Prevena Vascular Groin Wound Study

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02581904
• Other study ID #: 7179
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: October 8, 2015
• Last updated: October 20, 2015
• Start date: January 2015
• Est. completion date: February 2018

Study information

• Verified date: October 2015
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Surgical Wound Dehiscence
• Wound Infection

Intervention

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.
• Dry gauze dressing care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Groin Wound Complication	Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma	30 days	No
Secondary	Hospital Length of stay		30 days	No
Secondary	Return to Operating Room		30 days	No
Secondary	Hospital Readmission	Readmission for wound complication	30 days	No
Secondary	Index Hospital Cost		30 days	No