NCT03170843

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: Saint Vincent's Hospital, Korea · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgical Wound Infection

Interventions

Type	Name	Description
DEVICE	use of plastic ring wound retractor	the experimental arm will use the plastic ring wound retractor for wound protection.

Timeline

• Start date: 2017-07-12
• Primary completion: 2022-07-11
• Completion: 2022-09-30
• First posted: 2017-05-31
• Last updated: 2023-05-10

Locations

13 sites across 1 country: South Korea