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AimsTo explore barriers to, and facilitators of, adherence to compression therapy, from the perspective of people with venous leg ulcers.DesignAn interpretive, qualitative, descriptive study involving interviews with patients.MethodsParticipants were purposively sampled from respondents to a survey exploring attitudes to compression therapy in people with venous leg ulcers. Sampling continued until data saturation: 25 interviews between December 2019 and July 2020. Inductive thematic analysis of interview transcripts was undertaken to create a framework for the data, followed by deductive analysis informed by the Common-Sense Model of Self-Regulation.ResultsA range of knowledge and understanding about the cause of venous leg ulcers and the mechanisms of compression therapy was demonstrated, which was not particularly related to adherence. Participants talked about their experience with different compression methods and their concerns about the length of time healing could take. They also spoke about aspects of the organization of services which affected their care.ConclusionIdentifying specific, individual barriers/facilitators to compression therapy is not simple, rather factors combine to make adherence more or less likely or possible. There was no clear relationship between an understanding of the cause of VLUs or the mechanism of compression therapy and adherence; different compression therapies presented different challenges for patients; unintentional non-adherence was frequently mentioned; and the organization of services could impact on adherence. Ways in which people could be supported to adhere to compression therapy are indicated. Implications for practice include issues relating to communication with patients; taking into account patients' lifestyles and ensuring that they know about useful ‘aids’; providing services that are accessible and provide continuity of appropriately trained staff; minimizing unintentional non-adherence; and acknowledging that healthcare professionals will always need to support/advise those who cannot tolerate compression.ImpactCompression therapy is a cost-effective, evidence-based treatment for venous leg ulcers. However, there is evidence that patients do not always adhere to this therapy and there is limited research investigating reasons why patients do not wear compression. The study found no clear relationship between an understanding of the cause of VLUs or the mechanism of compression therapy and adherence; that different compression therapies presented different challenges for patients; that unintentional non-adherence was frequently mentioned and that the organization of services could impact on adherence. Attending to these findings offers the opportunity to increase the proportion of people undergoing appropriate compression therapy and achieving complete wound healing, the main outcome desired by this group.Patient/Public ContributionA patient representative sits on the Study Steering Group, contributing to the work from developing the study protocol and interview schedule to interpretation and discussion of findings. Members of a Wounds Research Patient and Public Involvement Forum were consulted about interview questions.

Understanding why some wounds are hard to heal is important for improving care and developing more effective treatments. The method of sample collection used is an integral step in the research process and thus may affect the results obtained. The primary objective of this study was to summarise and map the methods currently used to sample wound fluid for protein profiling and analysis. Eligible studies were those that used a sampling method to collect wound fluid from any human wound for analysis of proteins. A search for eligible studies was performed using MEDLINE, Embase and CINAHL Plus in May 2020. All references were screened for eligibility by one reviewer, followed by discussion and consensus with a second reviewer. Quantitative data were mapped and visualised using appropriate software and summarised via a narrative summary. After screening, 280 studies were included in this review. The most commonly used group of wound fluid collection methods were vacuum, drainage or use of other external devices, with surgical wounds being the most common sample source. Other frequently used collection methods were extraction from absorbent materials, collection beneath an occlusive dressing and direct collection of wound fluid. This scoping review highlights the variety of methods used for wound fluid collection. Many studies had small sample sizes and short sample collection periods; these weaknesses have hampered the discovery and validation of novel biomarkers. Future research should aim to assess the reproducibility and feasibility of sampling and analytical methods for use in larger longitudinal studies.

BackgroundIn the United Kingdom, the use of the terms ‘complex’ and ‘complexity’ alongside dementia is reflected in a number of policy and practice documents. However, there is a lack of evidence that explores how complexity is perceived, constructed and experienced by people with dementia, family carers and practitioners working in the NHS dementia inpatient assessment wards [dementia assessment wards].ObjectiveTo explore the meaning and concept of complexity in dementia from within the setting of a dementia assessment ward and develop a practice model.MethodsThe study was conducted over three phases: 1) an online electronic survey of UK national dementia leaders; 2) individual interviews and a focus group with dementia practitioners in two dementia assessment wards; 3) case studies of four patients with dementia resident on a dementia assessment ward which included their identified family carer/consultee, the named clinician on the ward involved in that person’s care and a care records review.ResultsThe findings highlighted that complexity is constructed through a number of interconnected and interrelated domains that vary in acuity. These findings have been developed into the ‘3 Fs Model of Complexity’ and the 3‘Fs’ stand for Fixed, Flexible and Fluctuating. The Fixed domain consists of six components which are always present in complexity. The Flexible domain consists of 14 components and a person with dementia may experience any number of Flexible domain components at any one time. The Fluctuating domain highlights that all components have the ability to vary in their acuity.ConclusionThe ‘3 Fs Model of Complexity’ may facilitate a more holistic view of a person with dementia than when ‘symptoms’ are viewed in isolation. Going forward, and subject to further refinement and testing, the ‘3 Fs Model of Complexity’ could help guide the selection of tailored, personalised interventions for people with dementia, including formulation approaches.

BackgroundThere is increasing demand for more rapid evaluation of innovation in health and social care, to support timely decision-making about service redesign. These pressures have increased during the COVID-19 pandemic. Making evaluations more rapid raises challenges in terms of ensuring rigour and the effective use of resources, but assessment of rapid evaluation methodologies has been lacking. MethodsWe conducted a scoping review to map the developing field of methods of rapid evaluation of innovation in health and social care, to describe the existing literature, categorise different approaches to rapid evaluation, and identify knowledge gaps. We searched multiple databases and websites of key organisations. We prioritised studies with relevance to the context of the NHS in England. We extracted information to enable us to classify and map existing studies on key characteristics. We undertook a narrative synthesis to identify the evidence and the gaps; focussing on the different approaches to conducting rapid evaluation in primary research. ResultsWe identified 14069 records from our searches of which 352 explored rapid evaluations of innovations, methods for rapid evaluation or rapid evaluation of implementation. Our scoping review identified four main approaches used for rapid evaluation: (1) Use of a methodology designed specifically for rapid evaluation;(2) Increasing rapidity by doing less or using a less time-intensive methodology;(3) Use of alternative technologies and/or data to increase the speed of an existing evaluation method; (4) Adaptation of part of a non-rapid evaluation DiscussionThis scoping review identified a lack of clarity about ‘rapid evaluation’ but identified some useful preliminary categories. There is very little comparative research on the impact of using rapid rather than standard evaluation. There is a need for clarity and consistency in terms of what constitutes rapid evaluation, the development of specific methodologies for making evaluation more rapid, and assessment of the advantages and disadvantages of rapid methodology in terms of rigour, cost and impact.

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.

AIMS AND OBJECTIVES: To explore surgeons' and nurses' perspectives of managing surgical wounds healing by secondary intention.BACKGROUND: Every year, more than 10 million surgical operations are performed in the NHS in the UK. Most surgical wounds heal by primary intention, where the edges of the wound are brought together with staples, sutures, adhesive glue or clips. Sometimes wounds are deliberately left open to heal, from the base up, known as "healing by secondary intention." These wounds are often slow to heal, prone to infection and complex to manage.DESIGN: A qualitative, descriptive approach, using semi-structured interviews.METHODS: Interviews with five (general, vascular and plastic) surgeons and 7 nurses (3 tissue viability nurses, 2 district and 1 community nurse, and 1 hospital nurse) working in hospital and community care settings in two locations in the north of England. Data analysis followed the recommended sequential steps of "Framework" approach. Consolidated criteria for reporting qualitative research guided the study report.RESULTS: Participants reported that the main types of wounds healing by secondary intention that they manage are extensive abdominal cavity wounds; open wounds relating to treatment for pilonidal sinus; large open wounds on the feet of patients with diabetes; and axilla and groin wounds, associated with removal of lymph nodes for cancer. Infection and prolonged time to healing were the main challenges. Negative pressure wound therapy was the most favoured treatment option.CONCLUSIONS: Negative pressure wound therapy was advocated by professionals despite a lack of research evidence indicating clinical or cost-effectiveness. Our findings underscore the need for rigorous evaluation of negative pressure wound therapy, and other wound care treatments, through studies that include economic evaluation.RELEVANCE FOR CLINICAL PRACTICE: Clinical decision-making in wound care could be optimised through further robust studies to inform practitioners about the cost-effectiveness of available treatments.

Protocol withdrawn from publication and review discontinued.

ObjectiveThe COVID-19 pandemic increased the demand for rapid evaluation of innovation in health and social care. Assessment of rapid methodologies is lacking although challenges in ensuring rigour and effective use of resources are known. We mapped reports of rapid evaluations of health and social care innovations, categorised different approaches to rapid evaluation, explored comparative benefits of rapid evaluation, and identified knowledge gaps.DesignScoping review.Data sourcesMEDLINE, EMBASE and Health Management Information Consortium (HMIC) databases were searched through 13 September 2022.Eligibility criteria for selecting studiesWe included publications reporting primary research or methods for rapid evaluation of interventions or services in health and social care in high-income countries.Data extraction and synthesisTwo reviewers developed and piloted a data extraction form. One reviewer extracted data, a second reviewer checked 10% of the studies; disagreements and uncertainty were resolved through consensus. We used narrative synthesis to map different approaches to conducting rapid evaluation.ResultsWe identified 16 759 records and included 162 which met inclusion criteria.We identified four main approaches for rapid evaluation: (1) Using methodology designed specifically for rapid evaluation; (2) Increasing rapidity by doing less or using less time-intensive methodology; (3) Using alternative technologies and/or data to increase speed of existing evaluation method; (4) Adapting part of non-rapid evaluation.The COVID-19 pandemic resulted in an increase in publications and some limited changes in identified methods. We found little research comparing rapid and non-rapid evaluation.ConclusionsWe found a lack of clarity about what ‘rapid evaluation’ means but identified some useful preliminary categories. There is a need for clarity and consistency about what constitutes rapid evaluation; consistent terminology in reporting evaluations as rapid; development of specific methodologies for making evaluation more rapid; and assessment of advantages and disadvantages of rapid methodology in terms of rigour, cost and impact.

Background Pressure ulcers (also known as pressure injuries, pressure sores and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Specific kinds of beds, overlays and mattresses are widely used with the aim of preventing and treating pressure ulcers. Objectives To summarise evidence from Cochrane Reviews that assess the effects of beds, overlays and mattresses on reducing the incidence of pressure ulcers and on increasing pressure ulcer healing in any setting and population. To assess the relative effects of different types of beds, overlays and mattresses for reducing the incidence of pressure ulcers and increasing pressure ulcer healing in any setting and population. To cumulatively rank the different treatment options of beds, overlays and mattresses in order of their effectiveness in pressure ulcer prevention and treatment. Methods In July 2020, we searched the Cochrane Library. Cochrane Reviews reporting the effectiveness of beds, mattresses or overlays for preventing or treating pressure ulcers were eligible for inclusion in this overview. Two review authors independently screened search results and undertook data extraction and risk of bias assessment using the ROBIS tool. We summarised the reported evidence in an overview of reviews. Where possible, we included the randomised controlled trials from each included review in network meta‐analyses. We assessed the relative effectiveness of beds, overlays and mattresses for preventing or treating pressure ulcers and their probabilities of being, comparably, the most effective treatment. We assessed the certainty of the evidence using the GRADE approach. Main results We include six Cochrane Reviews in this overview of reviews, all at low or unclear risk of bias. Pressure ulcer prevention: four reviews (of 68 studies with 18,174 participants) report direct evidence for 27 pairwise comparisons between 12 types of support surface on the following outcomes: pressure ulcer incidence, time to pressure ulcer incidence, patient comfort response, adverse event rates, health‐related quality of life, and cost‐effectiveness. Here we focus on outcomes with some evidence at a minimum of low certainty. (1) Pressure ulcer incidence: our overview includes direct evidence for 27 comparisons that mostly (19/27) have very low‐certainty evidence concerning reduction of pressure ulcer risk. We included 40 studies (12,517 participants; 1298 participants with new ulcers) in a network meta‐analysis involving 13 types of intervention. Data informing the network are sparse and this, together with the high risk of bias in most studies informing the network, means most network contrasts (64/78) yield evidence of very low certainty. There is low‐certainty evidence that, compared with foam surfaces (reference treatment), reactive air surfaces (e.g. static air overlays) (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.29 to 0.75), alternating pressure (active) air surfaces (e.g. alternating pressure air mattresses, large‐celled ripple mattresses) (RR 0.63, 95% CI 0.42 to 0.93), and reactive gel surfaces (e.g. gel pads used on operating tables) (RR 0.47, 95% CI 0.22 to 1.01) may reduce pressure ulcer incidence. The ranking of treatments in terms of effectiveness is also of very low certainty for all interventions. It is unclear which treatment is best for preventing ulceration. (2) Time to pressure ulcer incidence: four reviews had direct evidence on this outcome for seven comparisons. We included 10 studies (7211 participants; 699 participants with new ulcers) evaluating six interventions in a network meta‐analysis. Again, data from most network contrasts (13/15) are of very low certainty. There is low‐certainty evidence that, compared with foam surfaces (reference treatment), reactive air surfaces may reduce the hazard of developing new pressure ulcers (hazard ratio (HR) 0.20, 95% CI 0.04 to 1.05). The ranking of all support surfaces for preventing pressure ulcers in terms of time to healing is uncertain. (3) Cost‐effectiveness: this overview includes direct evidence for three comparisons. For preventing pressure ulcers, alternating pressure air surfaces are probably more cost‐effective than foam surfaces (moderate‐certainty evidence). Pressure ulcer treatment: two reviews (of 12 studies with 972 participants) report direct evidence for five comparisons on: complete pressure ulcer healing, time to complete pressure ulcer healing, patient comfort response, adverse event rates, and cost‐effectiveness. Here we focus on outcomes with some evidence at a minimum of low certainty. (1) Complete pressure ulcer healing: our overview includes direct evidence for five comparisons. There is uncertainty about the relative effects of beds, overlays and mattresses on ulcer healing. The corresponding network meta‐analysis (with four studies, 397 participants) had only three direct contrasts and a total of six network contrasts. Again, most network contrasts (5/6) have very low‐certainty evidence. There was low‐certainty evidence that more people with pressure ulcers may heal completely using reactive air surfaces than using foam surfaces (RR 1.32, 95% CI 0.96 to 1.80). We are uncertain which surfaces have the highest probability of being the most effective (all very low‐certainty evidence). (2) Time to complete pressure ulcer healing: this overview includes direct evidence for one comparison: people using reactive air surfaces may be more likely to have healed pressure ulcers compared with those using foam surfaces in long‐term care settings (HR 2.66, 95% CI 1.34 to 5.17; low‐certainty evidence). (3) Cost‐effectiveness: this overview includes direct evidence for one comparison: compared with foam surfaces, reactive air surfaces may cost an extra 26 US dollars for every ulcer‐free day in the first year of use in long‐term care settings (low‐certainty evidence). Authors' conclusions Compared with foam surfaces, reactive air surfaces may reduce pressure ulcer risk and may increase complete ulcer healing. Compared with foam surfaces, alternating pressure air surfaces may reduce pressure ulcer risk and are probably more cost‐effective in preventing pressure ulcers. Compared with foam surfaces, reactive gel surfaces may reduce pressure ulcer risk, particularly for people in operating rooms and long‐term care settings. There are uncertainties for the relative effectiveness of other support surfaces for preventing and treating pressure ulcers, and their efficacy ranking. More high‐quality research is required; for example, for the comparison of reactive air surfaces with alternating pressure air surfaces. Future studies should consider time‐to‐event outcomes and be designed to minimise any risk of bias., Plain language summary What are the benefits and risks of beds, mattresses and overlays for preventing and treating pressure ulcers? The overview presents a lot of data from randomised controlled trials and contains an advanced analysis called 'network meta‐analysis'. The analysis allows comparisons of all types of support surfaces for preventing or treating pressure ulcers. This interactive tool may help with navigation of the datahttps://stopthepressure.shinyapps.io/Cochrane_support_surface_reviews/. Key messages Static air mattresses or overlays, alternating pressure air mattresses or overlays, and gel pads used on operating tables may be better than foam mattresses for preventing pressure ulcers. Compared with foam mattresses, alternating pressure air mattresses or overlays probably result in health benefits that outweigh their costs in preventing pressure ulcers. Static air mattresses or overlays may be better than foam mattresses for ulcer healing, but may cost more. It is unclear what the best treatment is for either preventing or treating pressure ulcers; what the effects of these treatment options are on people’s comfort and quality of life; and whether or not there are any unwanted effects. What are pressure ulcers? Pressure ulcers (also known as pressure sores or bed sores) are wounds to the skin and underlying tissue caused by prolonged pressure or rubbing. People who have mobility problems or who lie in bed for long periods are at risk of developing pressure ulcers. What did we want to find out? There are many types of beds, mattresses and overlays specifically designed for people with pressure ulcers. These can be made from a range of materials (such as foam, air cells and gel pads) and are divided into two groups: ‐ reactive (static) surfaces that apply a constant pressure to the skin; and ‐ active (alternating pressure) surfaces that regularly redistribute the pressure under the body. We wanted to find out if different types of reactive and active surfaces: ‐ prevent pressure ulcers; ‐ help ulcers to heal; ‐ are comfortable and improve people’s quality of life; ‐ have health benefits that outweigh their costs; and ‐ have any unwanted effects. We also wanted to find out what the best treatment options are for either preventing or healing pressure ulcers. What did we do? We searched for Cochrane Reviews that summarised the results of all available carefully designed studies (controlled trials) evaluating different beds, mattresses and overlays in preventing and treating pressure ulcers. A Cochrane Review provides a high level of evidence on the effectiveness of healthcare interventions. We summarised the results of these reviews in a single document (called an overview of reviews). We also collected studies included in these reviews and compared all available treatments at the same time in a single analysis (called network meta‐analysis). We then summarised these results, and rated our confidence in the evidence, based on factors such as study methods and sizes. What did we find? Effects in preventing pressure ulcers We found four reviews on the use of beds, mattresses and overlays for preventing pressure ulcers. From these, we included 40 studies (12,517 people) in a network meta‐analysis evaluating reduction of pressure ulcer risk. The network meta‐analysis evidence suggests that static (reactive) air overlays, alternating pressure air mattresses, and (reactive) gel pads used on operating tables may reduce pressure ulcer risk compared with foam mattresses. We also included 10 studies (7211 people) in a network meta‐analysis evaluating the time taken for new ulcers to develop. The network meta‐analysis evidence suggests that reactive air surfaces may reduce the chances of developing new ulcers compared with foam surfaces. Effects in treating pressure ulcers We found two reviews on pressure ulcer healing. From these, we included four studies (397 people) in a network meta‐analysis. The network meta‐analysis evidence suggests that more people with ulcers may heal completely using reactive air surfaces than foam surfaces. The overview evidence suggests that, if the time needed to completely heal an ulcer is looked at, reactive air surfaces may improve the chances of pressure ulcers healing when compared with foam mattresses. However, it is unclear which treatment is best for either preventing or treating pressure ulcers. Other effects in preventing and treating pressure ulcers The overview evidence suggests that: ‐ compared with foam mattresses, alternating pressure air surfaces probably result in health benefits that outweigh their costs in preventing pressure ulcers; ‐ reactive air‐filled surfaces may cost more than foam mattresses in healing ulcers; and ‐ the other benefits and risks of these beds, mattresses and mattress overlays are unclear. What are the limitations of the evidence? Although the reviews we found used reliable methods, most of the studies in them were small and used methods likely to introduce errors in their results. How up‐to‐date is this evidence? The evidence in this overview is current to July 2020.

ObjectivesTo investigate factors that promote and prevent the use of compression therapy in people with venous leg ulcers.DesignQualitative interview study with nurses using the Theoretical Domains Framework (TDF).SettingThree National Health Service Trusts in England.ParticipantsPurposive sample of 15 nurses delivering wound care.ResultsNurses described factors which made provision of compression therapy challenging. Organisational barriers (TDF domains environmental context and resources/knowledge, skills/behavioural regulation) included heavy/increasing caseloads; lack of knowledge/skills and the provision of training; and prescribing issues (variations in bandaging systems/whether nurses could prescribe). Absence of specialist leg ulcer services to refer patients into was perceived as a barrier to providing optimal care by some community-based nurses. Compression use was perceived to be facilitated by clinics for timely initial assessment; continuity of staff and good liaison between vascular/leg ulcer clinics and community teams; clear local policies and care pathways; and opportunities for training such as ‘shadowing’ in vascular/leg ulcer clinics. Patient engagement barriers (TDF domains goals/beliefs about consequences) focused on getting patients ‘on board’ with compression, and supporting them in using it. Clear explanations were seen as key in promoting compression use.ConclusionsRising workload pressures present significant challenges to enhancing leg ulcer services. There may be opportunities to develop facilitated approaches to enable community nursing teams to make changes to practice, enhancing quality of patient care. The majority of venous leg ulcers could be managed in the community without referral to specialist community services if issues relating to workloads/skills/training are addressed. Barriers to promoting compression use could also be targeted, for example, through the development of clear patient information leaflets. While the patient engagement barriers may be easier/quicker to address than organisational barriers, unless organisational barriers are addressed it seems unlikely that all people who would benefit from compression therapy will receive it.

Background Leg ulcers are open skin wounds on the lower leg that can last weeks, months or even years. Most leg ulcers are the result of venous diseases. First‐line treatment options often include the use of compression bandages or stockings. Objectives To assess the effects of using compression bandages or stockings, compared with no compression, on the healing of venous leg ulcers in any setting and population. Search methods In June 2020 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In‐Process & Other Non‐Indexed Citations), Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta‐analyses and health technology reports to identify additional studies. There were no restrictions by language, date of publication or study setting. Selection criteria We included randomised controlled trials that compared any types of compression bandages or stockings with no compression in participants with venous leg ulcers in any setting. Data collection and analysis At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, and risk‐of‐bias assessment using the Cochrane risk‐of‐bias tool. We assessed the certainty of the evidence according to GRADE methodology. Main results We included 14 studies (1391 participants) in the review. Most studies were small (median study sample size: 51 participants). Participants were recruited from acute‐care settings, outpatient settings and community settings, and a large proportion (65.9%; 917/1391) of participants had a confirmed history or clinical evidence of chronic venous disease, a confirmed cause of chronic venous insufficiency, or an ankle pressure/brachial pressure ratio of greater than 0.8 or 0.9. The average age of participants ranged from 58.0 to 76.5 years (median: 70.1 years). The average duration of their leg ulcers ranged from 9.0 weeks to 31.6 months (median: 22.0 months), and a large proportion of participants (64.8%; 901/1391) had ulcers with an area between 5 and 20 cm2. Studies had a median follow‐up of 12 weeks. Compression bandages or stockings applied included short‐stretch bandage, four‐layer compression bandage, and Unna's boot (a type of inelastic gauze bandage impregnated with zinc oxide), and comparator groups used included 'usual care', pharmacological treatment, a variety of dressings, and a variety of treatments where some participants received compression (but it was not the norm). Of the 14 included studies, 10 (71.4%) presented findings which we consider to be at high overall risk of bias. Primary outcomes There is moderate‐certainty evidence (downgraded once for risk of bias) (1) that there is probably a shorter time to complete healing of venous leg ulcers in people wearing compression bandages or stockings compared with those not wearing compression (pooled hazard ratio for time‐to‐complete healing 2.17, 95% confidence interval (CI) 1.52 to 3.10; I2 = 59%; 5 studies, 733 participants); and (2) that people treated using compression bandages or stockings are more likely to experience complete ulcer healing within 12 months compared with people with no compression (10 studies, 1215 participants): risk ratio for complete healing 1.77, 95% CI 1.41 to 2.21; I2 = 65% (8 studies with analysable data, 1120 participants); synthesis without meta‐analysis suggests more completely‐healed ulcers in compression bandages or stockings than in no compression (2 studies without analysable data, 95 participants). It is uncertain whether there is any difference in rates of adverse events between using compression bandages or stockings and no compression (very low‐certainty evidence; 3 studies, 585 participants). Secondary outcomes Moderate‐certainty evidence suggests that people using compression bandages or stockings probably have a lower mean pain score than those not using compression (four studies with 859 participants and another study with 69 ulcers): pooled mean difference −1.39, 95% CI −1.79 to −0.98; I2 = 65% (two studies with 426 participants and another study with 69 ulcers having analysable data); synthesis without meta‐analysis suggests a reduction in leg ulcer pain in compression bandages or stockings, compared with no compression (two studies without analysable data, 433 participants). Compression bandages or stockings versus no compression may improve disease‐specific quality of life, but not all aspects of general health status during the follow‐up of 12 weeks to 12 months (four studies with 859 participants; low‐certainty evidence). It is uncertain if the use of compression bandages or stockings is more cost‐effective than not using them (three studies with 486 participants; very low‐certainty evidence). Authors' conclusions If using compression bandages or stockings, people with venous leg ulcers probably experience complete wound healing more quickly, and more people have wounds completely healed. The use of compression bandages or stockings probably reduces pain and may improve disease‐specific quality of life. There is uncertainty about adverse effects, and cost effectiveness. Future research should focus on comparing alternative bandages and stockings with the primary endpoint of time to complete wound healing alongside adverse events including pain score, and health‐related quality of life, and should incorporate cost‐effectiveness analysis where possible. Future studies should adhere to international standards of trial conduct and reporting., Plain language summary Compression bandages or stockings versus no compression for treating venous leg ulcers Key messages Compared with not using compression, compression therapy that uses bandages or stockings to treat venous leg ulcers: ‐ probably heals venous leg ulcers more quickly; ‐ probably increases the number of people whose ulcer has completely healed after 12 months; ‐ probably reduces pain; and ‐ may improve some aspects of people’s quality of life. However, there is still uncertainty about whether or not compression therapy causes unwanted side effects, and if the health benefits of using compression outweigh its cost. What are leg ulcers? Leg ulcers are open skin wounds on the lower leg that can last weeks, months or even years. Most leg ulcers are caused by venous diseases that affect the circulation of blood in leg veins. Venous leg ulcers can cause distress and pain to patients, and can be very costly to the health service. What did we want to find out? Standard treatment options for venous leg ulcers often include compression therapy. This involves applying external pressure around the lower leg to help the return of blood from the legs to the heart. Compression therapy uses bandages, stockings or other devices. We wanted to find out if compression therapy delivered by bandages and stockings compared with no compression: ‐ heals venous leg ulcers; ‐ has any unwanted effects; ‐ improves people’s quality of life; ‐ has health benefits that outweigh the costs (cost‐effectiveness); and ‐ reduces pain. What did we do? We searched for randomised controlled trials (clinical studies where the treatment or care people receive is chosen at random). This type of study design provides the most reliable health evidence about the effects of a treatment. We searched for studies that evaluated the effects of any types of compression bandages or stockings compared with no compression in people affected with venous leg ulcers in any care setting. We compared and summarised their results, and rated our confidence in the evidence, based on factors such as study methods and sizes. What did we find? We found 14 studies (1391 people, average age: 70.1 years) that lasted on average for 12 weeks. People in eight of the 14 studies were treated in outpatient and community settings. People had venous leg ulcers that had lasted for 22 months on average, and most ulcers had an area between 5 and 20 cm2. The studies used three types of compression therapy: short‐stretch bandage, four‐layer compression bandage, and Unna's boot (a type of compression bandage containing zinc oxide). These therapies were compared with no compression in forms of 'usual care', pharmacological treatment, a variety of dressings, and a variety of treatments where only some participants received compression (but it was not the norm). (1) Venous leg‐ulcer healing and unwanted effects Compared with no compression, the evidence suggests that: ‐ people wearing compression bandages or stockings probably experience complete ulcer healing more quickly; and ‐ more people treated using the compression bandages or stockings are likely to experience complete ulcer healing within 12 months. However, we did not find clear evidence to tell if using compression bandages or stockings causes any unwanted effects. (2) Other effects The evidence suggests that, compared with not using compression, the use of compression bandages or stockings: ‐ probably reduces pain more than not using compression; and ‐ may improve some aspects of people’s quality of life in 12 weeks to 12 months. However, we are uncertain if the use of compression bandages or stockings results in health benefits that outweigh their costs. What limited our confidence in the evidence? Most studies were small (51 people on average) and 10 of the 14 included studies used methods that could introduce errors in their results. How up‐to‐date is this review? The evidence in this Cochrane Review is current to June 2020.

Background Pressure ulcers (also known as pressure injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Reactive air surfaces (beds, mattresses or overlays) can be used for preventing pressure ulcers. Objectives To assess the effects of reactive air beds, mattresses or overlays compared with any support surface on the incidence of pressure ulcers in any population in any setting. Search methods In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In‐Process & Other Non‐Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta‐analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria We included randomised controlled trials that allocated participants of any age to reactive air beds, overlays or mattresses. Comparators were any beds, overlays or mattresses that were applied for preventing pressure ulcers. Data collection and analysis At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. If a reactive air surface was compared with surfaces that were not clearly specified, then we recorded and described the concerned study but did not included it in further data analyses. Main results We included 17 studies (2604 participants) in this review. Most studies were small (median study sample size: 83 participants). The average participant age ranged from 56 to 87 years (median: 72 years). Participants were recruited from a wide range of care settings with the majority being acute care settings. Almost all studies were conducted in the regions of Europe and America. Of the 17 included studies, two (223 participants) compared reactive air surfaces with surfaces that were not well described and therefore could not be classified. We analysed data for five comparisons: reactive air surfaces compared with (1) alternating pressure (active) air surfaces (seven studies with 1728 participants), (2) foam surfaces (four studies with 229 participants), (3) reactive water surfaces (one study with 37 participants), (4) reactive gel surfaces (one study with 66 participants), and (5) another type of reactive air surface (two studies with 223 participants). Of the 17 studies, seven (41.2%) presented findings which were considered at high overall risk of bias. Primary outcome: Pressure ulcer incidence Reactive air surfaces may reduce the proportion of participants developing a new pressure ulcer compared with foam surfaces (risk ratio (RR) 0.42; 95% confidence interval (CI) 0.18 to 0.96; I2 = 25%; 4 studies, 229 participants; low‐certainty evidence). It is uncertain if there is a difference in the proportions of participants developing a new pressure ulcer on reactive air surfaces compared with: alternating pressure (active) air surfaces (6 studies, 1648 participants); reactive water surfaces (1 study, 37 participants); reactive gel surfaces (1 study, 66 participants), or another type of reactive air surface (2 studies, 223 participants). Evidence for all these comparisons is of very low certainty. Included studies have data on time to pressure ulcer incidence for two comparisons. When time to pressure ulcer incidence is considered using a hazard ratio (HR), low‐certainty evidence suggests that in the nursing home setting, people on reactive air surfaces may be less likely to develop a new pressure ulcer over 14 days' of follow‐up than people on alternating pressure (active) air surfaces (HR 0.44; 95% CI 0.21 to 0.96; 1 study, 308 participants). It is uncertain if there is a difference in the hazard of developing new pressure ulcers between two types of reactive air surfaces (1 study, 123 participants; very low‐certainty evidence). Secondary outcomes Support‐surface‐associated patient comfort: the included studies have data on this outcome for three comparisons. We could not pool any data as comfort outcome measures differed between included studies; therefore a narrative summary is provided. It is uncertain if there is a difference in patient comfort responses between reactive air surfaces and foam surfaces over the top of an alternating pressure (active) air surfaces (1 study, 72 participants), and between those using reactive air surfaces and those using alternating pressure (active) air surfaces (4 studies, 1364 participants). Evidence for these two comparisons is of very low certainty. It is also uncertain if there is a difference in patient comfort responses between two types of reactive air surfaces (1 study, 84 participants; low‐certainty evidence). All reported adverse events: there were data on this outcome for one comparison: it is uncertain if there is a difference in adverse events between reactive air surfaces and foam surfaces (1 study, 72 participants; very low‐certainty evidence). The included studies have no data for health‐related quality of life and cost‐effectiveness for all five comparisons. Authors' conclusions Current evidence is uncertain regarding any differences in the relative effects of reactive air surfaces on ulcer incidence and patient comfort, when compared with reactive water surfaces, reactive gel surfaces, or another type of reactive air surface. Using reactive air surfaces may reduce the risk of developing new pressure ulcers compared with using foam surfaces. Also, using reactive air surfaces may reduce the risk of developing new pressure ulcers within 14 days compared with alternating pressure (active) air surfaces in people in a nursing home setting. Future research in this area should consider evaluation of the most important support surfaces from the perspective of decision‐makers. Time‐to‐event outcomes, careful assessment of adverse events and trial‐level cost‐effectiveness evaluation should be considered in future studies. Trials should be designed to minimise the risk of detection bias; for example, by using digital photography and adjudicators of the photographs being blinded to group allocation. Further review using network meta‐analysis will add to the findings reported here., Plain language summary Do beds, mattresses and mattress toppers with air‐filled surfaces that apply constant pressure to the skin prevent pressure ulcers? Key messages Reactive, air‐filled surfaces that apply constant pressure to the skin may reduce people’s chances of developing pressure ulcers compared with foam surfaces. They may also be better at preventing pressure ulcers among people in nursing homes than air‐filled surfaces that regularly redistribute pressure under the body. More research is needed to strengthen the evidence. Future studies should focus on options and effects that are important to decision‐makers, such as: ‐ Reactive, air‐filled surfaces that apply constant skin pressure, compared with air‐filled surfaces that regularly redistribute pressure; and ‐ whether and when pressure ulcers develop, unwanted effects and costs. What are pressure ulcers? Pressure ulcers are also known as pressure sores or bed sores. They are wounds to the skin and underlying tissue caused by prolonged pressure or rubbing. They often occur on bony parts of the body, such as heels, elbows, hips and the bottom of the spine. People who have mobility problems or who lie in bed for long periods are at risk of developing pressure ulcers. What did we want to find out? There are beds, mattresses and mattress toppers specifically designed for people at risk of pressure ulcers. These can be made of a range of materials (such as foam, air cells or water bags) and are divided into two groups: ‐ reactive (static) surfaces that apply a constant pressure to the skin, unless a person moves or is repositioned; and ‐ active (alternating pressure) surfaces that regularly redistribute the pressure under the body. We wanted to find out if reactive, air‐filled surfaces: ‐ prevent pressure ulcers; ‐ are comfortable and improve people’s quality of life; ‐ have health benefits that outweigh their costs; and ‐ have any unwanted effects. What did we do? We searched the medical literature for studies that evaluated the effects of beds, mattresses and mattress toppers with a reactive, air‐filled surface. We compared and summarised their results, and rated our confidence in the evidence, based on factors such as study methods and sizes. What did we find? We found 17 studies (2604 people, average age: 72 years) that lasted between five days and six months (average: 14 days). The studies compared reactive, air‐filled surfaces with: ‐ foam surfaces; ‐ active, air‐filled surfaces; and ‐ reactive surfaces filled with water, gel or other materials. Pressure ulcer prevention The evidence suggests that fewer people may develop pressure ulcers when lying on a reactive, air‐filled surface compared with: ‐ foam surfaces (four studies, 229 people); and ‐ an active, air‐filled surface (one study, 308 people in a nursing home, followed for 14 days). It is unclear whether reactive, air‐filled surfaces prevent ulcers more than other types of reactive surfaces. Other effects The studies did not provide sufficiently robust and clear evidence for us to determine how reactive, air‐filled surfaces affect comfort and unwanted effects. No studies reported information about quality of life and cost. What limited our confidence in the evidence? Most studies were small (83 people on average). Seven studies used methods likely to introduce errors in their results. It was unclear whether the other 10 studies used robust methods. How up‐to‐date is this review? The evidence in this Cochrane Review is current to November 2019.

Background Pressure ulcers (also known as pressure injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Beds, overlays or mattresses are widely used with the aim of treating pressure ulcers. Objectives To assess the effects of beds, overlays and mattresses on pressure ulcer healing in people with pressure ulcers of any stage, in any setting. Search methods In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In‐Process & Other Non‐Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta‐analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria We included randomised controlled trials that allocated participants of any age to pressure‐redistributing beds, overlays or mattresses. Comparators were any beds, overlays or mattresses that were applied for treating pressure ulcers. Data collection and analysis At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. Main results We included 13 studies (972 participants) in the review. Most studies were small (median study sample size: 72 participants). The average age of participants ranged from 64.0 to 86.5 years (median: 82.7 years) and all studies recruited people with existing pressure ulcers (the baseline ulcer area size ranging from 4.2 to 18.6 cm2,median 6.6 cm2). Participants were recruited from acute care settings (six studies) and community and long‐term care settings (seven studies). Of the 13 studies, three (224 participants) involved surfaces that were not well described and therefore could not be classified. Additionally, six (46.2%) of the 13 studies presented findings which were considered at high overall risk of bias. We synthesised data for four comparisons in the review: alternating pressure (active) air surfaces versus foam surfaces; reactive air surfaces versus foam surfaces; reactive water surfaces versus foam surfaces, and a comparison between two types of alternating pressure (active) air surfaces. We summarise key findings for these four comparisons below. (1) Alternating pressure (active) air surfaces versus foam surfaces: we are uncertain if there is a difference between alternating pressure (active) air surfaces and foam surfaces in the proportion of participants whose pressure ulcers completely healed (two studies with 132 participants; the reported risk ratio (RR) in one study was 0.97, 95% confidence interval (CI) 0.26 to 3.58). There is also uncertainty for the outcomes of patient comfort (one study with 83 participants) and adverse events (one study with 49 participants). These outcomes have very low‐certainty evidence. Included studies did not report time to complete ulcer healing, health‐related quality of life, or cost effectiveness. (2) Reactive air surfaces versus foam surfaces: it is uncertain if there is a difference in the proportion of participants with completely healed pressure ulcers between reactive air surfaces and foam surfaces (RR 1.32, 95% CI 0.96 to 1.80; I2 = 0%; 2 studies, 156 participants; low‐certainty evidence). When time to complete pressure ulcer healing is considered using a hazard ratio, data from one small study (84 participants) suggests a greater hazard for complete ulcer healing on reactive air surfaces (hazard ratio 2.66, 95% CI 1.34 to 5.17; low‐certainty evidence). These results are sensitive to the choice of outcome measure so should be interpreted as uncertain. We are also uncertain whether there is any difference between these surfaces in patient comfort responses (1 study, 72 participants; very low‐certainty evidence) and in adverse events (2 studies, 156 participants; low‐certainty evidence). There is low‐certainty evidence that reactive air surfaces may cost an extra 26 US dollars for every ulcer‐free day in the first year of use (1 study, 87 participants). Included studies did not report health‐related quality of life. (3) Reactive water surfaces versus foam surfaces: it is uncertain if there is a difference between reactive water surfaces and foam surfaces in the proportion of participants with healed pressure ulcers (RR 1.07, 95% CI 0.70 to 1.63; 1 study, 101 participants) and in adverse events (1 study, 120 participants). All these have very low‐certainty evidence. Included studies did not report time to complete ulcer healing, patient comfort, health‐related quality of life, or cost effectiveness. (4) Comparison between two types of alternating pressure (active) air surfaces: it is uncertain if there is a difference between Nimbus and Pegasus alternating pressure (active) air surfaces in the proportion of participants with healed pressure ulcers, in patient comfort responses and in adverse events: each of these outcomes had four studies (256 participants) but very low‐certainty evidence. Included studies did not report time to complete ulcer healing, health‐related quality of life, or cost effectiveness. Authors' conclusions We are uncertain about the relative effects of most different pressure‐redistributing surfaces for pressure ulcer healing (types directly compared are alternating pressure air surfaces versus foam surfaces, reactive air surfaces versus foam surfaces, reactive water surfaces versus foam surfaces, and Nimbus versus Pegasus alternating pressure (active) air surfaces). There is also uncertainty regarding the effects of these different surfaces on the outcomes of comfort and adverse events. However, people using reactive air surfaces may be more likely to have pressure ulcers completely healed than those using foam surfaces over 37.5 days' follow‐up, and reactive air surfaces may cost more for each ulcer‐free day than foam surfaces. Future research in this area could consider the evaluation of alternating pressure air surfaces versus foam surfaces as a high priority. Time‐to‐event outcomes, careful assessment of adverse events and trial‐level cost‐effectiveness evaluation should be considered in future studies. Further review using network meta‐analysis will add to the findings reported here., Plain language summary What are the benefits and risks of different types of beds, mattresses and mattress toppers for treating pressure ulcers? Key messages Due to a lack of robust evidence, the benefits and risks of most types of beds, mattresses and mattress toppers for treating pressure ulcers are unclear. Beds with an air‐filled surface that apply constant pressure to the skin may be better than mattresses and toppers made of foam for ulcer healing if the evidence on the time needed to completely heal an ulcer is looked at, but may cost more. Future research in this area should focus on options and effects that are important to decision‐makers, such as: ‐ foam or air‐filled surfaces that redistribute pressure under the body; and ‐ unwanted effects and costs. What are pressure ulcers? Pressure ulcers are also known as pressure sores or bed sores. They are wounds to the skin and underlying tissue caused by prolonged pressure or rubbing. They often occur on bony parts of the body, such as heels, elbows, hips and the bottom of the spine. People who have mobility problems or who lie in bed for long periods are at risk of developing pressure ulcers. What did we want to find out? There are beds, mattresses and mattress toppers specifically designed for people with pressure ulcers. These can be made from a range of materials (such as foam, air cells or water bags) and are divided into two groups: ‐ reactive (static) surfaces that apply a constant pressure to the skin, unless a person moves or is repositioned; and ‐ active (alternating pressure) surfaces that regularly redistribute the pressure under the body. We wanted to find out if reactive and active surfaces: ‐ help ulcers to heal; ‐ are comfortable and improve people’s quality of life; ‐ have health benefits that outweigh their costs; and ‐ have any unwanted effects. What did we do? We searched the medical literature for studies that evaluated the effects of beds, mattresses and mattress toppers. We compared and summarised their results, and rated our confidence in the evidence, based on factors such as study methods and sizes. What did we find? We found 13 studies (972 people, average age: 83 years) that lasted between seven days and 18 months (average: 37.5 days). In general, the studies did not provide sufficiently robust evidence for us to determine the effects of active and reactive surfaces. Evidence from two studies suggests that, when compared with mattresses and mattress toppers made of foam, beds with a reactive air‐filled surface may: ‐ improve chances of pressure ulcers healing if the data on the time needed to completely heal an ulcer is looked at (1 study, 84 people); ‐ cost an extra 26 US dollars per person for every ulcer‐free day in the first year of use (1 study, 87 people). The other benefits and risks of these and other surfaces are unclear. What limited our confidence in the evidence? Most studies were small (72 people on average) and nearly half of them (six studies) used methods likely to introduce errors in their results. How up‐to‐date is this review? The evidence in this Cochrane Review is current to November 2019.

BackgroundPeople with altered skin status are conventionally considered to have a higher risk of developing new ulcers. However, the evidence underpinning this potentially prognostic relationship is unclear.ObjectivesTo systematically review the evidence for the prognostic association of skin status with pressure ulcer risk.MethodsWe performed a comprehensive electronic database search in February 2017 to identify longitudinal studies that considered skin status in multivariable analysis for predicting pressure ulcer risk in any population. Study selection was conducted by two reviewers independently. We collected data on the characteristics of studies, participants, skin status, and results of multivariable analyses of skin status–pressure ulcer incidence associations. We applied the Quality In Prognosis Studies tool to assess risk of bias. We conducted meta-analyses using STATA where data were available from multivariable analyses. We used the Grades of Recommendation Assessment, Development and Evaluation approach to assess the certainty of evidence generated from each meta-analysis.ResultsWe included 41 studies (with 162,299 participants, and 7382 having new ulcers) that investigated 15 skin descriptors. Participants were predominantly hospitalised adults and long-term care residents (with a median age of 75.2 years). Studies had a median follow-up duration of 7.5 weeks. 61.0% (25/41) of studies were judged as being high risk of bias. 53.7% (22/41) of studies had small sample sizes. Subsequently, the certainty of evidence was rated as low or very low for all 13 meta-analyses that we conducted though all analyses showed statistically significant associations of specific skin descriptors–pressure ulcer incidence. People with non-blanchable erythema may have higher odds of developing pressure ulcers than those without (Odds Ratio 3.08, 95% Confidence Interval 2.26–4.20 if pressure ulcer preventive measures were not adjusted in multivariable analysis; 1.99, 1.76–2.25 if adjusted) (both low-certainty evidence). The evidence for other skin descriptors was judged as very low-certainty and their prognostic value is uncertain.ConclusionsThere is low-certainty evidence that people with non-blanchable erythema may be more likely to develop new pressure ulcers than those without non-blanchable erythema. The evidence for the prognostic effects of other skin descriptors (e.g., history of pressure ulcer) is of very low-certainty. The findings support regular skin assessment and preventive action being taken in the presence of non-blanchable erythema. Given the millions at risk of ulceration and the widely recommended use of skin status as part of risk assessment there is a need for more, high quality confirmatory studies.

This work was supported by the National Institute for Health Research (NIHR), Health Technology Assessment Programme, project number 17/147/47. The HTA Programme is funded by the NIHR, with contributions from the Chief Scientist Office in Scotland and National Institute for Social Care and Health Research in Wales and the Health and Social Care R&D Division, Public Health Agency in Northern Ireland. Sponsor: Imperial College London., Introduction Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT. Methods and analysis Pragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23-32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective. Ethics and dissemination UK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences., National Institute for Health Research (NIHR) 17/147/47, National Institute for Health Research (NIHR), Chief Scientist Office in Scotland, National Institute for Social Care and Health Research in Wales, Health and Social Care R&D Division, Public Health Agency in Northern Ireland, Imperial College London

This study is supported by the J P Moulton Charitable Foundation (grant number: N/A). The DCD allograft is provided free of charge by NHSBT., The authors wish to thank the principal investigators, research nurses and their teams at the recruiting sites. The authors also wish to thank the NHS Blood and Transplant (NHSBT) for providing the DCD allograft free of charge and for their support in training clinical staff, and the NIHR Clinical Research Networks (CRNs) for their support in identifying sites. Finally, the authors wish to thank all individuals who participated in the PPI focus groups and extend a special thank you to PPI representative Emanuel Ezeife, whose useful feedback helped to inform the design of the study., Introduction Venous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU. Methods and analysis This is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes. Ethics and dissemination Ethical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences., J P Moulton Charitable Foundation

Background Pressure ulcers (also known as injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Reactive surfaces that are not made of foam or air cells can be used for preventing pressure ulcers. Objectives To assess the effects of non‐foam and non‐air‐filled reactive beds, mattresses or overlays compared with any other support surface on the incidence of pressure ulcers in any population in any setting. Search methods In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In‐Process & Other Non‐Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta‐analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria We included randomised controlled trials that allocated participants of any age to non‐foam or non‐air‐filled reactive beds, overlays or mattresses. Comparators were any beds, overlays or mattresses used. Data collection and analysis At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. If a non‐foam or non‐air‐filled surface was compared with surfaces that were not clearly specified, then the included study was recorded and described but not considered further in any data analyses. Main results We included 20 studies (4653 participants) in this review. Most studies were small (median study sample size: 198 participants). The average participant age ranged from 37.2 to 85.4 years (median: 72.5 years). Participants were recruited from a wide range of care settings but were mainly from acute care settings. Almost all studies were conducted in Europe and America. Of the 20 studies, 11 (2826 participants) included surfaces that were not well described and therefore could not be fully classified. We synthesised data for the following 12 comparisons: (1) reactive water surfaces versus alternating pressure (active) air surfaces (three studies with 414 participants), (2) reactive water surfaces versus foam surfaces (one study with 117 participants), (3) reactive water surfaces versus reactive air surfaces (one study with 37 participants), (4) reactive water surfaces versus reactive fibre surfaces (one study with 87 participants), (5) reactive fibre surfaces versus alternating pressure (active) air surfaces (four studies with 384 participants), (6) reactive fibre surfaces versus foam surfaces (two studies with 228 participants), (7) reactive gel surfaces on operating tables followed by foam surfaces on ward beds versus alternating pressure (active) air surfaces on operating tables and subsequently on ward beds (two studies with 415 participants), (8) reactive gel surfaces versus reactive air surfaces (one study with 74 participants), (9) reactive gel surfaces versus foam surfaces (one study with 135 participants), (10) reactive gel surfaces versus reactive gel surfaces (one study with 113 participants), (11) reactive foam and gel surfaces versus reactive gel surfaces (one study with 166 participants) and (12) reactive foam and gel surfaces versus foam surfaces (one study with 91 participants). Of the 20 studies, 16 (80%) presented findings which were considered to be at high overall risk of bias. Primary outcome: Pressure ulcer incidence We did not find analysable data for two comparisons: reactive water surfaces versus foam surfaces, and reactive water surfaces versus reactive fibre surfaces. Reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds (14/205 (6.8%)) may increase the proportion of people developing a new pressure ulcer compared with alternating pressure (active) air surfaces applied on both operating tables and hospital beds (3/210 (1.4%) (risk ratio 4.53, 95% confidence interval 1.31 to 15.65; 2 studies, 415 participants; I2 = 0%; low‐certainty evidence). For all other comparisons, it is uncertain whether there is a difference in the proportion of participants developing new pressure ulcers as all data were of very low certainty. Included studies did not report time to pressure ulcer incidence for any comparison in this review. Secondary outcomes Support‐surface‐associated patient comfort: the included studies provide data on this outcome for one comparison. It is uncertain if there is a difference in patient comfort between alternating pressure (active) air surfaces and reactive fibre surfaces (one study with 187 participants; very low‐certainty evidence). All reported adverse events: there is evidence on this outcome for one comparison. It is uncertain if there is a difference in adverse events between reactive gel surfaces followed by foam surfaces and alternating pressure (active) air surfaces applied on both operating tables and hospital beds (one study with 198 participants; very low‐certainty evidence). We did not find any health‐related quality of life or cost‐effectiveness evidence for any comparison in this review. Authors' conclusions Current evidence is generally uncertain about the differences between non‐foam and non‐air‐filled reactive surfaces and other surfaces in terms of pressure ulcer incidence, patient comfort, adverse effects, health‐related quality of life and cost‐effectiveness. Reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds may increase the risk of having new pressure ulcers compared with alternating pressure (active) air surfaces applied on both operating tables and hospital beds. Future research in this area should consider evaluation of the most important support surfaces from the perspective of decision‐makers. Time‐to‐event outcomes, careful assessment of adverse events and trial‐level cost‐effectiveness evaluation should be considered in future studies. Trials should be designed to minimise the risk of detection bias; for example, by using digital photography and adjudicators of the photographs being blinded to group allocation. Further review using network meta‐analysis will add to the findings reported here., Plain language summary Do beds, mattresses and mattress toppers that apply constant pressure to the skin and are not air‐filled or made of foam prevent pressure ulcers? Key messages Due to a lack of robust evidence, it is unclear whether most types of surface that apply constant pressure to the skin and are not air‐filled or made of foam prevent pressure ulcers. Lying surgery patients on an operating table with a gel surface that applies constant pressure to the skin and then a hospital bed with a foam surface, rather than using air‐filled surfaces, may increase the risk of developing pressure ulcers. Future studies should focus on options and effects that are important to decision‐makers, such as: ‐ gel surfaces that apply constant pressure to the skin, compared to air‐filled or foam surfaces; and ‐ whether and when pressure ulcers develop, unwanted effects and costs. What are pressure ulcers? Pressure ulcers are also known as pressure sores or bed sores. They are wounds to the skin and underlying tissue caused by prolonged pressure or rubbing. They often occur on bony parts of the body, such as heels, elbows, hips and the bottom of the spine. People who have mobility problems or who lie in bed for long periods are at risk of developing pressure ulcers. What did we want to find out? There are beds, mattresses and mattress toppers specifically designed for people at risk of pressure ulcers. These can be made of a range of materials (such as foam, air cells or water bags) and are divided into two groups: ‐ reactive (static) surfaces that apply a constant pressure to the skin, unless a person moves or is repositioned; and ‐ active (alternating pressure) surfaces that regularly redistribute the pressure under the body. We wanted to find out if reactive surfaces that are not air‐filled or made of foam: ‐ prevent pressure ulcers; ‐ are comfortable and improve people’s quality of life; ‐ have health benefits that outweigh their costs; and ‐ have any unwanted effects. What did we do? We searched the medical literature for studies that evaluated the effects of beds, mattresses and mattress toppers with a reactive surface that was not air‐filled or made of foam. We compared and summarised the results of these studies, and rated our confidence in the evidence, based on factors such as study methods and sizes. What did we find? We found 20 studies (4653 people, average age: 73 years) that lasted between seven days and six months (average: four weeks). The studies compared reactive surfaces filled with water or gel, or made of fibre, against other active or reactive surfaces. In general, the studies did not provide sufficiently robust evidence for us to determine if reactive surfaces that are not air‐filled or made of foam prevent pressure ulcers. Evidence from two studies suggests that people who undergo surgery may be more likely to develop pressure ulcers when they lie on an operating table with a reactive gel surface and then a hospital bed with a foam surface, rather than on active air‐filled surfaces. The other benefits and risks of gel and other reactive surfaces are unclear. No studies reported information about quality of life and cost. What limited our confidence in the evidence? Most studies were small (198 people on average) and used methods likely to introduce errors in their results. How up‐to‐date is this review? The evidence in this Cochrane Review is current to November 2019.

Background Pressure ulcers (also known as pressure injuries, pressure sores, decubitus ulcers and bed sores) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Alternating pressure (active) air surfaces are widely used with the aim of preventing pressure ulcers. Objectives To assess the effects of alternating pressure (active) air surfaces (beds, mattresses or overlays) compared with any support surface on the incidence of pressure ulcers in any population in any setting. Search methods In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In‐Process & Other Non‐Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta‐analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria We included randomised controlled trials that allocated participants of any age to alternating pressure (active) air beds, overlays or mattresses. Comparators were any beds, overlays or mattresses. Data collection and analysis At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. Main results We included 32 studies (9058 participants) in the review. Most studies were small (median study sample size: 83 participants). The average age of participants ranged from 37.2 to 87.0 years (median: 69.1 years). Participants were largely from acute care settings (including accident and emergency departments). We synthesised data for six comparisons in the review: alternating pressure (active) air surfaces versus: foam surfaces, reactive air surfaces, reactive water surfaces, reactive fibre surfaces, reactive gel surfaces used in the operating room followed by foam surfaces used on the ward bed, and another type of alternating pressure air surface. Of the 32 included studies, 25 (78.1%) presented findings which were considered at high overall risk of bias. Primary outcome: pressure ulcer incidence Alternating pressure (active) air surfaces may reduce the proportion of participants developing a new pressure ulcer compared with foam surfaces (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.34 to 1.17; I2 = 63%; 4 studies, 2247 participants; low‐certainty evidence). Alternating pressure (active) air surfaces applied on both operating tables and hospital beds may reduce the proportion of people developing a new pressure ulcer compared with reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds (RR 0.22, 95% CI 0.06 to 0.76; I2 = 0%; 2 studies, 415 participants; low‐certainty evidence). It is uncertain whether there is a difference in the proportion of people developing new pressure ulcers between alternating pressure (active) air surfaces and the following surfaces, as all these comparisons have very low‐certainty evidence: (1) reactive water surfaces; (2) reactive fibre surfaces; and (3) reactive air surfaces. The comparisons between different types of alternating pressure air surfaces are presented narratively. Overall, all comparisons suggest little to no difference between these surfaces in pressure ulcer incidence (7 studies, 2833 participants; low‐certainty evidence). Included studies have data on time to pressure ulcer incidence for three comparisons. When time to pressure ulcer development is considered using a hazard ratio (HR), it is uncertain whether there is a difference in the risk of developing new pressure ulcers, over 90 days' follow‐up, between alternating pressure (active) air surfaces and foam surfaces (HR 0.41, 95% CI 0.10 to 1.64; I2 = 86%; 2 studies, 2105 participants; very low‐certainty evidence). For the comparison with reactive air surfaces, there is low‐certainty evidence that people treated with alternating pressure (active) air surfaces may have a higher risk of developing an incident pressure ulcer than those treated with reactive air surfaces over 14 days' follow‐up (HR 2.25, 95% CI 1.05 to 4.83; 1 study, 308 participants). Neither of the two studies with time to ulcer incidence data suggested a difference in the risk of developing an incident pressure ulcer over 60 days' follow‐up between different types of alternating pressure air surfaces. Secondary outcomes The included studies have data on (1) support‐surface‐associated patient comfort for comparisons involving foam surfaces, reactive air surfaces, reactive fibre surfaces and alternating pressure (active) air surfaces; (2) adverse events for comparisons involving foam surfaces, reactive gel surfaces and alternating pressure (active) air surfaces; and (3) health‐related quality of life outcomes for the comparison involving foam surfaces. However, all these outcomes and comparisons have low or very low‐certainty evidence and it is uncertain whether there are any differences in these outcomes. Included studies have data on cost effectiveness for two comparisons. Moderate‐certainty evidence suggests that alternating pressure (active) air surfaces are probably more cost‐effective than foam surfaces (1 study, 2029 participants) and that alternating pressure (active) air mattresses are probably more cost‐effective than overlay versions of this technology for people in acute care settings (1 study, 1971 participants). Authors' conclusions Current evidence is uncertain about the difference in pressure ulcer incidence between using alternating pressure (active) air surfaces and other surfaces (reactive water surfaces, reactive fibre surfaces and reactive air surfaces). Alternating pressure (active) air surfaces may reduce pressure ulcer risk compared with foam surfaces and reactive gel surfaces used on operating tables followed by foam surfaces applied on hospital beds. People using alternating pressure (active) air surfaces may be more likely to develop new pressure ulcers over 14 days' follow‐up than those treated with reactive air surfaces in the nursing home setting; but as the result is sensitive to the choice of outcome measure it should be interpreted cautiously. Alternating pressure (active) air surfaces are probably more cost‐effective than reactive foam surfaces in preventing new pressure ulcers. Future studies should include time‐to‐event outcomes and assessment of adverse events and trial‐level cost‐effectiveness. Further review using network meta‐analysis will add to the findings reported here., Plain language summary Do beds, mattresses and mattress toppers with air‐filled surfaces that regularly redistribute pressure under the body prevent pressure ulcers? Key messages Beds, mattresses and mattress toppers that regularly redistribute pressure under the body may reduce the chance of pressure ulcers developing when compared with surfaces that: ‐ apply a constant pressure to the skin; and ‐ are made of foam or gel. However, they may increase the risk of pressure ulcers developing among nursing home residents when compared with air surfaces that apply constant pressure. More research is needed to strengthen the evidence that compares air‐filled and other surfaces. Future studies should focus on effects that are important to decision‐makers, including: ‐ whether and when pressure ulcers develop; ‐ unwanted effects; and ‐ costs. What are pressure ulcers? Pressure ulcers are also known as pressure sores or bed sores. They are wounds to the skin and underlying tissue caused by prolonged pressure or rubbing. They often occur on bony parts of the body, such as heels, elbows, hips and the bottom of the spine. People who have mobility problems or who lie in bed for long periods are at risk of developing pressure ulcers. What did we want to find out? There are beds, mattresses and mattress toppers specifically designed for people at risk of pressure ulcers. These can be made of a range of materials (such as foam, air cells or water bags) and are divided into two groups: ‐ reactive (static) surfaces that apply a constant pressure to the skin, unless a person moves or is repositioned; and ‐ active (alternating pressure) surfaces that regularly redistribute the pressure under the body. We wanted to find out if active, air‐filled surfaces: ‐ prevent pressure ulcers; ‐ are comfortable and improve people’s quality of life; ‐ have health benefits that outweigh their costs (cost‐effectiveness); and ‐ have any unwanted effects. What did we do? We searched the medical literature for studies that evaluated the effects of beds, mattresses and mattress toppers with an active, air‐filled surface. We compared and summarised their results, and rated our confidence in the evidence, based on factors such as study methods and sizes. What did we find? We found 32 studies (9058 people, average age: 69 years) that lasted between three and 180 days (average: 14 days). The studies compared active, air‐filled surfaces with: ‐ foam, fibre, water‐filled or gel surfaces; and ‐ other air‐filled surfaces. Pressure ulcer prevention The evidence suggests that active, air‐filled surfaces may reduce the risk of pressure ulcers developing when compared with: ‐ foam surfaces; ‐ gel surfaces used on operating tables followed by foam surfaces used on hospitals beds, for people who undergo surgery. However, active, air‐filled surfaces may increase the risk of pressure ulcers developing when compared with reactive air surfaces (1 study, 308 nursing home residents, duration: 14 days). It is unclear if active air‐filled surfaces prevent pressure ulcers compared with surfaces other than reactive foam, gel or air‐filled surfaces. The type of active, air‐filled surface used may make little to no difference for preventing pressure ulcers. Other effects Active, air‐filled surfaces are probably more cost‐effective than foam. Mattresses with an active, air‐filled surface are probably more cost‐effective than mattress toppers with the same surface. We did not find sufficiently robust and clear evidence to determine how active, air‐filled surfaces affect comfort, quality of life and unwanted effects. What limited our confidence in the evidence? Most studies were small (83 people on average) and more than two‐thirds of them (25) used methods likely to introduce errors in their results. How up‐to‐date is this review? The evidence in this Cochrane Review is current to November 2019.

ObjectivesTo investigate the period prevalence of complex wounds among the overall inpatients, and the impact of complex wounds on inpatient health expense and length of hospital stay (LOS).DesignAn observational study.Setting6056 healthcare institutions across Sichuan province in China.ParticipantsThis study included 4 033 763 people admitted to healthcare institutions during 1 September 2018 and 31 December 2018.ResultsThe point prevalence of complex wounds was 4.07 per 1000 among inpatients in Sichuan. The most common complex wounds were pressure ulcers (1.47 per 1000 among inpatients). Older, male, Han ethnic groups and retired people were most likely to suffer from complex wounds. The median LOS was longer for those with complex wounds as their main condition of treatment compared with all-cause admissions in Sichuan (12 days compared with 7 days; pConclusionsComplex wounds, especially pressure ulcers, are common in Sichuan province and their presence is associated with significantly longer lengths of hospital stay and higher medical costs. Additionally, this study only included admitted inpatients during the sampling time period, hence the prevalence of complex wounds may be underestimated. The high prevalence rate and heavy direct and indirect disease burden of complex wounds indicate that health policies for early detection and prevention of complex wounds in elders are urgently needed.

Background: More than 2 million people per year are treated for surgical wounds in the UK. Over a quarter of these wounds are estimated to heal by secondary intention (from the “bottom up”) resulting in further complications and requiring increased healthcare resources. Identification of microbiological or host biomarkers that can predict healing outcomes may help to optimize the management of surgical wounds healing by secondary intention. However, the microbial and host factor heterogeneity amongst this diverse population is completely unexplored. Methods: We demonstrate feasibility of determining presence and levels of wound microbes and systemic host factors in an inception cohort of 54 people presenting with surgical wounds healing by secondary intention, who were subsequently followed-up for a period of 12-21 months. We present descriptive statistics for plasma levels of inflammatory, angiogenic cytokines and microRNAs, and we identify a range of wound colonizing microbes. We tentatively explore association with healing aiming to generate hypotheses for future research. Results: We report a potential correlation between poor healing outcomes and elevated interleukin (IL)-6 plasma levels at presentation (ρ=0.13) which requires confirmation. Conclusions: This study demonstrates the degree of biological heterogeneity amongst people with surgical wounds healing by secondary intention and proves the feasibility of embedding a biomarker discovery study in a cohort study in surgical wounds. Our results are essential for designing large biomarker discovery studies to further investigate the potential validity of circulating IL-6 or other factors as novel predictive biomarkers of healing for surgical wounds healing by secondary intention.

Background Most surgical incisions heal by primary intention (i.e. wound edges are apposed with sutures, clips or glue); however, some heal by secondary intention (i.e. the wound is left open and heals by formation of granulation tissue). There is, however, a lack of evidence regarding the epidemiology, management and impact on patients’ quality of life of these surgical wounds healing by secondary intention, resulting in uncertainty regarding effective treatments and difficulty in planning care and research. Objectives To derive a better understanding of the nature, extent, costs, impact and outcomes of surgical wounds healing by secondary intention, effective treatments, and the value and nature of further research. Design Cross-sectional survey; inception cohort; cost-effectiveness and value of implementation analyses; qualitative interviews; and pilot, feasibility randomised controlled trial. Setting Acute and community care settings in Leeds and Hull, Yorkshire, UK. Participants Adults (or for qualitative interviews, patients or practitioners) with previous experience of a surgical wound healing by secondary intention. Inclusion criteria varied between the individual workstreams. Interventions The pilot, feasibility randomised controlled trial compared negative-pressure wound therapy – a device applying a controlled vacuum to a wound via a dressing – with usual care (no negative-pressure wound therapy). Results Survey data estimated that treated surgical wounds healing by secondary intention have a point prevalence of 4.1 per 10,000 population (95% confidence interval 3.5 to 4.7 per 10,000 population). Surgical wounds healing by secondary intention most frequently occurred following colorectal surgery (n = 80, 42.8% cross-sectional survey; n = 136, 39.7% inception cohort) and were often planned before surgery (n = 89, 47.6% cross-sectional survey; n = 236, 60.1% inception cohort). Wound care was frequently delivered in community settings (n = 109, 58.3%) and most patients (n = 184, 98.4%) received active wound treatment. Cohort data identified hydrofibre dressings (n = 259, 65.9%) as the most common treatment, although 29.3% (n = 115) of participants used negative-pressure wound therapy at some time during the study. Surgical wounds healing by secondary intention occurred in 81.4% (n = 320) of participants at a median of 86 days (95% confidence interval 75 to 103 days). Baseline wound area (p ≤ 0.01), surgical wound contamination (determined during surgery; p = 0.04) and wound infection at any time (p ≤ 0.01) (i.e. at baseline or postoperatively) were found to be predictors of prolonged healing. Econometric models, using observational, cohort study data, identified that, with little uncertainty, negative-pressure wound therapy treatment is more costly and less effective than standard dressing treatment for the healing of open surgical wounds. Model A (ordinary least squares with imputation) effectiveness: 73 days longer than those who did not receive negative-pressure wound therapy (95% credible interval 33.8 to 112.8 days longer). Model A cost-effectiveness (associated incremental quality-adjusted life-years): observables –0.012 (standard error 0.005) and unobservables –0.008 (standard error 0.011). Model B (two-stage model, logistic and linear regression) effectiveness: 46 days longer than those who did not receive negative-pressure wound therapy (95% credible interval 19.6 to 72.5 days longer). Model B cost-effectiveness (associated incremental quality-adjusted life-years): observables –0.007 (standard error 0.004) and unobservables –0.027 (standard error 0.017). Patient interviews (n = 20) identified initial reactions to surgical wounds healing by secondary intention of shock and disbelief. Impaired quality of life characterised the long healing process, with particular impact on daily living for patients with families or in paid employment. Patients were willing to try any treatment promising wound healing. Health professionals (n = 12) had variable knowledge of surgical wound healing by secondary intention treatments and, frequently, favoured negative-pressure wound therapy, despite the lack of robust evidence. The pilot feasibility randomised controlled trial screened 248 patients for eligibility and subsequently recruited and randomised 40 participants to receive negative-pressure wound therapy or usual care (no negative-pressure wound therapy). Data indicated that it was feasible to complete a full randomised controlled trial to provide definitive evidence for the clinical effectiveness and cost-effectiveness of negative-pressure wound therapy as a treatment for surgical wounds healing by secondary intention. Key elements and recommendations for a larger randomised controlled trial were identified. Limitations This research programme was conducted in a single geographical area (i.e. Yorkshire and the Humber, UK) and local guidelines and practices may have affected treatment availability, and so may not represent UK-wide treatment choices. A wide range of wound types were included; however, some wound types may be under-represented, meaning that this research may not represent the overall surgical wound healing by secondary intention population. The lack of randomised controlled trial data on the relative effects of negative-pressure wound therapy in surgical wounds healing by secondary intention resulted in much of the economic modelling being based on observational data. Observational data, even with extensive adjustment, do not negate the potential for unresolved confounding to affect the results, which can reduce confidence in conclusions drawn from observational data. Definitive evidence from a randomised controlled trial may be the only way to overcome this lack of confidence. Conclusions This research has provided new information regarding the nature, extent, costs, impacts and outcomes of surgical wounds healing by secondary intention, treatment effectiveness, and the value and nature of future research, while addressing previous uncertainties regarding the problem of surgical wounds healing by secondary intention. Aspects of our research indicate that negative-pressure wound therapy is more costly and less effective than standard dressing for the healing of open surgical wounds. However, because this conclusion is based solely on observational data, it may be affected by unresolved confounding. Should a future randomised controlled trial be considered necessary, its design should reflect careful consideration of the findings of this programme of research. Future work This research signals the importance of further research on surgical wound healing by secondary intention. Key research questions raised by this programme of research include (1) which treatments are clinically effective and cost-effective for surgical wound healing by secondary intention for all patients or for particular patient subgroups? (2) Can particular prognostic factors predict time to healing of surgical wound healing by secondary intention? And (3) do psychosocial interventions have the potential to improve quality of life in people with hard-to-heal surgical wound healing by secondary intention? Given that negative-pressure wound therapy has been widely adopted, with relatively little evidence to support its use, the design and outcomes of a randomised controlled trial would need to be carefully considered. We focused in this research on wound healing, and maintain, based on the findings of patient interviews, that this is a key outcome for future research. Impacts of negative-pressure wound therapy on outcomes such as infection and reoperation should also be considered, as should patients’ views of the treatment. The type of patient group recruited and the outcomes of interest will all influence the duration of follow-up of any planned study. The comparator in any future study will also need careful consideration. Trial registration Current Controlled Trials ISRCTN12761776. Funding This project was funded by the National Institute for Health Research Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 8, No. 7. See the National Institute for Health Research Journals Library website for further project information.

Aim: To identify and synthesize the evidence for the effectiveness of psychosocial interventions to promote the healing, and/or reduce the occurrence of, foot ulceration in people with diabetes. Methods: In March 2019 we searched CENTRAL, Medline, Embase and PsycInfo for randomized controlled trials of interventions with psychosocial components for people with diabetes. The primary outcomes of this review were foot ulceration and healing. We assessed studies using the Cochrane risk‐of‐bias tool, the TIDieR checklist and GRADE. We conducted narrative synthesis and random‐effects meta‐analysis. Results: We included 31 randomized controlled trials (4511 participants), of which most (24 randomized controlled trials, 4093 participants) were prevention studies. Most interventions were educational with a modest psychosocial component. Ulceration and healing were not reported in most studies; secondary outcomes varied. Evidence was of low or very low quality because of high risks of bias and imprecision, and few studies reported adherence or fidelity. In groups where participants had prior ulceration, educational interventions had no clear effect on new ulceration (low‐quality evidence). Two treatment studies, assessing continuous pharmacist support and an intervention to promote understanding of well‐being, reported healing but their evidence was also of very low quality. Conclusion: Most psychosocial intervention randomized controlled trials assessing foot ulcer outcomes in people with diabetes were prevention studies, and most interventions were primarily educational. Ulcer healing and development were not well reported. There is a need for better understanding of psychological and behavioural influences on ulcer incidence, healing and recurrence in people with diabetes. Randomized controlled trials of theoretically informed interventions, which assess clinical outcomes, are urgently required. (PROSPERO registration: CRD42016052960).

Objectives This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of non‐foam or air‐filled reactive beds or mattresses compared with any alternative surface on the incidence of pressure ulcers in any setting and population.

Objectives This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of reactive air beds or mattresses compared with any alternative surface on the incidence of pressure ulcers in any setting and population.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of alternating pressure (active) air beds or mattresses compared with any alternative surface on the incidence of pressure ulcers in any setting and population.

Background Pressure ulcers (also known as pressure injuries) are localised injuries to the skin or underlying soft tissue, or both, caused by unrelieved pressure, shear or friction. Foam surfaces (beds, mattresses or overlays) are widely used with the aim of preventing pressure ulcers. Objectives To assess the effects of foam beds, mattresses or overlays compared with any support surface on the incidence of pressure ulcers in any population in any setting. Search methods In November 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In‐Process & Other Non‐Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta‐analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria We included randomised controlled trials that allocated participants of any age to foam beds, mattresses or overlays. Comparators were any beds, mattresses or overlays. Data collection and analysis At least two review authors independently assessed studies using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and the certainty of the evidence assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. If a foam surface was compared with surfaces that were not clearly specified, then the included study was recorded and described but not considered further in any data analyses. Main results We included 29 studies (9566 participants) in the review. Most studies were small (median study sample size: 101 participants). The average age of participants ranged from 47.0 to 85.3 years (median: 76.0 years). Participants were mainly from acute care settings. We analysed data for seven comparisons in the review: foam surfaces compared with: (1) alternating pressure air surfaces, (2) reactive air surfaces, (3) reactive fibre surfaces, (4) reactive gel surfaces, (5) reactive foam and gel surfaces, (6) reactive water surfaces, and (7) another type of foam surface. Of the 29 included studies, 17 (58.6%) presented findings which were considered at high overall risk of bias. Primary outcome: pressure ulcer incidence Low‐certainty evidence suggests that foam surfaces may increase the risk of developing new pressure ulcers compared with (1) alternating pressure (active) air surfaces (risk ratio (RR) 1.59, 95% confidence interval (CI) 0.86 to 2.95; I2 = 63%; 4 studies, 2247 participants), and (2) reactive air surfaces (RR 2.40, 95% CI 1.04 to 5.54; I2 = 25%; 4 studies, 229 participants). We are uncertain regarding the difference in pressure ulcer incidence in people treated with foam surfaces and the following surfaces: (1) reactive fibre surfaces (1 study, 68 participants); (2) reactive gel surfaces (1 study, 135 participants); (3) reactive gel and foam surfaces (1 study, 91 participants); and (4) another type of foam surface (6 studies, 733 participants). These had very low‐certainty evidence. Included studies have data on time to pressure ulcer development for two comparisons. When time to ulcer development is considered using hazard ratios, the difference in the risk of having new pressure ulcers, over 90 days' follow‐up, between foam surfaces and alternating pressure air surfaces is uncertain (2 studies, 2105 participants; very low‐certainty evidence). Two further studies comparing different types of foam surfaces also reported time‐to‐event data, suggesting that viscoelastic foam surfaces with a density of 40 to 60 kg/m3 may decrease the risk of having new pressure ulcers over 11.5 days' follow‐up compared with foam surfaces with a density of 33 kg/m3 (1 study, 62 participants); and solid foam surfaces may decrease the risk of having new pressure ulcers over one month's follow‐up compared with convoluted foam surfaces (1 study, 84 participants). Both had low‐certainty evidence. There was no analysable data for the comparison of foam surfaces with reactive water surfaces (one study with 117 participants). Secondary outcomes Support‐surface‐associated patient comfort: the review contains data for three comparisons for this outcome. It is uncertain if there is a difference in patient comfort measure between foam surfaces and alternating pressure air surfaces (1 study, 76 participants; very low‐certainty evidence); foam surfaces and reactive air surfaces (1 study, 72 participants; very low‐certainty evidence); and different types of foam surfaces (4 studies, 669 participants; very low‐certainty evidence). All reported adverse events: the review contains data for two comparisons for this outcome. We are uncertain about differences in adverse effects between foam surfaces and alternating pressure (active) air surfaces (3 studies, 2181 participants; very low‐certainty evidence), and between foam surfaces and reactive air surfaces (1 study, 72 participants; very low‐certainty evidence). Health‐related quality of life: only one study reported data on this outcome. It is uncertain if there is a difference (low‐certainty evidence) between foam surfaces and alternating pressure (active) air surfaces in health‐related quality of life measured with two different questionnaires, the EQ‐5D‐5L (267 participants) and the PU‐QoL‐UI (233 participants). Cost‐effectiveness: one study reported trial‐based cost‐effectiveness evaluations. Alternating pressure (active) air surfaces are probably more cost‐effective than foam surfaces in preventing pressure ulcer incidence (2029 participants; moderate‐certainty evidence). Authors' conclusions Current evidence suggests uncertainty about the differences in pressure ulcer incidence, patient comfort, adverse events and health‐related quality of life between using foam surfaces and other surfaces (reactive fibre surfaces, reactive gel surfaces, reactive foam and gel surfaces, or reactive water surfaces). Foam surfaces may increase pressure ulcer incidence compared with alternating pressure (active) air surfaces and reactive air surfaces. Alternating pressure (active) air surfaces are probably more cost‐effective than foam surfaces in preventing new pressure ulcers. Future research in this area should consider evaluation of the most important support surfaces from the perspective of decision‐makers. Time‐to‐event outcomes, careful assessment of adverse events and trial‐level cost‐effectiveness evaluation should be considered in future studies. Trials should be designed to minimise the risk of detection bias; for example, by using digital photography and by blinding adjudicators of the photographs to group allocation. Further review using network meta‐analysis will add to the findings reported here., Plain language summary Do mattresses and mattress toppers made of foam prevent pressure ulcers? Key messages Mattresses and mattress toppers made of foam: ‐ may increase the risk of developing pressure ulcers when compared with air‐filled surfaces; ‐ are probably less cost‐effective than air‐filled surfaces that regularly redistribute pressure under the body. It is unclear if foam has an effect on pressure ulcers compared with surfaces made of fibre, gel or water cells. Future studies should focus on options and effects that are important to decision‐makers, such as: ‐ gel surfaces that apply constant skin pressure, compared with foam surfaces; and ‐ whether and when pressure ulcers develop, unwanted effects and costs. What are pressure ulcers? Pressure ulcers are also known as pressure sores or bed sores. They are wounds to the skin and underlying tissue caused by prolonged pressure or rubbing. They often occur on bony parts of the body, such as heels, elbows, hips and the bottom of the spine. People who have mobility problems or who lie in bed for long periods are at risk of developing pressure ulcers. What did we want to find out? There are beds, mattresses and mattress toppers specifically designed for people at risk of pressure ulcers. These can be made of a range of materials (such as foam, fibre, air cells or water bags) and are divided into two groups: ‐ reactive (static) surfaces that apply a constant pressure to the skin, unless a person moves or is repositioned; and ‐ active (alternating pressure) surfaces that regularly redistribute the pressure under the body. We wanted to find out if mattresses and mattress toppers made of foam (a reactive surface): ‐ prevent pressure ulcers; ‐ are comfortable and improve people’s quality of life; ‐ have health benefits that outweigh their costs (cost‐effectiveness); and ‐ have any unwanted effects. What did we do? We searched the medical literature for studies that evaluated the effects of mattresses and mattress toppers made of foam. We compared and summarised their results, and rated our confidence in the evidence, based on factors such as study methods and sizes. What did we find? We found 29 studies (9566 people, average age: 76 years) that lasted between five days and one year (average: 15 days). The studies compared foam with active and reactive surfaces made of gel, air cells, water bags and other foam types. Pressure ulcer prevention The evidence suggests that: ‐ foam surfaces may increase the risk of developing pressure ulcers when compared with active or reactive air‐filled surfaces (8 studies); ‐ denser memory foam (foam that adapts to a person’s body shape) may be better than lighter memory foam for preventing pressure ulcers if the data on the time it takes to develop a new ulcer is looked at (1 study, duration: 11.5 days); ‐ flat foam surfaces may be better than ridged foam surfaces for preventing pressure ulcers if the data on the time it takes to develop a new ulcer is looked at (1 study, duration: 1 month). It is unclear if foam has an effect on pressure ulcers compared to water or gel surfaces. Other effects Evidence from one study suggests that foam is probably less cost‐effective than active, air‐filled surfaces. We did not find sufficiently robust and clear evidence to determine how foam affects comfort, quality of life and unwanted effects. What limited our confidence in the evidence? Most studies were small (101 people on average) and more than half (17 studies) used methods likely to introduce errors in their results. How up‐to‐date is this review? The evidence in this Cochrane Review is current to November 2019.

Objectives This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of beds and mattresses on pressure ulcer healing in people with pressure ulcers of any stage, in any setting.

Aim: To investigate whether ulceration, amputation and healing of foot ulcers in people living with diabetes are associated with psychosocial and behavioural factors. Methods: We searched MEDLINE, Embase, PsychINFO, CINAHL and The Cochrane Library to March 2019 for longitudinal studies with multivariable analyses investigating independent associations. Two reviewers extracted data and assessed risk of bias. Results: We identified 15 eligible studies involving over 12 000 participants. Clinical and methodological heterogeneity precluded meta-analysis, so we summarize narratively. Risk of bias was moderate or high. For ulceration, we found significantly different results for people with and without an ulcer history. For those with no ulcer history, moderate quality evidence suggests depression increases ulcer risk [three studies; e.g. hazard ratio (HR) 1.68 (1.20, 2.35) per Hospital Anxiety and Depression Scale (HADS) standard unit]. Better foot self-care behaviour reduces ulcer risk [HR 0.61 (0.40, 0.93) per Summary of Diabetes Self-Care Activities scale standard unit; one study]. For people with diabetes and previous ulcers, low- or very low-quality evidence suggests little discernible association between ulcer recurrence and depression [e.g. HR 0.88 (0.61, 1.27) per HADS standard unit], foot self-care, footwear adherence or exercise. Low-quality evidence suggests incomplete clinic attendance is strongly associated with amputation [odds ratio (OR) 3.84 (1.54, 9.52); one study]. Evidence for the effects of other psychosocial or behavioural factors on ulcer healing and amputation is very low quality and inconclusive. Conclusions: Psychosocial and behavioural factors may influence the development of first ulcers. More high quality research is needed on ulcer recurrence and healing. (Open Science Framework Registration: https://osf.io/ej689).

ObjectivesTo estimate and examine the direct healthcare costs of treating people with open venous leg ulcers in the UK.DesignCost-of-illness study.SettingA cross-sectional survey of nine National Health Service community locales over 2-week periods in 2015/2016.MethodsWe examined the resource use and prevalence of venous leg ulcer treatment in the community. Examination of variation in these obtained costs was performed by ordinary least squares regression. We used additional resource use information from a randomised control trial and extrapolated costs to the UK for an annual period.ResultsThe average 2-week per person cost of treating patients where a venous leg ulceration was the primary (most severe) wound was estimated at £166.39 (95% CI £157.78 to £175.00) with community staff time making up over half of this amount. Costs were higher where antimicrobial dressings were used and where wound care was delivered in the home. Among those with any recorded venous leg ulcer (primary and non-primary), we derived a point prevalence of 3.2 per 10 000 population and estimated that the annual prevalence could be no greater than 82.4 per 10 000 population. We estimated that the national cost of treating a venous leg ulcer was £102 million with a per person annual cost at £4787.70.ConclusionOur point prevalence figures are in line with the literature. However, our annual prevalence estimations and costs are far lower than those reported in recent literature which suggests that the costs of treating venous leg ulcers are lower than previously thought. Movement towards routinely collected and useable community care activity would help provide a transparent and deeper understanding of the scale and cost of wound care in the UK.

Background Surgical wounds healing by secondary intention (SWHSI) are increasingly being treated with negative‐pressure wound therapy (NPWT) despite a lack of high‐quality research evidence regarding its clinical and cost‐effectiveness. This pilot feasibility RCT aimed to assess the methods for and feasibility of conducting a future definitive RCT of NPWT for the treatment of SWHSI. Methods Eligible consenting adult patients receiving care at the study sites (2 acute and 1 community) and with a SWHSI appropriate for NPWT or wound dressing treatment were randomized 1 : 1 centrally to receive NPWT or usual care (no NPWT). Participants were followed up every 1–2 weeks for 3 months. Feasibility (recruitment rate, time to intervention delivery) and clinical (time to wound healing) outcomes were assessed. Results A total of 248 participants were screened for eligibility; 40 (16·1 per cent) were randomized, 19 to NPWT and 21 to usual care. Twenty‐four of the 40 wounds were located on the foot. Participants received NPWT for a median of 18 (range 0–72) days. Two participants in the NPWT group never received the intervention and 14 received NPWT within 48 h of randomization. Five participants in the usual care group received NPWT during the study. Ten of the 40 wounds were deemed to have healed during the study. Conclusion A full‐scale RCT to investigate the clinical and cost‐effectiveness of NPWT for SWHSI is feasible. This study identified crucial information on recruitment rates and data collection methods to consider during the design of a definitive RCT. Registration number: ISRCTN12761776 (www.iscrtn.com)

Study DesignNarrative review.ObjectivesPressure 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.SettingGlobal.MethodsThe 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.ResultsThe 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.ConclusionsThe 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.

Background Care bundles are a set of three to five evidence-informed practices performed collectively and reliably to improve the quality of care. Care bundles are used widely across healthcare settings with the aim of preventing and managing different health conditions. This is the first systematic review designed to determine the effects of care bundles on patient outcomes and the behaviour of healthcare workers in relation to fidelity with care bundles. Methods This systematic review is reported in line with the PRISMA statement for reporting systematic reviews and meta-analyses. A total of 5796 abstracts were retrieved through a systematic search for articles published between January 1, 2001, to February 4, 2017, in the Cochrane Central Register for Controlled Trials, MEDLINE, EMBASE, British Nursing Index, CINAHL, PsychInfo, British Library, Conference Proceeding Citation Index, OpenGrey trials (including cluster-randomised trials) and non-randomised studies (comprising controlled before-after studies, interrupted time series, cohort studies) of care bundles for any health condition and any healthcare settings were considered. Following the removal of duplicated studies, two reviewers independently screen 3134 records. Three authors performed data extraction independently. We compared the care bundles with usual care to evaluate the effects of care bundles on the risk of negative patient outcomes. Random-effect models were used to further explore the effects of subgroups. Results In total, 37 studies (6 randomised trials, 31 controlled before-after studies) were eligible for inclusion. The effect of care bundles on patient outcomes is uncertain. For randomised trial data, the pooled relative risk of negative effects between care bundle and control groups was 0.97 [95% CI 0.71 to 1.34; 2049 participants]. The relative risk of negative patient outcomes from controlled before-after studies favoured the care bundle treated groups (0.66 [95% CI 0.59 to 0.75; 119,178 participants]). However, using GRADE, we assessed the certainty of all of the evidence to be very low (downgraded for risk of bias, inconsistency, indirectness). Conclusions Very low quality evidence from controlled before-after studies suggests that care bundles may reduce the risk of negative outcomes when compared with usual care. By contrast, the better quality evidence from six randomised trials is more uncertain. Trial registration PROSPERO, CRD42016033175 Electronic supplementary material The online version of this article (10.1186/s13012-017-0670-0) contains supplementary material, which is available to authorized users.