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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Wound Infection; Aneurysm; Surgical Wound Dehiscence
• Intervention / Treatment: Device: Prevena Care; Device: Dry gauze dressing care

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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 Readmission	Readmission for wound complication	30 days
Hospital Length of Stay	Readmission to inpatient hospital for management of wound complications	30 days
Return to Operating Room	Return to operating room for surgical management of wound complications	30 days
Index Hospital Cost	Index Hospital Cost	30 days

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Paul DiMuzio, MD, Thomas Jefferson University

Publications and helpful links

General Publications

• Kwon J, Staley C, McCullough M, Goss S, Arosemena M, Abai B, Salvatore D, Reiter D, DiMuzio P. A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications. J Vasc Surg. 2018 Dec;68(6):1744-1752. doi: 10.1016/j.jvs.2018.05.224. Epub 2018 Aug 17.
• Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.
• Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: October 8, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimated): October 21, 2015

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Infections; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Pathological Conditions, Signs and Symptoms; Peripheral Arterial Disease; Aneurysm; Wound Infection; Surgical Wound Dehiscence
• Other Study ID Numbers: 7179