Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection

Mayo Clinic

Status: Completed

Conditions: Surgical Wound Infection

Treatments: Other: Conventional sterile dry wound dressing; Device: Prevena Incision Management System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02020018

16-007901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,869 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Transplant patients
2. BMI >30
3. Type I (insulin-dependent) diabetics
4. Severe chronic obstructive pulmonary disease (COPD)
5. Steroid-dependent patients
6. Previous Tracheostomy

Exclusion criteria

1. BMI<30
2. Thoracotomy

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,869 participants in 2 patient groups

Prospective group

Experimental group

Description:

Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.

Treatment:

Device: Prevena Incision Management System

Retrospective arm

Active Comparator group

Description:

Conventional sterile dry wound dressing applied immediately postoperatively.

Treatment:

Other: Conventional sterile dry wound dressing