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Abstract Introduction Delays exist at each stage of the chronic limb‐threatening ischaemia (CLTI) care pathway, but there is little known about patient factors influencing delay to diagnosis of CLTI. This study explores the experiences and perceptions of patients recently diagnosed with CLTI. Methods A qualitative interview study was conducted. Sixteen participants underwent semi‐structured interviews. Reflexive thematic analysis was performed on the data, aiming to understand factors which can influence delay in the CLTI care pathway. Results Five interrelated themes were developed: CLTI is a devastating condition; Reluctance to ask for help; When we are empowered we get better care; Luck plays a role in the process to diagnosis; and Vascular units can do better, comprising sub‐themes of information transfer—consider communication and arterial versus non‐arterial centres—proximity isn't everything. Conclusions The five themes generated from the interview data describe factors relevant to delay given meaning by participants who have lived experience of CLTI. Theme content should be noted by clinicians, commissioners and providers looking to improve care pathways for patients with CLTI. The importance of awareness for the public, patients and clinicians linked ideas in some themes and interventions to raise awareness should be considered.

Abstract Introduction Patients in the community with suspected Chronic limb‐threatening ischaemia (CLTI) should be urgently referred to vascular services for investigation and management. The Theoretical Domains Framework (TDF) allows identification of influences on health professional behaviour in order to inform future interventions. Here, the TDF is used to explore primary care clinicians' behaviours with regards to recognition and referral of CLTI. Methods Semi‐structured interviews were conducted with 20 podiatrists, nurses and general practitioners in primary care. Directed content analysis was performed according to the framework method. Utterances were coded to TDF domains, and belief statements were defined by grouping similar utterances. Relevance of domains was confirmed according to belief frequency, presence of conflicting beliefs and the content of the beliefs indicating relevance. Results Nine TDF domains were identified as relevant to primary care clinicians: Knowledge, Environmental context and resources, Memory, Decision and attention processes, Beliefs about capabilities, Skills, Emotions, Reinforcement and Behavioural regulation. Relationships across domains were identified, including how primary care clinician confidence and working in a highly pressurized environment can affect behaviour. Conclusion We have identified key barriers and enablers to timely recognition and referral behaviour. These beliefs identify targets for theory‐driven behaviour change interventions to reduce delays in CLTI pathways.

IntroductionSurgical site infections (SSI) are the most common healthcare-associated infections; however, access to healthcare services, lack of patient awareness of signs, and inadequate wound surveillance can limit timely diagnosis. Telemedicine as a method for remote postoperative follow-up has been shown to improve healthcare efficiency without compromising clinical outcomes. Furthermore, telemedicine would reduce the carbon footprint of the National Health Service (NHS) through minimising patient travel, a significant contributor of carbon dioxide equivalent (CO2e) emissions. Adopting innovative approaches, such as telemedicine, could aid in the NHS Net-Zero target by 2045. This study aimed to provide a comprehensive analysis of the feasibility and sustainability of telemedicine postoperative follow-up for remote diagnosis of SSI.MethodsPatients who underwent a lower limb vascular procedure were reviewed remotely at 30 days following the surgery, with a combined outcome measure (photographs and Bluebelle Wound Healing Questionnaire). A hybrid life-cycle assessment approach to carbon footprint analysis was used. The kilograms of carbon dioxide equivalent (kgCO2e) associated with remote methods were mapped prospectively. A simple outpatient clinic review, i.e., no further investigations or management required, was modelled for comparison. The Department of Environment, Food, and Rural Affairs (DEFRA) conversion factors plus healthcare specific sources were used to ascertain kgCO2e. Patient postcodes were applied to conversion factors based upon mode of travel to calculate kgCO2e for patient travel. Total and median (interquartile range) carbon emissions saved were presented for both patients with and without SSI.ResultsAltogether 31 patients (M:F 2.4, ±11.7 years) were included. The median return distance for patient travel was 42.5 (7.2–58.7) km. Median reduction in emissions using remote follow-up was 41.2 (24.5–80.3) kgCO2e per patient (P

Background Delays in the pathway from first symptom to treatment of chronic limb-threatening ischaemia (CLTI) are associated with worse mortality and limb loss outcomes. This study examined the processes used by vascular services to provide urgent care to patients with suspected CLTI referred from the community.Methods Vascular surgery units from various regions in England were invited to participate in a process mapping exercise. Clinical and non-clinical staff at participating units were interviewed, and process maps were created that captured key staff and structures used to create processes for referral receipt, triage and assessment at the units.Results Twelve vascular units participated, and process maps were created after interviews with 45 participants. The units offered multiple points of access for urgent referrals from general practitioners and other community clinicians. Triage processes were varied, with units using different mixes of staff (including medical staff, podiatrists and s) and this led to processes of varying speed. The organisation of clinics to provide slots for ‘urgent’ patients was also varied, with some adopting hot clinics, while others used dedicated slots in routine clinics. Service organisation could be further complicated by separate processes for patients with and without diabetes, and because of the organisation of services regionally into vascular networks that had arterial and non-arterial centres.Conclusions For referred patients with symptoms of CLTI, the points of access, triage and assessment processes used by vascular units are diverse. This reflects the local context and ingenuity of vascular units but can lead to complex processes. It is likely that benefits might be gained from simplification.

[This corrects the article DOI: 10.1371/journal.pone.0275025.].

Abstract The Sars-CoV-2 pandemic catalysed integration of telemedicine worldwide. This systematic review assesses it’s accuracy for diagnosis of Surgical Site Infection (SSI). Databases were searched for telemedicine and wound infection studies. All types of studies were included, only paired designs were taken to meta-analysis. QUADAS-2 assessed methodological quality. 1400 titles and abstracts were screened, 61 full text reports were assessed for eligibility and 17 studies were included in meta-analysis, mean age was 47.1 ± 13.3 years. Summary sensitivity and specificity was 87.8% (95% CI, 68.4–96.1) and 96.8% (95% CI 93.5–98.4) respectively. The overall SSI rate was 5.6%. Photograph methods had lower sensitivity and specificity at 63.9% (95% CI 30.4–87.8) and 92.6% (95% CI, 89.9–94.5). Telemedicine is highly specific for SSI diagnosis is highly specific, giving rise to great potential for utilisation excluding SSI. Further work is needed to investigate feasibility telemedicine in the elderly population group.

BackgroundThe European Association of Endoscopic Surgery (EAES) is a surgical society who promotes the development and expansion of minimally invasive surgery to surgeons and surgical trainees. It does so through its activities in education, training, and research. The EAES research committee aims to promote the highest quality clinical research in endoscopic and minimally invasive surgery. They have provided grant funding since 2009 in education, surgery, and basic science. Despite the success and longevity of the scheme, the academic and non-academic impact of the research funding scheme has not been evaluated.AimsThe primary aim of this project is to assess the short, long term academic and real world impact of the EAES funding scheme. The secondary aims are to identify barriers and facilitators for achieving good impact.MethodsThis will be a mixed qualitative and quantitative study. Semi-structured interviews will be performed with previous grant recipients. The questions for the interviews will be selected after a consensus is achieved amongst the members of the steering committee of this project. The responses will be transcribed and thematic analysis will be applied. The results of the thematic analysis will be used to populate a questionnaire which will be disseminated to grant recipients. This study is kindly funded by the EAES.DiscussionThe first question this project is expected to answer is whether the EAES research funding scheme had a significant positive impact on research output, career progression but also non-academic output such as change in clinical guidelines, healthcare quality and cost-effectiveness improvement. This project however is also expected to identify facilitators and barriers to successful completion of projects and to achieving high impact. This will inform EAES and the rest of the surgical and academic communities as to how clinicians would like to be supported when conducting research. There should also be a positive and decisive change towards removing factors that hinder the timely and successful completion of projects.

Background High-quality surgical care is vital to deliver the excellent outcomes patients deserve following surgical treatment. Quality improvement collaboratives (QICs) are based on a multicentre model for improving healthcare. They are increasingly used but their effectiveness in the context of surgical services is unclear. This review assessed effectiveness of QICs in National Health Service (NHS) surgical settings, and identified factors that influenced implementation.Methods A systematic search of MEDLINE and EMBASE, as well as grey literature, was conducted in January 2022 to identify evaluations of QICs in NHS surgical settings. Data were extracted on the intervention, setting, study results and factors that were identified as facilitators or barriers. These were coded using the Consolidated Framework for Implementation Research (CFIR). The quality of study reports was assessed using Quality Improvement Minimum Criteria Set.Results Fifteen reports on 10 QICs met inclusion criteria. The evaluations used study designs of different strength, with one using a stepped-wedge randomised controlled trial (RCT). Eight studies reported the QIC had been successful in achieving their principal aims, which covered a mix of patient outcomes and process indicators. The study based on the RCT found the QIC was not successful (no improvement in patient outcomes). Each article reported a range of facilitators and barriers to effectiveness of implementation of the QIC, which were spread across the CFIR domains (intervention, outer setting, inner setting, individuals and process). There were few barriers reported in the intervention domain that related to the QIC. There was no clear relationship between numbers of facilitators and barriers reported and effectiveness.Conclusions Studies have reported QICs to be effective in increasingly complex contexts, but their results must be treated with caution. The evaluations often used weak study designs and the quality of reports was variable. Evaluation with strong study design should be integral to future QICs.PROSPERO registration number CRD42022324970.

BackgroundMinimally invasive (MI) surgery has revolutionised surgery, becoming the standard of care in many countries around the globe. Observed benefits over traditional open surgery include reduced pain, shorter hospital stay, and decreased recovery time. Gastrointestinal surgery in particular was an early adaptor to both laparoscopic and robotic surgery. Within this review, we provide a comprehensive overview of the evolution of minimally invasive gastrointestinal surgery and a critical outlook on the evidence surrounding its effectiveness and safety.MethodsA literature review was conducted to identify relevant articles for the topic of this review. The literature search was performed using Medical Subject Heading terms on PubMed. The methodology for evidence synthesis was in line with the four steps for narrative reviews outlined in current literature. The key words used were minimally invasive, robotic, laparoscopic colorectal, colon, rectal surgery.ConclusionThe introduction of minimally surgery has revolutionised patient care. Despite the evidence supporting this technique in gastrointestinal surgery, several controversies remain. Here we discuss some of them; the lack of high level evidence regarding the oncological outcomes of TaTME and lack of supporting evidence for robotic colorectalrectal surgery and upper GI surgery. These controversies open pathways for future research opportunities with RCTs focusing on comparing robotic to laparoscopic with different primary outcomes including ergonomics and surgeon comfort.

Objective: To document the recovery of vascular services in Europe following the first COVID-19 pandemic peak. Methods: An online structured vascular service survey with repeated data entry between 23 March and 9 August 2020 was carried out. Unit level data were collected using repeated questionnaires addressing modifications to vascular services during the first peak (March – May 2020, “period 1”), and then again between May and June (“period 2”) and June and July 2020 (“period 3”). The duration of each period was similar. From 2 June, as reductions in cases began to be reported, centres were first asked if they were in a region still affected by rising cases, or if they had passed the peak of the first wave. These centres were asked additional questions about adaptations made to their standard pathways to permit elective surgery to resume. Results: The impact of the pandemic continued to be felt well after countries’ first peak was thought to have passed in 2020. Aneurysm screening had not returned to normal in 21.7% of centres. Carotid surgery was still offered on a case by case basis in 33.8% of centres, and only 52.9% of centres had returned to their normal aneurysm threshold for surgery. Half of centres (49.4%) believed their management of lower limb ischaemia continued to be negatively affected by the pandemic. Reduced operating theatre capacity continued in 45.5% of centres. Twenty per cent of responding centres documented a backlog of at least 20 aortic repairs. At least one negative swab and 14 days of isolation were the most common strategies used for permitting safe elective surgery to recommence. Conclusion: Centres reported a broad return of services approaching pre-pandemic “normal” by July 2020. Many introduced protocols to manage peri-operative COVID-19 risk. Backlogs in cases were reported for all major vascular surgeries.

Abstract Background Chronic limb‐threatening ischaemia (CLTI) is a condition associated with significant risks of lower limb loss and mortality, which increase with delays in management. Guidance recommends urgent referral and assessment, but delays are evident at every stage of the CLTI patient pathway. This study uses qualitative methods to explore hospital clinicians' experiences and perceptions of the existing CLTI pathway. Methods A qualitative interview study was conducted. Semi‐structured interviews were undertaken with 13 clinicians involved in the assessment of patients referred to hospital with suspected CLTI, identified via purposive sampling from English vascular surgery units. Clinicians included podiatrists, vascular specialist nurses and doctors. Reflexive thematic analysis was performed on the data from a critical realist position. Results The need for speed was the single overarching theme identified. Four linked underlying themes were also identified; 1. Vascular surgery as the poor relation (compared to cancer and other specialties), with a sub‐theme of CLTI being a challenging diagnosis. 2. Some patients are more equal than others, with sub‐themes of diabetes vs. non‐diabetes, hub vs. spoke and frailty vs. non‐frail. 3. Life in the National Health Service (NHS) is tough, with sub‐themes of lack of resource and we're all under pressure. 4. Non‐surgeons can help. Conclusions The underlying themes generated from the rich interview data describe barriers to timely referral, assessment and management of CLTI, as well as the utility of non‐surgical roles such as podiatrists and vascular specialist nurses as a potential solution for delays. The overarching theme of the need for speed highlights the meaning given to adverse consequences of delays in management of CLTI by clinicians involved in its assessment. Future improvement projects aimed at the CLTI pathway should take these findings into account.

Anastomotic bleeding in vascular surgery can be difficult to control. Patients, in particular those undergoing carotid surgery, have often been started on treatment with dual antiplatelet agents and receive systemic heparinization intraoperatively. The use of local hemostatic agents as an adjunct to conventional methods is widely reported. 3-D Matrix’s absorbable hemostatic material RADA16 (PuraStat®), is a fully synthetic resorbable hemostatic agent. The aim of this study is to confirm the safety and performance of this agent when used to control intraoperative anastomotic bleeding during carotid endarterectomy (CEA). A prospective, single-arm, multicenter study involving 65 patients, undergoing CEA, in whom the hemostatic agent was applied to the suture line after removal of arterial clamps. Patients were followed up at 24 h, discharge, and one month after surgery. Time to hemostasis was measured as the primary endpoint. Secondary endpoints included hemostasis efficacy and safety outcomes, blood loss, intraoperative and postoperative administration of blood products, and incidence of reoperation for bleeding. A total of 65 cases (51 male and 14 female) undergoing CEA, utilizing patch reconstruction (90. 8%), eversion technique (6.1%), and direct closure (3.1%) were analyzed. All patients received dual antiplatelet therapy preoperatively and were administered systemic intravenous heparin intraoperatively, as per local protocol. The mean time to hemostasis was 83 s ± 105 s (95% CI: 55-110 s). Primary hemostatic efficacy was 90.8%. The mean volume of product used was 1.7 mL ± 1.1 mL. Hemostasis was achieved with a single application of the product in 49 patients (75.3%). Two patients required a transfusion of blood products intraoperatively. There were no blood product transfusions during the postoperative period. The intraoperative mean blood loss was 127 mL ± 111.4 mL and postoperatively, the total mean drainage volume was 49.0 mL ± 51.2 mL. The mean duration of surgery was 119 ± 35 min, and the mean clamp time was 35 min 12 s ± 19 min 59 s. In 90.8% of patients, there was no presence of hematoma at 24 h postoperatively. Three returned to theatre due to bleeding (2 in the first 24 h), however, none of these cases were considered product related. Overall, there were no device-related serious adverse events (SAE) or unanticipated device-related SAEs reported. Use of the hemostatic agent PuraStat® is associated with a high rate of hemostatic efficacy (90.8%) and a short time to hemostasis. The safety of the product for use on vascular anastomoses has been demonstrated.

Abstract Background The majority of surgical wounds are closed (for example with sutures or staples) and so heal by primary intention. Where closure is not possible, or the wound subsequently breaks down, wounds may be left to heal from the bottom up (healing by secondary intention). Surgical wound healing by secondary intention (SWHSI) frequently presents a significant management challenge. Additional treatments are often required during the course of healing, and thus a significant financial burden is associated with treating these wounds. Increasingly, negative pressure wound therapy (NPWT) is used in the management of SWHSI. This wound dressing system provides a negative pressure (vacuum) to the wound, removing fluid into a canister, which is believed to be conducive to wound healing. Despite the increasing use of NPWT, there is limited robust evidence for the effectiveness of this device. A well-designed and conducted randomised controlled trial is now required to ascertain if NPWT is a clinically and cost-effective treatment for SWHSI. Methods SWHSI-2 is a pragmatic, multi-centre, cross surgical specialty, two arm, parallel group, randomised controlled superiority trial. Adult patients with a SWHSI will be randomised to receive either NPWT or usual care (no NPWT) and will be followed up for 12 months. The primary outcome will be time to healing (defined as full epithelial cover in absence of a scab) in number of days since randomisation. Secondary outcomes will include key clinical events (hospital admission or discharge, treatment status, reoperation, amputation, antibiotic use and death), wound infection, wound pain, health-related quality of life, health utility and resource use. Discussion Given the increasing use of NPWT, despite limited high-quality supporting evidence, the SWHSI-2 Trial will provide robust evidence on the clinical and cost-effectiveness of NPWT in the management of SWHSI. The SWHSI-2 Trial opened to recruitment in May 2019 and is currently recruiting across 20 participating centres. Trial registration ISRCTN 26277546 . Prospectively registered on 25 March 2019

AimAchieve an international consensus on how to recover lost training opportunities. The results of this study will help inform future EAES guidelines about the recovery of surgical training before and after the pandemic.BackgroundA global survey conducted by our team demonstrated significant disruption in surgical training during the COVID-19 pandemic. This was wide-spread and affected all healthcare systems (whether insurance based or funded by public funds) in all participating countries. Thematic analysis revealed the factors perceived by trainees as barriers to training and gave birth to four-point framework of recovery. These are recommendations that can be easily achieved in any country, with minimal resources. Their implementation, however, relies heavily on the active participation and leadership by trainers. Based on the results of the global trainee survey, the authors would like to conduct a Delphi-style survey, addressed to trainers on this occasion, to establish a pragmatic step-by-step approach to improve training during and after the pandemic.MethodsThis will be a mixed qualitative and quantitative study. Semi-structured interviews will be performed with laparoscopic trainers. These will be transcribed and thematic analysis will be applied. A questionnaire will then be proposed; this will be based on both the results of the semi structured interviews and of the global trainee survey. The questionnaire will then be validated by the steering committee of this group (achieve consensus of >80%). After validation, the questionnaire will be disseminated to trainers across the globe. Participants will be asked to consent to participate in further cycles of the Delphi process until more than 80% agreement is achieved.ResultsThis study will result in a pragmatic framework for continuation of surgical training during and after the pandemic (with special focus on minimally invasive surgery training).

Defunctioning stomas (ileostomy and colostomy) may be used prior to commencement of neoadjuvant therapy in patients with locally advanced colon or rectal cancer, in order to prevent clinical large bowel obstruction caused by radiotherapy associated oedema or progression of disease in patients who are not obstructed. However, the exact rate of clinical obstruction in patients undergoing neoadjuvant therapy who do not receive a defunctioning stoma is not known. Furthermore, it is not clear which factors predispose patients to developing clinical large bowel obstruction. Given that defunctioning stomas are associated with post operative and intra-operative risks, it is not currently possible to tailor defunctioning stomas to patients who have the greatest risk of developing obstruction. This systematic review which is in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement (PRISMA), aims to define the role of defunctioning stomas in prevention of obstruction patients with locally advanced colon or rectal cancer while undergoing neoadjuvant therapy. Two researchers will perform the literature search which will include all published and "in process" articles published in the English language between 2002-2022 in the following databases: EMBASE (OVID), MEDLINE (EBSCO), CINHAL complete, Web of Science, Cochrane Central Registry of Controlled Trials, Clinical Trials Registry. The full text of the selected articles will be independently screened by two researchers against the inclusion criteria. Data will be extracted from each article regarding: study design, participants, type of intervention and outcomes. The effect size will be expressed in incidence rates and when appropriate in relative risk with 95% confidence intervals. If possible, we will perform a meta-analysis. Heterogeneity will be assessed using I2 statistics. We will pool the data extracted from the randomised controlled trials to perform a meta-analysis using the Review Manager 5 software (RevMan 5). The Grades of Recommendation, Assessment, Development and Evaluation (GRADE) system will be used to assess the certainty of the evidence.

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.

Background: Venous leg ulcers (VLUs) are the most common cause of leg ulceration, affecting 1 in 100 adults. VLUs may take many months to heal (25% fail to heal). Estimated prevalence is between 1% and 3% of the elderly population. Compression is the mainstay of treatment and few additional therapies exist to improve healing. Two previous trials have indicated that low-dose aspirin, as an adjunct to standard care, may improve healing time, but these trials were insufficiently robust. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established. Objectives: Primary objective – to assess the effects of 300 mg of aspirin (daily) versus placebo on the time to healing of the reference VLU. Secondary objectives – to assess the feasibility of leading into a larger pragmatic Phase III trial and the safety of aspirin in this population. Design: A multicentred, pilot, Phase II randomised double-blind, parallel-group, placebo-controlled efficacy trial. Setting: Community leg ulcer clinics or services, hospital outpatient clinics, leg ulcer clinics, tissue viability clinics and wound clinics in England, Wales and Scotland. Participants: Patients aged ≥ 18 years with a chronic VLU (i.e. the VLU is > 6 weeks in duration or the patient has a history of VLU) and who are not regularly taking aspirin. Interventions: 300 mg of daily oral aspirin versus placebo. All patients were offered care in accordance with Scottish Intercollegiate Guidelines Network (SIGN) guidance with multicomponent compression therapy aiming to deliver 40 mmHg at the ankle when possible. Randomisation: Participants were allocated in a 1 : 1 (aspirin : placebo) ratio by the Research Pharmacy, St George’s University Hospitals NHS Foundation Trust, using a randomisation schedule generated in advance by the investigational medicinal product manufacturer. Randomisation was stratified according to ulcer size (≤ 5cm2 or > 5cm2). Main outcome measure: The primary outcome was time to healing of the largest eligible ulcer (reference ulcer). Feasibility results – recruitment: 27 patients were recruited from eight sites over a period of 8 months. The target of 100 patients was not achieved and two sites did not recruit. Barriers to recruitment included a short recruitment window and a large proportion of participants failing to meet the eligibility criteria. Results: The average age of the 27 randomised participants (placebo, n = 13; aspirin, n = 14) was 62 years (standard deviation 13 years), and two-thirds were male (n = 18). Participants had their reference ulcer for a median of 15 months, and the median size of ulcer was 17.1 cm2. There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis for log-ulcer area and duration (hazard ratio 0.58, 95% confidence interval 0.18 to 1.85; p = 0.357). One expected, related serious adverse event was recorded for a participant in the aspirin group. Limitations: The trial under-recruited because many patients did not meet the eligibility criteria. Conclusions: There was no evidence that aspirin was efficacious in hastening the healing of chronic VLUs. It can be concluded that a larger Phase III (effectiveness) trial would not be feasible. Trial registration: Clinical Trials.gov NCT02333123; European Clinical Trials Database (EudraCT) 2014-003979-39. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 55. See the NIHR Journals Library website for further project information.

Background: Foam sclerotherapy (foam) and endovenous laser ablation (EVLA) have emerged as alternative treatments to surgery for patients with varicose veins, but uncertainty exists regarding their effectiveness in the medium to longer term. Objectives: To assess the clinical effectiveness and cost-effectiveness of foam, EVLA and surgery for the treatment of varicose veins. Design: A parallel-group randomised controlled trial (RCT) without blinding, and economic modelling evaluation. Setting: Eleven UK specialist vascular centres. Participants: Seven hundred and ninety-eight patients with primary varicose veins (foam, n = 292; surgery, n = 294; EVLA, n = 212). Interventions: Patients were randomised between all three treatment options (eight centres) or between foam and surgery (three centres). Primary outcome measures: Disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic [European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36) physical and mental component scores] quality of life (QoL) at 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained. Secondary outcome measures: Quality of life at 6 weeks; residual varicose veins; Venous Clinical Severity Score (VCSS); complication rates; return to normal activity; truncal vein ablation rates; and costs. Results: The results appear generalisable in that participants’ baseline characteristics (apart from a lower-than-expected proportion of females) and post-treatment improvement in outcomes were comparable with those in other RCTs. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at 6 months [effect size −1.74, 95% confidence interval (CI) −2.97 to −0.50; p = 0.006], but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA (effect size 1.54, 95% CI 0.01 to 3.06; p = 0.048) but similar to that for surgery. There were no differences in EQ-5D or SF-36 component scores in the surgery versus foam or surgery versus EVLA comparisons at 6 months.: The trial-based cost-effectiveness analysis showed that, at 6 months, foam had the highest probability of being considered cost-effective at a ceiling willingness-to-pay ratio of £20,000 per QALY. EVLA was found to cost £26,107 per QALY gained versus foam, and was less costly and generated slightly more QALYs than surgery. Markov modelling using trial costs and the limited recurrence data available suggested that, at 5 years, EVLA had the highest probability (≈ 79%) of being cost-effective at conventional thresholds, followed by foam (≈ 17%) and surgery (≈ 5%).: With regard to secondary outcomes, health gains at 6 weeks (p