Prevena Vascular Groin Wound Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Wound Infection, Peripheral Arterial Disease, Aneurysm, Surgical Wound Dehiscence

Intervention / Treatment
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* Device: Prevena Care
* Device: Dry gauze dressing care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Risk - Prevena Care<br>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: Prevena Care<br>* 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.<br>* Other names: Closed Incision Negative Pressure Device;|
| Active Comparator: High Risk - Dry Gauze Dressing Care<br>Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily | Device: Dry gauze dressing care<br>* Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily<br>|
| Active Comparator: Low Risk - Dry Gauze Dressing Care<br>Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily | Device: Dry gauze dressing care<br>* Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Groin Wound Complication | Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of stay |  | 30 days | 
| Return to Operating Room |  | 30 days | 
| Hospital Readmission | Readmission for wound complication | 30 days | 
| Index Hospital Cost |  | 30 days |