Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT.

BACKGROUND: Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI. OBJECTIVE: To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds. DESIGN: Phase A - semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B - pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved. SETTING: Usual NHS care. PARTICIPANTS: Patients undergoing elective/non-elective abdominal surgery, including caesarean section. INTERVENTIONS: Phase A - none. Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing'. MAIN OUTCOME MEASURES: Phase A - pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B - participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers. DATA SOURCES: Phase A - interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B - participants and HCPs in five hospitals. RESULTS: Phase A - we interviewed 102 participants. HCPs interpreted 'dressing' variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a 'no dressing' group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B - from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n = 133; glue, n = 129; no dressing, n = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients' understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test-retest and Cronbach's alpha of > 0.7) and diagnostic accuracy (c-statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments. LIMITATIONS: Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres. CONCLUSIONS: A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4-8 weeks. TRIAL REGISTRATION: Phase A - Current Controlled Trials ISRCTN06792113; Phase B - Current Controlled Trials ISRCTN49328913. 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. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).

Wound infections are common after surgery. Some are cured with simple treatment, but others may lead to serious problems. Reducing the risk of a wound infection is important. We do not know if the type of dressing, or not using a dressing, influences the risk of infection. A study that allocated patients to receive different dressings (or no dressing) would answer this question. We did preliminary research to explore whether or not such a study is possible. We interviewed doctors, nurses and patients about their views on dressings and a future study. We also described dressings currently being used in the NHS and found that simple dressings and tissue adhesive (glue) 'as-a-dressing' are used most frequently. We studied existing evidence and interviewed experts to develop a questionnaire, completed by patients, to identify wound infections after patients leave hospital and tested its accuracy. We also explored taking photographs of wounds. We investigated whether or not a major study would be worth the cost and designed a pilot study to test its feasibility. The pilot study recruited 394 patients undergoing abdominal operations in five NHS hospitals. These patients were allocated to have a simple dressing, glue-as-a-dressing or no dressing, and 92% received the allocated dressing method. Patients and their doctors and nurses found the dressing methods to be acceptable. We showed that the new patient questionnaire accurately identified infections. Patients or their carers also found it acceptable to photograph their wounds. Our research suggests that a future large study would be worth the investment and is possible.

Did the 'Be Clear on Bowel Cancer' public awareness campaign pilot result in a higher rate of cancer detection?

OBJECTIVES: To assess the impact of a 7-week public bowel cancer awareness campaign pilot by reviewing the number of 2-week referrals from general practitioners (GPs) to hospital, endoscopic procedures and new cancers diagnosed throughout the five acute hospitals in The Peninsular Cancer Network, UK. DESIGN: A retrospective before and after study. SETTING: The Peninsula Cancer Network in the South West of England, UK. MAIN OUTCOME MEASURES: For the period July 2010-July 2011, data were collected on the number of 2-week referrals, number of endoscopic procedures performed and number of new cancers diagnosed. The average for the 6 months before the campaign was compared with the immediate 3 months and then the fourth to sixth months following the campaign. Student's t test was used to compare the means of the three groups. RESULTS: There was a statistically significant increase in the number of 2-week referrals from GPs to hospital in the 3 months following the campaign but this effect disappeared after that. There was no statistical increase in the number of endoscopic procedures or new cancers diagnosed following the awareness campaign. CONCLUSIONS: The pilot 'Be Clear on Cancer' awareness campaign had a significant effect on the number of patients being referred from GPs to hospital; however, the effect was short lived and had returned to baseline by 3 months. The campaign had no effect on the number of new cancers diagnosed, which was the stated underlying aim of the pilot.

Chronic asymptomatic dislocation of the bearing in an Oxford unicompartmental knee replacement.

Unicompartmental knee replacement is a common procedure for the treatment of osteoarthritis confined to one compartment of the knee. Dislocation of the mobile bearing is a recognised complication. We present a patient with a 6-year asymptomatic bearing dislocation, missed on original presentation.

Biological meshes: a review of their use in abdominal wall hernia repairs.

PURPOSE: Biological meshes are mostly used in infected fields within complex abdominal wall hernia repairs. There is no consensus, however, on the most appropriate material to be used in a given situation. METHODS: A literature review of published articles reporting the utilization of biological meshes in ventral/incisional hernia repair was conducted. Data were analyzed to compare the recurrence rates obtained with biological meshes. MAIN FINDINGS: Only a few prospective comparative studies were identified. Most publications relate to AlloDerm®, Permacol™ and Surgisis™ with data from other meshes insufficient to draw conclusions. AlloDerm has a 0-100% recurrence rate among studies. It compares poorly with Surgisis and results in an unfavorable outcome when used as a 'bridge prosthesis'. Permacol has consistent recurrence rates of 0-15%, whatever the patients' profiles or the context of infected fields, when considering the most relevant studies. The Surgisis results are more conflicting: the mesh exhibits low recurrence rates in clean fields, but in infected fields the recurrence rate is up to 39%. CONCLUSION: Taken together, these studies suggest that the cross-linked mesh, Permacol has the lowest failure rate and the longest time to failure, particularly in contaminated or infected fields. However, this data should be confirmed by large prospective randomized studies.

Unusual presentation of more common disease/injury: traumatic hand amputation while wakeboarding.

Wakeboarding is a sport increasing in popularity in the UK and the rest of the world. It is known to be associated with a high incidence of relatively minor injuries to the participating sportsperson. The authors present the case of a traumatic hand amputation to an associated third party and highlight the potential for serious injuries to all those directly involved with the sport. The authors demonstrate the successful application of military principles to a traumatic amputation in a civilian setting.

Traumatic hand amputation while wakeboarding.

Wakeboarding is a sport increasing in popularity in the UK and the rest of the world. It is known to be associated with a high incidence of relatively minor injuries to the participating sportsperson. The authors present the case of a traumatic hand amputation to an associated third party and highlight the potential for serious injuries to all those directly involved with the sport. The authors demonstrate the successful application of military principles to a traumatic amputation in a civilian setting.