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The Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

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@article{788c48f9c2d24c9898151b36d35dfd5c,
title = "The Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds",
abstract = "Objective: Surgical site infection (SSI) affects up to 25{\%} of primary surgical wounds. Dressingstrategies may influence SSI risk. The Bluebelle Study assessed the feasibility of a multi-centre RCT toevaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI inprimary surgical wounds.Design: A pilot, factorial randomised controlled trial (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 ‘nodressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosuretime, before or after wound closure).Primary and secondary outcome measures: Feasibility outcomes focussed on recruitment,adherence to randomised allocations, reference assessment of SSI and response rates to participantandobserver-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{\%}) wereeligible and approached, 415 (59.4{\%}) consented and 394 (35.3{\%}) were randomised (simpledressing=133; glue=129; ‘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{\%} beforeand after wound closure respectively. The overall rate of SSI (reference assessment) was 18.1{\%}(51/281). Response rates to the WHQ 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 workis needed to optimise questionnaire response rates.",
keywords = "randomised controlled trial, pilot study, surgical site infection, wound dressing, tissue adhesive as a dressing",
author = "Blazeby, {Jane M} and Macefield, {Rhiannon C}",
year = "2020",
month = "1",
day = "12",
doi = "10.1136/bmjopen-2019-030615",
language = "English",
volume = "10",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",

}

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TY - JOUR

T1 - The Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

AU - Blazeby, Jane M

AU - Macefield, Rhiannon C

PY - 2020/1/12

Y1 - 2020/1/12

N2 - Objective: Surgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressingstrategies may influence SSI risk. The Bluebelle Study assessed the feasibility of a multi-centre RCT toevaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI inprimary surgical wounds.Design: A pilot, factorial randomised controlled trial (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 ‘nodressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosuretime, before or after wound closure).Primary and secondary outcome measures: Feasibility outcomes focussed on recruitment,adherence to randomised allocations, reference assessment of SSI and response rates to participantandobserver-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%) wereeligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simpledressing=133; glue=129; ‘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% beforeand after wound closure respectively. The overall rate of SSI (reference assessment) was 18.1%(51/281). Response rates to the WHQ 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 workis needed to optimise questionnaire response rates.

AB - Objective: Surgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressingstrategies may influence SSI risk. The Bluebelle Study assessed the feasibility of a multi-centre RCT toevaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI inprimary surgical wounds.Design: A pilot, factorial randomised controlled trial (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 ‘nodressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosuretime, before or after wound closure).Primary and secondary outcome measures: Feasibility outcomes focussed on recruitment,adherence to randomised allocations, reference assessment of SSI and response rates to participantandobserver-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%) wereeligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simpledressing=133; glue=129; ‘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% beforeand after wound closure respectively. The overall rate of SSI (reference assessment) was 18.1%(51/281). Response rates to the WHQ 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 workis needed to optimise questionnaire response rates.

KW - randomised controlled trial

KW - pilot study

KW - surgical site infection

KW - wound dressing

KW - tissue adhesive as a dressing

U2 - 10.1136/bmjopen-2019-030615

DO - 10.1136/bmjopen-2019-030615

M3 - Article

VL - 10

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

M1 - 030615

ER -