Clinical trial

A Cluster-randomized Factorial Crossover Trial, Comparing Antibiotic Mono-prophylaxis With Cefazolin vs. Dual-prophylaxis With Cefazolin Plus Vancomycin and Conventional Wound Dressing vs. Prevena Negative-pressure Wound Management

Name

PICS-PREVENA V1_20171106

Description

This vanguard study will be conducted at two study sites in Canada. It is a cluster randomized trial to test a combination of two antibiotics for antibiotic prophylaxis as compared to routine prophylaxis with one single antibiotic, and to test a negative-pressure wound management system (Prevena) versus standard wound dressing to reduce chest wound infections.

Trial arms

Trial start

2018-03-05

Estimated PCD

2023-04-27

Trial end

2024-06-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Prevena

Negative-Pressure Wound Management System

Arms:

Arm 1, Arm 2

Cefazolin

antibiotic

Arms:

Arm 1, Arm 2, Arm 3, Arm 4

Vancomycin

antibiotic

Arms:

Arm 2, Arm 4

Other names:

Vancocin

standard wound dressing

Any non-negative pressure wound dressing that is routinely used at study sites will be considered standard of care in the control arms.

Arms:

Arm 3, Arm 4

Size

4107

Primary endpoint

Adherence to the wound management system

Prevena or standard wound dressing applied after surgery as per protocol, assessed up to 90 days after surgery

Adherence to the antibiotic regimen

Cefazolin: within an hour of surgery; one intra-operative dose at 4 hours after the first dose or upon wound closure (whatever comes first); two post-operative doses q8h. Vancomycin: initially intravenously; second dose 12 hrs after the first dose.

Loss of follow-up

up to 90 days after surgery

Eligibility criteria

Inclusion Criteria: - ≥18 years of age undergoing open-heart surgery (sternotomy, including minimally-invasive sternotomies) Exclusion Criteria: * On systemic antibiotics or with an active bacterial infection at the time of surgery * Patients previously enrolled in this trial * Patients known to be colonized with Methicillin-resistant S. aureus (MRSA)(unethical not to administer glycopeptides), beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively, or to silver precluding the use of Prevena * Participation in other studies that may interfere with this trial

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '1) cefazolin prophylaxis plus Prevena\\*(\\*diabetic and/or obese patients (BMI \\>30kg/m2)) 2) cefazolin and vancomycin prophylaxis plus Prevena\\*(\\*diabetic and/or obese patients (BMI \\>30kg/m2)), 3) cefazolin prophylaxis plus standard wound dressing, 4) cefazolin and vancomycin prophylaxis plus standard wound dressing.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Blinded adjudication of the s-SSIs will be performed by a committee consisting of three members.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 4107, 'type': 'ACTUAL'}}

Updated at

2024-04-03

1 organization

2 products

1 indication

Organization

Population Health Research Institute

Product

Cefazolin

Indication

Surgical Site Infections

Product

Vancomycin