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Circular pOlyethylene Drape in preVention of Surgical Site infEction: A Randomized Controlled Trial (COVER)

Primary Purpose

Surgical Wound Infection

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
use of plastic ring wound retractor
Sponsored by
Saint Vincent's Hospital, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Wound Infection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age older than 18 years or less than 70 years
  • either elective or emergent surgery for upper GI, small intestine, or colorectal disease
  • open laparotomy
  • the patient who agree to participate this trial

Exclusion Criteria:

  • concurrent abdominal wall infection
  • open conversion from laparoscopy
  • poor nutritional status, NRS 2002 score 3
  • combined hepatobiliary operation
  • pregnant or breast-feeding state
  • severe immunosuppression

Sites / Locations

  • Chonnam National University Hospital
  • Hallym University Chuncheon Sacred Heart Hospital
  • National Health Insurance Service Ilsan Hospital
  • Seoul National University Bundang Hospital
  • St. Vincent's Hospital
  • Ajou University of Hospital
  • Ujeongbu St Mary's Hospital, The Catholic University of Korea
  • Keimyung University Dongsan Medical Center
  • Kyung Hee University Hospital at Gangdong
  • Seoul St. Mary's Hospital, The Catholic University of Korea
  • Chung-Ang University Hospital
  • Eunpyeong St. Mary's hospital
  • Yeouido St. Mary's hospital, The Catholic University of Korea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

O-Trac

Surgical pad

Arm Description

The experimental group will use the plastic ring wound retractor for wound protection during the surgery.

The control group will use a conventional surgical pad for wound protection during the surgery.

Outcomes

Primary Outcome Measures

The rate of surgical wound infection
The rate of surgical wound infection will be monitored for each group.

Secondary Outcome Measures

Full Information

First Posted
May 26, 2017
Last Updated
May 9, 2023
Sponsor
Saint Vincent's Hospital, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03170843
Brief Title
Circular pOlyethylene Drape in preVention of Surgical Site infEction: A Randomized Controlled Trial
Acronym
COVER
Official Title
Randomized Controlled Trial to Evaluate the Effectiveness and Efficacy of a Sterile Circular Polyethylene Drape Compared to Conventional Surgical Dressing in Prevention of Surgical Site Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
July 11, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Vincent's Hospital, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to evaluate the effectiveness of the plastic ring wound retractor to reduce the rate of surgical site infection in patients who undergo open abdomen surgery for gastrointestinal tract.
Detailed Description
Participants who are determined to undergo open abdomen surgery will be screening for the eligibility first. If eligible and agreed to participate, each participant will be assigned to either the experimental group or control group based on the electronic randomization. The experimental group will use the plastic ring wound retractor, while the control group will use a conventional surgical pad for wound protection method. Each participant will be blind to the randomization result because he/she will be under general anesthesia. Once the surgery is finished, the patient will be assessed on the surgical wound at postoperative day 1, 7, 14, 30. Two groups will be compared for the surgical wound infection rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The experimental group will be using the plastic wound retractor, while the control group will use a conventional surgical pad for wound protection.
Masking
Participant
Masking Description
Each participant will be under the general anesthesia without knowing which group is assigned to.
Allocation
Randomized
Enrollment
457 (Actual)

8. Arms, Groups, and Interventions

Arm Title
O-Trac
Arm Type
Experimental
Arm Description
The experimental group will use the plastic ring wound retractor for wound protection during the surgery.
Arm Title
Surgical pad
Arm Type
No Intervention
Arm Description
The control group will use a conventional surgical pad for wound protection during the surgery.
Intervention Type
Device
Intervention Name(s)
use of plastic ring wound retractor
Intervention Description
the experimental arm will use the plastic ring wound retractor for wound protection.
Primary Outcome Measure Information:
Title
The rate of surgical wound infection
Description
The rate of surgical wound infection will be monitored for each group.
Time Frame
within 30 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age older than 18 years or less than 75 years either elective or emergent surgery for upper GI, small intestine, or colorectal disease open laparotomy the patient who agrees to participate in this trial Exclusion Criteria: concurrent abdominal wall infection open conversion from laparoscopy poor nutritional status, NRS 2002 score 3 combined hepatobiliary operation pregnant or breast-feeding state severe immunosuppression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HyungJin Kim, MD
Organizational Affiliation
Eunpyeong St. Mary's Hospital, The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hospital
City
Gwangju
State/Province
Chonnam
Country
Korea, Republic of
Facility Name
Hallym University Chuncheon Sacred Heart Hospital
City
Chuncheon
State/Province
Gangwondo
ZIP/Postal Code
200-704
Country
Korea, Republic of
Facility Name
National Health Insurance Service Ilsan Hospital
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10444
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
St. Vincent's Hospital
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Ajou University of Hospital
City
Suwon
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Ujeongbu St Mary's Hospital, The Catholic University of Korea
City
Uijeongbu-si
State/Province
Gyeonggi-do
ZIP/Postal Code
480-717
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
State/Province
Gyeongsangbukdo
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital, The Catholic University of Korea
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Eunpyeong St. Mary's hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yeouido St. Mary's hospital, The Catholic University of Korea
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22587425
Citation
Mihaljevic AL, Michalski CW, Erkan M, Reiser-Erkan C, Jager C, Schuster T, Schuhmacher C, Kleeff J, Friess H. Standard abdominal wound edge protection with surgical dressings vs coverage with a sterile circular polyethylene drape for prevention of surgical site infections (BaFO): study protocol for a randomized controlled trial. Trials. 2012 May 15;13:57. doi: 10.1186/1745-6215-13-57.
Results Reference
background
PubMed Identifier
25379844
Citation
Mihaljevic AL, Schirren R, Ozer M, Ottl S, Grun S, Michalski CW, Erkan M, Jager C, Reiser-Erkan C, Kehl V, Schuster T, Roder J, Clauer U, Orlitsch C, Hoffmann TF, Lange R, Harzenetter T, Steiner P, Michalski M, Henkel K, Stadler J, Pistorius GA, Jahn A, Obermaier R, Unger R, Strunk R, Willeke F, Vogelsang H, Halve B, Dietl KH, Hilgenstock H, Meyer A, Kramling HJ, Wagner M, Schoenberg MH, Zeller F, Schmidt J, Friess H, Kleeff J. Multicenter double-blinded randomized controlled trial of standard abdominal wound edge protection with surgical dressings versus coverage with a sterile circular polyethylene drape for prevention of surgical site infections: a CHIR-Net trial (BaFO; NCT01181206). Ann Surg. 2014 Nov;260(5):730-7; discussion 737-9. doi: 10.1097/SLA.0000000000000954.
Results Reference
result
PubMed Identifier
23903454
Citation
Pinkney TD, Calvert M, Bartlett DC, Gheorghe A, Redman V, Dowswell G, Hawkins W, Mak T, Youssef H, Richardson C, Hornby S, Magill L, Haslop R, Wilson S, Morton D; West Midlands Research Collaborative; ROSSINI Trial Investigators. Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial). BMJ. 2013 Jul 31;347:f4305. doi: 10.1136/bmj.f4305.
Results Reference
result
PubMed Identifier
31974091
Citation
Yoo RN, Kim HJ, Lee JI, Kang WK, Kye BH, Kim CW, Bae SU, Nam S, Kang BM. Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial. BMJ Open. 2020 Jan 22;10(1):e034687. doi: 10.1136/bmjopen-2019-034687.
Results Reference
derived

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Circular pOlyethylene Drape in preVention of Surgical Site infEction: A Randomized Controlled Trial

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