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

Research output: Contribution to journalArticlepeer-review

Authors

  • Mark Woodward
  • Nicky J Welton
  • Benjamin R Waterhouse
  • Andrew D Torrance
  • Sean Strong
  • Dimitrios Siassakos
  • William Seligman
  • Leila Rooshenas
  • Chris Rogers
  • Lloyd Rickard
  • Barnaby C Reeves
  • Anne M Pullyblank
  • Caroline Pope
  • Samir Pathak
  • Anwar Owais
  • Jamie O’Callaghan
  • Stephen O’Brien
  • Dmitri Nepogodiev
  • Khaldoun Nadi
  • Charlotte E Murkin
  • Tonia Munder
  • Tom Milne
  • David E Messenger
  • Matthew Mason
  • Morwena Marshall
  • Rhiannon Macefield
  • Richard Lovegrove
  • Robert J Longman
  • Jessica Lloyd
  • Jeffrey Lim
  • Kathryn Lee
  • Vijay Korwar
  • Daniel Hughes
  • George Hill
  • Rosie Harris
  • Mohammed Hamdan
  • Hannah Gould-Brown
  • Rachael Gooberman-Hill
  • Caroline Fryer
  • Daisy Elliott
  • Jo C Dumville
  • Tim Draycott
  • Jenny L. Donovan
  • Simon Davey
  • David Cotton
  • Joanna Coast
  • Madeleine Clout
  • Benjamin E Byrne
  • Oliver D Brown
  • Jane M Blazeby
  • Natalie S Blencowe
  • Katarzyna D. Bera
  • Joanne Bennett
  • Richard Bamford
  • Danya Bakhbakhi
  • Muhammad Atif
  • Kate Ashton
  • Elizabeth Armstrong
  • Lazaros Andronis
  • Piriyankan Ananthavarathan

External organisations

  • BRISTOL UNIVERSITY
  • University of Manchester
  • OXFORD UNIVERSITY

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 participant- and 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.

Details

Original languageEnglish
JournalBMJ open
Publication statusAccepted/In press - 11 Nov 2019

Keywords

  • Randomised controlled trial, Pilot study, Surgical site infection, Wound dressing, Tissue adhesive as a dressing