Prevena Vascular Groin Wound Study

Thomas Jefferson University

Status and phase: Unknown; Phase 4

Conditions: Aneurysm; Surgical Wound Dehiscence; Peripheral Arterial Disease; Wound Infection

Treatments: Device: Prevena Care; Device: Dry gauze dressing care

Study type: Interventional

Funder types: Other

Identifiers

NCT02581904

7179

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients undergoing a femoral incision during vascular reconstruction or repair will be considered for study

Exclusion criteria

• Emergency procedure
• Unable to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

High Risk - Prevena Care

Experimental group

Description:

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.

Treatment:

Device: Prevena Care

High Risk - Dry Gauze Dressing Care

Active Comparator group

Description:

Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily

Treatment:

Device: Dry gauze dressing care

Low Risk - Dry Gauze Dressing Care

Active Comparator group

Description:

Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily

Treatment:

Device: Dry gauze dressing care