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

Research output: Contribution to journalArticle

Original languageEnglish
JournalBMJ Open
DateAccepted/In press - 11 Nov 2019

Abstract

Objective: Surgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle Study assessed the feasibility of a multi-centre RCT to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds. Design: A pilot, factorial randomised controlled trial (RCT). Setting: Five UK hospitals. Participants: Adults undergoing abdominal surgery with a primary surgical wound. Interventions: Participants were randomised to ‘simple dressing’, ‘glue-as-a-dressing’ or ‘no dressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure). Primary and secondary outcome measures: Feasibility outcomes focussed on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participantand observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L). Results: Between March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133; glue=129; ‘no dressing’=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132) respectively. Adherence to disclosure time was 99% and 86% before and after wound closure respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the WHQ and other questionnaires ranged from >90% at 4 days to 68% at 4-8 weeks. Conclusions: A definitive RCT of dressing strategies including ‘no dressing’ is feasible. Further work is needed to optimise questionnaire response rates.

    Research areas

  • randomised controlled trial, pilot study, surgical site infection, wound dressing, tissue adhesive as a dressing

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