of follow-up number was significantly required less in the Sorbsan group, considerable saving staff time and chiropody of treatment allowing patients more Other comments of the initial number participants in each group was not presented; no on baseline information participants was given, it is not and therefore possible to assess the comparability of the groups.The authors conclusions do not seem the results from to follow in that the differences Sorbsan and between to be Anaflex appear marginal, in especially terms of the mean of visits per number patient and side-effects Study sponsor provided materials were Steriseal by Authors 67 participants the trial entered and 62 were included in the analysis; no information on presented those lost to follow-up : : : : alginate 24 (71%); : alginate 43 days; : mean : not stated, and no statistical : alginate 6; gauze 7 alginate 0; gauze 1 (4%) alginate 40 days; gauze 39 days Number of visits per patient to complete healing Number of participants reporting problems after the operation gauze 24 (86%) Number of participants with infection antibiotics that required postoperatively Statistical test used to compare groups data presented Results Healing time gauze 52 days nail avulsion – healing time Total alginate 45 days; gauze 69 days Partial nail avulsion – healing time No participants with insulin-dependent included diabetes were in the trial. Participants were in both groups been reported to have sex matched for evenly and age. No further reported details were characteristics = 13; = 28, n n :any = 17; partial n : dressings : when = 34, final = 15) : time to healing n n = 17) : (Melolin gauze derivative : calcium alginate n final number: total nail avulsion partial nail avulsion treatment Concurrent complete healing had occurred; the session was held 3 or first follow-up after surgery and then weekly 4 days until healing had occurred; on following visits the condition of nailbed and matrix was recorded of healing Measure of visits;and number complete healing was defined as when the eschar had resolved; was evidence photographic at all stages of the procedure taken Other outcome measures recorded complaints were volunteered held in place with tubular gauze; advice leaflet Duration of follow-up Comparator ( Anaflax powder) and dressing nail avulsion nail avulsion number: total nail avulsion dressing (Sorbsan) ( dressing Intervention : : : : Type of operation Type total or partial with nail avulsion phenolisation (80% liquefied phenol) Inclusion criteria none stated Exclusion criteria cases in which treat- ment other than Sorbsan or Melolin/ Anaflex was used or an emergency where had to be avulsion performed; no participants were excluded for medical reasons Bacterial growth not stated Details of the clinical trials included in the review : : UK 45 :to : acute Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Smith, 1992, Study design quasi-RCT Method of randomisation hospital, chiropody department Objective the use compare dressing of two regimens, Sorbsan and polynoxylin/ Melolin, after toenail in terms removal of healing time and postoperative complications participants were allocated numbers and those with numbers even with treated were Sorbsan, while the the others received dressing standard Setting 87 TABLE 12 contd TABLE Appendix 5 : – : the 23 continued conclusions ’ the Fibracol collagen was alginate dressing to be an effective found adjunct in the post- treatment operative protocol, shortening healing time and patient increasing satisfaction with this common procedure Other comments reported on authors only patient satisfaction with the Fibracol treatment, not with the control treatment, and so con- clusions cannot be drawn patient satis- regarding patients faction.Twenty randomised to were groups; treatment two however, the data were to the according analysed of wounds number Authors One patient was for not available and follow-up was excluded the analysis from = 0.03) p fully at the end of fully ’ : alginate 24.4 days -test was conducted for t healed : mean (range), median ‘ :a :a 56 days), ( 42 days 35 days), 26 days; 35.8 days control – – the 8 week trial the 8 week (19 patients group One of the control had not comparison of independent group means comparison of independent group Results Time to healing (14 Statistical test used to compare groups 63 years) – 79 years); control – characteristics Gender (male/female): alginate 1/2; 1/1 control Mean (range) age: alginate 42 years (12 (12 40 years = 5) = 9) n n = 9; n : all wounds alginate wound : 8 weeks; – : time to average = 4) n : wound no additional : collagen = 11) (13 separate pro- = 5; total nail avulsion n n total nail avulsion total nail avulsion until healing seen weekly patients were or until the 8 week had occurred end-point was reached of healing Measure healing; healing defined as absence of drainage, erythema, oedema and pain site at wound Concurrent treatment Concurrent of with a thin layer dressed were cream,sulfadiazine silver over applied in the treatment a Fibracol dressing group, with sterile gauze; and covered all patients told to soak the surgical site in a dilute salt solution, clean the with a cotton-tipped nail border applicator, of otic one drop apply Cortisporin solution to the nailbed with a bandage twice daily and cover Duration of follow-up cedures: partial nail avulsion dressing ( dressing Comparator (10 separate procedures: partial nail avulsion Intervention dressing (Fibracol) applied directly to directly (Fibracol) applied dressing of nail matrix,exposed area cuticle tissue and nailbed; cut patients given to sections of the alginate dressing change ( dressing at every apply : : : : arterial Type of operation Type toenail avulsion utilising 10% sodium was hydroxide performed; area with 5% irrigated acetic acid to neutralise chemical Inclusion criteria 20 consecutive patients who to the presented podiatry clinic; patients with or chronic infected toenails ingrown Exclusion criteria insufficiency; failure to demonstrate palpable pedal pulses; history of peripheral vascular disease; unable or unwilling to commit the plan full treatment Bacterial growth none of the patients in the 2 groups experienced post- infection operative Details of the clinical trials included in the review : : RCT ., :to alginate et al : – USA 46 Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Van Gils Van 1998, Study design Method of randomisation podiatry clinic Objective the evaluate efficacy of a collagen in dressing wound the postoperative management of chemical matricectomies 88 not stated Setting TABLE 12 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14 : : continued conclusions ’ hydrocolloid dressings hydrocolloid lessen pain and increase comfort patients after for excision of pilonidal sinus, though time to healing is no shorter than when a gauze conventional is used dressing Other comments the sample size was small and so the study the lacked have may to detect power significant differences the groups between Authors None reported :no 168 days) : – = 0.03) 168) – p : hydrocolloid 77 months) – > 0.05) s exact test and p ’ : 65 days hydrocolloid : 1999) (July Euros : of none after median follow-up = 0.05); difference median weekly : median (range) : 3 (13%); hydrocolloid gauze 1 (7%) : Fisher 36); gauze 68 (33 : dressings 14 of the hydrocolloid p Whitney test Whitney – – 137 days); (33 gauze 68 days : during first group less in hydrocolloid – > 0.05) p Number of dressings used Number of dressings 23 (13 at wound (dermal folliculitis Local intolerance margins) pathogen grew culture Postoperative 1;hydrocolloid gauze 5 ( ( in pain between groups was only significant was only groups in pain between 1 during week Leakage of poor attachment as a result leaked the edges of dressing; however, they and reported to be easy apply were remove; was no significant difference there types of hydrocolloid the two between used dressings Cost data Scar quality, of dressing, tolerance smell among groups significant differences Recurrence 74 months (range 59 Pain than in gauze postoperatively 4 weeks ( group Unit dressing: 4.0; hydrocolloid 1.3 control Cost per patient: 93.6; hydrocolloid 101.1 ( control Mann Results Healing time (40 Statistical test used to compare groups 48 years) – None of the patients with presented associated disease between No differences in sex,groups age or area size of resected of tissue 31 men and 7 women Mean age 24 years (range 16 characteristics : infection : washing of : the median : time to healing : cost per patient = 15) n = 12) and Varihesive = 11) : gauze with conventional : dressings hydrocolloid n n 3 days); no further details on – Concurrent treatment Concurrent was 1 day hospital stay postoperative (range 1 wound in saline and replacement of in saline and replacement wound dressing Duration of follow-up Comparator povidone iodine ( povidone stated duration of follow-up of healing Measure Other outcome measures rate, intolerance, odour, pain (during and sessions, care between rated on a visual analogue scale), comfort, ease of management, leakage and recurrence Cost-effectiveness cost and unit dressing Intervention combined in analysis),(groups Comfeel (Coloplast) ( ( (Convatec) : : : : = 0.03); p Type of operation Type surgery under local anaesthetic; an elliptical incision was made to remove the cyst en bloc to fascia, the presacral the wound leaving open to heal by secondary intention Inclusion criteria none stated Exclusion criteria patients with pilonidal abscesses Bacterial growth bacteriological made cultures of bed wound during surgery and on cure; specimens the collected from during wounds operation failed to pathogens; grow during follow-up cultures 5 positive group control from the and 1 from combined hydro- grew colloid group pathogens ( bacterial contami- nation had no on clinical effect healing wound Details of the clinical trials included in the review : : ., :to : outpatient et al Spain 47 Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Viciano 2000, Study design RCT Method of randomisation department Objective assess the efficacy of hydrocolloid in wound dressings management after excision of pilonidal sinus not stated Setting 89 TABLE 12 contd TABLE Appendix 5 : : continued conclusions ’ Table 13 Table there was not a statistic- there significant difference ally in hospital discharge Eusol dressing times for in either or Silastic foam group.The authors that pilonidal advocate disease should be sinus simple incision by treated dressing and Silastic foam hospital stay reducing time and nursing expenditure Other comments no baseline details reported; the sample size was small and so lack the the study may to detect signifi- power between cant differences groups; the treatment partic-75 consecutive recruited, ipants were with no specific exclusion criteria specified See also Authors None reported 53 days) 46 days) : foam – – : foam : 39.8 days foam : 30.0 days foam > 0.05) > 0.05) p 13 days); gauze 14.6 days 20 days); gauze 15.2 days p – – : mean (range) : not stated 19 days) ( 19 days) 54 days); (27 gauze 39.6 days 39 days); (20 gauze 33.0 days – 27 days) ( 27 days) – – > 0.05) > 0.05) – p p (10 11.5 days (4 11.5 days Time to hospital discharge – abscess ( (3 Time to hospital discharge – sinus Time to full healing – abscess ( (6 12.8 days (26 Statistical test used to compare groups Results Time to full healing – sinus (21 33 years – Mean age: men 25 years; 19 years women Age range: 16 96% male characteristics = 17) : time n = 41: : not stated n : patients = 21) : time to n = 17; sinus n : Eusol half-strength : sponge silicone foam = 20; sinus n = 34: abscess n discharged when only required required discharged when only changes as an dressing once daily managing their outpatient or were Silastic foam own of healing Measure full healing Other outcome measures to discharge Concurrent treatment Concurrent Duration of follow-up abscess Comparator laid into cavity gauze dressing soaked initially,twice daily then once daily clean was considered when wound staff ( nursing enough by Intervention (Silastic); and patients removed washed sponge twice daily; sponge new constructed when the existing one into the cavity no longer fitted easily ( : : : : consecutive patients consecutive admitted to the Hospital, Naval Royal Gosport, with either or pilonidal sinus abscess; patients into 2 grouped depending on groups had whether they or pilonidal sinus abscess Exclusion criteria none stated Bacterial growth not stated Type of operation Type acute abscesses and were sinuses chronic similarly: treated incision of sinus, and excision of chronic tissue granulation and hair; wounds with dressed initially ribbon gauze (2.5 cm in wide) and soaked Eusol; half-strength patients randomised 48 to treatments hours after the operation Inclusion criteria Details of the clinical trials included in the review : : ., :to : naval et al UK 48 Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Walker Walker 1991, Study design RCT Method of randomisation hospital and (seen community district nurse) by Objective Eusol compare and Silastic foam in the dressing postoperative management of pilonidal sinus 90 not stated Setting TABLE 12 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14 : : continued conclusions ’ the wounds dressed dressed the wounds did with Silastic foam quickly not heal more than those managed with a moistened gauze pack. has dressing Silastic foam undoubted advantages the nurse,for purse and patient Other comments the authors only for reported the results the participants followed up; it is not clear whether were number a greater randomised and whether occurred;drop-outs no inclusion and exclusion specified criteria were Authors Not stated; not results clear from presented : : foam : foam : foam : foam : 38.6 ± foam 24.9 days; : mean ± SD : no statistical analysis Statistical test used to compare groups was undertaken Results Number of days to complete healing 66.2 ±foam 26.1; gauze 57.7 ± 19.6 Number of days packed 41.5 ± 21.2; gauze 41.8 ± 26.7 of hospital stay Duration 8.5 ± 12.3 days; gauze 7.3 ± 6.2 days lost Work gauze 45.4 ± 19.9 days Number of home nursing visits 4.6 ± 1.5; gauze 35.1 ± 17.4 Discomfort removal on dressing 1.4 ± 0.6, mild; gauze 2.9 ± 2.6, severe Mean ± SD wound volume: foam 59 ± 57.7 ml; gauze 64 ± 74.5 ml characteristics : duration : each wound : patients were : time to complete : packing with daily : elastomer silicone foam = 44, final number) n = 36, final number) n Intervention at weekly (Silastic) refashioned dressing intervals ( Comparator in a 0.5% aqueous gauze soaked solution of chlorhexidine (Habitant) ( was until the wound weekly reviewed epithelialised completely of healing Measure (when surface was healing of wound epithelialised),completely and time until packing was no longer required Other outcome measures of hospital stay; lost; days work number visits;of home nursing discomfort on reported by (score removal dressing patient: 3, extreme moderate 2, mild 1, none 0); of discomfort degree the was experienced when the dressing 1 was obtained by changed in week that for dividing the total score of dressing the number by week changes undertaken Concurrent treatment Concurrent in a gauze roll 4 days for was packed prior to emulsion in flavine soaked randomisation Duration of follow-up : : : : Type of operation Type excision of pilonidal sinus Inclusion criteria not stated Exclusion criteria not stated Bacterial growth not stated Details of the clinical trials included in the review : : ., :to et al : UK 49 Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Williams 1981, RCT Method of randomisation study multicentre set in hospitals and the community Objective the investigate advantages of using a silastic foam in the dressing management of open granulating wounds Study design not stated Setting 91 TABLE 12 contd TABLE Appendix 5 : : the conclusions ’ the results indicate that the results for the time taken to heal is wounds comparable with both methods of treatment. to pain appears Wound both groups be similar for treated.The incidence of erythema, oedema and slough was similar for and both our groups no late were there skin reactions adverse Other comments small sample size would made it difficult to have difference detect any the groups between Authors None reported s ’ : : : Student : mean ± SE > 0.05) p -test dextranomer 5.32 ± 0.55 days; 5.64 ±foam 0.45 days for The time taken of erythema,disappearance oedema and slough was similar groups treatment in the two Time to pain-free wounds Time to pain-free t Results Time to complete healing dextranomer 40.92 ± 3.98 days; 36.90 ±foam 3.18 days ( Statistical test used to groups compare Number of wounds left open Number of wounds primarily: dextranomer 8; 8 foam Mean ± age: SD dextranomer 44.48 ± 5.17 years; foam 49.64 ± 4.57 years of wound in the Types groups two treatment not significant): (difference Midline: dextranomer 3; 8 foam Upper paramedian: dextranomer 2; 1 foam paramedian:Lower dextranomer 7; 10 foam Subcostal: dextranomer 3; 0 foam Grid iron: dextranomer 9; 5 foam Other: dextranomer 1; 1 foam Mean ± SD wound measurements: Length: dextranomer 5.53 ± 0.55 cm; foam 6.57 ± 0.89 cm Breadth: dextranomer 2.25 ± 0.33 cm; foam 2.48 ± 0.32 cm Depth: dextranomer 1.80 ± 0.20 cm; foam 2.24 ± 0.29 cm Volume: dextranomer 4.92 ± 1.15 ml; foam 6.37 ± 1.30 ml characteristics : wounds : all 3 (0, no : until – : length, breadth = 25) n : silicone foam : dextranomer polysac- = 25) n complete healing; were wounds 1, on days reviewed 3 and 7 following breakdown, weekly and thereafter of healing Measure measured and depth of each wound recorded;and volume the latter filling was obtained by measurement with sterile saline;the wound a photo- of individual wounds record graphic was obtained, at a standard taken distance of 0.45 m; to time taken complete healing in each patient was recorded Other outcome measures erythema, examined for were oedema, rash, odour and slough; the comfort was assessed by of the dressing asking the patient; the pain of was graded as 0 wound wounds were initially treated with treated initially were wounds gauze packing for conventional 48 hours Duration of follow-up pain; 3, pain) severe elastomer (Silastic, Corning Dow Ltd); was removed dressing foam initially,and cleaned twice daily and when the discharge then once daily decreased; stents were foam new ( made weekly treatment Concurrent Comparator charide beads (Debrisan, Pharmacia); initially,changed twice daily and then in discharge when reduction once daily permitted ( Intervention : : : : Type of operation Type for appendectomy or a gangrenous appendix perforated peritoneal with free pus Inclusion criteria all patients who a surgical developed breakdown; wounds left open after surgery in the superficial part the muscle from outwards layers Exclusion criteria not stated Bacterial growth bacteriological swabs of any taken were that were wounds odorous, contained excess slough or discharged frank pus; the findings not presented were Details of the clinical trials included in the review : : :to : hospital UK 50 Study and design Participants Intervention and study details Baseline Results Withdrawals Comments Young and Wheeler, and Young 1982, Study design RCT Method of randomisation setting with patients discharged home Objective the compare efficacy of dextra- nomer beads (Debrisan) and silicone foam elastomer (Silastic) in patients with surgical wounds that had either or down broken had been left open postoperatively 92 system random card Setting TABLE 12 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14

Appendix 6 Summary of included economic evaluations

93 Appendix 6 ’ : . ’ continued : this simple 20 per week for 20 per week – 1999 data and other dressings – ‘ : data (acquisition costs and findings suggest that ’ conclusions ’ analysis suggests that the use of Cutinova analysis to moist gauze in the in preference of difficult-to-heal surgical dressing and NHS resources will save wounds the decreasing costs both by reduce the reducing spend on disposables and by changes. in dressing time involved nursing will vary Although the potential savings patient to patient,from in the reduction to be £5 costs is likely each patient of result and direction Magnitude the authors is dominant (less costly Cutinova effective) and more Comments the one patient from time) from nursing not were who had a deep wound survey as included in the economic evaluation outliers.When considered the data were this patient considering the data from the survey cost from the mean Cutinova was higher than the Authors The sample size was small for both The sample size was small for and cost data.effectiveness No statistical was undertaken.Theanalysis sensitivity and the one-way was only analysis data was uncertainty of the effectiveness used were sources not considered.Two the cost data (case study and hospital for was presented and no information survey) combined. these were on how Staff costs based on 1998 were acquisition costs on 1996 prices. was It combined. these were not stated how retrospectively Costing was undertaken and not conducted on the sample used study,in the effectiveness and therefore of assumptions. included a number limitations the authors the above Given conclusions do not seem to be justified :if the frequency of Cutinova the frequency is doubled the dressings almost,savings but not quite, disappear, suggesting that the conclusion of is robust cost saving savings if Cutinova Potential changed twice are dressings as often: 1:Week £2.38 (gauze £17.76, £15.39) Cutinova 2:Week £3.23 (gauze £12.11, £8.88) Cutinova 3:Week £2.49 (gauze £6.89, £4.41) Cutinova 4:Week £1.66 (gauze £3.90, £2.24) Cutinova priceIf the Cutinova is of a factor by increased 3 the cost advantage is retained: 1:Week £8.34 (gauze £35.53, £27.19) Cutinova 2:Week £8.54 (gauze £24.23, £15.69) Cutinova 3:Week £6.00 (gauze £13.78, £7.79) Cutinova 4:Week £3.84 (gauze £7.79, £3.95) Cutinova Sensitivity analysis : : : no statistical calculation : Clinical outcome/benefits wound rapid patients experienced more Cutinova healing and less pain on changing dressings.The was shorter time per wound with Cut- dressing per dressings needed fewer and this group inova was undertaken). (no statistical analysis week in also found The shorter times were nursing conducted in a NHS hospital the survey Costs Cost per week of nursing time: 1:Week gauze £19.18, £9.49; Cutinova £9.69 saving 2:Week gauze £13.08, £5.48; Cutinova £7.61 saving 3:Week gauze £7.44, £2.72; Cutinova £4.73 saving 4:Week gauze £4.21, £1.38; Cutinova £2.83 saving Estimation of acquisition cost per week: 1:Week gauze £16.35, £5.90; Cutinova £10.44 saving 2:Week gauze £11.15, £3.41; Cutinova £7.74 saving 3:Week gauze £6.34, £1.69; Cutinova £4.65 saving 4:Week gauze £3.58, £0.86; Cutinova £2.73 saving Synthesis of costs and benefits using Cutinova: saving per week from Potential 1:Week £20.14 (gauze £35.53, £15.39) Cutinova 2:Week £15.35 (gauze £24.23, £8.88) Cutinova 3:Week £9.38 (gauze £13.78, £4.41) Cutinova 4:Week £5.55 (gauze £7.79, £2.24) Cutinova Statistical analysis the costs of was conducted to compare treatments two : was 43 206 : :NA 1999 NHS – Valuation for Valuation clinical outcomes or benefits of interpretation surgical team.The time per nursing per dressing week was calculated from regarding information time per the nursing (in minutes) dressing and the mean number changes of dressing from taken per week the randomised data comparative and the survey data and the survey 5 patients from Estimation of costs costs that were included considered acquisition costs of and nursing dressings time per dressing based Staff costs were on 1998 based on 1996 prices Modelling costs and dressing the from costs were drug tariff in February 2000.The acquisition in costs per dressing the case study of benefits/costs 206 ) : a case 30 Table 12 Table (see 43 : a decision to conduct Source of effectiveness Source data a CMA was based on the findings of a published syste- of the literature matic review on the debridement of wounds,chronic including healing by surgical wounds secondary intention The duration of the trial was 4 weeks of cost data Source study of a patient who had infection wound postoperative surgery colorectal following Effectiveness data for the CMA data for Effectiveness based on the findings of were and gauze a RCT of Cutinova in 43 patients with secondary after a laparo- healing wounds or surgical incision of tomy an abscess conducted at and a survey an NHS hospital looking at time and costs of nursing in the disposables involved of (difficult to heal) dressing in consecutive surgical wounds period a 1-week patents over the case study,For initial were dressings postoperative 20 days,used for then and Cutinova cavity Cutinova 23 days; used for were hydro changed on were dressings alternate days collected Cost data were retrospectively : : : 62 : health Details of the economic evaluations includedDetails of the economic evaluations in the review :CEA : polyurethane Study details of data Source estimation Method for Results/statistical analysis Sensitivity analysis Comments Beiersdorf, 2000 (Part of the manu- and sponsor facturer submission made to Beiersdorf NICE by UK Ltd) question Research what is the cost- of effectiveness in the Cutinova management of difficult to heal surgical wounds to gauze as compared dressings? of economic Type evaluation (CMA) Country/currency UK, pounds sterling; (a single price year to which financial year the economic evalu- not ations relate) specified Perspective service, hospital Study population patients with difficult to heal surgical wounds Interventions (including com- parator) 94 (Cutinova, dressings Beiersdorf UK Ltd); comparator, gauze TABLE 13 TABLE Health Technology Assessment 2001; Vol. 5: No. 14 :no continued s ’ ). Subjective : the study Table 1 Table assessments. No ’ : trial had the effectiveness blinded ‘ conclusions ’ Authors support of advo- findings would the view the abandonment of use cates for for protocols dressing sodium hypochlorite surgical wounds, caused as hypochlorite patient discomfort without yielding more healing rate or cost benefits.Theany heal- to be similar but this ing rates appeared to detect the power study did not have in healing rate moderate differences of result and direction Magnitude between was found significant difference the interventions in terms of healing time, and the but both the alginate dressing to found pad were Combine dressing advantageous be economically Comments (see validity problems decisions, such as time to discharge and exudate being low,time to wound means blinding is essential.that proper Wound blinded the only size and pain were outcome measures. It was reported that experienced surgical nurses,three who in the gastrointestinal not working were instructed in and surgical unit and were familiar with the study protocol, con- ducted all on further was provided information blinded and the assessors were how the success of blinding was not checked. using a by depth was measured Wound depth gauge at the deepest point.Wound this was then calculated from volume single measurement. test was No reliability depth. measuring wound conducted for size was not comparable The initial wound groups the treatment between : Sensitivity analysis none reported analysis = 0.636) = 0.069) p p = 0.069; sodium p 5.49 to 3.29; 0.35 to 8.58; – – : not applicable : significant differences no statistically 1.10 (95% CI, – :ANOVA was used to compare maximum cost maximum was used to compare :ANOVA : = 0.052).The higher costs in the sodium for principal reason Clinical outcome/benefits observed.Thein healing rates were pain reported for maximum higher in the to be significantly type was found each dressing than either the alginate protocol group sodium hypochlorite group. protocol or the Combine dressing group treatment During protocol participantsthe first week in the sodium hypochlorite less satisfaction with the dressing reported significantly group or those group than either those in the alginate treatment process protocol.Therein the Combine dressing was no statistically at the last groups the three between significant difference assessment visit Costs cost per dressing: Total protocol:Alginate dressing changed Australian $12.94 (dressing once per day) protocol:Sodium hypochlorite changed Australian $11.54 (dressing twice per day) protocol:Combine dressing changed Australian $8.78 (dressing twice per day). cost per day (mean ±Total SD): protocol:AustralianAlginate dressing $15.25 ± 1.26 protocol:AustralianSodium hypochlorite $19.36 ± 4.12; difference 4.12 (95% CI, alginate dressing from protocol, Combine dressing versus protocol hypochlorite p amount of nursing was the greater group protocol hypochlorite time needed to carry protocol out the dressing Synthesis of costs and benefits Statistical analysis intervention groups the three variables for Combine dressing protocol:AustralianCombine dressing $14.14 ± 1.71; difference alginate dressing from no different indicate that costs during this phase were The results and the Combine dressing group the alginate treatment between group,protocol in the sodium hypochlorite and that dressings than in either expensive more substantially were group protocol (sodium groups protocol the alginate or Combine dressing alginate dressing, versus protocol hypochlorite : inter- :no : not : materials : Valuation for Valuation clinical outcomes or benefits surgical by preted team Estimation of costs costs Direct used, which include pack basic dressing pack,(dressing gloves, normal saline sachet, forceps, scissors), intervention dressing and film dressing (Tegaderm) per day Cost incurred during hospital stay (material cost plus time) nursing costs Indirect indirect costs were indirect included Modelling applicable of benefits/costs : 36 : = 10), n = 36) n = 3,Australian n Source of Source data effectiveness a from data derived single RCT ( 5) (see also appendix Source of cost data Source costs prior to hospital measured discharge were calculating material by time costs and nursing expended in completing for protocol the dressing each patient.The cost of materials was derived cost the purchase from Australian hosp- the by ital. Nursing costs were based on a midpoint rate for pay hourly nurse surgical registered (Australian $15.60). was Alginate dressing costed on the basis of use among those in the alginate treatment group: flat dressing ( $2.89; packing ( Australian $10.44 Cost was considered prospectively : : 36 Details of the economic evaluations includedDetails of the economic evaluations in the review : ., 1998 : hospital :CEA : calcium et al Study details of data Source estimation Method for Results/statistical analysis Sensitivity Comments to compare the perfor- to compare dress- mance of three in the ing protocols management of dehisced surgical abdominal wounds of economic Type evaluation (CCA) Country/currency Australia,Australian dollars, 1996 Perspective Study population Cannavo Cannavo question Research a gastro- patients from intestinal surgical unit with surgical abdominal breakdown wound Interventions (including com- parator) alginate dressing (Sorbsan); comparator included sodium (0.05%) hypochlorite solution moistened with a gauze dressing pad Combine dressing (an absorbent wound that consists dressing and of cotton wool gauze) or a Combine pad alone dressing 95 TABLE 13 contd TABLE Appendix 6 continued analysis of benefits/costs Details of the economic evaluations includedDetails of the economic evaluations in the review – 63 Study details of data Source estimation Method for Results/statistical analysis Sensitivity Comments 96 ConvaTec, 2000 in (Commercial confidence data omitted) TABLE 13 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14 continued : bearing : the trial that : the study Problems include Problems conclusions ’ 42 ). Authors in mind the qualifications con- costed cerning the resources characteristic of (which are studies in which the economic component was not incorpor- ated into the initial research also that the design) and given costs attributed seem to favour FE, while omissions in the suggest that the relative analysis than lower even costs of FE are suggested, have we conclude we of cheapness that the relative result: robust FE is a fairly the the medium cost per case for the gauze FE method is only method, while the medium cost the gauze method per case for than the lower marginally is only highest of our estimates the cost per case of the FE method and direction Magnitude of results that demonstrates at a minimum the FE intervention is equally and less costly.At best, effective and FE is dominant (less costly effective).Asmore such, no in- CEA was performed cremental Comments data was derived effectiveness validity from suffered from problems, to which carry over (see the economic evaluation 1 Table lack of blinding, no information reported on method of random- isation and no ITT. The price was 1982 and the methods year have of clinical practice may time changed over ’ medium A form of A form sensitivity analysis was performed. Three estimates of cost were presented through- out: a mean estimate (or ‘ value where calculations do not permit an estimate of the true mean), a high estimate and a low estimate : :there : low, £54.72; : no statistical : low, £32.78; medium, : low, £47.90; medium, : low, £20.80; medium, : < 0.001) p Costs material FE cost per case for Total group dressing £77.80; high, £109.70 non-material FE cost per case for Total group dressing £80.60; high, £305.90 GD cost per case Clinical outcomes/benefits significant differ- was no statistically volumes ence in the initial wound the groups,between or in the time until full epithelialisation or the length of inpatient stay. However, patients required the FE dressing receiving visits district nurse fewer significantly ( £61.31; high, £89.91 District nurse time medium, £196.98; high, £455.40 Comparisons of the total cost per case (all inclusive) FE dressings and GDs for (selective): Low: FE, £68.70; GD, £87.50 Medium: FE, £158.40; GD, £258.30 High: FE, £415.60; GD, £545.30 Comparison FE of the cost per case for and GD (all inclusivedressings items, also includes cost of analgesia): Low: FE, £70.50; GD, £146.10 Medium: FE, £162.10; GD, £417.60 High: FE, £422.00; GD, £984.40 Synthesis of costs and benefits none reported of Statistical analysis quantities/cost calculation was conducted to the costing of two compare treatments : items costed included: : not applicable – : not applicable items costed included: – Valuation for clinical outcomes or for Valuation benefits Estimation of costs FE dressing (FE Material costs of the treatments dressings, dry pads, dressing syringes and packs) dressing standard Other inpatient hospital costs (hotel costs, costs). nursing after discharge Other costs incurred costs and outpatient (district nurse clinic costs) Morbidity costs due to complications excluded on account of the arising were expected morbidity costs per case being than £0.50) so small (not more Outpatient clinic costs included transport. In the absence of details mode of transport (e.g. private car, bus or ambulance) the same cost per mile transport. district nurse was used as for GD District nursing costs District nursing Costs of dressing items It was thought that these two to establish costly sufficiently alone were cost- concerning the relative the result of the FE dressing.effectiveness Patients to not required were in the gauze group wound attend the outpatient clinic for dressing also include items would (All inclusive pads,dressing analgesia (pethidine), packs,dressing costs inpatient nursing transportand district nurse costs) was throughout The procedure conducted to bias the costing procedure treatment against the FE dressing Modelling of benefits/costs analysis s time ’ s NI and SA ’ 42 s national insurance ’ pay scale) and nursing time scale) and nursing pay ’ : a from derived data were : costed fall into the resources = 50) (see also appendix 5) = 50) (see also appendix n Source of efficacy data Source single RCT ( contributions Outpatient clinic costs included transport, driver the costs included district nursing GD treatment For (patients in the GD cost and the of dressings to attend the outpatient clinic) not required were group Source of cost data Source of reliability: categories three 1.The which the to use of materials for data relating collected were available (SDs) were deviations standard during the trial. of dis- the number regarding Information and the SD was also available visits per group trict nurse 2. time in hospital, to nursing Data relating which were a small sample of 10 patients in the trial. obtained from these,For available ranges were only 3. guesses. informed only were which there Data for been spent This included the time estimated to have and patient care on travel district nurses by was calculated based on The quantity of FE dressing the trial plus 15% extra volume data from volume wound wastage and handling.for elastomer stents were New fashioned weekly The decision to include an economic component in the after the final trial design had been was taken analysis cost analysis) out (retrospective established and carried and The quantity of GD used was not calculated directly discussed in the cost estimate was based on a formula the text was calculated using the cost per minute The nursing salary at the midpoint of salary of a staff nurse scale employer 1982) and adding (31 March (SA) contributions,(NI) and superannuation and the salary of a student nurse, also at the midpoint of salary scale. estimated taking into Costs per mile were account petrol, a small rates for and interest depreciation was excluded. car of about 1000 cc capacity.Taxation the midpoint of time was calculated from District nurse salary scale,the relevant including employer earnings),(salaries based on average clerical staff (mid- point of the clerical officers Details of the economic evaluations includedDetails of the economic evaluations in the review 60 51 : :CEA ., 1984 : UK, :to : silicone et al : patients Study details of data Source estimation Method for Results/statistical analysis Sensitivity Comments Culyer and Culyer Wagstaff, 1984; Culyer Research question the compare cost per case of wounds treating with conventional gauze dressings elastomer versus dressings foam of Type economic evaluation Country/ currency pounds sterling, 1982 Perspective hospital and health service Study popu- lation with granulating perineal wounds abdomin- following operineal excision of the rectum Interventions (including com- parator) elastomer foam (FE) dressings (Silastic, Dow- Corning); com- parator included gauze conventional (GD) dressing 97 TABLE 13 contd TABLE Appendix 6 : : using Silastic by ). Discharge and Table 1 Table : based were the cost results conclusions ’ foam, £500 of over total saving an average per patient can be made of result and direction Magnitude between was no significant difference there the interventions in terms of healing time, to was found dressing but the silastic foam advantageous be economically Comments data (time on non-significant effectiveness to hospital discharge).The effectiveness methodological from trial also suffered (see problems very subjective complete healing are outcome measures, which means that blinding is essential. Blinding was not reported in the trial was calculated The cost of hospital stay based on participants being discharged group. earlier in the silicone foam 3 days to be was not found This difference significant. A better approach, therefore, days been to assume zero have would and use,difference example, for the 3 days in the sensitivity analysis.difference 95% CIs should be part of the sensitivity (multiway,analysis together with other variables) Authors : Sensitivity analysis none reported analysis : not applicable : no statistically were there : no statistical calculation was conducted : Clinical outcome/benefits the for groups the two between significant differences outcomes of time to full healing and hospital discharge. was not statistically Although the difference significant, and abscess the patients in both simple sinus 3 days hospital on average discharged from were groups with Silastic foam earlier if treated 2 or 3 visits by only patients required treated Silastic foam dressings. foam of new refashioning to allow the district nurse up to 4 weeks visits for daily patients required Eusol-treated Costs Cost of 3 hospital bed days: £400 cost: district nurse Gross £8.50/hour, not including travel service nursing to the community could be The cost saving £100 and £200 per patient between one dressing suitable to make Each 20 g pack of Silastic foam costs £5.87. not expensive; Eusol and ribbon gauze alone are changes Silastic foam equate to three treatments 18 daily are with Silastic foam It was reported that patients treated able to change their are earlier as they to work able to return dressings own Synthesis of costs and benefits Statistical analysis treatments the costing of two to compare : : : Valuation for for Valuation clinical outcomes or benefits a by interpreted surgical team and district nurse Estimation of costs costs: Direct Cost of hospital bed days district nurse Gross costs (including travelling) cost Dressing costs: Indirect Lost productivity assessed (not actually but estimated) Modelling not applicable of benefits/costs : 48 : = 75) n (see also appendix 5) (see also appendix Source of cost data Source the cost of hospital and community stay was derived nursing the District from Portsmouth Treasurer, and South Hampshire Health Authority. prices (1990) Trade the used for were cost of dressings Cost was considered retrospectively Source of Source data effectiveness a from data derived single RCT ( : Details of the economic evaluations includedDetails of the economic evaluations in the review : 48 : silicone 1990 1991 – : hospital : : UK, pounds et al., Study details of data Source estimation Method for Results/statistical analysis Sensitivity Comments CCA, cost–consequence analysis; CEA, analysis; cost-effectiveness CMA, cost-minimisation analysis to compare Eusol to compare and Silastic foam in the dressing management of pilonidal sinus of economic Type evaluation CEA (CMA) Country/ currency sterling, 1989 Walker Walker question Research and health service Study population 98 Perspective participants who had surgery for received either a pilonidal sinus or an abscess Interventions (including comparator) elastomer dres- foam sing (Silastic, Dow- Corning); comparator included a half-strength gauze Eusol soaked dressing TABLE 13 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14

Appendix 7 Search strategies

Identifying research for the review 12. (#10 or #11) and #9 13. (infect* near surg* near (wound* or cavit*)) The following databases were searched: in ti, ab 14. dehiscen* near ((wound* or cavit*) in ti, ab) • MEDLINE (SilverPlatter), 1966 to June 2000 15. sepsis near ((wound* or cavit*) in ti, ab) • EMBASE (SilverPlatter), 1980 to June 2000 16. exudat* near ((wound* or cavit*) in ti, ab) • CINAHL (SilverPlatter), 1982 to May 2000 17. nectrot near ((wound* or cavit*) in ti, ab) • Health Management Information Consortium, 18. necrot* near ((wound* or cavit*) in ti, ab) Issue 2000 19. slough* near ((wound* or cavit*) in ti, ab) • CCTR (Cochrane Library), Issue 2, 2000 20. (((non-heal*) or (non heal*) or nonheal* or • National Research Register, Issue 1, 2000 problem or difficult* or complic*) near • NHS Economic Evaluation Database, June 2000 (wound* or cavit*)) in ti, ab • HEED, June 2000. 21. #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 Search strategies were developed using an iterative 22. #3 and #21 process; additional terms were added as they were 23. #9 or #22 identified and the strategies re-run. Note that 24. “Debridement”/ all subheadings searches are presented as runs: spelling mistakes in 25. debrid* in ti, ab early searches were rectified in later iterations. 26. “larva”/ all subheadings 27. larva* in ti, ab Searches for relevant conference papers in 28. maggot* in ti, ab conference proceedings were also conducted 29. ((bio-surg* or (bio surg*) or biosurg*)) in ti, ab by searching conference databases and the 30. ((trypsin or collagenase or streptokinase or world wide web. streptodornase) and (wound* or cavit*)) in ti, ab 31. (varidase near topical) in ti, ab Topic 1:effectiveness of 32. (wet to dry dress*) in ti, ab debridement for difficult to heal 33. (saline gauz*) in ti, ab 34. (dextranomer polysaccharid*) in ti, ab surgical wounds 35. (polysaccharid* (bead or paste)) in ti, ab The search strategies used are given below. 36. dextranomer* in ti, ab 37. xerogel* in ti, ab MEDLINE 38. (cadexomer iodine) in ti, ab The MEDLINE search was done via Academic 39. (iodoflex or iodosorb) in ti, ab Reference Centre (ARC)/SilverPlatter, as follows. 40. hydrogel* in ti, ab 41. ((intrasite gel) or intrasitegel or sterigel or First iteration granugel or (aquaform hydrogel) or (nu-gel) 1. explode “Surgical-Procedures-Operative”/ or (nu gel) or nugel or (purilon gel) or vigilon all subheadings or (2nd skin) or (second skin)) in ti, ab 2. (surgery or surgical)in ti, ab 42. (pressur* wound* irrigation*) in ti, ab 3. #1 or #2 43. woorlpool 4. “surgical-wound-infection”/ all subheadings 44. hydrochlorite solution 5. “surgical-wound-dehiscence”/ all subheadings 45. ((sodium hypochlorite) near (wound* or 6. “Postoperative-Complications”/ cavit*)) in ti, ab all subheadings 46. ((dakin* solution) near (wound* or cavit)) 7. (wound* or cavit*)in ti, ab in ti, ab 8. #6 and #7 47. eusol near ((wound* or cavit*) in ti, ab) 9. #4 or #5 or #8 48. (((malic acid) or (benzoic acid) or (salicylic 10. explode “infection”/ all subheadings acid) or (propylene glycol)) near (wound* 11. “bacterial infections”/ all subheadings or cavit*)) in ti, ab 99 Appendix 7

49. (proteolytic* or fibrinolytic* or collagenase*) 17. nectrot near ((wound* or cavit*) in ti, ab) near ((wound* or cavit*) in ti, ab) 18. necrot* near ((wound* or cavit*) in ti, ab) 50. ((hydrocholloid* or granuflex or (comfeel 19. slough* near ((wound* or cavit*) in ti, ab) plus) or tegasorb or hydrocoll or aqualcel or 20. (((non-heal*) or (non heal*) or nonheal* or combiderm or duoderm) near (wound* or problem or difficult* or complic*) near cavit*)) in ti, ab (wound* or cavit*)) in ti, ab 51. ((polysaccharid* dress*) near (wound* or 21. #12 or #13 or #14 or #15 or #16 or #17 or #18 cavit*)) in ti, ab or #19 or #20 52. hydrofibre dress* 22. #3 and #21 53. debrisan in ti, ab 23. #9 or #22 54. (bioclusive of cutifilm or epiview of mefilm or 24. explode “health facilities”/ all subheadings (opsite flexigrid) or tegaderm) in ti, ab 25. explode “health services”/ all subheadings 55. ((polyurethane foam dress*) or allevyn or 26. explode “delivery of health care”/ lyfoam or tielle or lyofoam) in ti, ab all subheadings 56. ((alginat* dress*) or sorbsan or tegagel or 27. “postoperative care”/ all subheadings kaltostat or kaltogel or (comfeel seasorb) or 28. “Aftercare”/ all subheadings algisite or algosteril or megisorb or (cutinova 29. tissue viability nurs* in ti, ab cavity) or (seasorb filler)) in ti, ab 30. ((post operative care) or (postoperative care) 57. ((parafin gauze dress*) or (tulle gras) or or aftercare) in ti, ab jelonet or bactigras or chlorhexitulle or 31. ((nurse or nurses or doctor* or physician or serotulle or (fucidin intertulle) or (sofra gp or practitioner or (health visit*) or staff or tulle)) in ti, ab personnel) near (wound* or cavit*)) in ti, ab 58. (((vapour permeable (membrane or 32. ((setting or hospital or hospitals or membranes)) or spyrosorb or flexipore or community or clinic or clinics or home or omiderm or surfasoft or tegapore) near centre* or center* or department* or unit or (wound* or cavit*)) in ti, ab units) near (wound* or cavit*)) in ti, ab 59. #24 or #25 or #26 or #27 or #28 or #29 or #30 33. ((facilit* or location or outpatient* or or #31 or #32 or #33 or #34 or #35 or #36 or inpatient* or rehabilitation or acute) near #37 or #38 or #39 or #40 or #41 or #42 or #43 (wound* or cavit*)) in ti, ab or #44 or #45 or #46 or #47 or #48 or #49 or 34. ((management or treatment* or program* or #50 or #51 or #52 or #53 or #54 or #55 or #56 service* or delivery or care) near (wound* or or #57 or #58 cavit*)) in ti, ab 60. #23 and #59 35. #24 or #25 or #26 or #27 or #28 or #29 or #30 or #31 or #32 or #33 or #34 The above was combined with the Cochrane 36. #23 and #35 Collaboration’s MEDLINE search for trials.207 37. explode “Health-Care-Evaluation- Second iteration Mechanisms”/ all subheadings 1. explode “Surgical-Procedures-Operative”/ 38. explode “Evaluation-Studies”/ all subheadings all subheadings 39. (trial* or stud* or evaluat* or examin*) in 2. (surgery or surgical)in ti, ab ti, ab 3. #1 or #2 40. #37 or #38 or #39 4. “surgical-wound-infection”/ all subheadings 41. #36 and #40 5. “surgical-wound-dehiscence”/ all subheadings 42. alginate 6. “Postoperative-Complications”/ all 43. granulating wound* subheadings 44. enzymes or enzymotic 7. (wound* or cavit*) in ti, ab 45. (secondary or film or gauze or fibre or fiber or 8. #6 and #7 occlusive or wound) dressing* 9. #4 or #5 or #8 46. (paraffin or impregnated) gauze 10. explode “infection”/ all subheadings 47. aquacel or aloe vera or wound gel or 11. “bacterial infections”/ all subheadings hydrocolloid or polynoxylin 12. (#10 or #11) and #9 48. melolin or emsol or silastic foam or hydrofibre 13. (infect* near surg* near (wound* or cavit*)) or hydrofiber in ti, ab 49. polyurethane or hydrocellular or foam 14. dehiscen* near ((wound* or cavit*) in ti, ab) elastomer or cellulose 15. sepsis near ((wound* or cavit*) in ti, ab) 50. alginate near (wound* or cavit*) 100 16. exudat* near ((wound* or cavit*) in ti, ab) 51. granulating wound* near (wound* or cavit*) Health Technology Assessment 2001; Vol. 5: No. 14

52. (enzymes or enzymotic) near (wound* 31. (pressur* wound* irrigation*) in ti, ab or cavit*) 32. whirlpool in ti, ab 53. (secondary or film or gauze or fibre or fiber 33. (hydrochlorite solution) in ti, ab or occlusive or wound) dressing* 34. (sodium hypochlorite) in ti, ab 54. (paraffin gauze or impregnated gauze) near 35. (dakin* solution) in ti, ab (wound* or cavit*) 36. eusol in ti, ab 55. (aquacel or aloe vera or wound gel or 37. (malic acid or benzoic acid or salicylic acid or hydrocolloid or polynoxylin) near (wound* propylene glycol) in ti, ab or cavit*) 38. (proteolytic* or fibrinolytic* or collagenase*) 56. (melolin or emsol or silastic foam or hydrofibre in ti, ab or hydrofiber) near (wound* or cavit*) 39. (hydrocholloid* or granuflex or comfeel or 57. (polyurethane or hydrocellular or foam tegasorb or hydrocolloid* or aqualcel or elastomer or cellulose) near (wound* combiderm or duoderm) in ti, ab or cavit*) 40. (hydrofibre or debrisan) in ti, ab 41. (bioclusive or cutifilm or epiview of mefilm or Third (set 72) and fourth (set 80) iterations (opsite flexigrid) or tegaderm) in ti, ab 1. explode “Surgical-Procedures-Operative”/ 42. ((polyurethane foam) or allevyn or lyfoam or all subheadings tielle or lyofoam) in ti, ab 2. surgery or surgical 43. (alginate* or sorbsan or tegagel or kaltostat or 3. #1 or #2 kaltogel or seasorb or algisite or algosteril or 4. “surgical-wound-infection”/ all subheadings megisorb or cutinova cavity) in ti, ab 5. “surgical-wound-dehiscence”/ all subheadings 44. (tulle gras or jelonet or bactigras or 6. “Postoperative-Complications”/ all chlorhexitulle or serotulle or (fucidin subheadings intertulle) or (sofra tulle)) in ti, ab 7. (wound* or cavit* or incision*)in ti, ab 45. (vapour permeable membrane* or spyrosorb 8. #6 and #7 or flexipore or omiderm or surfasoft or 9. #3 or #4 or #5 or #8 tegapore) in ti, ab 10. (dehiscen* or sepsis or exudat* or necrot* or 46. (enzymes or enzymotic) in ti, ab slough*) in ti, ab 47. (secondary dressing* or film or films or gauze 11. (non-heal* or non heal* or nonheal*) in ti, ab or fibre or fiber or occlusive dressing*) in ti, 12. (problem or difficult* or complic*) near ab (wound* or cavit* or incision*) in ti, ab 48. (aquacel or aloe vera or wound gel* or 13. (chronic wound*) in ti, ab polynoxylin) in ti, ab 14. (granulating wound*) in ti, ab 49. (melolin or emsol or silastic foam* or 15. (postoperative near wound*) in ti, ab hydrofibre* or hydrofiber*) in ti, ab 16. (pilonidal sinus* or pilonidal abcess*) in ti, ab 50. (polyurethane or hydrocellular or foam 17. #10 or #11 or #12 or #13 or #14 or #15 elastomer or cellulose) in ti, ab or #16 51. #19 or #20 or #21 or #22 or #23 18. #9 or #17 52. #24 or #25 or #26 or #27 19. “Debridement”/ all subheadings 53. #28 or #29 or #30 or #31 20. debrid* in ti, ab 54. #32 or #33 or #34 or #35 21. “larva”/ all subheadings 55. #36 or #37 or #38 or #39 22. larva* in ti, ab 56. #40 or #41 or #42 or #43 23. (maggot or maggots) in ti, ab 57. #44 or #45 or #46 or #47 or #48 or #49 or #50 24. (bio-surg* or bio surg* or biosurg*) in ti, ab 58. #51 or #52 or #53 or #54 or #55 or #56 or #57 25. (trypsin or collagenase or streptokinase or 59. #18 and #58 streptodornase) in ti, ab 60. wound or wounds or cavity or cavities or 26. (varidase near topical) in ti, ab abscess* or sinus or sinuses or incision or 27. (wet near dry near dress*) in ti, ab incisions 28. (polysaccharid* or dextranomer* or xerogel 61. #59 and #60 or cadexomer iodine) in ti, ab 62. sutur* near wound* 29. (iodoflex or iodosorb or hydrogel*) in ti, ab 63. skin graft* 30. ((intrasite gel) or intrasitegel or sterigel or 64. explode “Burns”/ all subheadings granugel or (aquaform hydrogel) or (nu-gel) 65. explode “Eye-Diseases”/ all subheadings or (nu gel) or nugel or (purilon gel) or 66. explode “Dentistry”/ all subheadings vigilon or (2nd skin) or (second skin)) 67. #62 or #63 or #64 or #65 or #66 in ti, ab 68. #61 not #67 101 Appendix 7

69. exact{ANIMAL} in TG 33. (hydrochlorite solution) in ti, ab 70. exact{HUMAN} in TG 34. (sodium hypochlorite) in ti, ab 71. #69 not (#69 and #70) 35. (dakin* solution) in ti, ab 72. #68 not #71 36. eusol in ti, ab 73. mesalt 37. (malic acid or benzoic acid or salicylic acid 74. sodium chloride near dressing* or propylene glycol) in ti, ab 75. hypergel or normlgel or mepilex or mepitel 38. (proteolytic* or fibrinolytic* or collagenase*) 76. silicone near dressing* in ti, ab 77. alldress or mepore or mesorb or (cellulose 39. (hydrocholloid* or granuflex or comfeel or near dressing*) tegasorb or hydrocolloid* or aqualcel or 78. #73 or #74 or #75 or #76 or #77 combiderm or duoderm) in ti, ab 79. #18 and #78 40. (hydrofibre or debrisan) in ti, ab 80. #79 not #72 41. (bioclusive or cutifilm or epiview of mefilm or (opsite flexigrid) or tegaderm) in ti, ab Fifth iteration 42. ((polyurethane foam) or allevyn or lyfoam or 1. explode “Surgical-Procedures-Operative”/ tielle or lyofoam) in ti, ab all subheadings 43. (alginate* or sorbsan or tegagel or kaltostat or 2. surgery or surgical kaltogel or seasorb or algisite or algosteril or 3. #1 or #2 megisorb or cutinova cavity) in ti, ab 4. “surgical-wound-infection”/ all subheadings 44. (tulle gras or jelonet or bactigras or 5. “surgical-wound-dehiscence”/ all subheadings chlorhexitulle or serotulle or (fucidin 6. “Postoperative-Complications”/ all intertulle) or (sofra tulle)) in ti, ab subheadings 45. (vapour permeable membrane* or spyrosorb 7. (wound* or cavit* or incision*)in ti, ab or flexipore or omiderm or surfasoft or 8. #6 and #7 tegapore) in ti, ab 9. #3 or #4 or #5 or #8 46. (enzymes or enzymotic) in ti, ab 10. (dehiscen* or sepsis or exudat* or necrot* or 47. (secondary dressing* or film or films or slough*) in ti, ab gauze or fibre or fiber or occlusive dressing*) 11. (non-heal* or non heal* or nonheal*) in ti, ab in ti, ab 12. (problem or difficult* or complic*) near 48. (aquacel or aloe vera or wound gel* or (wound* or cavit* or incision*) in ti, ab polynoxylin) in ti, ab 13. (chronic wound*) in ti, ab 49. (melolin or emsol or silastic foam* or 14. (granulating wound*) in ti, ab hydrofibre* or hydrofiber*) in ti, ab 15. (postoperative near wound*) in ti, ab 50. (polyurethane or hydrocellular or foam 16. (pilonidal sinus* or pilonidal abcess*) in ti, ab elastomer or cellulose) in ti, ab 17. #10 or #11 or #12 or #13 or #14 or #15 or #16 51. #19 or #20 or #21 or #22 or #23 18. #9 or #17 52. #24 or #25 or #26 or #27 19. “Debridement”/ all subheadings 53. #28 or #29 or #30 or #31 20. debrid* in ti, ab 54. #32 or #33 or #34 or #35 21. “larva”/ all subheadings 55. #36 or #37 or #38 or #39 22. larva* in ti, ab 56. #40 or #41 or #42 or #43 23. (maggot or maggots) in ti, ab 57. #44 or #45 or #46 or #47 or #48 or #49 or #50 24. (bio-surg* or bio surg* or biosurg*) in ti, ab 58. #51 or #52 or #53 or #54 or #55 or #56 or #57 25. (trypsin or collagenase or streptokinase or 59. #18 and #58 streptodornase) in ti, ab 60. wound or wounds or cavity or cavities or 26. (varidase near topical) in ti, ab abscess* or sinus or sinuses or incision or 27. (wet near dry near dress*) in ti, ab incisions 28. (polysaccharid* or dextranomer* or xerogel 61. #59 and #60 or cadexomer iodine) in ti, ab 62. sutur* near wound* 29. (iodoflex or iodosorb or hydrogel*) in ti, ab 63. skin graft* 30. ((intrasite gel) or intrasitegel or sterigel or 64. explode “Burns”/ all subheadings granugel or (aquaform hydrogel) or (nu-gel) 65. explode “Eye-Diseases”/ all subheadings or (nu gel) or nugel or (purilon gel) or 66. explode “Dentistry”/ all subheadings vigilon or (2nd skin) or (second skin)) 67. #62 or #63 or #64 or #65 or #66 in ti, ab 68. #61 not #67 31. (pressur* wound* irrigation*) in ti, ab 69. exact{ANIMAL} in TG 102 32. whirlpool in ti, ab 70. exact{HUMAN} in TG Health Technology Assessment 2001; Vol. 5: No. 14

71. #69 not (#69 and #70) 29. ((trypsin or collagenase or streptokinase or 72. #68 not #71 streptodornase) and (wound* or cavit*)) 73. mesalt in ts, ab 74. sodium chloride near dressing* 30. (varidase near topical) in ts, ab 75. hypergel or normlgel or mepilex or mepitel 31. (wet to dry dress*) in ts, ab 76. silicone near dressing* 32. (saline gauz*) in ts, ab 77. alldress or mepore or mesorb or (cellulose 33. (dextranomer polysaccharid*) in ts, ab near dressing*) 34. (polysaccharid* (bead or paste)) in ts, ab 78. #73 or #74 or #75 or #76 or #77 35. dextranomer* or (xerogel* in ts, ab) 79. #18 and #78 36. (cadexomer iodine) in ts, ab 80. #79 not #72 37. (iodoflex or iodosorb) in ts, ab 81. enzymatic 38. hydrogel* in ts, ab 82. hypochlorite 39. ((intrasite gel) or intrasitegel or sterigel or 83. solution granugel or (aquaform hydrogel) or (nu-gel) 84. enzymatic or hypochlorite solution or (nu gel) or nugel or (purilon gel) or vigilon 85. #84 and #18 or (2nd skin) or (second skin)) in ts, ab 86. #85 and #60 40. (pressur* wound* irrigation*) in ts, ab 41. woorlpool EMBASE 42. hydrochlorite solution The EMBASE search was done via ARC/ 43. ((sodium hypochlorite) near (wound* or SilverPlatter, as follows. cavit*)) in ts, ab 44. ((dakin* solution) near (wound* or cavit*)) First iteration in ts, ab 1. explode “surgery”/ all subheadings 45. eusol near ((wound* or cavit*) in ts, ab) 2. (surgery or surgical) in ts, ab 46. (((malic acid) or (benzoic acid) or (salicylic 3. #1 or #2 acid) or (propylene glycol)) near (wound* or 4. “surgical-wound”/ all subheadings cavit*)) in ts, ab 5. “wound-dehiscence”/ all subheadings 47. (proteolytic* or fibrinolytic* or collagenase*) 6. “wound-infection”/ all subheadings near ((wound* or cavit*) in ts, ab) 7. “postoperative-complication”/ all subheadings 48. ((hydrocholloid* or granuflex or (comfeel 8. (wound* or cavit*) in ts, ab plus) or tegasorb or hydrocoll or aqualcel or 9. #7 and #8 combiderm or duoderm) near (wound* or 10. #4 or #5 or #6 or #9 cavit*)) in ts, ab 11. explode “infection”/ all subheadings 49. ((polysaccharid* dress*) near (wound* or 12. “bacterial-infection”/ all subheadings cavit*)) in ts, ab 13. (#11 or #12) and #10 50. (bioclusive or cutifilm or epiview or mefilm or 14. (infect* near surg* near (wound* or cavit*)) (opsite flexigrid) or tegaderm) in ts, ab in ts, ab 51. ((polyurethane foam dress*) or allevyn or 15. (dehiscen* near (wound* or cavit*)) in lyfoam or tielle or lyofoam) in ts, ab ts, ab 52. ((alginat* dress*) or sorbsan or tegagel or 16. sepsis near ((wound* or cavit*) in ts, ab) kaltostat or kaltogel or (comfeel seasorb) or 17. exudat* near ((wound* or cavit*) in ts, ab) algisite or algosteril or megisorb or (cutinova 18. necrot* near ((wound* or cavit*) in ts, ab) cavity) or (seasorb filler)) in ts, ab 19. slough* near ((wound* or cavit*) in ts, ab) 53. ((parafin gauze dress*) or (tulle gras) or 20. (((non-heal*) or (non heal*) or nonheal* jelonet or bactigras or chlorhexitulle or or problem or difficult* or complic*) near serotulle or (fucidin intertulle) or (sofra (wound* or cavit*)) in ts, ab tulle)) in ts, ab 21. #13 or #14 or #15 or #16 or #17 or #18 or 54. (((vapour permeable (membrane or #19 or #20 membranes)) or spyrosorb or flexipore or 22. #3 and #21 omiderm or surfasoft or tegapore) near 23. #10 or #22 (wound* or cavit*)) in ts, ab 24. “debridement”/ all subheadings 55. #24 or #25 or #26 or #27 or #28 or #29 or #30 25. debrid* in ts, ab or #31 or #32 or #33 or #34 or #35 or #36 or 26. “larva”/ all subheadings #37 or #38 or #39 or #40 or #41 or #42 or #43 27. larva* or (maggot* in ts, ab) or #44 or #45 or #46 or #47 or #48 or #49 or 28. ((bio-surg*) or (bio surg*) or biosurg*) #50 or #51 or #52 or #53 or #54 in ts, ab 56. #23 and #55 103 Appendix 7

Second iteration 42. (alginate* or sorbsan or tegagel or kaltostat or 1. explode “surgery”/ all subheadings kaltogel or seasorb or algisite or algosteril or 2. surgery or surgical megisorb or cutinova cavity) in ti, ab 3. #1 or #2 43. (tulle gras or jelonet or bactigras or 4. “surgical-wound”/ all subheadings chlorhexitulle or serotulle or (fucidin 5. “wound-dehiscence”/ all subheadings intertulle) or (sofra tulle)) in ti, ab 6. “wound-infection”/ all subheadings 44. (vapour permeable membrane* or spyrosorb 7. “postoperative-complication”/ all subheadings or flexipore or omiderm or surfasoft or 8. (wound* or cavit*) in ts, ab tegapore) in ti, ab 9. #7 and #8 45. (enzymes or enzymotic) in ti, ab 10. #3 or #4 or #5 or #6 or #9 46. (secondary dressing* or film or films or 11. (dehiscen* or sepsis or exudat* or necrot* or gauze or fibre or fiber or occlusive dressing*) slough*) in ti, ab in ti, ab 12. (non-heal* or non heal* or nonheal* or 47. (aquacel or aloe vera or wound gel* or problem or difficult* or complic*) near polynoxylin) in ti, ab (wound* or cavit* or incision*) in ti, ab 48. (melolin or emsol or silastic foam* or 13. (chronic wound*) in ti, ab hydrofibre* or hydrofiber*) in ti, ab 14. (granulating wound*) in ti, ab 49. (polyurethane or hydrocellular or foam 15. (postoperative near wound*) in ti, ab elastomer or cellulose) in ti, ab 16. (pilonidal sinus* or pilonidal abcess*) in ti, ab 50. #18 or #19 or #20 or #21 or #22 or #23 17. #10 or #11 or #12 or #13 or #14 or #15 or #16 51. #24 or #25 or #26 or #27 or #28 or #29 18. “Debridement”/ all subheadings 52. #30 or #31 or #32 or #33 or #34 or #35 19. debrid* in ti, ab 53. #36 or #37 or #38 or #39 or #40 or #41 20. “larva”/ all subheadings 54. #42 or #43 or #44 or #45 or #46 or #47 or #48 21. larva* in ti, ab or #49 22. (maggot or maggots) in ti, ab 55. #50 or #51 or #52 or #53 or #54 23. (bio-surg* or bio surg* or biosurg*) in ti, ab 56. #55 and #17 24. (trypsin or collagenase or streptokinase or 57. wound or wounds or cavity or cavities or streptodornase) in ti, ab abscess* or sinus or sinuses or incision or 25. (varidase near topical) in ti, ab incisions 26. (wet near dry near dress*) in ti, ab 58. #56 and #57 27. (polysaccharid* or dextranomer* or xerogel 59. sutur* near wound* or cadexomer iodine) in ti, ab 60. explode “burn”/all subheadings 28. (iodoflex or iodosorb or hydrogel*) in ti, ab 61. “burn-dressing”/all subheadings 29. ((intrasite gel) or intrasitegel or sterigel or 62. explode “eye-disease”/all subheadings granugel or (aquaform hydrogel) or (nu-gel) 63. explode “dentistry”/all subheadings or (nu gel) or nugel or (purilon gel) or 64. explode “dental-care”/all subheadings vigilon or (2nd skin) or (second skin)) 65. #59 or #60 or #61 or #62 or #63 or #64 in ti, ab 30. (pressur* wound* irrigation*) in ti, ab 66. #58 not #65 31. whirlpool in ti, ab 67. “case-report”/ all subheadings 32. (hydrochlorite solution) in ti, ab 68. “case-study”/ all subheadings 33. (sodium hypochlorite) in ti, ab 69. “retrospective-study”/ all subheadings 34. (dakin* solution) in ti, ab 70. #67 or #68 or #69 35. eusol in ti, ab 71. #66 not #70 36. (malic acid or benzoic acid or salicylic acid or propylene glycol) in ti, ab Third (set 71) and fourth (set 79) iterations 37. (proteolytic* or fibrinolytic* or collagenase*) 1. explode “surgery”/ all subheadings in ti, ab 2. surgery or surgical 38. (hydrocholloid* or granuflex or comfeel or 3. #1 or #2 tegasorb or hydrocolloid* or aqualcel or 4. “surgical-wound”/ all subheadings combiderm or duoderm) in ti, ab 5. “wound-dehiscence”/ all subheadings 39. (hydrofibre or debrisan) in ti, ab 6. “wound-infection”/ all subheadings 40. (bioclusive or cutifilm or epiview of mefilm or 7. “postoperative-complication”/ all subheadings (opsite flexigrid) or tegaderm) in ti, ab 8. (wound* or cavit*) in ts,ab 41. ((polyurethane foam) or allevyn or lyfoam or 9. #7 and #8 104 tielle or lyofoam) in ti, ab 10. #3 or #4 or #5 or #6 or #9 Health Technology Assessment 2001; Vol. 5: No. 14

11. (dehiscen* or sepsis or exudat* or necrot* or 46. (secondary dressing* or film or films or slough*) in ti, ab gauze or fibre or fiber or occlusive dressing*) 12. (non-heal* or non heal* or nonheal* or in ti, ab problem or difficult* or complic*) near 47. (aquacel or aloe vera or wound gel* or (wound* or cavit* or incision*) in ti, ab polynoxylin) in ti, ab 13. (chronic wound*) in ti, ab 48. (melolin or emsol or silastic foam* or 14. (granulating wound*) in ti, ab hydrofibre* or hydrofiber*) in ti, ab 15. (postoperative near wound*) in ti, ab 49. (polyurethane or hydrocellular or foam 16. (pilonidal sinus* or pilonidal abcess*) in ti, ab elastomer or cellulose) in ti, ab 17. #10 or #11 or #12 or #13 or #14 or #15 or #16 50. #18 or #19 or #20 or #21 or #22 or #23 18. “Debridement”/ all subheadings 51. #24 or #25 or #26 or #27 or #28 or #29 19. debrid* in ti, ab 52. #30 or #31 or #32 or #33 or #34 or #35 20. “larva”/ all subheadings 53. #36 or #37 or #38 or #39 or #40 or #41 21. larva* in ti, ab 54. #42 or #43 or #44 or #45 or #46 or #47 or #48 22. (maggot or maggots) in ti, ab or #49 23. (bio-surg* or bio surg* or biosurg*) in ti, ab 55. #50 or #51 or #52 or #53 or #54 24. (trypsin or collagenase or streptokinase or 56. #55 and #17 streptodornase) in ti, ab 57. wound or wounds or cavity or cavities or 25. (varidase near topical) in ti, ab abscess* or sinus or sinuses or incision or incisions 26. (wet near dry near dress*) in ti, ab 58. #56 and #57 27. (polysaccharid* or dextranomer* or xerogel 59. sutur* near wound* or cadexomer iodine) in ti, ab 60. explode “burn”/all subheadings 28. (iodoflex or iodosorb or hydrogel*) in ti, ab 61. “burn-dressing”/all subheadings 29. ((intrasite gel) or intrasitegel or sterigel or 62. explode “eye-disease”/all subheadings granugel or (aquaform hydrogel) or (nu-gel) 63. explode “dentistry”/all subheadings or (nu gel) or nugel or (purilon gel) or 64. explode “dental-care”/all subheadings vigilon or (2nd skin) or (second skin)) 65. #59 or #60 or #61 or #62 or #63 or #64 in ti, ab 66. #58 not #65 30. (pressur* wound* irrigation*) in ti, ab 67. “case-report”/ all subheadings 31. whirlpool in ti, ab 68. “case-study”/ all subheadings 32. (hydrochlorite solution) in ti, ab 69. “retrospective-study”/ all subheadings 33. (sodium hypochlorite) in ti, ab 70. #67 or #68 or #69 34. (dakin* solution) in ti, ab 71. #66 not #70 35. eusol in ti, ab 72. mesalt 36. (malic acid or benzoic acid or salicylic acid or 73. sodium chloride near dressing* propylene glycol) in ti, ab 74. hypergel or normlgel or mepilex or mepitel 37. (proteolytic* or fibrinolytic* or collagenase*) 75. silicone near dressing* in ti, ab 76. alldress or mepore or mesorb or (cellulose 38. (hydrocholloid* or granuflex or comfeel or near dressing*) tegasorb or hydrocolloid* or aqualcel or 77. #72 or #73 or #74 or #75 or #76 combiderm or duoderm) in ti, ab 78. #17 and #77 39. (hydrofibre or debrisan) in ti, ab 79. #78 not #71 40. (bioclusive or cutifilm or epiview of mefilm or (opsite flexigrid) or tegaderm) in ti, ab Fifth iteration 41. ((polyurethane foam) or allevyn or lyfoam or 1. explode “surgery”/ all subheadings tielle or lyofoam) in ti, ab 2. surgery or surgical 42. (alginate* or sorbsan or tegagel or kaltostat or 3. #1 or #2 kaltogel or seasorb or algisite or algosteril or 4. “surgical-wound”/ all subheadings megisorb or cutinova cavity) in ti, ab 5. “wound-dehiscence”/ all subheadings 43. (tulle gras or jelonet or bactigras or 6. “wound-infection”/ all subheadings chlorhexitulle or serotulle or (fucidin 7. “postoperative-complication”/ all subheadings intertulle) or (sofra tulle)) in ti, ab 8. (wound* or cavit*) in ts,ab 44. (vapour permeable membrane* or spyrosorb 9. #7 and #8 or flexipore or omiderm or surfasoft or 10. #3 or #4 or #5 or #6 or #9 tegapore) in ti, ab 11. (dehiscen* or sepsis or exudat* or necrot* 45. (enzymes or enzymotic) in ti, ab or lsough*) in ti, ab 105 Appendix 7

12. (non-heal* or non heal* or nonheal* or 47. (aquacel or aloe vera or wound gel* or problem or difficult* or complic*) near polynoxylin) in ti, ab (wound* or cavit* or incision*) in ti, ab 48. (melolin or emsol or silastic foam* or 13. (chronic wound*) in ti, ab hydrofibre* or hydrofiber*) in ti, ab 14. (granulating wound*) in ti, ab 49. (polyurethane or hydrocellular or foam 15. (postoperative near wound*) in ti, ab elastomer or cellulose) in ti, ab 16. (pilonidal sinus* or pilonidal abcess*) in ti, ab 50. #18 or #19 or #20 or #21 or #22 or #23 17. #10 or #11 or #12 or #13 or #14 or #15 or #16 51. #24 or #25 or #26 or #27 or #28 or #29 18. “Debridement”/ all subheadings 52. #30 or #31 or #32 or #33 or #34 or #35 19. debrid* in ti, ab 53. #36 or #37 or #38 or #39 or #40 or #41 20. “larva”/ all subheadings 54. #42 or #43 or #44 or #45 or #46 or #47 or #48 21. larva* in ti, ab or #49 22. (maggot or maggots) in ti, ab 55. #50 or #51 or #52 or #53 or #54 23. (bio-surg* or bio surg* or biosurg*) in ti, ab 56. #55 and #17 24. (trypsin or collagenase or streptokinase or 57. wound or wounds or cavity or cavities or streptodornase) in ti, ab abscess* or sinus or sinuses or incision or 25. (varidase near topical) in ti, ab incisions 26. (wet near dry near dress*) in ti, ab 58. #56 and #57 27. (polysaccharid* or dextranomer* or xerogel 59. sutur* near wound* or cadexomer iodine) in ti, ab 60. explode “burn”/all subheadings 28. (iodoflex or iodosorb or hydrogel*) in ti, ab 61. “burn-dressing”/all subheadings 29. ((intrasite gel) or intrasitegel or sterigel or 62. explode “eye-disease”/all subheadings granugel or (aquaform hydrogel) or (nu-gel) 63. explode “dentistry”/all subheadings or (nu gel) or nugel or (purilon gel) or 64. explode “dental-care”/all subheadings vigilon or (2nd skin) or (second skin)) 65. #59 or #60 or #61 or #62 or #63 or #64 in ti, ab 66. #58 not #65 30. (pressur* wound* irrigation*) in ti, ab 67. “case-report”/ all subheadings 31. whirlpool in ti, ab 68. “case-study”/ all subheadings 32. (hydrochlorite solution) in ti, ab 69. “retrospective-study”/ all subheadings 33. (sodium hypochlorite) in ti, ab 70. #67 or #68 or #69 34. (dakin* solution) in ti, ab 71. #66 not #70 35. eusol in ti, ab 72. mesalt 36. (malic acid or benzoic acid or salicylic acid or 73. sodium chloride near dressing* propylene glycol) in ti, ab 74. hypergel or normlgel or mepilex or mepitel 37. (proteolytic* or fibrinolytic* or collagenase*) 75. silicone near dressing* in ti, ab 76. alldress or mepore or mesorb or (cellulose 38. (hydrocholloid* or granuflex or comfeel or near dressing*) tegasorb or hydrocolloid* or aqualcel or 77. #72 or #73 or #74 or #75 or #76 combiderm or duoderm) in ti, ab 78. #17 and #77 39. (hydrofibre or debrisan) in ti, ab 79. #78 not #71 40. (bioclusive or cutifilm or epiview of mefilm or 80. enzymatic opsite flexigrid or tegaderm) in ti, ab 81. hypochlorite 41. (polyurethane foam or allevyn or lyfoam or 82. solution tielle or lyofoam) in ti, ab 83. enzymatic or hypochlorite solution 42. (alginate* or sorbsan or tegagel or kaltostat or 84. #17 and #83 kaltogel or seasorb or algisite or algosteril or 85. #84 and #57 megisorb or cutinova cavity) in ti, ab 86. #85 not #58 43. (tulle gras or jelonet or bactigras or chlorhexitulle or serotulle or fucidin intertulle CINAHL or sofra tulle) in ti, ab The CINAHL search was done via ARC/ 44. (vapour permeable membrane* or spyrosorb SilverPlatter, as follows. or flexipore or omiderm or surfasoft or tegapore) in ti, ab First iteration 45. (enzymes or enzymotic) in ti, ab 1. explode “Surgery-Operative”/ all topical 46. (secondary dressing* or film or films or subheadings / all age subheadings gauze or fibre or fiber or occlusive dressing*) 2. surgery or (surgical in ti, ab) 106 in ti, ab 3. #1 or #2 Health Technology Assessment 2001; Vol. 5: No. 14

4. “Surgical-Wound”/ all topical subheadings / 43. (dakin* solution) in ti, ab all age subheadings 44. eusol near ((wound* or cavit*) in ti, ab) 5. “Surgical-Wound-Dehiscence”/ all topical 45. (((malic acid) or (benzoic acid) or (salicylic subheadings / all age subheadings acid) or (propylene glycol)) near (wound* or 6. “Surgical-Wound-Infection”/ all topical cavit*)) in ti, ab subheadings / all age subheadings 46. (proteolytic* or fibrinolytic* or collagenase*) 7. “Postoperative-Complications”/ all topical near ((wound* or cavit*) in ti, ab) subheadings / all age subheadings 47. ((hydrocholloid* or granuflex or (comfeel 8. wound* or (cavit* in ti, ab) plus) or tegasorb or hydrocoll or aqalcel or 9. #7 and #8 combiderm or duoderm) near (wound* or 10. #4 or #5 or #6 or #9 cavit*)) in ti, ab 11. explode “Infection”/ all topical subheadings / 48. (polysaccharid* dress*) in ti, ab all age subheadings 49. hydrofibre dress* in ti, ab 12. “Bacterial-Infections”/ all topical subheadings / 50. debrisan in ti, ab all age subheadings 51. (bioclusive or cutifilm or epiview or mefilm or 13. (#11 or #12) and #8 (opsite flexigrid) or tegaderm) in ti, ab 14. (infect* near surg* near (wound* or cavit*)) 52. ((polyurethane foam dress*) or allevyn or in ti, ab lyfoam or tielle or lyofoam) in ti, ab 15. dehiscen* near ((wound* or cavit*) in ti, ab) 53. ((alginat* dress*) or sorbsan or tegagel or 16. sepsis near ((wound* or cavit*) in ti, ab) kaltostat or kaltogel or (comfeel seasorb) or 17. necrot* near ((wound* or surg*) in ti, ab) algisite or algosteril or megisorb or (cutinova 18. slough* near ((wound* or cavit*) in ti, ab) cavity) or (seasorb filler)) in ti, ab 19. (((non-heal*) or (non heal*) or nonheal* or 54. ((parafin gauze dress*) or (tulle gras) or problem* or difficult* or complic*) near gelonet or bactigras or chlorhexitulle or (wound* or cavit*)) in ti, ab serotulle or (fucidin intertulle) or (sofra 20. #13 or #14 or #15 or #16 or #17 or #18 or #19 tulle)) in ti, ab 21. #3 and #20 55. #23 or #24 or #25 or #26 or #27 or #28 or #29 22. #10 or #21 or #30 or #31 or #32 or #33 or #34 or #35 or 23. “Debridement”/ all topical subheadings / #36 or #37 or #38 or #39 or #40 or #41 or #42 all age subheadings or #43 or #44 or #45 or #46 or #47 or #48 or 24. debrid* in ti, ab #49 or #50 or #51 or #52 or #53 or #54 25. larva* or (maggot* in ti, ab) 56. #22 and #55 26. ((bio-surg*) or (bio surg*) or biosurg*) in ti, ab Second iteration 27. ((trypsin or collagenase or streptokinase or 1. explode “Surgery-Operative”/ all topical streptodornase) and (wound* or cavit*)) subheadings / all age subheadings in ti, ab 28. (varidase near topical) in ti, ab 2. surgery or (surgical in ti, ab) 29. wet to dry dress* in ti, ab 3. #1 or #2 30. (saline gauz*) in ti, ab 4. “Surgical-Wound”/ all topical subheadings / 31. (dextranomer polysaccharid*) in ti, ab all age subheadings 32. (polysaccharid* (bead* or paste)) in ti, ab 5. “Surgical-Wound-Dehiscence”/ all topical 33. dextranomer in ti, ab subheadings / all age subheadings 34. xerogel* in ti, ab 6. “Surgical-Wound-Infection”/ all topical 35. (cadexomer iodine) in ti, ab subheadings / all age subheadings 36. (iodoflex or iodosorb) in ti, ab 7. “Postoperative-Complications”/ all topical 37. hydrogel* in ti, ab subheadings / all age subheadings 38. ((intrasite gel) or intrasitegel or sterigel or 8. wound* or (cavit* in ti, ab) granugel or (aquaform hydrogel) or (nu-gel) 9. #7 and #8 or (nu gel) or nugel or (purilon gel) or 10. #4 or #5 or #6 or #9 vigilon or (2nd skin) or (second skin)) 11. explode “Infection”/ all topical subheadings / in ti, ab all age subheadings 39. (pressur* wound* irrigation*) in ti, ab 12. “Bacterial-Infections”/ all topical subheadings / 40. woorlpool all age subheadings 41. hydrochlorite solution 13. (#11 or #12) and #8 42. (sodium hypochlorite) near ((wound* or 14. (infect* near surg* near (wound* or cavit*)) cavit*) in ti, ab) in ti, ab 107 Appendix 7

15. dehiscen* near ((wound* or cavit*) in ti, ab) 52. ((alginat* dress*) or sorbsan or tegagel or 16. sepsis near ((wound* or cavit*) in ti, ab) kaltostat or kaltogel or (comfeel seasorb) or 17. necrot* near ((wound* or surg*) in ti, ab) algisite or algosteril or megisorb or (cutinova 18. slough* near ((wound* or cavit*) in ti, ab) cavity) or (seasorb filler)) in ti, ab 19. (((non-heal*) or (non heal*) or nonheal* or 53. ((parafin gauze dress*) or (tulle gras) or problem* or difficult* or complic*) near gelonet or bactigras or chlorhexitulle or (wound* or cavit*)) in ti, ab serotulle or (fucidin intertulle) or (sofra 20. #13 or #14 or #15 or #16 or #17 or #18 or #19 tulle)) in ti, ab 21. #3 and #20 54. #23 or #24 or #25 or #26 or #27 or #28 or #29 22. #10 or #21 or #30 or #31 or #32 or #33 or #34 or #35 or 23. “Debridement”/ all topical subheadings / #36 or #37 or #38 or #39 or #40 or #41 or #42 all age subheadings or #43 or #44 or #45 or #46 or #47 or #48 or 24. debrid* in ti, ab #49 or #50 or #51 or #52 or #53 25. larva* or (maggot* in ti, ab) 55. #22 and #53 26. ((bio-surg*) or (bio surg*) or biosurg*) in ti, ab Third (set 72) and fourth (set 80) iterations 27. ((trypsin or collagenase or streptokinase or 1. explode “Surgery-Operative”/ all topical streptodornase) and (wound* or cavit*)) subheadings / all age subheadings in ti, ab 2. surgery or (surgical in ti, ab) 28. (varidase near topical) in ti, ab 3. #1 or #2 29. wet to dry dress* in ti, ab 4. “Surgical-Wound”/ all topical subheadings / 30. (saline gauz*) in ti, ab all age subheadings 31. (dextranomer polysaccharid*) in ti, ab 5. “Surgical-Wound-Dehiscence”/ all topical 32. (polysaccharid* (bead* or paste)) in ti, ab subheadings / all age subheadings 33. dextranomer in ti, ab 6. “Surgical-Wound-Infection”/ all topical 34. xerogel* in ti, ab subheadings / all age subheadings 35. (cadexomer iodine) in ti, ab 7. “Postoperative-Complications”/ all topical 36. (iodoflex or iodosorb) in ti, ab subheadings / all age subheadings 37. hydrogel* in ti, ab 8. wound* or (cavit* in ti, ab) 38. ((intrasite gel) or intrasitegel or sterigel or 9. #7 and #8 granugel or (aquaform hydrogel) or (nu-gel) 10. #3 or #4 or #5 or #6 or #9 or (nu gel) or nugel or (purilon gel) or 11. (dehiscen* or sepsis or exudat* or necrot* or vigilon or (2nd skin) or (second skin)) slough*) in ti, ab in ti, ab 12. (non-heal* or non heal* or nonheal*) in ti, ab 39. (pressur* wound* irrigation*) in ti, ab 13. (problem or difficult* or complic*) near woorlpool (wound* or cavit* or incision*) in ti, ab 40. hydrochlorite solution 14. (chronic wound*) in ti, ab 41. (sodium hypochlorite) near ((wound* or 15. (granulating wound*) in ti, ab cavit*) in ti, ab) 16. (postoperative near wound*) in ti, ab 42. (dakin* solution) in ti, ab 17. (pilonidal sinus* or pilonidal abcess*) 43. eusol near ((wound* or cavit*) in ti, ab) in ti, ab 44. (((malic acid) or (benzoic acid) or (salicylic 18. #10 or #11 or #12 or #13 or #14 or #15 acid) or (propylene glycol)) near (wound* or or #16 or #17 cavit*)) in ti, ab 19. “Debridement”/ all topical subheadings / 45. (proteolytic* or fibrinolytic* or collagenase*) all age subheadings near ((wound* or cavit*) in ti, ab) 20. debrid* in ti, ab 46. ((hydrocholloid* or granuflex or (comfeel 21. “larva”/ all subheadings plus) or tegasorb or hydrocoll or aqalcel or 22. larva* in ti, ab combiderm or duoderm) near (wound* or 23. (maggot or maggots) in ti, ab cavit*)) in ti, ab 24. (bio-surg* or bio surg* or biosurg*) in ti, ab 47. (polysaccharid* dress*) in ti, ab 25. (trypsin or collagenase or streptokinase or 48. hydrofibre dress* in ti, ab streptodornase) in ti, ab 49. debrisan in ti, ab 26. (varidase near topical) in ti, ab 50. (bioclusive or cutifilm or epiview or mefilm 27. (wet near dry near dress*) in ti, ab or (opsite flexigrid) or tegaderm) in ti, ab 28. (polysaccharid* or dextranomer* or xerogel 51. ((polyurethane foam dress*) or allevyn or or cadexomer iodine) in ti, ab 108 lyfoam or tielle or lyofoam) in ti, ab 29. (iodoflex or iodosorb or hydrogel*) in ti, ab Health Technology Assessment 2001; Vol. 5: No. 14

30. ((intrasite gel) or intrasitegel or sterigel or 64. explode “Burns”/ all subheadings granugel or (aquaform hydrogel) or (nu-gel) 65. explode “Eye-Diseases”/ all subheadings or (nu gel) or nugel or (purilon gel) or 66. explode “Dentistry”/ all subheadings vigilon or (2nd skin) or (second skin)) 67. #62 or #63 or #64 or #65 or #66 in ti, ab 68. #61 not #67 31. (pressur* wound* irrigation*) in ti, ab 69. “Case-Studies”/ all topical subheadings / all 32. whirlpool in ti, ab age subheadings 33. (hydrochlorite solution) in ti, ab 70. “Retrospective-Design”/ all topical 34. (sodium hypochlorite) in ti, ab subheadings / all age subheadings 35. (dakin* solution) in ti, ab 71. #69 or #70 36. eusol in ti, ab 72. #68 not #71 37. (malic acid or benzoic acid or salicylic acid or 73. mesalt propylene glycol) in ti, ab 74. sodium chloride near dressing* 38. (proteolytic* or fibrinolytic* or collagenase*) 75. hypergel or normlgel or mepilex or mepitel in ti, ab 76. silicone near dressing* 39. (hydrocholloid* or granuflex or comfeel or 77. alldress or mepore or mesorb or (cellulose tegasorb or hydrocolloid* or aqualcel or near dressing*) combiderm or duoderm) in ti, ab 78. #73 or #74 or #75 or #76 or #77 40. (hydrofibre or debrisan) in ti, ab 79. #18 and #78 41. (bioclusive or cutifilm or epiview or mefilm or 80. #79 not #72 (opsite flexigrid) or tegaderm) in ti, ab 42. ((polyurethane foam) or allevyn or lyfoam or Fifth iteration tielle or lyofoam) in ti, ab 1. explode “Surgery-Operative”/ all topical 43. (alginate* or sorbsan or tegagel or kaltostat or subheadings / all age subheadings kaltogel or seasorb or algisite or algosteril or 2. surgery or (surgical in ti, ab) megisorb or cutinova cavity) in ti, ab 3. #1 or #2 44. (tulle gras or jelonet or bactigras or 4. “Surgical-Wound”/ all topical subheadings / chlorhexitulle or serotulle or (fucidin all age subheadings intertulle) or (sofra tulle)) in ti, ab 5. “Surgical-Wound-Dehiscence”/ all topical 45. (vapour permeable membrane* or spyrosorb subheadings / all age subheadings or flexipore or omiderm or surfasoft or 6. “Surgical-Wound-Infection”/ all topical tegapore) in ti, ab subheadings / all age subheadings 46. (enzymes or enzymotic) in ti, ab 7. “Postoperative-Complications”/ all topical 47. (secondary dressing* or film or films or subheadings / all age subheadings gauze or fibre or fiber or occlusive dressing*) 8. wound* or (cavit* in ti, ab) in ti, ab 9. #7 and #8 48. (aquacel or aloe vera or wound gel* or 10. #3 or #4 or #5 or #6 or #9 polynoxylin) in ti, ab 11. (dehiscen* or sepsis or exudat* or necrot* or 49. (melolin or emsol or silastic foam* or slough*) in ti, ab hydrofibre* or hydrofiber*) in ti, ab 12. (non-heal* or non heal* or nonheal*) in ti, ab 50. (polyurethane or hydrocellular or foam 13. (problem or difficult* or complic*) near elastomer or cellulose) in ti, ab (wound* or cavit* or incision*) in ti, ab 51. #19 or #20 or #21 or #22 or #23 14. (chronic wound*) in ti, ab 52. #24 or #25 or #26 or #27 15. (granulating wound*) in ti, ab 53. #28 or #29 or #30 or #31 16. (postoperative near wound*) in ti, ab 54. #32 or #33 or #34 or #35 17. (pilonidal sinus* or pilonidal abcess*) in ti, ab 55. #36 or #37 or #38 or #39 18. #10 or #11 or #12 or #13 or #14 or #15 or #16 56. #40 or #41 or #42 or #43 or #17 57. #44 or #45 or #46 or #47 or #48 or #49 or #50 19. “Debridement”/ all topical subheadings / all 58. #51 or #52 or #53 or #54 or #55 or #56 or #57 age subheadings 59. #18 and #58 20. debrid* in ti, ab 60. wound or wounds or cavity or cavities or 21. “larva”/ all subheadings abscess* or sinus or sinuses or incision or 22. larva* in ti, ab incisions 23. (maggot or maggots) in ti, ab 61. #59 and #60 24. (bio-surg* or bio surg* or biosurg*) in ti, ab 62. sutur* near wound* 25. (trypsin or collagenase or streptokinase or 63. skin graft* streptodornase) in ti, ab 109 Appendix 7

26. (varidase near topical) in ti, ab 60. wound or wounds or cavity or cavities or 27. (wet near dry near dress*) in ti, ab abscess* or sinus or sinuses or incision or 28. (polysaccharid* or dextranomer* or xerogel incisions or cadexomer iodine) in ti, ab 61. #59 and #60 29. (iodoflex or iodosorb or hydrogel*) in ti, ab 62. sutur* near wound* 30. ((intrasite gel) or intrasitegel or sterigel or 63. skin graft* granugel or (aquaform hydrogel) or (nu-gel) 64. explode “Burns”/ all subheadings or (nu gel) or nugel or (purilon gel) or vigilon 65. explode “Eye-Diseases”/ all subheadings or (2nd skin) or (second skin)) in ti, ab 66. explode “Dentistry”/ all subheadings 31. (pressur* wound* irrigation*) in ti, ab 67. #62 or #63 or #64 or #65 or #66 32. whirlpool in ti, ab 68. #61 not #67 33. (hydrochlorite solution) in ti, ab 69. “Case-Studies”/ all topical subheadings / all 34. (sodium hypochlorite) in ti, ab age subheadings 35. (dakin* solution) in ti, ab 70. “Retrospective-Design”/ all topical 36. eusol in ti, ab subheadings / all age subheadings 37. (malic acid or benzoic acid or salicylic acid or 71. #69 or #70 propylene glycol) in ti, ab 72. #68 not #71 38. (proteolytic* or fibrinolytic* or collagenase*) 73. mesalt in ti, ab 74. sodium chloride near dressing* 39. (hydrocholloid* or granuflex or comfeel or 75. hypergel or normlgel or mepilex or mepitel tegasorb or hydrocolloid* or aqualcel or 76. silicone near dressing* combiderm or duoderm) in ti, ab 77. alldress or mepore or mesorb or (cellulose 40. (hydrofibre or debrisan) in ti, ab near dressing*) 41. (bioclusive or cutifilm or epiview or mefilm or 78. #73 or #74 or #75 or #76 or #77 (opsite flexigrid) or tegaderm) in ti, ab 79. #18 and #78 42. ((polyurethane foam) or allevyn or lyfoam or 80. #79 not #72 tielle or lyofoam) in ti, ab 81. enzymatic 43. (alginate* or sorbsan or tegagel or kaltostat or 82. hypochlorite kaltogel or seasorb or algisite or algosteril or 83. solution megisorb or cutinova cavity) in ti, ab 84. enzymatic or hypochlorite solution 44. (tulle gras or jelonet or bactigras or 85. #84 and #18 chlorhexitulle or serotulle or (fucidin 86. #85 and #60 intertulle) or (sofra tulle)) in ti, ab 45. (vapour permeable membrane* or spyrosorb CCTR/CENTRAL and NRR or flexipore or omiderm or surfasoft or The CCTR/CENTRAL and NRR search was done tegapore) in ti, ab on CD-ROM, the former via the Cochrane Library, 46. (enzymes or enzymotic) in ti, ab as follows. 47. (secondary dressing* or film or films or gauze or fibre or fiber or occlusive dressing*) First iteration in ti, ab 1. SURGICAL-PROCEDURES-OPERATIVE*:ME 48. (aquacel or aloe vera or wound gel* or 2. (SURGERY or SURGICAL) polynoxylin) in ti, ab 3. (#1 or #2) 49. (melolin or emsol or silastic foam* or 4. POSTOPERATIVE-COMPLICATIONS:ME hydrofibre* or hydrofiber*) in ti, ab 5. (WOUND* or CAVIT*) 50. (polyurethane or hydrocellular or foam 6. (#4 and #5) elastomer or cellulose) in ti, ab 7. SURGICAL-WOUND-DEHISCENCE:ME 51. #19 or #20 or #21 or #22 or #23 8. SURGICAL-WOUND-INFECTION:ME 52. #24 or #25 or #26 or #27 9. ((#6 or #7) or #8) 53. #28 or #29 or #30 or #31 10. INFECTION*:ME 54. #32 or #33 or #34 or #35 11. BACTERIAL-INFECTIONS:ME 55. #36 or #37 or #38 or #39 12. (#10 or #11) 56. #40 or #41 or #42 or #43 13. (#6 and #12) 57. #44 or #45 or #46 or #47 or #48 or #49 14. ((INFECT* near SURG*) near WOUND*) or #50 15. ((INFECT* near SURG*) near CAVIT*) 58. #51 or #52 or #53 or #54 or #55 or #56 16. (DEHISCEN* near WOUND*) or #57 17. (DEHISCEN* near CAVIT*) 110 59. #18 and #58 18. (SEPSIS near WOUND*) Health Technology Assessment 2001; Vol. 5: No. 14

19. (SEPSIS near CAVIT*) 56. (“HYDROCHOLLOID* OR GRANUFLEX 20. (EXUDAT* near WOUND*) OF “COMFEEL PLUS” OR TEGASORB OR 21. (EXUDAT* near CAVIT*) HYDROCOLL OR AQUALCEL OR 22. (NECROT* near WOUND*) COMBIDERM OR DUODERM) AND 23. (NECROT* near CAVIT*) (WOUND* OR CAVIT*) 24. (SLOUGH* near WOUND*) 57. (“HYDROCHOLLOID* OR GRANUFLEX OF 25. (SLOUGH* near CAVIT*) “COMFEEL PLUS” OR TEGASORB OR 26. ((((((NON-HEAL* or (NON next HEAL*)) HYDROCOLL OR AQUALCEL OR OR NONHEAL*) OR DIFFICULT*) OR COMBIDERM OR DUODERM) AND PROBLEM*) OR COMPLIC*) AND (WOUND* OR CAVIT*) (WOUND* OR CAVIT*)) 58. (“HYDROCHOLLOID* OR GRANUFLEX OR 27. (((((((((((((#13 or #14) or #15) or #16) or “COMFEEL PLUS” OR TEGASORB OR #17) or #18) or #19) or #20) or #21) or #22) HYDROCOLL OR AQUALCEL OR or #23) or #24) or #25) or #26) COMBIDERM OR DUODERM) AND 28. (#3 and #27) (WOUND* OR CAVIT*) 29. (#9 or #28) 59. ((((((((HYDROCHOLLOID* or 30. DEBRIDEMENT*:ME GRANUFLEX) OR (COMFEEL next PLUS)) 31. DEBRID* OR TEGASORB) OR HYDROCOLL) OR 32. LARVA*:ME AQUALCEL) OR COMBIDERM) OR 33. (LARVA* or MAGGOT*) DUODERM) AND (WOUND* OR CAVIT*)) 60. ((POLYSACCHARID* next DRESS*) near 34. ((BIO-SURG* or (BIO next SURG*)) OR WOUND*) BIOSURG*) 61. ((POLYSACCHARID* next DRESS*) near 35. ((((TRYPSIN or COLLAGENASE) or CAVIT*) STREPTOKINASE) or STREPTODORNASE) 62. (HYDROFIBRE next DRESS*) and (WOUND* or CAVIT*)) 63. DEBRISAN 36. (VARIDASE near TOPICAL) 64. (((((BIOCLUSIVE or CUTIFILM) or 37. ((WET near DRY) near DRESS*) EPIVIEW) or MEFILM) OR (OPSITE next 38. (SALINE next GAUZ*) FLEXIGRID)) OR TEGADERM) 39. (DEXTRANOMER next POLYSACCHARID*) 65. (((((POLYURETHAN* next (FOAM next 40. (POLYSACCHARIDE next BEAD*) DRESS*)) or ALLEVYN) OR LYFOAM) OR 41. (POLYSACCHARIDE next PASTE) TIELLE) OR LYOFOAM) 42. DEXTRANOMER* 66. (((((((((((ALGINAT* next DRESS*) or 43. XEROGEL* SORBSAN) OR TEGAGEL) OR KALTOSTAT) 44. (CADEXOMER next IODINE) OR KALTOGEL) OR (COMFEEL NEXT 45. (IODOFLEX or IODOSORB) SEASORB)) OR ALGISITE) OR 46. HYDROGEL* ALGOSTERIL) OR MEGISORB) OR 47. (((((((((INTRASITE next GEL) or (CUTINOVA NEXT CAVITY)) OR INTRASITEGEL) OR STERIGEL) OR (SEASORB NEXT FILLER)) GRANUGEL) OR (AQUAFORM NEXT 67. ((((((((PARAFIN next (GAUZE next HYDROGEL)) OR NUGEL) OR (PURILON DRESS*)) or (TULLE next GRAS)) OR NEXT GEL)) OR VIGILON) OR (SECOND JELONET) OR BACTIGRAS) OR NEXT SKIN)) CHLORHEXITULLE) OR SEROTULLE) 48. (PRESSUR* next (WOUND* next OR (FUCIDIN NEXT INTERTULLE)) OR IRRIGATION*)) (SOFRA NEXT TULLE)) 49. WOORLPOOL 68. ((((((((VAPOUR next (PERMEABLE next 50. (HYDROCHLORITE next SOLUTION) MEMBRANE)) or (VAPOUR next 51. (SODIUM next HYPOCHLORITE) (PERMEABLE next MEMBRANES))) OR 52. (DAKIN* next SOLUTION) SYPROSORB) OR FLEXIPORE) OR 53. EUSOL OMIDERM) OR SURFASOFT) OR 54. (((((MALIC next ACID) or (BENZOID next TEGAPORE) AND (WOUND* OR CAVIT*)) ACID)) OR (SALICYLIC NEXT ACID)) OR 69. (((((((((#30 or #31) or #32) or #33) or #34) (PROPYLENE NEXT GLYCOL)) AND or #35) or #36) or #37) or #38) or #39) (WOUND* OR CAVIT*)) 70. (((((((((#40 or #41) or #42) or #43) or #44) 55. (((PROTEOLYTIC* or FIBRINOLYTIC*) or or #45) or #46) or #47) or #48) or #49) COLLAGENASE*) and (WOUND* or 71. (((((((((#50 or #51) or #52) or #53) or #54) CAVIT*)) or #55) or #56) or #57) or #58) or #59) 111 Appendix 7

72. ((((((((#60 or #61) or #62) or #63) or #64) or 30. (((proteolytic* or fibrinolytic*) or #65) or #66) or #67) or #68) hydrocholloid*) or granuflex) 73. (((#69 or #70)or #71) or #72) 31. (((comfeel or tegasorb) or hydrocolloid*) 74. (#29 and #73) or aqualcel) 32. (((combiderm or duoderm) or hydrofibre) Second iteration or debrisan) 1. SURGICAL-PROCEDURES-OPERATIVE*:ME 33. (((bioclusive or cutifilm) or epiview) 2. SURGICAL-WOUND-INFECTION*:ME or mefilm) 3. SURGICAL-WOUND-DEHISCENCE*:ME 34. (((opsite next flexigrid) or tegaderm) 4. POSTOPERATIVE-COMPLICATIONS*:ME or (polyurethane next foam)) 5. ((WOUND* or CAVIT*) or INCISION*) 35. (((allevyn or lyfoam) or tielle) or lyofoam) 6. (SURGICAL or SURGERY) 36. (((alginate* or sorbsan) or tegagel) 7. ((((DEHISCEN* or SEPSIS) or EXUDAT*) or or kaltostat) NECORT*) or SLOUGH*) 37. (((kaltogel or seasorb) or algisite) 8. (NECROT* or NONHEAL*) or algosteril) 9. (PROBLEM near ((WOUND* or CAVIT*) or 38. (((megisorb or cutinova) or tulle) or jelonet) INCISION*)) 39. (((bactigras or chlorhexitulle) or serotulle) or intertulle) 10. (DIFFICULT near ((WOUND* or CAVIT*) or 40. (((sofra or spyrosorb) or flexipore) INCISION*)) or omiderm) 11. (COMPLICAT* near ((WOUND* or CAVIT*) 41. (vapour next permeable next membrane*) or INCISION*)) 42. (((surfasoft or tegapore) or enzyme*) 12. (CHRONIC and WOUND*) or enzymatic) 13. (GRANULATING and WOUND*) 43. (((secondary next dressing*) or film) 14. (POSTOPERATIVE near WOUND*) or films) 15. ((PILONIDAL and SINUS*) or (PILONIDAL 44. (((gauze or fiber) or fibre) or (occlusive and ABSCESS*)) next dressing*)) 16. (((#4 or #1) or #6) and #5) 45. (((aquacel or aloe) or (wound next gel*)) 17. (((((((((((#2 or #3) or #7) or #8) or #9) or or polynoxylin) #10) or #11) or #12) or #13) or #14) or #15) 46. (((melolin or emsol) or silastic) or hydrofib*) or #16) 47. (((polyurethane or hydrocellular) or 18. DEBRIDEMENT:ME cellulose) or (foam next elastomer)) 19. (((DEBRID* or LARVA*) or MAGGOT) or 48. ((((((((wound or wounds) or cavity) or MAGGOTS) cavities) or abscess*) or sinus) or sinuses) 20. LARVA:ME or incision) or incisions) 21. (((BIOSURG* or BIO-SURG*) or TRYPSIN) 49. ((((((((((((((((((((((((((((#18 or #19) or or COLLAGENASE) #20) or #21) or #22) or #23) or #24) or #25) 22. ((STREPTOKINASE or STREPTODORNASE) or #26) or #27) or #28) or #29) or #30) or not THROMBOLY*) #31) or #32) or #33) or #34) or #35) or #36) 23. (VARIDASE near TOPICAL*) or #37) or #38) or #39) or #40) or #41) or 24. (((POLYSACCHARID* or DEXTRANOMER*) #42) or #43) or #44) or #45) or #46) or XEROGEL) OR (CADEXOMER next 50. (#17 and #49) IODINE)) 51. (#47 and #50) 25. ((((IODOFLEX or IODOSORB) or HYDROGEL*) or INTRASITE*) or Third iteration STERIGEL) The following terms were added to the second 26. ((((GRANUGEL or NUGEL) or NU-GEL) iteration search terms; previous results OR (PURILON next GEL)) OR were excluded: VIGILON) 27. ((((SECOND next SKIN) or IRRIGATION) • MESALT OR WHIRLPOOL) OR (HYDROCHLORITE • ((SODIUM next CHLORIDE) near NEXT SOLUTION)) DRESSING*) 28. (((((SODIUM next HYPOCHLORITE) or • ((HYPERGEL or NORMLGEL) or MEPILEX) DAKIN*) OR EUSOL) OR (MALIC NEXT • ((HYPERGEL or NORMLGEL) or MEPILEX) ACID)) OR (BENZOIC NEXT ACID)) • (SILICONE near DRESSING*) 29. ((salicylic next acid) or (propylene • (((MEPITEL or ALLDRESS) or MEPORE) 112 next glycol)) or MESORB) Health Technology Assessment 2001; Vol. 5: No. 14

Topic 2:settings of care for 30. ((nurse or nurses or doctor* or physician or difficult to heal surgical wounds gp or practitioner or (health visit*) or staff or personnel) near (wound* or cavit*)) in ts, ab MEDLINE 31. ((setting or hospital or hospitals or The MEDLINE search was done via ARC/ community or clinic or clinics or home or SilverPlatter, as follows. (Searches 1–23 were as centre* or center* or department* or unit or for the debridement search, first iteration.) units) near (wound* or cavit*)) in ts, ab 32. ((facilit* or location or outpatient* or 24. explode “health facilities”/ all subheadings inpatient* or rehabilitation or acute) near 25. explode “health services”/ all subheadings (wound* or cavit*)) in ts, ab 26. explode “delivery of health care”/ 33. ((management or treatment* or program* or all subheadings service* or delivery or care) near (wound* or 27. “postoperative care”/ all subheadings cavit*)) in ts, ab 28. “Aftercare”/ all subheadings 34. #24 or #25 or #26 or #27 or #28 or #29 or #30 29. tissue viability nurs* in ti, ab or #31 or #32 or #33 30. ((post operative care) or (postoperative care) 35. #23 and #34 or aftercare) in ti, ab 36. explode “health-care-quality”/ all subheadings 31. ((nurse or nurses or doctor* or physician 37. explode “evaluation-and-follow-up”/ all or gp or practitioner or (health visit*) or subheadings staff or personnel) near (wound* or cavit*)) 38. explode “comparative-study”/ all subheadings in ti, ab 39. explode “controlled-study”/ all subheadings 32. ((setting or hospital or hospitals or 40. explode “methodology”/ all subheadings community or clinic or clinics or home or 41. “feasibility-study”/ all subheadings centre* or center* or department* or unit or 42. “theoretical-study”/ all subheadings units) near (wound* or cavit*)) in ti, ab 43. (trial* or stud* or evaluat* or examin*) 33. ((facilit* or location or outpatient* or in ts, ab inpatient* or rehabilitation or acute) near 44. #36 or #37 or #38 or #39 or #40 or #41 (wound* or cavit*)) in ti, ab or #42 or #43 34. ((management or treatment* or program* or 45. #35 and #44 service* or delivery or care) near (wound* or cavit*)) in ti, ab CINAHL 35. #24 or #25 or #26 or #27 or #28 or #29 or #30 The CINAHL search was done via ARC/ or #31 or #32 or #33 or #34 SilverPlatter, as follows. (Searches 1–22 were as 36. #23 and #35 for the debridement search, first iteration.) 37. explode “Health-Care-Evaluation- Mechanisms”/ all subheadings 23. explode “Health-Facilities”/ all topical 38. explode “Evaluation-Studies”/ all subheadings subheadings / all age subheadings 39. (trial* or stud* or evaluat* or examin*) 24. explode “Health-Services”/ all topical in ti, ab subheadings / all age subheadings 40. #37 or #38 or #39 25. explode “Health-Care-Delivery”/ all topical 41. #36 and #40 subheadings / all age subheadings 26. explode “Postoperative-Care”/ all topical EMBASE subheadings / all age subheadings The MEDLINE search was done via ARC/ 27. explode “Patient-Care” tree: 2/ all topical SilverPlatter, as follows. (Searches 1–23 were as subheadings / all age subheadings for the debridement search, first iteration.) 28. “After-Care”/ all topical subheadings / all age subheadings 24. explode “health-care-facilities-and-services”/ 29. tissue viability nurs* in ti, ab all subheadings 30. ((post operative care) or (postoperative care) 25. explode “health-care-delivery”/ or aftercare) in ti, ab all subheadings 31. ((nurse or nurses or doctor* or physician or 26. “postoperative-care”/ all subheadings gp or practitioner or (health visit*) or staff or 27. explode “aftercare”/ all subheadings personnel) near (wound* or cavit*)) in ti, ab 28. tissue viability nurs* in ti, ab 32. ((setting or hospital or hospitals or 29. (((post operative care) or (postoperative community or clinic or clinics or home or care) or aftercare) near (wound* or cavit*)) centre* or center* or department* or unit or in ts, ab units) near (wound* or cavit*)) in ti, ab 113 Appendix 7

33. ((facilit* or location or outpatient* or 21. #15 or #16 or #17 or #18 or #19 or #20 inpatient* or rehabilitation or acute) near 22. #14 and #21 (wound* or cavit*)) in ti, ab 34. ((management or treatment* or program* or NRR service* or delivery or care) near (wound* or The NRR search was done using the CD-ROM, cavit*)) in ti, ab 2000, Issue 1, as follows: 35. #23 or #24 or #25 or #26 or #27 or #28 or #29 or #30 or #31 or #32 or #33 or #34 1. POSTOPERATIVE-COMPLICATIONS:ME 36. #22 and #35 2. (WOUND* or CAVIT*) 37. explode “Quality-Assessment”/ all topical 3. (#1 and #2) subheadings / all age subheadings 4. SURGICAL-WOUND-DEHISCENCE:ME 38. “Program-Evaluation”/ all topical subheadings 5. SURGICAL-WOUND-INFECTION:ME / all age subheadings 6. ((#3 or #4) or #5) 39. “Evaluation”/ all topical subheadings / 7. INFECTION*:ME all age subheadings 8. BACTERIAL-INFECTIONS:ME 40. (trial* or stud* or evaluat* or examin*) in ti, ab 9. (#7 or #8) 41. #37 or #38 or #39 or #40 10. (#2 and #9) 42. #36 and #41 11. ((INFECT* near SURG*) near WOUND*) 12. ((INFECT* near SURG*) near CAVIT*) HMIC 13. (DEHISCEN* near WOUND*) The HMIC search was done via ARC/SilverPlatter, 14. (DEHISCEN* near CAVIT*) as follows. 15. (SEPSIS near WOUND*) 16. (SEPSIS near CAVIT*) 1. (wound* or cavit*) in ti, ab, de 17. (EXUDAT* near WOUND*) 2. postoperative complic* in ti, ab, de 18. (EXUDAT* near CAVIT*) 3. postoperative problem* in ti, ab de 19. (NECROT* near WOUND*) 4. infection* in ti, ab, de 20. (NECROT* near CAVIT*) 5. (#2 or #3 or #4) and #1 21. (SLOUGH* near WOUND*) 6. (dehiscen* near (wound* or cavit*)) in ti, 22. (SLOUGH* near CAVIT*) ab, de 23. ((((((NON-HEAL* or (NON next HEAL*)) 7. (sepsis near (wound* or cavit*)) in ti, ab, de OR NONHEAL*) OR DIFFICULT*) OR 8. exudat* near ((wound* or cavit*) in ti, ab, de) PROBLEM*) OR COMPLIC*) AND 9. (necrot* near (wound* or cavit*)) in ti, ab, de (WOUND* OR CAVIT*)) 10. (slough* near (wound* or cavit*)) in ti, ab, de 24. ((((((((((#10 or #11 or #12 or #13 or #14) or 11. (((non-heal*) or (non heal*) or nonheal* or #15) or #16) or #17) or #18) or #19) or #20) problem* or difficult* or complic*) near or #21) or #22) or #23) (wound* or cavit*)) in ti, ab, de 25. (#6 or #24) 12. (infect* near (wound* or cavit*)) in ti, ab, de 13. #6 or #7 or #8 or #9 or #10 or #11 or #12 14. #5 or #13 Topic 3:economic evaluations 15. tissue viability nurs* in ti, ab 16. ((post operative care) or (postoperative care) MEDLINE or aftercare) in ti, ab, de The MEDLINE search was done via 17. ((nurse or nurses or doctor* or physician or ARC/SilverPlatter. The following search was gp or practitioner or (health visit*) or staff appended to the bottom of the search for the or personnel) near (wound* or cavit*)) in effectiveness of debridement, first iteration. ti, ab, de 18. ((setting or hospital or hospitals or 61. “Economics”/ all subheadings community or clinic or clinics or home or 62. explode “Costs-and-Cost-Analysis”/ centre* or center* or department* or unit or all subheadings units) near (wound* or cavit*)) in ti, ab, de 63. “Economic-Value-of-Life” 19. ((facilit* or location or outpatient* or 64. explode “Economics-Hospital”/ inpatient* or rehabilitation or acute) near all subheadings (wound* or cavit*)) in ti, ab, de 65. explode “Economics-Medical”/ 20. ((management or treatment* or program* or all subheadings service* or delivery or care) near (wound* or 66. “Economics-Nursing”/ all subheadings 114 cavit*)) in ti, ab, de 67. “Economics-Pharmaceutical”/ all subheadings Health Technology Assessment 2001; Vol. 5: No. 14

68. explode “Fees-and-Charges”/ all subheadings 57. “Economics”/ all topical subheadings / 69. explode “Budgets”/ all subheadings all age subheadings 70. explode “Models-Economic”/ all subheadings 58. explode “Costs-and-Cost-Analysis”/ all 71. #61 or #62 or #63 or #64 or #65 or #66 or #67 topical subheadings / all age subheadings or #68 or #69 or #70 59. “Economic-Aspects-of-Illness”/ all topical 72. (cost or costs or costed or costly or costing) in subheadings / all age subheadings ti, ab 60. “Economics-Pharmaceutical”/ all topical 73. (economic* or pharmacoeconomic* or price subheadings / all age subheadings or prices or pricing or qaly*) in ti, ab 61. “Economic-Value-of-Life”/ all topical 74. #71 or #72 or #73 subheadings / all age subheadings 75. #60 and #74 62. explode “Fees-and-Charges”/ all topical subheadings / all age subheadings EMBASE 63. “Budgets”/ all topical subheadings / The EMBASE search was done via ARC/ all age subheadings SilverPlatter. The following search was appended to 64. #57 or #58 or #59 or #60 or #61 or #62 the bottom of the search for the effectiveness of or #63 debridement, first iteration. 65. (cost or costs or costed or costly or costing) in ti, ab 57. explode “health-economics”/ all subheadings 58. “cost”/ all subheadings 66. (economic* or pharmacoeconomic* 59. explode “health-care-cost”/ all subheadings or price or prices or pricing) in ti, ab 60. #57 or #58 or #59 67. #64 or #65 or #66 61. explode “economic-evaluation”/ all 68. #56 and #67 subheadings 62. (cost or costs or costing or costed or costly) in ti, ab Search for conference 63. (economic* or pharmaceconomic* or price or proceedings prices or pricing) in ti, ab 64. #60 or #61 or #62 or #63 Named wound care conferences and wound 65. #56 and #64 care organisations were identified by searching the Inside Conferences and Index to Conference CINAHL Proceedings database on the Dialog Service. The CINAHL search was done via ARC/ The world wide web was also searched for SilverPlatter. The following search was appended conference proceedings and web pages that to the bottom of the search for the effectiveness might provide records of conference papers. of debridement, first iteration. The findings are summarised in Table 14.

115 Appendix 7

TABLE 14 Results of search for conference proceedings

Conference Inside Conferences Index to Conference Web page database Proceedings

World Conference No references No references No details of past conferences on that of Phlebology web site or on that of the International Union (parent organisation)

European Venous Forum No references No references http://www.esvs.org/esvs/evf2000.html

European Wound References identified References identified EWMA web site: Management Conferences and downloaded and downloaded http://www.leahcim.demon.co.uk/ ewma.htm. However, no conference listings

European Tissue References identified No references http://www.leahcim.demon.co.uk/etrs.htm Repair Society and downloaded 1996–1997 meeting abstracts on web site, but not updated since

European Advisory Panel on No references No references Meeting abstracts: http://www.leahcim. Pressure Ulceration demon.co.uk/epuap/

Tissue Viability Conference References identified No references Tissue Viability Society: and downloaded http://www.tvs.org.uk/

Wound Care Society No references No references WCS home page: Conferences http://www.leahcim.demon.co.uk/ wcs/wcs_hp.htm (old); http://www. woundcaresociety.org/ (new)

Symposium on advanced References identified No references 15th conference: http://www.woundcarenet. wound care and medical and downloaded com/wcsymp00/program.htm research forum on wound care 12th symposium: http://www.medscape.com/ HMP/wounds/1999/woundConf/public/ toc-woundsConf.html

1997 symposium: http://www.medexpo.com/ Pages/schedule.html. conf15

American Wound No references No references http://www.leahcim.demon.co.uk/ Healing Society whs-usa/whs.htm

No abstracts

Canadian Association of No references No references No home page identified Wound Care

Australian Wound No references No references http://www.awma.com.au/pages/about.html Management Association

116 Health Technology Assessment 2001; Vol. 5: No. 14

Appendix 8 Manufacturer and sponsor submissions made to NICE

117 Appendix 8 62 continued investigations), RCT in vitro 43 and controlled studies because they and controlled other cost studies as based on difficult to heal surgical wounds chronic wounds chronic based on a case Included: cost-minimisation study, based on cavity Excluded: studies with inappropriate 206 43 = 2), n ulcers also included cost data) study design Cost-effectiveness study Cost-effectiveness presented, used data from type or study wound inappropriate in ™ ™ in leg wounds trials of chronic design. analysis Cost-effectiveness ™ or Granuflex ™ = 6) = 16) = 4) n n n = 1): in cavity Cutinova non-surgical wounds = 1), SeaSorb vs Kaltostat in = 2): sores pressure looked = 1): in cavity Cutinova Meyer, n n = 1): and hydro Cutinova ( n = 4): Purilon vs Intrasite n n n = 1): insufficient details non-surgical wounds; at chronic looked n = 2), SeaSorb vs Kaltostat n = 1), SeaSorb vs gauze in exuding cavity 2) = 1) and Comfeel vs gauze in leg ulcers = 1) and Comfeel n = 5) in diabetic foot ulcers in diabetic foot wounds of cavity report RCT = 1) and Biatain vs Allevyn in leg ulcersAllevyn = 1) and Biatain vs to excluded because data relate n = 5): sores in pressure Purilon vs control analysis Cost-effectiveness Excluded: all other studies due to = 1): leg ulcers, at venous looked no (the Some cost data provided Excluded: all other studies due to = 1): vs moist gauze, Cutinova treatment data reported Cost per dressing in Cost-minimisation study of Cutinova n n = n ™ n ( ( n n = 1) = 1) = 1),Varihesive vs Comfeel n n n ( leg ulcers ( Controlled trials ( Controlled measure of healingmeasure leg RCT looking at venous type or wound inappropriate In vitro Unpublished case studies ( In vitro secondary healing deep wounds, not clear if controlledClinical article ( in 43 patients wound study ( Uncontrolled exuding wounds heavily Case studies and series ( studies, designs (uncontrolled case studies and ( General papers Published case histories ( Wider implications ( ) information Product and ischaemic ulcers (hydrocolloid) ™ (alginate) ulcers ( (foam, hydro, Allevyn Manufacturer and sponsor submissions made to NICE Manufacturer ™ (flat alginate dressing) ulcers ( diabetic foot : Debridement : study ( Controlled : details Product in leg ulcers ( (flat foam dressing) (flat foam ( wounds ™ (sterile larvae studies ( Controlled ™ ™ ™ Lucilia sericata of Biatain LarvE Products Biosurgical Research UnitBiosurgical Research details Wound RCT ( (Medical Division) of ulcers CompanyBeiersdorf UK Ltd Cutinova and thin),cavity description Product polyurethane dressings providedhydroactive Information Clinical data RCT ( ( Clinical evaluation Cost data Action Comfeel Plus Comfeel SeaSorb Coloplast healing and management Wound RCTs ( Products Purilon gel 118 Products TABLE 15 TABLE Health Technology Assessment 2001; Vol. 5: No. 14 continued 63 41 and RCT of Algosteril and RCT of 38 as used data on ulcers (calcium alginate) vs povidone iodine for (calcium alginate) vs povidone Included: economic evaluation = 3) types or study wound inappropriate n Refers to HTA report, to HTA Refers no dataadditional Excluded: types wound inappropriate and study designs 30,31

™ = 1) = 1) or gauze n n = 1), treating alginate for = 3) = 7) = 1) n n n n = 3): in skin graft donor VAC = 2) = 1) and alginate + zinc for = 1) and alginate + zinc for types. designs or wound inappropriate n = 4): vs dextranomer Algosteril pilonidal abscesses infected n n n = 3): vs surgical intervention VAC design = 1), vs gauze in skin Algosteril Excluded: all other studies, either n = 2) n n = 2) = 1) Cost-minimisation study excluded n n = 2) = 2): vs wet-to-dry in mainly VAC studies Cost-effectiveness Excluded: as was not considered VAC = 1): iodine for vs povidone Algosteril Cost-minimisation analysis: Included: trial on alginate for controlled = 1): vs Intrasite, Aquaform wounds, mixed Some cost information, Excluded: types or wound inappropriate = 1): NU-GEL to Intrasite compared n = 2), not stated ( wounds n studies ( ( n n n n grafts (donor sites) ( leg ulcers ( In vitro abscess cavities ( abscess cavities infected pilonidal abscessesinfected decubitus ulcers used data from abscess cavities all chronic, of healing measures no objective Case studies and series ( but no analysis study designs Case studies and series ( Case studies and series ( In vitro chronic woundschronic reported, on chronic mainly a debriding agent. Most studies included Case study ( Uncontrolled studies ( Uncontrolled sites ( and precautions ( wounds) (in chronic Manufacturer and sponsor submissions made to NICE Manufacturer ) Indications, contraindications mediastinitis) ( (post-sternotomy ™ ™ (alginate studies ( Controlled (hydrogel (hydrogel sores in pressure : : Mechanism of action ( wounds : description Dressing : description Product RCT ( ™ ™ ™ Algosteril Products Aquaform Les Laboratoires BrothierLes Laboratoires Debridement RCT ( Maersk Medical description and use Product RCT ( Vacuum Assisted Closure Assisted Closure Vacuum (VAC therapy trials ( Controlled Products CompanyConvaTec in confidence (Commercial data, omitted) Description of products Medical and Johnson Johnson provided Information Debridement Wider NHS implications Clinical dataActisorb-Plus Kinetic Concepts Inc. data clinical effectiveness for report to HTA Refers Description Cost data RCTs ( dressing) Action Wider NHS implications ulcers ( pressure paste for Products Products NU-GEL with alginate) 119 TABLE 15 contd TABLE Appendix 8 continued include healing as an outcome measure because it looked at pressure sores at pressure because it looked Iodosorb/Iodoflex, effectiveness Excluded: types or wound inappropriate 30,31 = 2) n = 6) = 12) n n = 3): Mesalt in old vs new = 1), Mesalt vs saline in pressure n n = 1): of Sterigel tests = 1) and Sterigel vs Intrasite in pressure = 1) and Sterigel vs Intrasite in pressure = 1) and Mesalt vs benzoyl peroxide = 1) and Mesalt vs benzoyl = 2): of leg Sterigel vs gauze in treatment = 5): pressure Intrasite vs Debrisan for based on data are and effectiveness = 1) = 2) and cadexomer iodine vs standard paste, chronic wounds = 1): Hypergel vs enzymatic debridement looking at Cost analysis Excluded: types and wound inappropriate n n n n n ( n n n Case studies and series ( Case studies and series ( of the literatureRCTs ( ulcers ( ( sores study designs other studies: wounds chronic data for study designs. did not Cost analysis In vitro ulcers ( in dermal ulcers sores pressure study designs. excluded Cost analysis Debridement ( sores ™ Manufacturer and sponsor submissions made to NICE Manufacturer Iodoflex (alginate dressing) (normal sodium powder and powder leg ulcers ( venous for treatment (high sodium gel in ulcers ™ gel (hydrogel) (soft silicone : Management : healing Wound : healing Wound (soft silicone ™ ™ (vapour-permeable (vapour-permeable ™ ™ (high sodium chloride trials ( Controlled ™ ™ ™ ™ ™ ™ lnlycke Healthcarelnlycke details Dressing RCT ( ö ointment description Product Iodosorb Hypergel chloride hypergel) NormIgel chloride hypergel) Mepilex backing) with foam dressing Mepitel CompanyM provided Information Clinical dataMelgisorb Cost dataIntrasite Action SSL International plcProducts Sterige Debridement data, No additional review their own present Excluded: types and wound inappropriate Products Cadexomer iodine in the form of Iodoflex RCTs ( wound dressing) wound Mefilm dressing) non-woven dressing)non-woven Debridement ( dermal wounds Products Mesalt 120 Smith and Nephew Surgical practice reports, HTA come from Most references TABLE 15 contd TABLE Health Technology Assessment 2001; Vol. 5: No. 14 no direct analysisno direct be debriding agents = 1):Aquaflo in chronic None reported Excluded: studies with inappropriate n = 1): vs other Eakin cohesive data on cost of Present Excluded: study designs or inappropriate n = 8) = 1) n n = 1) n ( pastes, all surgical wounds, used paste then Eakin, dressings. Some cost of healing provided, no measure fistula and acute woundsIn vitro designs Manufacturer and sponsor submissions made to NICE Manufacturer (alginate Case study ( : inclusion Rationale for of healing no measure provided, information but to pouches not considered and wound : ™ (hydrogel) ™ (fistula and wound (fistula and wound ™ ™ Curafil gel Aquaflo CompanyTG Eakin LtdProducts Eakin pouches) provided Information Eakin cohesive Clinical data Wider implications trial ( Controlled Case studies ( Cost data Action Tyco Healthcare (UK) Ltd Healthcare Tyco Debridementhydrocolloid) study ( Uncontrolled Products Ultec*Pro 121 TABLE 15 contd TABLE

Health Technology Assessment 2001; Vol. 5: No. 14

Health Technology Assessment Programme

Prioritisation Strategy Group

Members

Chair Professor Shah Ebrahim Dr Ron Zimmern Professor Kent Woods Professor of Epidemiology Director, Public Health Director, of Ageing Genetics Unit NHS HTA Programme, & University of Bristol Strangeways Research Professor of Therapeutics Laboratories, Cambridge University of Leicester Dr John Reynolds Professor Bruce Campbell Clinical Director Consultant General Surgeon Acute General Medicine SDU Royal Devon & Exeter Hospital Oxford Radcliffe Hospital

HTA Commissioning Board

Members

Programme Director Ms Christine Clark Professor Jenny Hewison Dr Sarah Stewart-Brown Professor Kent Woods Freelance Medical Writer Senior Lecturer Director, Health Services Director, NHS HTA Bury, Lancs School of Psychology Research Unit Programme, & University of Leeds University of Oxford Professor of Therapeutics Professor Martin Eccles University of Leicester Professor of Professor Alison Kitson Professor Ala Szczepura Clinical Effectiveness Director, Royal College of Director, Centre for Health Chair University of Newcastle- Nursing Institute, London Services Studies upon-Tyne University of Warwick Professor Shah Ebrahim Dr Donna Lamping Professor of Epidemiology Dr Andrew Farmer Head, Health Services Dr Gillian Vivian of Ageing Research Unit Consultant in Nuclear University of Bristol General Practitioner & NHS R&D London School of Hygiene Medicine & Radiology Clinical Scientist & Tropical Medicine Royal Cornwall Hospitals Trust Deputy Chair Truro Professor Jon Nicholl Institute of Health Sciences Professor David Neal Director, Medical Care University of Oxford Professor of Surgery Professor Graham Watt Research Unit Department of Professor Adrian Grant University of Newcastle- University of Sheffield upon-Tyne General Practice Director, Health Services University of Glasgow Research Unit Professor Gillian Parker University of Aberdeen Nuffield Professor of Dr Jeremy Wyatt Senior Fellow Professor Douglas Altman Community Care Dr Alastair Gray University of Leicester Health Knowledge Director, ICRF Medical Director, Health Economics Management Centre Statistics Group Research Centre Dr Tim Peters University College London University of Oxford Institute of Health Sciences Reader in Medical Statistics University of Oxford University of Bristol Professor John Bond Director, Centre for Health Professor Mark Haggard Professor Martin Severs Services Research Director, MRC Institute Professor in Elderly University of Newcastle- of Hearing Research Health Care upon-Tyne University of Nottingham University of Portsmouth

Current and past membership details of all HTA ‘committees’ are available from the HTA website (see inside front cover for details) 129

continued Health Technology Assessment Programme

continued Diagnostic Technologies & Screening Panel Members Chair Dr Barry Cookson Mr Steve Ebdon-Jackson Dr JA Muir Gray Dr Ron Zimmern Director, Laboratory of Head, Diagnostic Imaging & Joint Director, National Director, Public Health Hospital Infection Radiation Protection Team Screening Committee Genetics Unit Public Health Department of Health, London NHS Executive, Oxford Strangeways Research Laboratory Service, London Laboratories Dr Peter Howlett Cambridge Dr Tom Fahey Executive Director – Senior Lecturer in Development Professor Howard Cuckle General Practice Portsmouth Hospitals Professor of Reproductive University of Bristol NHS Trust Dr Philip J Ayres Epidemiology Consultant in Epidemiology University of Leeds Professor Alistair McGuire Dr Andrew Farmer & Public Health Professor of Health Economics General Practitioner & The Leeds Teaching Hospitals City University, London NHS Clinical Scientist NHS Trust Institute of Health Sciences Dr Carol Dezateux University of Oxford Mrs Kathlyn Slack Mrs Stella Burnside Senior Lecturer in Professional Support Chief Executive, Altnagelvin Paediatric Epidemiology Diagnostic Imaging & Hospitals Health & Social Institute of Child Health Mrs Gillian Fletcher Radiation Protection Team Services Trust London Antenatal Teacher & Tutor Department of Health Londonderry National Childbirth Trust London Northern Ireland Reigate Mr Tony Tester Dr Paul O Collinson Professor Adrian K Dixon Chief Officer, South Consultant Chemical Professor of Radiology Professor Jane Franklyn Bedfordshire Community Pathologist & Senior Lecturer Addenbrooke’s Hospital Professor of Medicine Health Council St George’s Hospital, London Cambridge University of Birmingham Luton

Pharmaceuticals Panel Members Chair Mrs Jeannette Howe Dr Frances Rotblat Dr Richard Tiner Dr John Reynolds Senior Principal Pharmacist Manager, Biotechnology Group Medical Director Clinical Director – Department of Health, London Medicines Control Agency Association of the British Acute General Medicine SDU London Pharmaceutical Industry Oxford Radcliffe Hospital London Dr Andrew Mortimore Mr Bill Sang Consultant in Public Chief Executive Professor Jenifer Health Medicine Salford Royal Hospitals Wilson-Barnett Southampton & South West NHS Trust Head, Florence Nightingale Hants Health Authority Dr Felicity J Gabbay Division of Nursing Managing Director, Dr Eamonn Sheridan & Midwifery Transcrip Ltd Mr Nigel Offen Consultant in Clinical Genetics King’s College, London Milford-on-Sea, Hants Head of Clinical Quality St James’s University Hospital NHS Executive – Eastern Leeds Mr David J Wright Milton Keynes Chief Executive Mr Peter Golightly Mrs Katrina Simister International Glaucoma Director, Trent Drug New Products Manager Association, London Information Services Professor Robert Peveler National Prescribing Centre Leicester Royal Infirmary Professor of Liaison Psychiatry Liverpool Royal South Hants Hospital Southampton Dr Alastair Gray Dr Ross Taylor Director, Health Economics Senior Lecturer Research Centre Mrs Marianne Rigge Department of General Institute of Health Sciences Director, College of Health Practice & Primary Care University of Oxford London University of Aberdeen

130 Current and past membership details of all HTA ‘committees’ are available from the HTA website (see inside front cover for details) Health Technology Assessment 2001; Vol. 5: No. 14

Therapeutic Procedures Panel Members Chair Professor Collette Clifford Mr Richard Johanson Dr John C Pounsford Professor Bruce Campbell Professor of Nursing Consultant & Senior Lecturer Consultant Physician Consultant General Surgeon University of Birmingham North Staffordshire Infirmary Frenchay Healthcare Trust Royal Devon & Exeter Hospital NHS Trust, Stoke-on-Trent Bristol Dr Katherine Darton Information Unit Dr Duncan Keeley Dr Mark Sculpher MIND – The Mental Health General Practitioner Senior Research Fellow in Professor John Bond Charity, London Thame, Oxon Health Economics Professor of University of York Health Services Research Mr John Dunning Dr Phillip Leech University of Newcastle- Consultant Cardiothoracic Principal Medical Officer Dr Ken Stein upon-Tyne Surgeon Department of Health, London Consultant in Public Papworth Hospital NHS Trust Health Medicine Cambridge Professor James Lindesay Ms Judith Brodie North & East Devon Professor of Psychiatry for Health Authority, Exeter Head of Cancer Mr Jonothan Earnshaw the Elderly Support Service Consultant Vascular Surgeon University of Leicester Cancer BACUP, London Gloucestershire Royal Hospital Professor Rajan Madhok Ms Tracy Bury Professor David Field Director of Health Policy Head of Research Professor of Neonatal Medicine & Public Health & Development The Leicester Royal Infirmary East Riding & Hull Chartered Society of NHS Trust Health Authority Physiotherapy, London Professor FD Richard Hobbs Dr Mike McGovern Mr Michael Clancy Professor of Primary Care Branch Head Consultant in A&E Medicine & General Practice Department of Health Southampton General Hospital University of Birmingham London

Expert Advisory Network Members

Professor John Brazier Dr Neville Goodman Dr Sue Moss Dr Sarah Stewart-Brown Director of Health Economics Consultant Anaesthetist Associate Director, Cancer Director, Health Services University of Sheffield Southmead Hospital, Bristol Screening Evaluation Unit Research Unit Institute of Cancer Research University of Oxford Mr Shaun Brogan Professor Robert E Hawkins Sutton, Surrey Chief Executive, Ridgeway CRC Professor & Director of Dr Gillian Vivian Primary Care Group Medical Oncology Mrs Julietta Patnick Consultant in Nuclear Aylesbury, Bucks Christie Hospital NHS Trust National Coordinator Medicine & Radiology Manchester NHS Cancer Screening Royal Cornwall Hospitals Trust Mr John A Cairns Programmes, Sheffield Truro Director, Health Economics Professor Allen Hutchinson Research Unit Director of Public Health & Professor Jennie Popay Mrs Joan Webster University of Aberdeen Deputy Dean, ScHARR Professor of Sociology & Former Chair University of Sheffield Community Health Southern Derbyshire Dr Nicky Cullum University of Salford Community Health Council Professor David Mant Reader in Health Studies Nottingham Professor of General Practice University of York Institute of Health Sciences Professor Chris Price University of Oxford Professor of Professor Pam Enderby Clinical Biochemistry Chair of Community Professor Alexander Markham St Bartholomew’s & The Rehabilitation Director Royal London School of University of Sheffield Molecular Medicine Unit Medicine & Dentistry St James’s University Hospital Mr Leonard R Fenwick Leeds Mr Simon Robbins Chief Executive Chief Executive Freeman Hospital Dr Chris McCall Camden & Islington Newcastle-upon-Tyne General Practitioner Health Authority, London Corfe Mullen, Dorset Ms Grace Gibbs Dr William Rosenberg Deputy Chief Executive Dr Peter Moore Senior Lecturer & West Middlesex Freelance Science Writer Consultant in Medicine University Hospital Ashtead, Surrey University of Southampton

Current and past membership details of all HTA ‘committees’ are available from the HTA website (see inside front cover for details) 131

Health Technology Assessment 2001; Vol. 5: No. 14 Debriding agents used to treat surgical wounds ISSN 1366-5278 Feedback your views about this report. views your us to transfer them to the website. us to transfer We look forward to hearing from you. to hearing from look forward We The Correspondence Page on the HTA website Page on the HTA The Correspondence (http://www.ncchta.org) is a convenient way to publish way is a convenient (http://www.ncchta.org) to the address below, to the address like would telling us whether you The HTA programme and the authors would like to know know to like and the authors would programme The HTA your comments.your prefer, If you comments can send your you The National Coordinating Centre for Health Technology Assessment, Technology Health for Centre The National Coordinating Mailpoint 728, Boldrewood, of Southampton, University Southampton, SO16 7PX, UK. Fax: +44 (0) 23 8059 5639 Email: [email protected] http://www.ncchta.org Copies of this report can be obtained from: