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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
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.
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Groin Wound Complication
Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma
Time frame: 30 days
Hospital Length of Stay
Readmission to inpatient hospital for management of wound complications
Time frame: 30 days
Return to Operating Room
Return to operating room for surgical management of wound complications
Time frame: 30 days
Hospital Readmission
Readmission for wound complication
Time frame: 30 days
Index Hospital Cost
Index Hospital Cost
Time frame: 30 days
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