1. Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds
- Author
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Cathy Winter, Joanna Coast, Danya Bakhbakhi, Dimitrios Siassakos, Nicky J Welton, Benjamin E Byrne, Leila Rooshenas, Jane M Blazeby, Natalie Jackson, Richard Lovegrove, Christel McMullan, Barnaby C Reeves, Natalie S Blencowe, Jane Blazeby, Rachael Gooberman-Hill, Lucy Ellis, Jo C Dumville, Tim Draycott, Anne Pullyblank, Elizabeth Armstrong, Rhiannon Macefield, Lazaros Andronis, Kate Ashton, Madeleine Clout, Daisy Elliott, Rosie Harris, Caroline Pope, Sean Strong, Helen Talbot, Muhammad Atif, Barry Main, Jessica Thrush, Julie Wollaston, Karen Bobruk, Louise Flintoff, Joanna Nicklin, Jo Chambers, Katy Chalmers, Andrew D Torrance, Thomas D Pinkney, Jonathan M Mathers, Robert J Longman, Jenny L Donovan, Melanie J Calvert, Tom Milne, Benjamin R Waterhouse, William Seligman, Lloyd Rickard, Samir Pathak, Anwar Owais, Jamie O'Callaghan, Stephen O'Brien, Khaldoun Nadi, Charlotte Murkin, Tonia Munder, David Messenger, Matthew Mason, Morwena Marshall, Jessica Lloyd, Jeffrey Lim, Kathryn Lee, Vijay Korwar, Daniel Hughes, George Hill, Mohammed Hamdan, Hannah Gould Brown, Caroline Fryer, Simon Davey, David Cotton, Oliver D Brown, Katarzyna D Bera, Joanne Bennett, Richard Bamford, Piriyankan Ananthavarathan, Rebecca Houlihan, Helen Cheshire, Suriya Kirkpatrick, Louise Solomon, Alice Jarvie, Clementine Skilton, Susan Hughes, Michelle Mayer, Jade Knowlden, Mary Alvarez, Sherrie Villis, Kelly Hollier, Victoria Hardy, David Tyrell, Sharon Garner, Arlo Whitehouse, Caroline Alton, Katrina Hurley, David Hutton, and Trudie Young
- Subjects
Medicine - 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 multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds.Design A pilot, factorial 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 focused on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant-completed 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 and ‘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 Wound Healing Questionnaire 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.Trial registration number 49328913; Pre-results.
- Published
- 2020
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