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

Not Applicable

Completed

• Conditions: Surgical Wound Infection
• Interventions: Device: use of plastic ring wound retractor

• Registration Number: NCT03170843
• Lead Sponsor: Saint Vincent's Hospital, Korea

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.

Study Timeline

• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-31
• Study Start: 2017-07-12
• Primary Completion: 2022-07-11
• Study Completion: 2022-09-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 457

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
O-Trac	use of plastic ring wound retractor	The experimental group will use the plastic ring wound retractor for wound protection during the surgery.

Primary Outcome Measures

Name	Time	Method
The rate of surgical wound infection	within 30 days postoperative	The rate of surgical wound infection will be monitored for each group.

Trial Locations

Locations (13)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Chonnam, Korea, Republic of

Hallym University Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwondo, Korea, Republic of

St. Vincent's Hospital; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of

Ujeongbu St Mary's Hospital, The Catholic University of Korea; 🇰🇷 Uijeongbu-si, Gyeonggi-do, Korea, Republic of

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Gyeongsangbukdo, Korea, Republic of

Seoul St. Mary's Hospital, The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Yeouido St. Mary's hospital, The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of

Eunpyeong St. Mary's hospital; 🇰🇷 Seoul, Korea, Republic of

National Health Insurance Service Ilsan Hospital; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Ajou University of Hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of