NCT01341444

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

The Use of the Prevena Incision Management System on Closed Recipient Site Incisions in Renal Transplant Subjects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: KCI USA, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Reaction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2011-04-25
• Last updated: 2024-10-16
• Results posted: 2017-07-02

Locations

1 site across 1 country: United States