NCT02581904

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
8.9 years until next milestone

Results Posted

Study results publicly available

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

October 8, 2015

Results QC Date

February 6, 2026

Last Update Submit

February 6, 2026

Conditions

Wound InfectionPeripheral Arterial DiseaseAneurysmSurgical Wound Dehiscence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Hospital Length of Stay

    30 days

  • Return to Operating Room

    30 days

  • Hospital Readmission

    30 days

  • Index Hospital Cost

    30 days

Study Arms (3)

High Risk - Prevena Care

EXPERIMENTAL

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

High Risk - Dry Gauze Dressing Care

ACTIVE COMPARATOR

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

Device: Dry gauze dressing care

Low Risk - Dry Gauze Dressing Care

ACTIVE COMPARATOR

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

Device: Dry gauze dressing care

Interventions

Prevena CareDEVICE

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.

Also known as: Closed Incision Negative Pressure Device
High Risk - Prevena Care
Dry gauze dressing careDEVICE

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

High Risk - Dry Gauze Dressing CareLow Risk - Dry Gauze Dressing Care

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Emergency procedure
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (3)

  • 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.

    PMID: 41159585DERIVED

  • 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.

    PMID: 40260835DERIVED

  • 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.

    PMID: 30126781DERIVED

MeSH Terms

Conditions

Wound InfectionPeripheral Arterial DiseaseAneurysmSurgical Wound Dehiscence

Condition Hierarchy (Ancestors)

InfectionsAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Paul DiMuzio, MD
Organization
Thomas Jefferson University
paul.dimuzio@jefferson.edu
2159558304

Study Officials

  • Paul DiMuzio, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 21, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

February 25, 2026

Results First Posted

February 25, 2026

Record last verified: 2026-02

Locations

US(1)