NCT02954835

Brief Summary

The purpose of this study is to compare wound infection rates between negative pressure therapy (Prevena) and the traditional sterile dry dressing among patients undergoing vascular surgery involving groin incisions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2016

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

First Submitted

Initial submission to the registry

November 2, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2019

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

2.8 years

First QC Date

November 2, 2016

Last Update Submit

February 5, 2020

Conditions

Wound Infection

Outcome Measures

Primary Outcomes (1)

  • Infection rate

    17 weeks

Study Arms (2)

Prevena

ACTIVE COMPARATOR

Subjects randomized to the Prevena dressing will have the dressing in place for 5 to 7 days postoperatively and removed before discharge, or at the first outpatient visit.

Device: Prevena

Traditional Dressing

ACTIVE COMPARATOR

Subjects randomized to the traditional dressing will undergo dressing changes as per the standard protocol with the first dressing change at postoperative day 2 or 3, or at the discretion of the attending surgeon.

Device: Traditional Dressing

Interventions

PrevenaDEVICE

Prevena is a sterile silver dressing. On top of the silver dressing is an adhesive plastic, which is connected to a therapy unit through a short length suction tube.

Prevena
Traditional DressingDEVICE

Sterile gauze dressing secured by tape.

Traditional Dressing

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing vascular surgery with a groin incision.

You may not qualify if:

  • Allergy to silver.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Related Links

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Thomas Bernik, MD

    Englewood Hospital and Medical Center

    PRINCIPAL INVESTIGATOR

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

November 2, 2016

First Posted

November 3, 2016

Study Start

December 1, 2016

Primary Completion

September 3, 2019

Study Completion

September 3, 2019

Last Updated

February 7, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)