Clinical trial NCT03170843: Circular pOlyethylene Drape in preVention of Surgical Site infEction: A Randomized Controlled Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infection
Lead sponsor: Saint Vincent's Hospital, Korea
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 457
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The rate of surgical wound infection
timeFrame: within 30 days postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Chonnam
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Chuncheon Sacred Heart Hospital
state: Gangwondo
city: Goyang-si
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: St. Vincent's Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University of Hospital
state: Gyeonggi-do
city: Uijeongbu-si
country: Korea, Republic of
facility: Ujeongbu St Mary's Hospital, The Catholic University of Korea
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
state: Gyeongsangbukdo
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Eunpyeong St. Mary's hospital
city: Seoul
country: Korea, Republic of
facility: Yeouido St. Mary's hospital, The Catholic University of Korea
Study officials:
affiliation: Eunpyeong St. Mary's Hospital, The Catholic University of Korea
name: HyungJin Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.