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The AVATAR Trial: Applying VAcuum To Accomplish Reduced Wound Infections

NCT01623427 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-12-02

No results posted yet for this study

Summary

Postoperative pain and time taken to return to normal activities after laparoscopic surgery are significantly shorter. Wound infections still occur and contribute to prolonged hospital stays and morbidity. Typically, port incision sites are covered with a standard dressing (approximating strips and a gauze). Although the umbilical wound infection rate in laparoscopic surgery is considered to be low, a recent study by Muensterer and Keijzer showed that the umbilical wound infection rate after single incision laparoscopic appendectomy in children is approximately 7%. In the same retrospective study, the investigators demonstrated that a simple low cost vacuum dressing can significantly reduce the infection rate. The aim of this prospective randomized controlled trial is to determine if the simple vacuum dressing is superior to a standard dressing in reducing laparoscopic postoperative umbilical wound infections. All patients under 17 years of age undergoing a laparoscopic operation in the Children's Hospital will be randomized to a standard postoperative dressing or a standard postoperative dressing with vacuum applied to it. The vacuum will be applied with a 22g needle on a 10ml syringe passed percutaneously from outside the dressing into the gauze and the air around the gauze is evacuated. The umbilical wounds will be evaluated 8-10 days postoperatively in the clinical research unit of the Manitoba Institute of Child Heath according to a standardized and validated wound evaluation tool from the Canadian Center for Disease Control. Primary outcome measure in this study is postoperative wound infection. A sample size calculation using the retrospective data demonstrated that the investigators need 275 patients in each group for the Chi-squared test to have an 80% chance of detecting a difference in wound infection rate of 6% at the 5% level of significance. Based on the annual number of laparoscopic operations in the Children's Hospital (around 400) the investigators anticipate completing the inclusion of patients within a two-year period.

Conditions

  • Post-laparoscopy Umbilical Port-site Wound Infection

Interventions

PROCEDURE

Application of vacuum

The vacuum will be applied to the wound dressing of the umbilical port site using a 22 g needle on a 10 ml syringe passed percutaneously from the outside of the dressing into the gauze and the air around the gauze is evacuated.

PROCEDURE

No vacuum

Except for the vacuum, the wound dressing for the umbilical port site will be the same. No vacuum will be applied to the wound dressing of this group

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Richard Keijzer, MD PhD MSc · University of Manitoba

  • Robin Visser, MD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-08-31
Completion
2015-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01623427 on ClinicalTrials.gov