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

Saint Vincent's Hospital, Korea457 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

457

Conditions

Surgical Wound Infection

Interventions

use of plastic ring wound retractorDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (13)

Chonnam National University Hospital

Gwangju, Chonnam, South Korea

Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, Gangwondo, South Korea

National Health Insurance Service Ilsan Hospital

Outcomes

Primary Outcomes

The rate of surgical wound infection

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

Time frame: within 30 days postoperative

Data from ClinicalTrials.gov

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