Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds.
pilot study
randomised controlled trial
surgical site infection
tissue adhesive as a dressing
wound dressing
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
12 01 2020
12 01 2020
Historique:
entrez:
15
1
2020
pubmed:
15
1
2020
medline:
10
2
2021
Statut:
epublish
Résumé
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. A pilot, factorial RCT. Five UK hospitals. Adults undergoing abdominal surgery with a primary surgical wound. 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). 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). 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. A definitive RCT of dressing strategies including 'no dressing' is feasible. Further work is needed to optimise questionnaire response rates. 49328913; Pre-results.
Identifiants
pubmed: 31932387
pii: bmjopen-2019-030615
doi: 10.1136/bmjopen-2019-030615
pmc: PMC7045119
doi:
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e030615Subventions
Organisme : Department of Health
ID : DRF-2011-04-016
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/K025643/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/S001751/1
Pays : United Kingdom
Organisme : Department of Health
ID : NIHR300175
Pays : United Kingdom
Investigateurs
Nicky J Welton
(NJ)
Andrew D Torrance
(AD)
Leila Rooshenas
(L)
Anne Pullyblank
(A)
Barnaby C Reeves
(BC)
Thomas D Pinkney
(TD)
Jonathan M Mathers
(JM)
Richard Lovegrove
(R)
Robert J Longman
(RJ)
Rachael Gooberman-Hill
(R)
Jo C Dumville
(JC)
Tim Draycott
(T)
Jenny L Donovan
(JL)
Joanna Coast
(J)
Melanie J Calvert
(MJ)
Jane M Blazeby
(JM)
Natalie S Blencowe
(NS)
Lazaros Andronis
(L)
Dimitrios Siassakos
(D)
Caroline Pope
(C)
Tom Milne
(T)
Christel McMullan
(C)
Rhiannon Macefield
(R)
Rosie Harris
(R)
Lucy Ellis
(L)
Daisy Elliott
(D)
Madeleine Clout
(M)
Benjamin E Byrne
(BE)
Kate Ashton
(K)
Benjamin R Waterhouse
(BR)
Sean Strong
(S)
William Seligman
(W)
Lloyd Rickard
(L)
Samir Pathak
(S)
Anwar Owais
(A)
Jamie O'Callaghan
(J)
Stephen O'Brien
(S)
Dmitri Nepogodiev
(D)
Khaldoun Nadi
(K)
Charlotte Murkin
(C)
Tonia Munder
(T)
David Messenger
(D)
Matthew Mason
(M)
Morwena Marshall
(M)
Jessica Lloyd
(J)
Jeffrey Lim
(J)
Kathryn Lee
(K)
Vijay Korwar
(V)
Daniel Hughes
(D)
George Hill
(G)
Mohammed Hamdan
(M)
Hannah Gould Brown
(HG)
James Glasbey
(J)
Caroline Fryer
(C)
Simon Davey
(S)
David Cotton
(D)
Oliver D Brown
(OD)
Katarzyna D Bera
(KD)
Joanne Bennett
(J)
Richard Bamford
(R)
Danya Bakhbakhi
(D)
Muhammad Atif
(M)
Elizabeth Armstrong
(E)
Piriyankan Ananthavarathan
(P)
Rebecca Houlihan
(R)
Joanna Nicklin
(J)
Louise Flintoff
(L)
Jo Chambers
(J)
Karen Bobruk
(K)
Helen Cheshire
(H)
Suriya Kirkpatrick
(S)
Louise Solomon
(L)
Alice Jarvie
(A)
Cathy Winter
(C)
Clementine Skilton
(C)
Susan Hughes
(S)
Michelle Mayer
(M)
Jade Knowlden
(J)
Mary Alvarez
(M)
Sherrie Villis
(S)
Kelly Hollier
(K)
Natalie Jackson
(N)
Victoria Hardy
(V)
David Tyrell
(D)
Sharon Garner
(S)
Arlo Whitehouse
(A)
Caroline Alton
(C)
Jessica Thrush
(J)
Julie Wollaston
(J)
Katrina Hurley
(K)
David Hutton
(D)
Helen Talbot
(H)
Laura Magill
(L)
Trudie Young
(T)
Katy Chalmers
(K)
Barry Main
(B)
Informations de copyright
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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