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Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial

BACKGROUND: Surgical site infection in vascular surgery has a reported incidence of up to 19%. A novel method of reducing this rate of infection is dressings coated with dialkylcarbamoylchloride (DACC), a hydrophobic wound contact layer that binds bacteria and removes them from the wound bed. Early...

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Autores principales: Totty, Joshua P., Harwood, Amy E., Cai, Paris L., Hitchman, Louise H., Smith, George E., Chetter, Ian C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6337832/
https://www.ncbi.nlm.nih.gov/pubmed/30680225
http://dx.doi.org/10.1186/s40814-019-0400-2
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author Totty, Joshua P.
Harwood, Amy E.
Cai, Paris L.
Hitchman, Louise H.
Smith, George E.
Chetter, Ian C.
author_facet Totty, Joshua P.
Harwood, Amy E.
Cai, Paris L.
Hitchman, Louise H.
Smith, George E.
Chetter, Ian C.
author_sort Totty, Joshua P.
collection PubMed
description BACKGROUND: Surgical site infection in vascular surgery has a reported incidence of up to 19%. A novel method of reducing this rate of infection is dressings coated with dialkylcarbamoylchloride (DACC), a hydrophobic wound contact layer that binds bacteria and removes them from the wound bed. Early research has suggested that DACC-coated wound dressings are effective in reducing surgical site infection when applied to wounds healing by primary intention post-operatively, therefore this trial aims to assess the feasibility of producing high-quality evidence assessing this theory. METHODS: Patients undergoing clean or clean-contaminated vascular surgery will be randomised to have their surgical wounds dressed with a DACC-coated dressing or a non-coated occlusive absorbent post-operative dressing. All other aspects of their peri-operative care will be standardised or carried out in line with hospital policy. Wound assessments will be carried out between day 5–7, day 30 (± 3 days) and 6 months post-operatively (± 7 days) by a blinded assessor using the ASEPSIS scoring tool. Quality of life data using EQ-5D and SF-36, resource use and mortality data will also be collected. This feasibility trial will dictate the conduct of a full-scale trial through the collection of data on recruitment and retention rates, and fitness-for-purpose of the follow-up arrangements. DISCUSSION: Surgical site infections are now the second most common hospital acquired infections with a significant cost implication. The aim of the DRESSINg trial is to investigate the effectiveness of a novel preventative measure at reducing wound infections post-surgery and will provide robust evidence to support or deny its use. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02992951, Registered 12/12/16. REC Reference: 16/LO/2135.
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spelling pubmed-63378322019-01-24 Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial Totty, Joshua P. Harwood, Amy E. Cai, Paris L. Hitchman, Louise H. Smith, George E. Chetter, Ian C. Pilot Feasibility Stud Study Protocol BACKGROUND: Surgical site infection in vascular surgery has a reported incidence of up to 19%. A novel method of reducing this rate of infection is dressings coated with dialkylcarbamoylchloride (DACC), a hydrophobic wound contact layer that binds bacteria and removes them from the wound bed. Early research has suggested that DACC-coated wound dressings are effective in reducing surgical site infection when applied to wounds healing by primary intention post-operatively, therefore this trial aims to assess the feasibility of producing high-quality evidence assessing this theory. METHODS: Patients undergoing clean or clean-contaminated vascular surgery will be randomised to have their surgical wounds dressed with a DACC-coated dressing or a non-coated occlusive absorbent post-operative dressing. All other aspects of their peri-operative care will be standardised or carried out in line with hospital policy. Wound assessments will be carried out between day 5–7, day 30 (± 3 days) and 6 months post-operatively (± 7 days) by a blinded assessor using the ASEPSIS scoring tool. Quality of life data using EQ-5D and SF-36, resource use and mortality data will also be collected. This feasibility trial will dictate the conduct of a full-scale trial through the collection of data on recruitment and retention rates, and fitness-for-purpose of the follow-up arrangements. DISCUSSION: Surgical site infections are now the second most common hospital acquired infections with a significant cost implication. The aim of the DRESSINg trial is to investigate the effectiveness of a novel preventative measure at reducing wound infections post-surgery and will provide robust evidence to support or deny its use. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02992951, Registered 12/12/16. REC Reference: 16/LO/2135. BioMed Central 2019-01-18 /pmc/articles/PMC6337832/ /pubmed/30680225 http://dx.doi.org/10.1186/s40814-019-0400-2 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Totty, Joshua P.
Harwood, Amy E.
Cai, Paris L.
Hitchman, Louise H.
Smith, George E.
Chetter, Ian C.
Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial
title Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial
title_full Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial
title_fullStr Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial
title_full_unstemmed Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial
title_short Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial
title_sort assessing the effectiveness of dialkylcarbamoylchloride (dacc)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the dressing trial): study protocol for a pilot feasibility randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6337832/
https://www.ncbi.nlm.nih.gov/pubmed/30680225
http://dx.doi.org/10.1186/s40814-019-0400-2
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