NCT02581904

A Randomized Clinical Trial Evaluating Negative Pressure Therapy to Decrease Vascular Groin Incision Complications

Evaluation of Closed Incision Negative Pressure Device (Prevena) to Prevent Vascular Wound Complications

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.

Detailed description

The study randomizes patients (1:1) considered high risk, according to a specific set of risk factors, for wound complications into standard post-op dressings vs. Prevena vacuum dressing. The wounds will then be assessed for wound complications in the 30 days postoperatively. Wound complications include breakdown, infection and lymph leak. Patients not considered high risk will have standard post-op dressings and followed similarly to controls. The investigators will also assess economic impact of negative pressure dressing on length of stay and overall inpatient costs.

Conditions

• Wound Infection
• Peripheral Arterial Disease
• Aneurysm
• Surgical Wound Dehiscence

Interventions

Type	Name	Description
DEVICE	Prevena Care	The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
DEVICE	Dry gauze dressing care	Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-12-01
• Completion: 2017-04-01
• First posted: 2015-10-21
• Last updated: 2026-02-25
• Results posted: 2026-02-25

Locations

1 site across 1 country: United States