NCT02836990

Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery

Prevena™ Incision Management System Versus Dermabond in the Prevention of Groin Wound Infections in Patients Undergoing Vascular Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision Management System versus Dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond and the other half will receive the Prevena Incision Management System for their groin wounds.

Detailed description

Dermabond and the Prevena Incision Management System are both FDA approved wound care products. Prevena is a negative pressure system which holds the wound together and removes exudate and debris from the site to prevent infection. Dermabond is a surgical glue which holds the wound together to prevents infection. Prevena is more expensive to apply. However, the hypothesis is that the Prevena System will decrease infection rates and therefore, decrease the ultimate cost of the health care needed after surgery.

Conditions

• Wound Infection

Interventions

Type	Name	Description
DEVICE	Prevena Incision Management System	A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections
DEVICE	Dermabond	A surgical skin adhesive used to prevent surgical wound infections

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2016-07-19
• Last updated: 2020-12-28
• Results posted: 2020-12-28

Locations

2 sites across 1 country: United States