Protease activity as a prognostic factor for wound healing in complex wounds.

Healing mechanisms are disrupted in complex wounds. Proteases may persist longer in nonhealing wounds. We sought to investigate whether protease activity, protease inhibitor activity, or their combinations are independent prognostic factors for healing of complex wounds. We searched MEDLINE, EMBASE, CINAHL, and The Cochrane Library to March 2019. Study selection comprised longitudinal studies assessing the independent effect of proteases, their inhibitors or ratios of the two, on healing of complex wounds, while controlling for confounding factors. Two reviewers independently extracted data and assessed risk of bias. We conducted meta-analyses separately for proteases, inhibitors, and ratios. We graded the evidence certainty (quality). We identified eight eligible studies in 10 cohorts involving 343 participants. Risk of bias was moderate or high. Elevated protease activity may be associated with less wound healing (standardized mean difference [SMD]: -0.41, 95% CI -0.72 to -0.11; nine cohorts); and elevated protease inhibitor activity with more healing (SMD: 0.37, 95% CI 0.06-0.68; five cohorts), this is low certainty evidence. Increased protease: inhibitor ratios may be associated with less healing (SMD -0.47, 95% CI -0.94 to -0.01; four cohorts), but this evidence is of very low certainty. Heterogeneity in protease activity was unexplained by prespecified subgroup analyses for wound type or protease activity status, but partially explained by protease class. Posthoc analysis suggested elevated levels of a particular protease, MMP-1, may be associated with more healing and other proteases with less healing. This is low/very low certainty evidence. Limitations were small included studies at moderate or high risk of bias, and the use of posthoc analyses. Elevated protease activity and protease: inhibitor ratios may be associated with less healing, and elevated inhibitor levels with more healing. There may be important differences between MMP-1 and other proteases. High quality research is needed to explore these new findings further.

What factors influence community wound care in the UK? A focus group study using the Theoretical Domains Framework.

OBJECTIVES: Research has found unwarranted variation across community wound care services in the North of England, with underuse of evidence-based practice and overuse of interventions where there is little or no known patient benefit. This study explored the factors that influence care in community settings for people with complex wounds, to develop a deeper understanding of the current context of wound care and variation in practice. DESIGN: Qualitative focus group study using the Theoretical Domains Framework (TDF) to structure the questions, prompts and analyses. SETTING: Community healthcare settings in the North of England, UK. PARTICIPANTS: Forty-six clinical professionals who cared for patients with complex wounds and eight non-clinical professionals who were responsible for procuring wound care products participated across six focus group interviews. RESULTS: We found the TDF domains: environmental context and resources, knowledge, skills, social influences and behaviour regulation to best explain the variation in wound care and the underuse of research evidence. Factors such as financial pressures were perceived as having a negative effect on the continuity of care, the availability of wound care services and workloads. We found practice to be mainly based on experiential knowledge and personal preference and highly influenced by colleagues, patients and the pharmaceutical industry, although not by research evidence. CONCLUSIONS: Our study provides new insight into the role that experiential learning and social influences play in determining wound care and on the limited influence of research. Workforce pressures and limited resources are perceived to impede care by reducing patient access to services and the ability to provide holistic care. Participative collaboration between university and healthcare organisations may offer a supportive route to addressing issues, implementing sustainable changes to practice and service delivery and a resolute commitment to research use among clinical professionals.

Opportunities for better value wound care: a multiservice, cross-sectional survey of complex wounds and their care in a UK community population.

BACKGROUND: Complex wounds impose a substantial health economic burden worldwide. As wound care is managed across multiple settings by a range of healthcare professionals with varying levels of expertise, the actual care delivered can vary considerably and result in the underuse of evidence-based interventions, the overuse of interventions supported by limited evidence and low value healthcare. OBJECTIVES: To quantify the number, type and management of complex wounds being treated over a two-week period and to explore variations in care by comparing current practices in wound assessment, prevention and treatment. DESIGN: A multiservice cross-sectional survey. SETTING: This survey spanned eight community services within five Northern England NHS Trusts. RESULTS: The point prevalence of complex wounds in this community-based population was 16.4 per 10 000 (95% CI 15.9 to 17.0). Based on data from 3179 patients, antimicrobial dressings were being used as the primary dressing for 36% of patients with complex wounds. Forty per cent of people with leg ulcers either had not received the recommended Doppler-aided Ankle Brachial Pressure Index assessment or it was unclear whether a recording had been taken. Thirty-one per cent of patients whose most severe wound was a venous leg ulcer were not receiving compression therapy, and there was limited use of two-layer compression hosiery. Of patients with a pressure ulcer, 39% were not using a pressure-relieving cushion or mattress. CONCLUSIONS: Marked variations were found in care, underuse of evidence-based practices and overuse of practices that are not supported by robust research evidence. Significant opportunities for delivering better value wound care therefore exist. Efforts should now focus on developing strategies to identify, assess and disinvest from products and practices supported by little or no evidence and enhance the uptake of those that are.

Do systematic reviews address community healthcare professionals' wound care uncertainties? Results from evidence mapping in wound care.

BACKGROUND: Complex wounds such as leg and foot ulcers are common, resource intensive and have negative impacts on patients' wellbeing. Evidence-based decision-making, substantiated by high quality evidence such as from systematic reviews, is widely advocated for improving patient care and healthcare efficiency. Consequently, we set out to classify and map the extent to which up-to-date systematic reviews containing robust evidence exist for wound care uncertainties prioritised by community-based healthcare professionals. METHODS: We asked healthcare professionals to prioritise uncertainties based on complex wound care decisions, and then classified 28 uncertainties according to the type and level of decision. For each uncertainty, we searched for relevant systematic reviews. Two independent reviewers screened abstracts and full texts of reviews against the following criteria: meeting an a priori definition of a systematic review, sufficiently addressing the uncertainty, published during or after 2012, and identifying high quality research evidence. RESULTS: The most common uncertainty type was 'interventions' 24/28 (85%); the majority concerned wound level decisions 15/28 (53%) however, service delivery level decisions (10/28) were given highest priority. Overall, we found 162 potentially relevant reviews of which 57 (35%) were not systematic reviews. Of 106 systematic reviews, only 28 were relevant to an uncertainty and 18 of these were published within the preceding five years; none identified high quality research evidence. CONCLUSIONS: Despite the growing volume of published primary research, healthcare professionals delivering wound care have important clinical uncertainties which are not addressed by up-to-date systematic reviews containing high certainty evidence. These are high priority topics requiring new research and systematic reviews which are regularly updated. To reduce clinical and research waste, we recommend systematic reviewers and researchers make greater efforts to ensure that research addresses important clinical uncertainties and is of sufficient rigour to inform practice.

Interventions for pressure ulcers: a summary of evidence for prevention and treatment.

STUDY DESIGN: Narrative review. OBJECTIVES: Pressure ulcers are a common complication in people with reduced sensation and limited mobility, occurring frequently in those who have sustained spinal cord injury. This narrative review summarises the evidence relating to interventions for the prevention and treatment of pressure ulcers, in particular from Cochrane systematic reviews. It also aims to highlight the degree to which people with spinal cord injury have been included as participants in randomised controlled trials included in Cochrane reviews of such interventions. SETTING: Global. METHODS: The Cochrane library (up to July 2017) was searched for systematic reviews of any type of intervention for the prevention or treatment of pressure ulcers. A search of PubMed (up to July 2017) was undertaken to identify other systematic reviews and additional published trial reports of interventions for pressure ulcer prevention and treatment. RESULTS: The searches revealed 38 published systematic reviews (27 Cochrane and 11 others) and 6 additional published trial reports. An array of interventions is available for clinical use, but few have been evaluated adequately in people with SCI. CONCLUSIONS: The effects of most interventions for preventing and treating pressure ulcers in people with spinal cord injury are highly uncertain. Existing evaluations of pressure ulcer interventions include very few participants with spinal cord injury. Subsequently, there is still a need for high-quality randomised trials of such interventions in this patient population.

Rapid research and implementation priority setting for wound care uncertainties.

INTRODUCTION: People with complex wounds are more likely to be elderly, living with multimorbidity and wound related symptoms. A variety of products are available for managing complex wounds and a range of healthcare professionals are involved in wound care, yet there is a lack of good evidence to guide practice and services. These factors create uncertainty for those who deliver and those who manage wound care. Formal priority setting for research and implementation topics is needed to more accurately target the gaps in treatment and services. We solicited practitioner and manager uncertainties in wound care and held a priority setting workshop to facilitate a collaborative approach to prioritising wound care-related uncertainties. METHODS: We recruited healthcare professionals who regularly cared for patients with complex wounds, were wound care specialists or managed wound care services. Participants submitted up to five wound care uncertainties in consultation with their colleagues, via an on-line survey and attended a priority setting workshop. Submitted uncertainties were collated, sorted and categorised according professional group. On the day of the workshop, participants were divided into four groups depending on their profession. Uncertainties submitted by their professional group were viewed, discussed and amended, prior to the first of three individual voting rounds. Participants cast up to ten votes for the uncertainties they judged as being high priority. Continuing in the professional groups, the top 10 uncertainties from each group were displayed, and the process was repeated. Groups were then brought together for a plenary session in which the final priorities were individually scored on a scale of 0-10 by participants. Priorities were ranked and results presented. Nominal group technique was used for generating the final uncertainties, voting and discussions. RESULTS: Thirty-three participants attended the workshop comprising; 10 specialist nurses, 10 district nurses, seven podiatrists and six managers. Participants had been qualified for a mean of 20.7 years with a mean of 16.8 years of wound care experience. One hundred and thirty-nine uncertainties were submitted electronically and a further 20 were identified on the day of the workshop following lively, interactive group discussions. Twenty-five uncertainties from the total of 159 generated made it to the final prioritised list. These included six of the 20 new uncertainties. The uncertainties varied in focus, but could be broadly categorised into three themes: service delivery and organisation, patient centred care and treatment options. Specialist nurses were more likely to vote for service delivery and organisation topics, podiatrists for patient centred topics, district nurses for treatment options and operational leads for a broad range. CONCLUSIONS: This collaborative priority setting project is the first to engage front-line clinicians in prioritising research and implementation topics in wound care. We have shown that it is feasible to conduct topic prioritisation in a short time frame. This project has demonstrated that with careful planning and rigor, important questions that are raised in the course of clinicians' daily decision making can be translated into meaningful research and implementation initiatives that could make a difference to service delivery and patient care.

Outcomes in Cochrane systematic reviews related to wound care: An investigation into prespecification.

The choice of outcomes in systematic reviews of the effects of interventions is crucial, dictating which data are included and analyzed. Full prespecification of outcomes in systematic reviews can reduce the risk of outcome reporting bias but, this issue has not been widely investigated. This study is the first to analyze the nature and specification of outcomes used in Cochrane Wounds (CW) systematic reviews. Adequacy of outcome specification was assessed using a five-element framework of key outcome components: outcome domain, specific measurement, specific metric, method of aggregation, and time points. We identified all CW review titles associated with a protocol published on or before October 1, 2014. We categorized all reported outcome domains and recorded whether they were primary or secondary outcomes. We explored outcome specification for outcome domains reported in 25% or more of the eligible protocols. We included 106 protocols and 126 outcome domains; 24.6% (31/126) domains were used as primary outcomes at least once. Eight domains were reported in ≥25% of protocols: wound healing, quality of life, costs, adverse events, resource use, pain, wound infection, and mortality. Wound healing was the most completely specified outcome domain (median 3; interquartile range [IQR] =1-5) along with resource use (median 3; IQR 2-4). Quality of life (median 1; IQR 1-3), pain (median 1; IQR 1-3), and costs (median 1; IQR 1-4) were the least completely specified outcome domains. Outcomes are frequently poorly prespecified and the elements of metric, aggregation, and time-point are rarely adequately specified. We strongly recommend that reviewers be more vigilant about prespecifying outcomes, using the five-element framework. Better prespecification is likely to improve review quality by reducing bias in data abstraction and analysis, and by reducing subjectivity in the decision of which outcomes to extract; it may also improve outcome specification in clinical trial design and reporting.

Validation of the VEINES-QOL quality of life instrument in venous leg ulcers: repeatability and validity study embedded in a randomised clinical trial.

BACKGROUND: VEINES-QOL/Sym is a disease-specific quality of life instrument for use in venous diseases of the leg. Its relative scoring system precludes comparisons between studies. There were very few venous leg ulcer patients in the validation samples. We report a validation study for venous leg ulcers and develop a scoring system which enables comparison between studies. METHODS: Four hundred fifty-one participants in the VenUS IV trial of the management of venous leg ulcers were asked to complete a VEINES-QOL questionnaire at recruitment, along with SF-12, pain, and other aspects of quality of life. VEINES-QOL was repeated after two weeks and after 4 months. Healing of ulcers was confirmed by blind assessment of digital photographs. Three scoring systems for VEINES-QOL were compared. RESULTS: No floor or ceiling effects were observed for VEINES-QOL items, item-item correlations were weak to moderate, item-score correlations were moderate. Internal reliability was good. The VEINES-Sym subscale was confirmed by factor analysis. Test-retest reliability was satisfactory for the scale scores; individual items showed moderate to good agreement. Relationships with SF-12, pain, and the quality items confirmed construct validity. Participants whose ulcers had healed showed greater mean increase in scores than did those yet to heal, though they continued to report leg problems. An intrinsic scoring method appeared superior to the original relative method. CONCLUSIONS: VEINES-QOL was suitable for use in the study of venous leg ulcers. The intrinsic scoring method should be adopted, to facilitate comparisons between studies. TRIAL REGISTRATION: VenUS IV is registered with the ISRCTN register, number ISRCTN49373072 .

Can different primary care databases produce comparable estimates of burden of disease: results of a study exploring venous leg ulceration.

BACKGROUND: Primary care databases from the UK have been widely used to produce evidence on the epidemiology and health service usage of a wide range of conditions. To date there have been few evaluations of the comparability of estimates between different sources of these data. AIM: To estimate the comparability of two widely used primary care databases, the Health Improvement Network Database (THIN) and the General Practice Research Database (GPRD) using venous leg ulceration as an exemplar condition. DESIGN OF STUDY: Cross prospective cohort comparison. SETTING: GPRD and the THIN databases using data from 1998 to 2006. METHOD: A data set was extracted from both databases containing all cases of persons aged 20 years or greater with a database diagnosis of venous leg ulceration recorded in the databases for the period 1998-2006. Annual rates of incidence and prevalence of venous leg ulceration were calculated within each database and standardized to the European standard population and compared using standardized rate ratios. RESULTS: Comparable estimates of venous leg ulcer incidence from the GPRD and THIN databases could be obtained using data from 2000 to 2006 and of prevalence using data from 2001 to 2006. CONCLUSIONS: Recent data collected by these two databases are more likely to produce comparable results of the burden venous leg ulceration. These results require confirmation in other disease areas to enable researchers to have confidence in the comparability of findings from these two widely used primary care research resources.

VenUS IV (Venous leg Ulcer Study IV) - compression hosiery compared with compression bandaging in the treatment of venous leg ulcers: a randomised controlled trial, mixed-treatment comparison and decision-analytic model.

BACKGROUND: Compression is an effective and recommended treatment for venous leg ulcers. Although the four-layer bandage (4LB) is regarded as the gold standard compression system, it is recognised that the amount of compression delivered might be compromised by poor application technique. Also the bulky nature of the bandages might reduce ankle or leg mobility and make the wearing of shoes difficult. Two-layer compression hosiery systems are now available for the treatment of venous leg ulcers. Two-layer hosiery (HH) may be advantageous, as it has reduced bulk, which might enhance ankle or leg mobility and patient adherence. Some patients can also remove and reapply two-layer hosiery, which may encourage self-management and could reduce costs. However, little robust evidence exists about the effectiveness of two-layer hosiery for ulcer healing and no previous trials have compared two-layer hosiery delivering 'high' compression with the 4LB. OBJECTIVES: Part I To compare the clinical effectiveness and cost-effectiveness of HH and 4LB in terms of time to complete healing of venous leg ulcers. Part II To synthesise the relative effectiveness evidence (for ulcer healing) of high-compression treatments for venous leg ulcers using a mixed-treatment comparison (MTC). Part III To construct a decision-analytic model to assess the cost-effectiveness of high-compression treatments for venous leg ulcers. DESIGN: Part I A multicentred, pragmatic, two-arm, parallel, open randomised controlled trial (RCT) with an economic evaluation. Part II MTC using all relevant RCT data - including Venous leg Ulcer Study IV (VenUS IV). Part III A decision-analytic Markov model. SETTINGS: Part I Community nurse teams or services, general practitioner practices, leg ulcer clinics, tissue viability clinics or services and wound clinics within England and Northern Ireland. PARTICIPANTS: Part I Patients aged ≥ 18 years with a venous leg ulcer, who were willing and able to tolerate high compression. INTERVENTIONS: Part I Participants in the intervention group received HH. The control group received the 4LB, which was applied according to standard practice. Both treatments are designed to deliver 40 mmHg of compression at the ankle. Part II and III All relevant high-compression treatments including HH, the 4LB and the two-layer bandage (2LB). MAIN OUTCOME MEASURES: Part I The primary outcome measure was time to healing of the reference ulcer (blinded assessment). Part II Time to ulcer healing. Part III Quality-adjusted life-years (QALYs) and costs. RESULTS: Part I A total of 457 participants were recruited. There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis [hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.79 to 1.25; p = 0.96]. Time to ulcer recurrence was significantly shorter in the 4LB group (HR = 0.56, 95% CI 0.33 to 0.94; p = 0.026). In terms of cost-effectiveness, using QALYs as the measure of benefit, HH had a > 95% probability of being the most cost-effective treatment based on the within-trial analysis. Part II The MTC suggests that the 2LB has the highest probability of ulcer healing compared with other high-compression treatments. However, this evidence is categorised as low to very low quality. Part III Results suggested that the 2LB had the highest probability of being the most cost-effective high-compression treatment for venous leg ulcers. CONCLUSIONS: Trial data from VenUS IV found no evidence of a difference in venous ulcer healing between HH and the 4LB. HH may reduce ulcer recurrence rates compared with the 4LB and be a cost-effective treatment. When all available high-compression treatments were considered, the 2LB had the highest probability of being clinically effective and cost-effective. However, the underpinning evidence was sparse and more research is needed. Further research should thus focus on establishing, in a high-quality trial, the effectiveness of this compression system in particular. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49373072. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 57. See the NIHR Journals Library website for further project information.

Point prevalence of complex wounds in a defined United Kingdom population.

Complex wounds (superficial-, partial-, or full-thickness skin loss wounds healing by secondary intention) are common; however, there is a lack of high-quality, contemporary epidemiological data. This paper presents point prevalence estimates for complex wounds overall as well as for individual types. A multiservice, cross-sectional survey was undertaken across a United Kingdom city (Leeds, population 751,485) during 2 weeks in spring of 2011. The mean age of people with complex wounds was approximately 70 years, standard deviation 19.41. The point prevalence of complex wounds was 1.47 per 1,000 of the population, 95% confidence interval 1.38 to 1.56. While pressure ulcers and leg ulcers were the most frequent, one in five people in the sample population had a less common wound type. Surveys confined to people with specific types of wound would underestimate the overall impact of complex wounds on the population and health care resources.

Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial.

BACKGROUND: Drawbacks exist with the standard treatment (four-layer compression bandages) for venous leg ulcers. We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers. METHODS: We undertook this pragmatic, open, randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland. The centres were community nurse teams or services, family doctor practices, leg ulcer clinics, tissue viability clinics or services, and wound clinics. Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 0·8, and were tolerant of high compression. We randomly allocated participants (1:1) to receive two-layer compression hosiery or a four-layer bandage, using a remote randomisation service and prevalidated computer randomisation program. Participants were stratified by ulcer duration and ulcer area with permuted blocks (block sizes four and six). The primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Although participants and health-care providers were not masked to treatment allocation, the primary endpoint was measured by masked assessment of photographs. Primary analysis was intention to treat with Cox regression, with adjustment for ulcer area, ulcer duration, physical mobility, and centre. This trial is registered with the ISRCTN register, number ISRCTN49373072. FINDINGS: We randomly allocated 457 participants to the two treatment groups: 230 to two-layer hosiery and 227 to the four-layer bandage, of whom 453 (230 hosiery and 223 bandage) contributed data for analysis. Median time to ulcer healing was 99 days (95% CI 84-126) in the hosiery group and 98 days (85-112) in the bandage group, and the proportion of ulcers healing was much the same in the two groups (70·9% hosiery and 70·4% bandage). More hosiery participants changed their allocated treatment (38·3% hosiery vs 27·0% bandage; p=0·02). 300 participants had 895 adverse events, of which 85 (9·5%) were classed as serious but unrelated to trial treatment. INTERPRETATION: Two-layer compression hosiery is a viable alternative to the four-layer bandage-it is equally as effective at healing venous leg ulcers. However, a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients. FUNDING: NIHR Health Technology Assessment programme (07/60/26).

Investigation of the effect of deprivation on the burden and management of venous leg ulcers: a cohort study using the THIN database.

BACKGROUND: There has been limited examination of the contribution of socio-economic factors to the development of leg ulcers, despite the social patterning of many underlying risk factors. No previous studies were found that examined social patterns in the quality of treatment received by patients with leg ulcers. METHODS: Using The Health Improvement Network (THIN) database we identified a cohort of over 14000 patients with a diagnosis of venous leg ulceration, prospectively recorded between the years 2001 and 2006, with linked area-level socio-economic information (Townsend deprivation quintile). We assessed socio-economic differences in the incidence and prevalence of leg ulcers using negative binomial regression. Socio-economic differences in two key areas of guideline recommended leg ulcer management, arterial Doppler assessment and compression bandaging, were assessed using multilevel regression. RESULTS: The risk of incident venous leg ulceration increased for patients living in areas of higher deprivation, even after adjustment for known risk factors age and gender. Overall reported rates of Doppler assessment and provision of compression therapy were low, with less than sixteen per cent of patients having a database record of receiving these recommended diagnostic and treatment options. Patients diagnosed with incident venous leg ulcers living in the most deprived areas were less likely to receive the recommended Doppler-aided assessment for peripheral vascular disease than patients living in the least deprived areas (odds ratio 0.43, 95% confidence interval 0.24-0.78). Documented provision of compression therapy did not vary with deprivation. CONCLUSIONS: A socio-economic gradient in venous leg ulcer disease was observed. The overall rates of people with venous leg ulcers who were documented as receiving guideline recommended care (2001-2006) were low. Reported use of Doppler ultrasound assessment was negatively associated with socio-economic status. These findings suggest that the inequalities experienced by leg ulcer patients may be exacerbated by reduced access to guideline-based management.

A systematic review of the performance of instruments designed to measure the dimensions of pressure ulcers.

The objective was to undertake a systematic review of the performance of wound measurement instruments used for patients with pressure ulcers. Studies of any design, evaluating methods for estimating wound diameter, depth, surface area, or volume in patients with pressure ulcers were included. Eligible evaluations had to report intra- or inter-rater reliability, accuracy, agreement, or feasibility of methods. Electronic databases and other sources were accessed for study identification. Included studies were critically appraised using a modified checklist for diagnostic test evaluations. Twelve studies were included. Most had methodological problems and/or used inappropriate statistical methods. Reliable methods for measuring pressure ulcer surface area may include: grid tracings from photographs combined with whole plus partial square count; a portable digital pad; and stereophotogrammetry combined with computerized image analysis. The agreement between photographic tracing and direct transparency tracing may be satisfactory (both methods being combined with computerized planimetry). No definitive conclusions could be reached about studies of diameter or depth; this means that there is little evidence to underpin recommendations in clinical guidelines. Evaluations of volume measurement were of poor quality, and there were few data on feasibility. Further primary research is needed to evaluate methods of wound measurement used in clinical practice.

Electromagnetic therapy for treating venous leg ulcers.

BACKGROUND: Leg ulceration is a common, chronic, recurring condition. The estimated prevalence of leg ulcers in the UK population is 1.5 to 3 per 1000. Venous ulcers (also called stasis or varicose ulcers) comprise 80% to 85% of all leg ulcers. Electromagnetic therapy (EMT) is sometimes used as a treatment to assist the healing of chronic wounds such as venous leg ulcers. OBJECTIVES: To assess the effects of EMT on the healing of venous leg ulcers. SEARCH STRATEGY: For this second update, Cochrane Wounds Group Specialised Register (searched 16 February 2011); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 1); Ovid MEDLINE (1950 to February Week 1 2011); Ovid MEDLINE (In-Process & Other Non-Indexed Citations February 15, 2011); Ovid EMBASE (1980 to 2011 Week 06); and EBSCO CINAHL (1982 to 11 February 2011). We applied no date or language restrictions. SELECTION CRITERIA: Randomised controlled trials comparing EMT with sham-EMT or other treatments. DATA COLLECTION AND ANALYSIS: At least two review authors independently scrutinised search results and obtained full reports of potentially eligible studies for further assessment. We extracted and summarised details of eligible studies using a data extraction sheet, and made attempts to obtain missing data by contacting study authors. A second review author checked data extraction, and we resolved disagreements after discussion between review authors. MAIN RESULTS: Three randomised controlled trials (RCTs) of variable quality involving 94 people were included in the original review; subsequent updates have identified no new trials. All the trials compared the use of EMT with sham-EMT. In the two trials that reported healing rates; one small trial (44 participants) reported that significantly more ulcers healed in the EMT group than the sham-EMT group however this result was not robust to different assumptions about the outcomes of participants who were lost to follow up. The second trial that reported numbers of ulcers healed found no significant difference in healing. The third trial was also small (31 participants) and reported significantly greater reductions in ulcer size in the EMT group however this result may have been influenced by differences in the prognostic profiles of the treatment groups. AUTHORS' CONCLUSIONS: There is no high quality evidence that electromagnetic therapy increases the rate of healing of venous leg ulcers, and further research is needed.

Electromagnetic therapy for treating pressure ulcers.

BACKGROUND: Pressure ulcers are defined as areas "of localized damage to the skin and underlying tissue caused by pressure, shear, friction and/or the combination of these". Electromagnetic therapy (EMT), in which electrodes produce an electromagnetic field across the wound, may improve healing of chronic wounds such as pressure ulcers. OBJECTIVES: To assess the effects of EMT on the healing of pressure ulcers. SEARCH STRATEGY: For this update we searched the Cochrane Wounds Group Specialised Register (2 June 2010); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 2); Ovid MEDLINE (2007 to May Week 3 2010); Ovid EMBASE (2007 to Week 21 2010) and EBSCO CINAHL (2007 to 1 June 2010). SELECTION CRITERIA: Randomised controlled trials comparing EMT with sham EMT or other (standard) treatment. DATA COLLECTION AND ANALYSIS: For this update two review authors independently scrutinised the results of the search to identify relevant RCTs and obtained full reports of potentially eligible studies. We made attempts to obtain missing data by contacting study authors. A second review author checked data extraction and disagreements were resolved after discussion between review authors. MAIN RESULTS: We identified no new trials for this update.Two randomised controlled trials (RCTs), involving 60 participants, at unclear risk of bias were included in the original review. Both trials compared the use of EMT with sham EMT, although one of the trials included a third arm in which only standard therapy was applied. Neither study found a statistically significant difference in complete healing in people treated with EMT compared with those in the control group. In one trial that assessed percentage reduction in wound surface area, the difference between the two groups was reported to be statistically significant in favour of EMT. However, this result should be interpreted with caution as this is a small study and this finding may be due to chance. Additionally, the outcome, percentage reduction in wound area, is less clinically meaningful than complete healing. AUTHORS' CONCLUSIONS: The results provide no strong evidence of benefit in using EMT to treat pressure ulcers. However, the possibility of a beneficial or harmful effect cannot be ruled out because there were only two included trials, both with methodological limitations and small numbers of participants. Further research is recommended.

Therapeutic ultrasound for venous leg ulcers.

BACKGROUND: Venous leg ulcers pose a significant burden for patients and healthcare systems. Ultrasound (US) may be a useful treatment for these ulcers. OBJECTIVES: To determine whether US increases the healing of venous leg ulcers. SEARCH STRATEGY: We searched the Cochrane Wounds Group Specialised Register (searched 24 February 2010); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2010); Ovid MEDLINE (1950 to February Week 2 2010); In-Process & Other Non-Indexed Citations (searched 24 February 2010); Ovid EMBASE 1980 to 2010 Week 07; EBSCO CINAHL 1982 to 24 February 2010. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing US with no US. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the search results and selected eligible studies. Details from included studies were summarised using a data extraction sheet, and double-checked. We tried to contact trial authors for missing data. MAIN RESULTS: Eight trials were included; all had unclear, or high, risks of bias, with differences in duration of follow-up, and US regimens. Six trials evaluated high frequency US and five of these reported healing at 7 - 8 weeks. Significantly more patients healed with US than without it at 7 - 8 weeks (pooled RR 1.4, 95% CI 1.0 to 1.96), but later assessments at 12 weeks showed the increased risk of healing with US was no longer statistically significant (pooled RR 1.47, 95% CI 0.99 to 2.20). One poor-quality study of high-frequency US found no evidence of an effect on healing after three weeks' treatment.Two trials evaluated low frequency US and reported healing at different time points. Both trials reported no evidence of a difference in the proportion of ulcers healed with US compared with no US: both were significantly underpowered. AUTHORS' CONCLUSIONS: The trials evaluating US for venous leg ulcers are small, poor-quality and heterogeneous. There is no reliable evidence that US hastens healing of venous ulcers. There is a small amount of weak evidence of increased healing with US, but this requires confirmation in larger, high-quality RCTs. There is no evidence of a benefit associated with low frequency US.

Compression for venous leg ulcers.

BACKGROUND: Around one percent of people in industrialised countries will suffer from a leg ulcer at some time. The majority of these leg ulcers are due to problems in the veins, resulting in an accumulation of blood in the legs. Leg ulcers arising from venous problems are called venous (varicose or stasis) ulcers. The main treatment has been a firm compression garment (bandage or stocking) in order to aid venous return. There is a large number of compression garments available and it is unclear whether they are effective in treating venous ulcers and which compression garment is the most effective. OBJECTIVES: To undertake a systematic review of all randomised controlled trials of the clinical effectiveness of compression bandage or stocking systems in the treatment of venous leg ulceration.Specific questions addressed by the review are:1. Does the application of compression bandages or stockings aid venous ulcer healing? 2. Which compression bandage or stocking system is the most effective? SEARCH STRATEGY: For this update we searched the Cochrane Wounds Group Specialised Register (14/10/08); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4 2008); Ovid MEDLINE (1950 to October Week 1 2008); Ovid EMBASE (1980 to 2008 Week 41) and Ovid CINAHL (1982 to October Week 1 2008). No date or language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials recruiting people with venous leg ulceration that evaluated any type of compression bandage system or compression hosiery were eligible for inclusion. Comparators included no compression (e.g. primary dressing alone, non-compressive bandage) or an alternative type of compression. Trials had to report an objective measure of ulcer healing in order to be included (primary outcome for the review). Secondary outcomes of the review included ulcer recurrence, costs, quality of life, pain, adverse events and withdrawals. There was no restriction on date, language or publication status of trials. DATA COLLECTION AND ANALYSIS: Details of eligible studies were extracted and summarised using a data extraction table. Data extraction was performed by one review author and verified independently by a second review author. MAIN RESULTS: Overall, 39 RCTs reporting 47 comparisons were included.Review question 1: there was reasonable evidence from seven RCTs that venous ulcers heal more rapidly with compression than without.Review question 2: findings from six trials of single-component compression suggested that this strategy was less effective than multi-component compression. Evidence from compression systems with two components (3 trials) and three components (4 trials) suggested better outcomes when an elastic component was included. Different versions of compression with four-components (based on the Charing Cross four-layer bandage system) have similar effectiveness (3 trials). Compression with four components (variants of the Charing Cross four-layer bandage) is more effective than multi-component compression that includes a short-stretch bandage (6 trials). It is difficult to determine the relative effectiveness of the four-layer bandage compared with paste bandage systems because of differences in the paste systems (5 trials). There was no difference in effectiveness between the adjustable compression boot and compression bandages (2 trials) or between single-layer compression stockings and paste bandages (2 trials). Two-layer stockings appeared more effective than the short-stretch bandage (2 trials). The relative effectiveness of tubular compression when compared with compression bandages was not clear from current evidence (2 trials).Three trials reported ulcer recurrence; because of sparseness of data and trials not being primarily designed to assess this outcome, firm conclusions could not be drawn. Although several trials included cost data, only one reported a rigorously conducted cost-effectiveness analysis with findings suggesting that the four-layer bandage was more cost-effective than multi-component compression comprising a short-stretch bandage. Seven trials assessed health-related quality of life and none observed significant differences between treatment groups. Several trials evaluated pain either as a stand-alone outcome, or as part of the assessment of adverse events. In general, the data did not indicate clear differences between treatment groups. It is possible that stockings could be associated with less pain than bandages but in view of scarcity of available data this requires further evaluation. Many of the trials reported adverse events and / or withdrawals. Overall, these outcomes appeared similar across different treatment groups. AUTHORS' CONCLUSIONS: Compression increases ulcer healing rates compared with no compression. Multi-component systems are more effective than single-component systems. Multi-component systems containing an elastic bandage appear more effective than those composed mainly of inelastic constituents.

Support surfaces for pressure ulcer prevention.

BACKGROUND: Pressure ulcers (also known as bedsores, pressure sores, decubitus ulcers) are areas of localised damage to the skin and underlying tissue due to pressure, shear or friction. They are common in the elderly and immobile and costly in financial and human terms. Pressure-relieving beds, mattresses and seat cushions are widely used as aids to prevention in both institutional and non-institutional settings. OBJECTIVES: This systematic review seeks to answer the following questions:(1) to what extent do pressure-relieving cushions, beds, mattress overlays and mattress replacements reduce the incidence of pressure ulcers compared with standard support surfaces?(2) how effective are different pressure-relieving surfaces in preventing pressure ulcers, compared to one another? SEARCH STRATEGY: For this second update the Cochrane Wounds Group Specialised Register was searched (28/2/08), The Cochrane Central Register of Controlled Trials (CENTRAL)(2008 Issue 1), Ovid MEDLINE (1950 to February Week 3 2008), Ovid EMBASE (1980 to 2008 Week 08) and Ovid CINAHL (1982 to February Week 3 2008). The reference sections of included studies were searched for further trials. SELECTION CRITERIA: Randomised controlled trials (RCTs), published or unpublished, which assessed the effectiveness of beds, mattresses, mattress overlays, and seating cushions for the prevention of pressure ulcers, in any patient group, in any setting. Study selection was undertaken by at least two authors independently with a third author resolving uncertainty. RCTs were eligible for inclusion if they reported an objective, clinical outcome measure such as incidence and severity of new of pressure ulcers developed. Studies which only reported proxy outcome measures such as interface pressure were excluded. DATA COLLECTION AND ANALYSIS: Trial data were extracted by one researcher and checked by a second. The results from each study are presented as relative risk for dichotomous variables. Where deemed appropriate, similar studies were pooled in a meta analysis. MAIN RESULTS: For this second update 11 trials met the inclusion criteria bringing the total number of RCTs included in the review to 52.Foam alternatives to the standard hospital foam mattress can reduce the incidence of pressure ulcers in people at risk. The relative merits of alternating and constant low pressure devices are unclear. There is one high quality trial comparing the different alternating pressure devices for pressure ulcer prevention which suggests that alternating pressure mattresses may be more cost effective than alternating pressure overlays.Pressure-relieving overlays on the operating table have been shown to reduce postoperative pressure ulcer incidence, although two studies indicated that foam overlays resulted in adverse skin changes. Two trials indicated that Australian standard medical sheepskins prevented pressure ulcers. There is insufficient evidence to draw conclusions on the value of seat cushions, limb protectors and various constant low pressure devices as pressure ulcer prevention strategies.A study of Accident & Emergency trolley overlays did not identify a reduction in pressure ulcer incidence. There are tentative indications that foot waffle heel elevators, a particular low air loss hydrotherapy mattress and two types of operating theatre overlays are harmful. AUTHORS' CONCLUSIONS: In people at high risk of pressure ulcer development higher specification foam mattresses rather than standard hospital foam mattresses should be used. The relative merits of higher-tech constant low pressure and alternating pressure for prevention are unclear but alternating pressure mattresses may be more cost effective than alternating pressure overlays. Medical grade sheepskins are associated with a decrease in pressure ulcer development. Organisations might consider the use of some forms of pressure relief for high risk patients in the operating theatre. Seat cushions and overlays designed for use in Accident & Emergency settings have not been adequately evaluated.