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NCT Number: NCT03170843

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

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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Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chonnam National University Hospital, Gwangju, Chonnam, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

use of plastic ring wound retractor

Device

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

Primary outcomes

  1. The rate of surgical wound infection

    Time frame: within 30 days postoperative

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

Sponsors and collaborators

Lead sponsor

Saint Vincent's Hospital, Korea

Other

Registry information

Official study title

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

Acronym: COVER

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 31, 2017
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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