MedTrace Logo

The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant Subjects

NCT01341444 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-10-16

Study results available
· View outcomes & findings →

Summary

This study is being conducted to see how safe and effective the Prevena Incision Management System "Prevena" is when placed over a renal transplantation incision. Prevena provides negative pressure (suction) wound therapy. Prevena will be tested while applied during the time each subject is hospitalized and up to 5 days after the surgery. Prevena is a small portable negative pressure device which consists of a therapy unit that delivers negative pressure. It also includes a dressing system that is intended for use over closed incisions after surgery.

The intent of this study is to evaluate Prevena versus the standard care that a doctor would use normally after a kidney transplant.

Conditions

  • Surgical Site Reaction

Interventions

DEVICE

Prevena Incision Management System

It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT).

OTHER

Standard of Care for Surgical Incisions

Sterile 4X4 Non-Penetrable barrier

Sponsors & Collaborators

  • KCI USA, Inc

    lead INDUSTRY

Principal Investigators

  • Matthew Cooper, MD · MedStar Georgetown University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01341444 on ClinicalTrials.gov