NCT01380665

Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty

Prospective, Single Arm, Post-Marketing Trial to Examine the Safety and Functionality of the Prevena™ Incision Management System, A Negative Pressure Based Surgical Wound Management System, Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: KCI USA, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intent of this study is to evaluate the Prevena ™ 125 Unit and dressing system, when applied to either the hip or knee area over a surgical cut for the time you are hospitalized.

Conditions

• Linear or Emi-linear Incisions
• Total Hip Arthroplasty
• Total Knee Arthroplasty

Interventions

Type	Name	Description
DEVICE	Prevena Incisional Management System	All evaluable patients will utilize the Prevena Incisional Management System

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2011-06-27
• Last updated: 2024-10-16