A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial

Research output: Contribution to journalArticle

Authors

  • Barnaby C. Reeves
  • Lazaros Andronis
  • Jane M Blazeby
  • Natalie S Blencowe
  • Melanie Calvert
  • Joanna Coast
  • Tim Draycott
  • Jenny L Donovan
  • Rachael Gooberman-Hill
  • Robert J Longman
  • Laura Magill
  • Jonathan Mathers
  • Thomas D Pinkney
  • Chris A Rogers
  • Leila Rooshenas
  • Andrew Torrance
  • Nicky J Welton
  • Mark Woodward
  • Kate Ashton
  • Katarzyna D Bera
  • Gemma L Clayton
  • Lucy A Culliford
  • Jo C Dumville
  • Daisy Elliott
  • Lucy Ellis
  • Hannah Gould-Brown
  • Rhiannon C Macefield
  • Christel McMullan
  • Caroline Pope
  • Dimitrios Siassakos
  • Sean Strong
  • Helen Talbot
  • The Bluebelle Study Group

External organisations

  • Health Economics Unit, School of Health and Population Sciences, Public Health Building, University of Birmingham, Birmingham, B15 2TT.
  • Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol
  • Centre for Patient Reported Outcomes Research, University of Birmingham, Edgbaston, Birmingham, United Kingdom.
  • Institute of Applied Health Research, University of Birmingham, Birmingham, Uk.
  • North Bristol NHS Trust
  • NIHR Collaboration for Leadership in Applied Health Research and Care West at University Hospitals Bristol NHS Trust, Bristol, UK.
  • BRISTOL UNIVERSITY
  • Academic Department of Surgery, Queen Elizabeth Hospital, Edgbaston, Birmingham UK; College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
  • Department of Surgery, Sandwell and West Birmingham NHS Trust, Birmingham, UK.
  • University of Manchester

Abstract

BACKGROUND: Surgical site infections (SSIs) are common, occurring in up to 25% of > 4 million operations performed in England each year. Previous trials of the effect of wound dressings on the risk of developing a SSI are of poor quality and underpowered.

METHODS/DESIGN: This study is a feasibility and pilot trial to examine the feasibility of a full trial that will compare simple dressings, no dressing and tissue-glue as a dressing. It is examining the overall acceptability of trial participation, identifying opportunities for refinement, testing the feasibility of and validating new outcome tools to assess SSI, wound management issues and patients' wound symptom experiences. It is also exploring methods for avoiding performance bias and blinding outcome assessors by testing the feasibility of collecting wound photographs taken in theatre immediately after wound closure and, at 4-8 weeks after surgery, taken by participants themselves or their carers. Finally, it is identifying the main cost drivers for an economic evaluation of dressing types. Integrated qualitative research is exploring acceptability and reasons for non-adherence to allocation. Adults undergoing primary elective or unplanned abdominal general surgery or Caesarean section are eligible. The main exclusion criteria are abdominal or other major surgery less than three months before the index operation or contraindication to dressing allocation. The trial is scheduled to recruit for nine months. The findings will be used to inform the design of a main trial.

DISCUSSION: This pilot trial is the first pragmatic study to randomise participants to no dressing or tissue-glue as a dressing versus a simple dressing. Early evidence from the ongoing pilot shows that recruitment is proceeding well and that the interventions are acceptable to participants. Combined with the qualitative findings, the findings will inform whether a main, large trial is feasible and, if so, how it should be designed.

TRIAL REGISTRATION: ISRCTN49328913 . Registered on 20 October 2015.

Details

Original languageEnglish
Article number401
JournalTrials
Volume18
Issue number1
Publication statusPublished - 29 Aug 2017

Keywords

  • wound dressing, Pilot study, feasibility study, randomised controlled trial, Caesarean Section, surgical site infection, abdominal surgery