Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery

NAUnknownINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

April 30, 2019

Study Completion Date

April 30, 2019

Conditions
Peripheral Artery DiseaseCritical Limb IschemiaClaudication
Interventions
OTHER

standard gauze dressing

Standard gauze dressing with tape will be placed over the surgical incision in the operating room and left on the incision as dictated by standard of care

OTHER

Prevena Incision Management system

The Prevena dressing system over the closed surgical incision. The dressing consists of a sterile sponge that is placed over the incision followed by a plastic adhesive covering that is used to secure it to the skin forming an air-tight seal. The sponge is then connected by tubing to a vacuum that applies negative pressure to the closed system. This allows fluid to drain from the wound and into a container connected to the dressing.

Trial Locations (5)

04102

RECRUITING

Maine Medical Center, Portland

02115

RECRUITING

Brigham and Women's Hospital, Boston

02215

RECRUITING

Beth Isreal Deaconess Medical Center, Boston

03766

RECRUITING

Dartmouth Hitchcock Medical Center, Lebanon

05401

RECRUITING

University of Vermont Medical Center, Burlington

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

KCI USA, Inc

INDUSTRY

collaborator

MaineHealth

OTHER

collaborator

Brigham and Women's Hospital

OTHER

collaborator

Beth Israel Deaconess Medical Center

OTHER

collaborator

Dartmouth-Hitchcock Medical Center

OTHER

lead

University of Vermont Medical Center

OTHER