NCT04520841

Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings

Monocentric Randomized Clinical Trial Comparing Negative Pressure Wound Therapy (PREVENA™) and Standard Dry Dressings on Oozing of Closed Incision After Revision Total Hip and Knee Arthroplasty Surgery or Lower Extremity Amputation Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Lausanne Hospitals · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Negative pressure dressings are currently widely used in wound management. Their use is gradually being extended to surgical scars. However, studies demonstrating a clear benefit are rare, particularly in terms of postoperative discharge, the need for surgical revision due to prolonged oozing and cost. The aim of this study is to evaluate the benefit of such a device in post-operative revision prosthesis surgery (hip and knee), as well as lower limb amputations.

Conditions

• Arthroplasty Complications
• Amputation
• Prosthesis-Related Infections

Interventions

Type	Name	Description
DEVICE	Prevena TM	A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.
DEVICE	Dry dressing	A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery

Timeline

• Start date: 2020-06-01
• Primary completion: 2023-06-01
• Completion: 2024-06-01
• First posted: 2020-08-20
• Last updated: 2022-05-25

Locations

1 site across 1 country: Switzerland