Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection

Not Applicable

Completed

• Conditions: Surgical Wound Infection
• Interventions: Device: Prevena Incision Management System; Other: Conventional sterile dry wound dressing

• Registration Number: NCT02020018
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-18
• Study First Posted: 2013-12-24
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Results First Submitted: 2019-04-16
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-05
• Last Update Submitted: 2019-11-05
• Results First Posted: 2019-11-06
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1869

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective group	Prevena Incision Management System	Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.
Retrospective arm	Conventional sterile dry wound dressing	Conventional sterile dry wound dressing applied immediately postoperatively.

Primary Outcome Measures

Name	Time	Method
Wound Infection After Open Heart Surgery	30 days post-surgery	The total number of participants with surgical site infections after cardiac surgery.

Secondary Outcome Measures

Name	Time	Method
Reoperation for Wound Infection	30 days post surgery	The total number of reoperations required due to infection.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States