Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| O-Trac | Experimental | The experimental group will use the plastic ring wound retractor for wound protection during the surgery. |
|
| Surgical pad | No Intervention | The control group will use a conventional surgical pad for wound protection during the surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| use of plastic ring wound retractor | Device | the experimental arm will use the plastic ring wound retractor for wound protection. |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| HyungJin Kim, MD | Eunpyeong St. Mary's Hospital, The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Gwangju | Chonnam | South Korea | |||
| Hallym University Chuncheon Sacred Heart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22587425 | Background | 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. | |
| 25379844 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The experimental group will be using the plastic wound retractor, while the control group will use a conventional surgical pad for wound protection.
Not provided
Not provided
Each participant will be under the general anesthesia without knowing which group is assigned to.
| Chuncheon |
| Gangwondo |
| 200-704 |
| South Korea |
| National Health Insurance Service Ilsan Hospital | Goyang-si | Gyeonggi-do | 10444 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| St. Vincent's Hospital | Suwon | Gyeonggi-do | 442-723 | South Korea |
| Ajou University of Hospital | Suwon | Gyeonggi-do | South Korea |
| Ujeongbu St Mary's Hospital, The Catholic University of Korea | Uijeongbu-si | Gyeonggi-do | 480-717 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | Gyeongsangbukdo | 41931 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| Seoul St. Mary's Hospital, The Catholic University of Korea | Seoul | 06591 | South Korea |
| Chung-Ang University Hospital | Seoul | South Korea |
| Eunpyeong St. Mary's hospital | Seoul | South Korea |
| Yeouido St. Mary's hospital, The Catholic University of Korea | Seoul | South Korea |
| Result |
| 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. |
| 23903454 | Result | 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. |
| 38656413 | Derived | Yoo N, Mun JY, Kye BH, Kim CW, Lee JI, Park YY, Kang BM, Park BK, Kwak HD, Kang WK, Bae SU, Oh HK, Hong Y, Kim HJ. Plastic Wound Protector vs Surgical Gauze for Surgical Site Infection Reduction in Open GI Surgery: A Randomized Clinical Trial. JAMA Surg. 2024 Jul 1;159(7):737-746. doi: 10.1001/jamasurg.2024.0765. |
| 31974091 | Derived | 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. |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided