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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-12

Study Completion Date

2022-09-30

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.

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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.

Conditions

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Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The experimental group will be using the plastic wound retractor, while the control group will use a conventional surgical pad for wound protection.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Each participant will be under the general anesthesia without knowing which group is assigned to.

Study Groups

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O-Trac

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

Group Type EXPERIMENTAL

use of plastic ring wound retractor

Intervention Type DEVICE

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

Surgical pad

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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use of plastic ring wound retractor

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes