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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Device: use of plastic ring wound retractor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: O-Trac<br>The experimental group will use the plastic ring wound retractor for wound protection during the surgery. | Device: use of plastic ring wound retractor<br>* the experimental arm will use the plastic ring wound retractor for wound protection.<br>|
| No Intervention: Surgical pad<br>The control group will use a conventional surgical pad for wound protection during the surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |