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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound Infection
• Intervention / Treatment: Device: use of plastic ring wound retractor

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 Type: Interventional
• Enrollment (Actual): 457
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HyungJin Kim, MD; Phone Number: 82-31-249-7170; Email: hj@catholic.ac.kr
• Study Contact Backup: Name: Ri Na Yoo, MD; Phone Number: 82-31-249-8278; Email: ninayoo1111@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-ang University Hospital
  • Seoul, Korea, Republic of, 05278
    • Kyung Hee University Hospital at Gangdong
  • Seoul, Korea, Republic of, 06591
    • Seoul St. Mary's Hospital, The Catholic University of Korea
  • Seoul, Korea, Republic of
    • Eunpyeong ST. Mary's Hospital
  • Seoul, Korea, Republic of
    • Yeouido St. Mary's hospital, The Catholic University of Korea
  • Chonnam
    • Gwangju, Chonnam, Korea, Republic of
      • Chonnam National University Hospital
  • Gangwondo
    • Chuncheon, Gangwondo, Korea, Republic of, 200-704
      • Hallym University Chuncheon Sacred Heart Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10444
      • National Health Insurance Service Ilsan Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Suwon, Gyeonggi-do, Korea, Republic of
      • Ajou University of Hospital
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 442-723
      • St. Vincent's Hospital
    • Uijeongbu-si, Gyeonggi-do, Korea, Republic of, 480-717
      • Ujeongbu St Mary's Hospital, The Catholic University of Korea
  • Gyeongsangbukdo
    • Daegu, Gyeongsangbukdo, Korea, Republic of, 41931
      • Keimyung University Dongsan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: O-Trac; The experimental group will use the plastic ring wound retractor for wound protection during the surgery.	Device: use of plastic ring wound retractor; the experimental arm will use the plastic ring wound retractor for wound protection.
No Intervention: Surgical pad; The control group will use a conventional surgical pad for wound protection during the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of surgical wound infection	The rate of surgical wound infection will be monitored for each group.	within 30 days postoperative

Collaborators and Investigators

• Sponsor: Saint Vincent's Hospital, Korea
• Investigators: Principal Investigator: HyungJin Kim, MD, Eunpyeong St. Mary's Hospital, The Catholic University of Korea

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Actual): July 11, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Disease Attributes; Infections; Communicable Diseases; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: OTracSSI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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