Cargando…

Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial

INTRODUCTION: Surgical site infection (SSI) after abdominal surgery remains a significant cause of morbidity and is associated with an increased socioeconomic burden and a reduced quality of life. Circular wound protectors have been expected to reduce the risk of SSI, but previous studies reported c...

Descripción completa

Detalles Bibliográficos
Autores principales: Yoo, Ri Na, Kim, Hyung Jin, Lee, Jae Im, Kang, Won-Kyung, Kye, Bong-Hyeon, Kim, Chang Woo, Bae, Sung Uk, Nam, Soomin, Kang, Byung Mo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044988/
https://www.ncbi.nlm.nih.gov/pubmed/31974091
http://dx.doi.org/10.1136/bmjopen-2019-034687
_version_ 1783501685571715072
author Yoo, Ri Na
Kim, Hyung Jin
Lee, Jae Im
Kang, Won-Kyung
Kye, Bong-Hyeon
Kim, Chang Woo
Bae, Sung Uk
Nam, Soomin
Kang, Byung Mo
author_facet Yoo, Ri Na
Kim, Hyung Jin
Lee, Jae Im
Kang, Won-Kyung
Kye, Bong-Hyeon
Kim, Chang Woo
Bae, Sung Uk
Nam, Soomin
Kang, Byung Mo
author_sort Yoo, Ri Na
collection PubMed
description INTRODUCTION: Surgical site infection (SSI) after abdominal surgery remains a significant cause of morbidity and is associated with an increased socioeconomic burden and a reduced quality of life. Circular wound protectors have been expected to reduce the risk of SSI, but previous studies reported conflicting results on their protective effects. The purpose of this study was to evaluate the efficacy of circular wound protectors in reducing SSI in open abdominal surgery. METHODS AND ANALYSIS: The circular pOlyethylen drape in preVEntion of suRgical site infection (COVER) trial investigates whether the application of a dual-ring circular plastic wound protector reduces the rate of SSI in patients undergoing elective or emergent open abdominal surgery related to the gastrointestinal tract, regardless of the type of wound classified by the Centers for Disease Control. The COVER trial is a multicentre, randomised controlled clinical trial with two parallel arms—one using a dual-ring wound protector with circular polyethylene drape and the other using conventional surgical dressing gauze. The primary outcome will measure the rate of SSI within 30 days after surgery in two groups. Statistical analysis of the primary end point will be based on the intention-to-treat population. The sample size was determined to achieve a study power of 80% with 95% two-sided confidence limits. Considering a dropout rate of up to 5%, a total of 458 patients, 229 patients in each group, will be enrolled in this study. ETHICS AND DISSEMINATION: The trial protocol and informed consent document have been reviewed and approved by the institutional review board at each participating centre. Written informed consent will be obtained from each study participant. The clinical outcomes of this trial will be submitted to an international peer-reviewed journal and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT 03170843.
format Online
Article
Text
id pubmed-7044988
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-70449882020-03-09 Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial Yoo, Ri Na Kim, Hyung Jin Lee, Jae Im Kang, Won-Kyung Kye, Bong-Hyeon Kim, Chang Woo Bae, Sung Uk Nam, Soomin Kang, Byung Mo BMJ Open Surgery INTRODUCTION: Surgical site infection (SSI) after abdominal surgery remains a significant cause of morbidity and is associated with an increased socioeconomic burden and a reduced quality of life. Circular wound protectors have been expected to reduce the risk of SSI, but previous studies reported conflicting results on their protective effects. The purpose of this study was to evaluate the efficacy of circular wound protectors in reducing SSI in open abdominal surgery. METHODS AND ANALYSIS: The circular pOlyethylen drape in preVEntion of suRgical site infection (COVER) trial investigates whether the application of a dual-ring circular plastic wound protector reduces the rate of SSI in patients undergoing elective or emergent open abdominal surgery related to the gastrointestinal tract, regardless of the type of wound classified by the Centers for Disease Control. The COVER trial is a multicentre, randomised controlled clinical trial with two parallel arms—one using a dual-ring wound protector with circular polyethylene drape and the other using conventional surgical dressing gauze. The primary outcome will measure the rate of SSI within 30 days after surgery in two groups. Statistical analysis of the primary end point will be based on the intention-to-treat population. The sample size was determined to achieve a study power of 80% with 95% two-sided confidence limits. Considering a dropout rate of up to 5%, a total of 458 patients, 229 patients in each group, will be enrolled in this study. ETHICS AND DISSEMINATION: The trial protocol and informed consent document have been reviewed and approved by the institutional review board at each participating centre. Written informed consent will be obtained from each study participant. The clinical outcomes of this trial will be submitted to an international peer-reviewed journal and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT 03170843. BMJ Publishing Group 2020-01-22 /pmc/articles/PMC7044988/ /pubmed/31974091 http://dx.doi.org/10.1136/bmjopen-2019-034687 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Surgery
Yoo, Ri Na
Kim, Hyung Jin
Lee, Jae Im
Kang, Won-Kyung
Kye, Bong-Hyeon
Kim, Chang Woo
Bae, Sung Uk
Nam, Soomin
Kang, Byung Mo
Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial
title Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial
title_full Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial
title_fullStr Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial
title_full_unstemmed Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial
title_short Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial
title_sort circular polyethylene drape in prevention of surgical site infection (cover trial): study protocol for a randomised controlled trial
topic Surgery
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044988/
https://www.ncbi.nlm.nih.gov/pubmed/31974091
http://dx.doi.org/10.1136/bmjopen-2019-034687
work_keys_str_mv AT yoorina circularpolyethylenedrapeinpreventionofsurgicalsiteinfectioncovertrialstudyprotocolforarandomisedcontrolledtrial
AT kimhyungjin circularpolyethylenedrapeinpreventionofsurgicalsiteinfectioncovertrialstudyprotocolforarandomisedcontrolledtrial
AT leejaeim circularpolyethylenedrapeinpreventionofsurgicalsiteinfectioncovertrialstudyprotocolforarandomisedcontrolledtrial
AT kangwonkyung circularpolyethylenedrapeinpreventionofsurgicalsiteinfectioncovertrialstudyprotocolforarandomisedcontrolledtrial
AT kyebonghyeon circularpolyethylenedrapeinpreventionofsurgicalsiteinfectioncovertrialstudyprotocolforarandomisedcontrolledtrial
AT kimchangwoo circularpolyethylenedrapeinpreventionofsurgicalsiteinfectioncovertrialstudyprotocolforarandomisedcontrolledtrial
AT baesunguk circularpolyethylenedrapeinpreventionofsurgicalsiteinfectioncovertrialstudyprotocolforarandomisedcontrolledtrial
AT namsoomin circularpolyethylenedrapeinpreventionofsurgicalsiteinfectioncovertrialstudyprotocolforarandomisedcontrolledtrial
AT kangbyungmo circularpolyethylenedrapeinpreventionofsurgicalsiteinfectioncovertrialstudyprotocolforarandomisedcontrolledtrial