NCT02020018

Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection

Negative Pressure Wound Therapy for Prevention of Wound Infection After Heart Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,869 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.

Detailed description

Surgical site infection after cardiac surgery is a major cause for increased morbidity and mortality. Vacuum assisted closure (VAC) has been used in the management of open and infected wounds. However, its effectiveness as a prophylactic measure for prevention of surgical site infection after routine cardiac surgery is unknown.

Conditions

• Surgical Wound Infection

Interventions

Type	Name	Description
DEVICE	Prevena Incision Management System	negative pressure therapy that will be applied instead of the regular dressing immediately postoperatively in high risk patients and kept for 6-7 days
OTHER	Conventional sterile dry wound dressing	regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy

Timeline

• Start date: 2013-10-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2013-12-24
• Last updated: 2019-11-06
• Results posted: 2019-11-06

Locations

1 site across 1 country: United States