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

Saint Vincent's Hospital, Korea

Status: Completed

Conditions: Surgical Wound Infection

Treatments: Device: use of plastic ring wound retractor

Study type: Interventional

Funder types: Other

Identifiers

NCT03170843

OTracSSI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 457 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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457 participants in 2 patient groups

O-Trac

Experimental group

Description:

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

Treatment:

Device: use of plastic ring wound retractor

Surgical pad

No Intervention group

Description:

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