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

Surgical Wound Infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170843
• Other study ID #: OTracSSI
• Status: Completed
• Phase: N/A
• Start date: July 12, 2017
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2023
• Source: Saint Vincent's Hospital, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 457
• Est. completion date: September 30, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Device:
• use of plastic ring wound retractor
the experimental arm will use the plastic ring wound retractor for wound protection.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Chuncheon Sacred Heart Hospital	Chuncheon	Gangwondo
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu	Gyeongsangbukdo
Korea, Republic of	National Health Insurance Service Ilsan Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Chonnam National University Hospital	Gwangju	Chonnam
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Eunpyeong St. Mary's hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul
Korea, Republic of	Yeouido St. Mary's hospital, The Catholic University of Korea	Seoul
Korea, Republic of	Ajou University of Hospital	Suwon	Gyeonggi-do
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

Sponsors (1)

Lead Sponsor	Collaborator
Saint Vincent's Hospital, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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, O — View 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 prot — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of surgical wound infection	The rate of surgical wound infection will be monitored for each group.	within 30 days postoperative