BMJ Open (Jan 2020)
Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds
- 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,
- Trudie Young
Affiliations
- Cathy Winter
- North Bristol NHS Trust, Bristol, UK
- Joanna Coast
- Population Health Sciences, University of Bristol, Bristol, UK
- Danya Bakhbakhi
- 1 Centre for Academic Women`s Health, University of Bristol, Bristol, UK
- Dimitrios Siassakos
- 1 Institute for Women`s Health, University College London, London, UK
- Nicky J Welton
- Population Health Sciences, University of Bristol, Bristol, UK
- Benjamin E Byrne
- Leila Rooshenas
- National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK
- Jane M Blazeby
- National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK
- Natalie Jackson
- Richard Lovegrove
- Christel McMullan
- Institute of Applied Health Research, University of Birmingham, Birmingham, UK
- Barnaby C Reeves
- 1 Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK
- Natalie S Blencowe
- National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK
- Jane Blazeby
- professor
- Rachael Gooberman-Hill
- NIHR Bristol Biomedical Research Centre, Bristol, UK
- Lucy Ellis
- Jo C Dumville
- Division of Nursing, Midwifery and Social Work, School of Health Sciences, The University of Manchester, Manchester, UK
- Tim Draycott
- Department of Women`s Health, North Bristol NHS Trust, Westbury on Trym, Bristol, UK
- Anne Pullyblank
- 3 West of England Academic Health Science Network, Bristol, UK
- Elizabeth Armstrong
- School of Population Health, Faculty of Medicine and Health, UNSW Sydney, Sydney, New South Wales, Australia
- Rhiannon Macefield
- National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK
- Lazaros Andronis
- Kate Ashton
- Madeleine Clout
- 1 Bristol Trials Centre, University of Bristol, Bristol, UK
- Daisy Elliott
- National Institute for Health and Care Research Bristol Biomedical Research Centre, Bristol Centre for Surgical Research, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK
- Rosie Harris
- 1 Bristol Medical School, University of Bristol Faculty of Health Sciences, Bristol, UK
- Caroline Pope
- Sean Strong
- Helen Talbot
- Muhammad Atif
- Barry Main
- 1 Bristol Dental School, Faculty of Health Sciences, University of Bristol, Bristol, UK
- Jessica Thrush
- Julie Wollaston
- Karen Bobruk
- Louise Flintoff
- Joanna Nicklin
- Division of Surgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK
- Jo Chambers
- Katy Chalmers
- Surgical Innovation theme, Bristol National Institute for Health and Care Research (NIHR) Biomedical Research Centre; Royal College of Surgeons of England (RCSEng) Bristol Surgical Trials Centre, Centre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
- Andrew D Torrance
- Thomas D Pinkney
- specialist registrar, general surgery
- Jonathan M Mathers
- Institute of Applied Health Research, University of Birmingham, Birmingham, West Midlands, UK
- Robert J Longman
- Jenny L Donovan
- Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
- Melanie J Calvert
- Centre for Patient Reported Outcome Research, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
- Tom Milne
- Benjamin R Waterhouse
- William Seligman
- Lloyd Rickard
- Samir Pathak
- Centre for Surgical Research, Population Health Sciences, University of Bristol, Bristol, UK
- Anwar Owais
- Jamie O'Callaghan
- Trauma and Orthopaedics, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK
- Stephen O'Brien
- General Surgery, Our Lady of Lourdes Hospital, Drogheda, Louth, Ireland
- Khaldoun Nadi
- Charlotte Murkin
- Bristol NIHR Biomedical Research Centre and Centre for Surgical Research, Population Health Sciences, Bristol Medical School, Bristol University, Bristol, UK
- Tonia Munder
- David Messenger
- Matthew Mason
- Morwena Marshall
- Jessica Lloyd
- Jeffrey Lim
- 1Institute of Molecular and Cell Biology (IMCB), A*-STAR, Singapore, Singapore
- Kathryn Lee
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Vijay Korwar
- Daniel Hughes
- George Hill
- Mohammed Hamdan
- Hannah Gould Brown
- Caroline Fryer
- Simon Davey
- David Cotton
- Oliver D Brown
- Katarzyna D Bera
- University of Oxford St Anne`s College, Oxford, UK
- Joanne Bennett
- Department of Colorectal Surgery, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK
- Richard Bamford
- Piriyankan Ananthavarathan
- NMR Research Unit, Department of Neuroinflammation, University College London Queen Square Multiple Sclerosis Centre, London, UK
- 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
- National Institute for Social Care and Health Research, Cardiff, UK
- David Tyrell
- Sharon Garner
- Arlo Whitehouse
- Caroline Alton
- Katrina Hurley
- David Hutton
- Trudie Young
- DOI
- https://doi.org/10.1136/bmjopen-2019-030615
- Journal volume & issue
-
Vol. 10,
no. 1
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.
