NCT02006511

Incisional Negative Pressure Dressing on Clean Closed Groin Incisions

Incisional Negative Pressure Dressing on Clean Closed Groin Incisions in High Risk Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Wound complications associated with surgical incisions range from minor to life threatening. Surgical site infections occurring usually occur within 30 days and are one of the most common surgical complications. Perigraft infections in groin wounds can be devastating. Even superficial wounds can progress to deep wounds resulting in graft infection, need for explantation, and sepsis or amputation requirement. Negative pressure wound therapy has had favorable results on closed wounds in trauma populations. Similarly, negative pressure wound therapy has had positive benefits in closed incisions such as sternal wounds following cardiac surgery. As a result, the PrevenaTM Incision Management System(IMS) was developed to allow easier application of negative pressure therapy to closed wounds. Application of the PrevenaTM IMS dressing would portend the aforementioned benefits of Vacuum Assisted Closure (VAC®) therapy with the added benefits of protecting the wound from contamination and bolstering the wound edges for better approximation and consequently better aesthetic outcome. However, no comparison between negative pressure therapy as a dressing and standard wound dressings exists. The purpose of this study is to assess the efficacy and safety of topical negative pressure therapy application with Prevena™ versus standard of care wound therapy on closed groin incisions in high risk patients undergoing vascular surgery.

Conditions

• Complication of Surgical Procedure

Interventions

Type	Name	Description
DEVICE	Incisional Neg Pressure Wound Therapy (Prevena™)	Negative pressure wound therapy dressing applied over closed surgical incision
OTHER	Standard of Care wound therapy	Gauze type dressing.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-12-10
• Last updated: 2023-05-06

Locations

1 site across 1 country: United States