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Postoperative negative-pressure incision therapy following open colorectal surgery (Poniy): study protocol for a randomized controlled trial

BACKGROUND: Postoperative surgical site infections cause substantial morbidity, prolonged hospitalization, costs and even mortality, and remain one of the most frequent surgical complications. In prospective trials with adequate follow-up, more than 20 % of patients undergoing elective colorectal su...

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Autores principales: Mihaljevic, André L., Schirren, Rebekka, Müller, Tara C., Kehl, Victoria, Friess, Helmut, Kleeff, Jörg
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4617637/
https://www.ncbi.nlm.nih.gov/pubmed/26482031
http://dx.doi.org/10.1186/s13063-015-0995-4
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author Mihaljevic, André L.
Schirren, Rebekka
Müller, Tara C.
Kehl, Victoria
Friess, Helmut
Kleeff, Jörg
author_facet Mihaljevic, André L.
Schirren, Rebekka
Müller, Tara C.
Kehl, Victoria
Friess, Helmut
Kleeff, Jörg
author_sort Mihaljevic, André L.
collection PubMed
description BACKGROUND: Postoperative surgical site infections cause substantial morbidity, prolonged hospitalization, costs and even mortality, and remain one of the most frequent surgical complications. In prospective trials with adequate follow-up, more than 20 % of patients undergoing elective colorectal surgery are affected and methods to reduce surgical site infections are urgently needed. Negative-pressure incision therapy is a novel intervention that holds promise to reduce postoperative wound infection rates, but has not yet been rigorously tested in a randomized controlled trial. METHODS/DESIGN: The aim is to investigate whether the postoperative application of a negative-pressure incision therapy device for 5–7 days reduces the rate of surgical site infections following open elective colorectal surgery by 50 %. This is a randomized, controlled, observer-blinded multicentre clinical trial with two parallel study groups. The primary outcome measure will be the rate of surgical site infections within 30 days postoperatively. Surgical site infections are defined according to criteria of the US Centers for Disease Control and Prevention. Statistical analysis of the primary endpoint measure will be based on the intention-to-treat population. The global level of significance is set at 5 % (two-sided) and the sample size (n = 170 per group) is determined to assure a power of 80 %. DISCUSSION: The Poniy trial will explore whether the rate of surgical site infections can be reduced by the application of a negative-pressure incision therapy device in patients undergoing open elective colorectal surgery. Its pragmatic design guarantees high external validity and clinical relevance. TRIAL REGISTRATION: Deutsches Register Klinischer Studien DRKS00006199.
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spelling pubmed-46176372015-10-24 Postoperative negative-pressure incision therapy following open colorectal surgery (Poniy): study protocol for a randomized controlled trial Mihaljevic, André L. Schirren, Rebekka Müller, Tara C. Kehl, Victoria Friess, Helmut Kleeff, Jörg Trials Study Protocol BACKGROUND: Postoperative surgical site infections cause substantial morbidity, prolonged hospitalization, costs and even mortality, and remain one of the most frequent surgical complications. In prospective trials with adequate follow-up, more than 20 % of patients undergoing elective colorectal surgery are affected and methods to reduce surgical site infections are urgently needed. Negative-pressure incision therapy is a novel intervention that holds promise to reduce postoperative wound infection rates, but has not yet been rigorously tested in a randomized controlled trial. METHODS/DESIGN: The aim is to investigate whether the postoperative application of a negative-pressure incision therapy device for 5–7 days reduces the rate of surgical site infections following open elective colorectal surgery by 50 %. This is a randomized, controlled, observer-blinded multicentre clinical trial with two parallel study groups. The primary outcome measure will be the rate of surgical site infections within 30 days postoperatively. Surgical site infections are defined according to criteria of the US Centers for Disease Control and Prevention. Statistical analysis of the primary endpoint measure will be based on the intention-to-treat population. The global level of significance is set at 5 % (two-sided) and the sample size (n = 170 per group) is determined to assure a power of 80 %. DISCUSSION: The Poniy trial will explore whether the rate of surgical site infections can be reduced by the application of a negative-pressure incision therapy device in patients undergoing open elective colorectal surgery. Its pragmatic design guarantees high external validity and clinical relevance. TRIAL REGISTRATION: Deutsches Register Klinischer Studien DRKS00006199. BioMed Central 2015-10-19 /pmc/articles/PMC4617637/ /pubmed/26482031 http://dx.doi.org/10.1186/s13063-015-0995-4 Text en © Mihaljevic et al. 2015 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
Mihaljevic, André L.
Schirren, Rebekka
Müller, Tara C.
Kehl, Victoria
Friess, Helmut
Kleeff, Jörg
Postoperative negative-pressure incision therapy following open colorectal surgery (Poniy): study protocol for a randomized controlled trial
title Postoperative negative-pressure incision therapy following open colorectal surgery (Poniy): study protocol for a randomized controlled trial
title_full Postoperative negative-pressure incision therapy following open colorectal surgery (Poniy): study protocol for a randomized controlled trial
title_fullStr Postoperative negative-pressure incision therapy following open colorectal surgery (Poniy): study protocol for a randomized controlled trial
title_full_unstemmed Postoperative negative-pressure incision therapy following open colorectal surgery (Poniy): study protocol for a randomized controlled trial
title_short Postoperative negative-pressure incision therapy following open colorectal surgery (Poniy): study protocol for a randomized controlled trial
title_sort postoperative negative-pressure incision therapy following open colorectal surgery (poniy): study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4617637/
https://www.ncbi.nlm.nih.gov/pubmed/26482031
http://dx.doi.org/10.1186/s13063-015-0995-4
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