Article ; Online: Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT.
Health technology assessment (Winchester, England)
2019 Volume 23, Issue 39, Page(s) 1–166
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 ... ...
| 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, 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 |
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| MeSH term(s) | Abdomen/surgery ; Adult ; Aged ; Bandages/classification ; Bandages/microbiology ; Cesarean Section/adverse effects ; Cost-Benefit Analysis ; Feasibility Studies ; Female ; Humans ; Male ; Middle Aged ; Pilot Projects ; Quality-Adjusted Life Years ; Reproducibility of Results ; Surgical Procedures, Operative/adverse effects ; Surgical Wound Infection/microbiology ; Surgical Wound Infection/prevention & control ; Surveys and Questionnaires |
| Language | English |
| Publishing date | 2019-09-04 |
| Publishing country | England |
| Document type | Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 2006765-3 |
| ISSN | 2046-4924 ; 1366-5278 |
| ISSN (online) | 2046-4924 |
| ISSN | 1366-5278 |
| DOI | 10.3310/hta23390 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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