Prevena Vascular Groin Wound Study

Phase 4

• Conditions: Wound Infection; Peripheral Arterial Disease; Aneurysm; Surgical Wound Dehiscence
• Interventions: Device: Dry gauze dressing care; Device: Prevena Care

• Registration Number: NCT02581904
• Lead Sponsor: Thomas Jefferson University

Brief 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.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-10
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-20
• Last Update Submitted: 2015-10-20
• Study First Posted: 2015-10-21
• Last Update Posted: 2015-10-21
• Primary Completion: 2017-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Risk - Dry Gauze Dressing Care	Dry gauze dressing care	Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
High Risk - Dry Gauze Dressing Care	Dry gauze dressing care	Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
High Risk - Prevena Care	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.

Primary Outcome Measures

Name	Time	Method
Groin Wound Complication	30 days	Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma

Secondary Outcome Measures

Name	Time	Method
Hospital Readmission	30 days	Readmission for wound complication
Return to Operating Room	30 days
Index Hospital Cost	30 days
Hospital Length of stay	30 days

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States