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

Abstract

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).

Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

“…In a main trial, it is expected that training for recruitment and materials used to optimise recruitment will be available based on lessons learnt in this pilot. It is likely that a main two-group trial would address whether ‘no dressings’ are non-inferior to a simple dressing in terms of SSI; this is the comparison is of greatest value to the National Health Service 18. A main trial with three groups would be more efficient than a separate trial to test the superiority of ‘glue-as-a-dressing’ to simple dressings.…”

“…Skin transfers (temporary adherent tattoos) were placed next to the wound to encourage adherence to allocated dressing type after leaving the operating theatre (figure 1). The feasibility of collecting other data (likely to be used in a main trial) and their completeness was investigated for: patient and observer reported questionnaires measuring SSI with the newly validated WHQ; patient and observer reported questionnaires to assess symptoms and experiences of wounds and dressings; preference-based health-related quality of life (EuroQoL-five-dimension-five-level: EQ-5D-5L) 17; wound complications and resource use 18. A face-to-face wound assessment was carried out at 4-6 weeks to validate the WHQ 19.…”

Patient involvement in surgical wound care research: A scoping review

“…After title and abstract screening by two reviewers (RM and JP), further 4584 articles were removed, resulting in 26 articles for full‐text review. Following full‐text review, further 18 articles were excluded and 8 articles 36‐43 included in review (Figure 1).…”

“…Table 1 summarises the eight included studies. Of them, five were conducted in the United States, 36,37,41‐43 and three in the United Kingdom 38‐40 . All studies were published between 2013 and 2019.…”

“…All studies were published between 2013 and 2019. The terms “patient” and “patient advisor” were used in both the US and UK studies to refer to those involved in surgical wound care research, whereas “patient representative” and “patient and public involvement member” (PPI member) were used exclusively in two UK studies, 39,40 and “patient advocate” in one US study 42 . The context of the research reflected a wide variety of surgical procedures.…”