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A pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride-coated dressings versus standard care for the primary prevention of surgical site infection

Totty, Joshua P.; Hitchman, Louise H.; Cai, Paris L.; Wallace, Tom; Harwood, Amy E.; Carradice, Dan; Smith, George E.; Chetter, Ian C.

Authors

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Mr Josh Totty J.Totty@hull.ac.uk
NIHR Clinical Lecturer in Plastic Surgery

Louise H. Hitchman

Paris L. Cai

Tom Wallace

Amy E. Harwood

Dan Carradice

George E. Smith

Ian C. Chetter



Abstract

A surgical site infection (SSI) may occur in up to 30% of procedures and results in significant morbidity and mortality. We aimed to assess the feasibility of conducting a randomised controlled trial (RCT) examining the use of dialkylcarbamoylchloride (DACC)-impregnated dressings, which bind bacteria at the wound bed, in the prevention of SSI in primarily closed incisional wounds. This pilot RCT recruited patients undergoing clean or clean-contaminated vascular surgery. Participants were randomised intraoperatively on a 1:1 basis to either a DACC-coated dressing or a control dressing. Outcomes were divided into feasibility and clinical outcomes. The primary clinical outcome was SSI at 30 days (assessed using Centers for Disease Control criteria and Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of the deep tissues, Isolation of bacteria and duration of inpatient Stay scoring methods). This study recruited 144 patients in 12 months at a median rate of 10 per month. Eligibility was 73% and recruitment 60%. At 30 days, there was a 36.9% relative risk reduction in the DACC-coated arm (16.22% versus 25.71%, odds ratio 0.559, P = 0.161). The number needed to treat was 11 patients. A large-scale RCT is both achievable and desirable given the relative risk reduction shown in this study. Further work is needed to improve the study protocol and involve more centres in a full-scale RCT.

Citation

Totty, J. P., Hitchman, L. H., Cai, P. L., Wallace, T., Harwood, A. E., Carradice, D., …Chetter, I. C. (2019). A pilot feasibility randomised clinical trial comparing dialkylcarbamoylchloride-coated dressings versus standard care for the primary prevention of surgical site infection. International wound journal, 16(4), 883-890. https://doi.org/10.1111/iwj.13113

Journal Article Type Article
Acceptance Date Feb 26, 2019
Online Publication Date Mar 14, 2019
Publication Date Aug 1, 2019
Deposit Date Sep 14, 2021
Publicly Available Date Sep 24, 2021
Journal International Wound Journal
Print ISSN 1742-4801
Electronic ISSN 1742-481X
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 16
Issue 4
Pages 883-890
DOI https://doi.org/10.1111/iwj.13113
Keywords Dialkycarbamoylchloride; RCT; Surgical site; Infection wound dressings
Public URL https://hull-repository.worktribe.com/output/1386745

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Publisher Licence URL
https://creativecommons.org/licenses/by/4.0/

Copyright Statement
© 2019 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.





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