A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients

Stopped early · Not applicable

Conditions studied: Surgical Procedure, Unspecified

In brief

The purpose of this research study is to investigate if a new negative pressure incision (surgical cut) management system, could reduce the occurrence of groin wound infections after vascular surgery. This is a single use, sterile dressing that is applied to the patient's skin. It has an attached battery-powered unit that provides negative pressure (a vacuum environment) to the dressing and a disposable canister for the collection of wound fluids. The patient is being asked to participate in this study because the patient is planning to have a vascular surgery procedure that involves groin incision.

Key facts

Study ID

NCT02399111

Run by

Northwell Health

People needed

9

Starts

2013-10-01

Expected to finish

2015-06-01

Last updated by the study team

2016-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Older than 18 years
• Subjects are capable of giving informed written consent
• Undergoing a vascular surgery procedure that involves a groin incision at North Shore University Hospital and Long Island Jewish Hospital.

You may not qualify if…

• The patient has a history of blood clotting disorders
• Patient has evidence of infection in the groin area, where surgical procedure is planned
• Patient body habitus precludes placement of Prevena dressing.
• Allergy to Silver or acrylic adhesive

Where it is running

• North Shore-LIJ Health System — Lake Success, New York, United States

Full record on ClinicalTrials.gov

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