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

Not Applicable

Terminated

• Conditions: Surgical Site Reaction
• Interventions: Other: Standard of Care for Surgical Incisions; Device: Prevena Incision Management System

• Registration Number: NCT01341444
• Lead Sponsor: KCI USA, Inc

Brief 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.

Detailed Description

This is a randomized, single-center, comparative interventional study looking at the effect of Prevena™ on renal transplant surgical Subjects compared to a control arm treated with the standard-of-care wound dressing. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of PrevenaTM in this clinical indication.

Study Timeline

• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-04-22
• Study First Posted: 2011-04-25
• Study Start: 2013-08
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2017-02-03
• Results First Submitted QC: 2017-06-01
• Results First Posted: 2017-07-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care for Surgical Incisions	Standard of Care for Surgical Incisions	Sterile gauze and a non-penetrable barrier
Prevena Incision Management System	Prevena Incision Management System	Negative Pressure Therapy Device

Primary Outcome Measures

Name	Time	Method
Number of Participants With Surgical Site Complications (SSCs)	62 Days	The primary objective to compare short-term surgical incision-related clinical outcomes in Subjects undergoing open renal transplant surgery when treated with Prevena vs. the standard-of-care wound dressing. Clinical outcomes of interest are defined as Surgical Site Complications (SSCs) that include incisional fluid accumulation (i.e. seroma, hematoma, abscess), dehiscence, surgical site infection (SSI). These outcomes will be compared to a control group consisting of subjects screened for the same inclusion/exclusion criteria but treated with standard-of-care incision dressing.

Trial Locations

Locations (1)

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States