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Prevena Vascular Groin Wound Study

Primary Purpose

Wound Infection, Peripheral Arterial Disease, Aneurysm

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prevena Care
Dry gauze dressing care
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

High Risk - Prevena Care

High Risk - Dry Gauze Dressing Care

Low Risk - Dry Gauze Dressing Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Groin Wound Complication
Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma

Secondary Outcome Measures

Hospital Length of stay
Return to Operating Room
Hospital Readmission
Readmission for wound complication
Index Hospital Cost

Full Information

First Posted
October 8, 2015
Last Updated
October 20, 2015
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT02581904
Brief Title
Prevena Vascular Groin Wound Study
Official Title
Evaluation of Closed Incision Negative Pressure Device (Prevena) to Prevent Vascular Wound Complications
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection, Peripheral Arterial Disease, Aneurysm, Surgical Wound Dehiscence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Risk - Prevena Care
Arm Type
Experimental
Arm Description
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.
Arm Title
High Risk - Dry Gauze Dressing Care
Arm Type
Active Comparator
Arm Description
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Arm Title
Low Risk - Dry Gauze Dressing Care
Arm Type
Active Comparator
Arm Description
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Intervention Type
Device
Intervention Name(s)
Prevena Care
Other Intervention Name(s)
Closed Incision Negative Pressure Device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Dry gauze dressing care
Intervention Description
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Primary Outcome Measure Information:
Title
Groin Wound Complication
Description
Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Hospital Length of stay
Time Frame
30 days
Title
Return to Operating Room
Time Frame
30 days
Title
Hospital Readmission
Description
Readmission for wound complication
Time Frame
30 days
Title
Index Hospital Cost
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul DiMuzio, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30126781
Citation
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.
Results Reference
derived

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Prevena Vascular Groin Wound Study

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