Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing

Stanford University

Status: Enrolling

Conditions: Wound of Skin

Treatments: Device: Standard Island Dressing; Device: Prevena Negative Pressure wound dressing; Device: Mepilex Border Post-Op Ag

Study type: Interventional

Funder types: Other

Identifiers

NCT03346694

41985

Details and patient eligibility

About

This study will evaluate two alternative dressings compared to a standard Island dressing presently in use at Stanford Hospital to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients. Cardiovascular surgery patients who will have a sternotomy incision as a routine part of their surgery will be approached to voluntarily participate. Participants will be randomized to one of three dressing to determine which dressing has the lowest rate of sternal wound infection. The investigators will also assess the impact of alternative dressing use on hospital 30-day readmission rates related to SSI.

Enrollment: 660 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who will undergo cardiac surgery via a sternotomy incision.Inclusion criteria will be patients having surgical valve, CABGs, aortic dissection, myectomy and myotomy, Cox MAZE, Myocardial bridge Un-roofing

Exclusion criteria

• Patients undergoing heart transplants, Ventricular Assist Device (VAD), with postoperative courses complicated by tamponade, take-backs, and open chest incisions will also be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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660 participants in 3 patient groups

Dressing 1: Standard Island Dressing

Active Comparator group

Description:

Standard dressing that is applied on most patients with a sternotomy wound incision immediately after cardiovascular surgery before leaving the operating room. Dressing will be removed 48 hours after surgery.

Treatment:

Device: Standard Island Dressing

Dressing 2: Prevena negative pressure

Active Comparator group

Description:

Prevena negative pressure wound suction machine dressing applied to sternotomy wound incision immediately after cardiovascular surgery. Dressing will be in use for 7 days or removed sooner if participant is discharged before end of 7 day post-operative time period.

Treatment:

Device: Prevena Negative Pressure wound dressing

Dressing 3: Mepilex Border Post-Op Ag

Active Comparator group

Description:

Mepilex Border PostOp AG dressing impregnated with silver ions. Dressing will be in use for 7 days or removed earlier if patient is discharged before end of 7 days post0operative time period.

Treatment:

Device: Mepilex Border Post-Op Ag