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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

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 M. 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

Published in: Trials | Issue 1/2017

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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.
Appendix
Available only for authorised users
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Metadata
Title
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
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 M. 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
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2102-5

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