Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds. Issue 1 (12th January 2020)

• Record Type: Journal Article
• Authors: Blazeby, Jane
• Other Names: author non-byline.; Welton Nicky J author non-byline.; Torrance Andrew D author non-byline.; Rooshenas Leila author non-byline.; Pullyblank Anne author non-byline.; Reeves Barnaby C author non-byline.; Pinkney Thomas D author non-byline.; Mathers Jonathan M author non-byline.; Lovegrove Richard author non-byline.; Longman Robert J author non-byline.; Gooberman-Hill Rachael author non-byline.; Dumville Jo C author non-byline.; Draycott Tim author non-byline.; Donovan Jenny L author non-byline.; Coast Joanna author non-byline.; Calvert Melanie J author non-byline.; Blazeby Jane M author non-byline.; Blencowe Natalie S author non-byline.; Andronis Lazaros author non-byline.; Siassakos Dimitrios author non-byline.; Pope Caroline author non-byline.; Milne Tom author non-byline.; McMullan Christel author non-byline.; Macefield Rhiannon author non-byline.; Harris Rosie author non-byline.; Ellis Lucy author non-byline.; Elliott Daisy author non-byline.; Clout Madeleine author non-byline.; Byrne Benjamin E author non-byline.; Ashton Kate author non-byline.; Waterhouse Benjamin R author non-byline.; Strong Sean author non-byline.; Seligman William author non-byline.; Rickard Lloyd author non-byline.; Pathak Samir author non-byline.; Owais Anwar author non-byline.; O'Callaghan Jamie author non-byline.; O'Brien Stephen author non-byline.; Nepogodiev Dmitri author non-byline.; Nadi Khaldoun author non-byline.; Murkin Charlotte author non-byline.; Munder Tonia author non-byline.; Messenger David author non-byline.; Mason Matthew author non-byline.; Marshall Morwena author non-byline.; Lloyd Jessica author non-byline.; Lim Jeffrey author non-byline.; Lee Kathryn author non-byline.; Korwar Vijay author non-byline.; Hughes Daniel author non-byline.; Hill George author non-byline.; Hamdan Mohammed author non-byline.; Brown Hannah Gould author non-byline.; Glasbey James author non-byline.; Fryer Caroline author non-byline.; Davey Simon author non-byline.; Cotton David author non-byline.; Brown Oliver D author non-byline.; Bera Katarzyna D author non-byline.; Bennett Joanne author non-byline.; Bamford Richard author non-byline.; Bakhbakhi Danya author non-byline.; Atif Muhammad author non-byline.; Armstrong Elizabeth author non-byline.; Ananthavarathan Piriyankan author non-byline.; Houlihan Rebecca author non-byline.; Nicklin Joanna author non-byline.; Flintoff Louise author non-byline.; Chambers Jo author non-byline.; Bobruk Karen author non-byline.; Cheshire Helen author non-byline.; Kirkpatrick Suriya author non-byline.; Solomon Louise author non-byline.; Jarvie Alice author non-byline.; Winter Cathy author non-byline.; Skilton Clementine author non-byline.; Hughes Susan author non-byline.; Mayer Michelle author non-byline.; Knowlden Jade author non-byline.; Alvarez Mary author non-byline.; Villis Sherrie author non-byline.; Hollier Kelly author non-byline.; Jackson Natalie author non-byline.; Hardy Victoria author non-byline.; Tyrell David author non-byline.; Garner Sharon author non-byline.; Whitehouse Arlo author non-byline.; Alton Caroline author non-byline.; Thrush Jessica author non-byline.; Wollaston Julie author non-byline.; Hurley Katrina author non-byline.; Hutton David author non-byline.; Talbot Helen author non-byline.; Magill Laura author non-byline.; Young Trudie author non-byline.; Chalmers Katy author non-byline.; Main Barry author non-byline.;
• Is Part Of: BMJ open. Volume 10:Issue 1(2020)
• Publication Date: 2020-01-12
• Subjects: randomised controlled trial -- pilot study -- surgical site infection -- wound dressing -- tissue adhesive as a dressing; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-030615
• Languages: English
• ISSNs: 2044-6055

Abstract

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.