NCT03170843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
457

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 12, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

5 years

First QC Date

May 26, 2017

Last Update Submit

May 9, 2023

Conditions

Surgical Wound Infection

Outcome Measures

Primary Outcomes (1)

  • The rate of surgical wound infection

    The rate of surgical wound infection will be monitored for each group.

    within 30 days postoperative

Study Arms (2)

O-Trac

EXPERIMENTAL

The experimental group will use the plastic ring wound retractor for wound protection during the surgery.

Device: use of plastic ring wound retractor

Surgical pad

NO INTERVENTION

The control group will use a conventional surgical pad for wound protection during the surgery.

Interventions

use of plastic ring wound retractorDEVICE

the experimental arm will use the plastic ring wound retractor for wound protection.

O-Trac

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Chonnam National University Hospital

Gwangju, Chonnam, South Korea

Location

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwondo, 200-704, South Korea

Location

National Health Insurance Service Ilsan Hospital

Goyang-si, Gyeonggi-do, 10444, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

St. Vincent's Hospital

Suwon, Gyeonggi-do, 442-723, South Korea

Location

Ajou University of Hospital

Suwon, Gyeonggi-do, South Korea

Location

Ujeongbu St Mary's Hospital, The Catholic University of Korea

Uijeongbu-si, Gyeonggi-do, 480-717, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, Gyeongsangbukdo, 41931, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, 06591, South Korea

Location

Chung-Ang University Hospital

Seoul, South Korea

Location

Eunpyeong St. Mary's hospital

Seoul, South Korea

Location

Yeouido St. Mary's hospital, The Catholic University of Korea

Seoul, South Korea

Location

Related Publications (5)

  • 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.

    PMID: 22587425BACKGROUND

  • 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.

    PMID: 25379844RESULT

  • 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.

    PMID: 23903454RESULT

  • 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.

    PMID: 38656413DERIVED

  • 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.

    PMID: 31974091DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • HyungJin Kim, MD

    Eunpyeong St. Mary's Hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Each participant will be under the general anesthesia without knowing which group is assigned to.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The experimental group will be using the plastic wound retractor, while the control group will use a conventional surgical pad for wound protection.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 26, 2017

First Posted

May 31, 2017

Study Start

July 12, 2017

Primary Completion

July 11, 2022

Study Completion

September 30, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(13)