The Use of the Prevena Incision Management System (PIMS) on Closed Incisions in Renal Transplant Subjects (PIMS)
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.
|Surgical Site Reaction||Device: Prevena Incision Management System Other: Standard of Care for Surgical Incisions|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||The Use of the Prevena Incision Management System on Closed Recipient Site Incisions in Renal Transplant Subjects|
- Number of Participants With Surgical Site Complications (SSCs) [ Time Frame: 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.
|Study Start Date:||August 2013|
|Study Completion Date:||May 2016|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Prevena Incision Management System
Negative Pressure Therapy Device
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).
Placebo Comparator: Standard of Care for Surgical Incisions
Sterile gauze and a non-penetrable barrier
Other: Standard of Care for Surgical Incisions
Sterile 4X4 Non-Penetrable barrier
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341444
|United States, District of Columbia|
|MedStar Georgetown University Hospital|
|Washington, D.C., District of Columbia, United States, 20007|
|Principal Investigator:||Matthew Cooper, MD||MedStar Georgetown University Hospital|