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Completed

NCT Number: NCT02954835

Negative Pressure Therapy for Groin Wounds

The purpose of this study is to compare wound infection rates between negative pressure therapy (Prevena) and the traditional sterile dry dressing among patients undergoing vascular surgery involving groin incisions.

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Key information

Conditions

Wound Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

About this study

This is a prospective, investigator-initiated, post-market data collection study comparing wound infection rates among patients undergoing vascular surgery involving groin incisions. Patients will be randomized on the day of surgery to receive the traditional sterile dry dressing or Prevena. Patients with the traditional dressing will undergo dressing changes as per the standard protocol with the first dressing change at postoperative day 2 or 3, or at the discretion of the attending surgeon. The patients with Prevena dressing will have the dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the first outpatient visit. The Primary Objective of this study is to see if using negative pressure therapy decreases the rate of infection. The Secondary Objectives will include multivariate analysis to understand which patients may have a compounded benefit from Prevena (e.g. smokers, diabetics, and obese patients). The Prevena System is an FDA approved bandage and will be used in this study for on-label purposes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing vascular surgery with a groin incision.

Exclusion criteria

  • Allergy to silver.

Treatment and study plan

Prevena

Device

Prevena is a sterile silver dressing. On top of the silver dressing is an adhesive plastic, which is connected to a therapy unit through a short length suction tube.

Traditional Dressing

Device

Sterile gauze dressing secured by tape.

Primary outcomes

  1. Infection rate

    Time frame: 17 weeks

Sponsors and collaborators

Lead sponsor

Englewood Hospital and Medical Center

Other

Registry information

Official study title

Negative Pressure Therapy for Closed Groin Wounds in Patients Undergoing Vascular Surgery

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 3, 2016
Registry last updated
Feb 7, 2020

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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