Prevention of Infections in Cardiac Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2023
• Main ID: NCT02285140
• Date of registration: 04/11/2014
• Prospective Registration: Yes
• Primary sponsor: Hamilton Health Sciences Corporation
• Public title: Prevention of Infections in Cardiac Surgery PICS
• Scientific title: Prevention of Infections in Cardiac Surgery: a Cluster-randomized Factorial Cross-over Trial
• Date of first enrolment: April 2015
• Target sample size: 3000
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02285140
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Dominik Mertz, MD, MSc
• Affiliation: Hamilton Health Sciences Corporation

Key inclusion & exclusion criteria

Inclusion Criteria:

- All adult patients (=18 years of age) undergoing open-heart surgery (sternotomy,
including minimally-invasive surgical techniques).

Exclusion Criteria:

- Patients on antibiotics at the time of surgery.

- Previous enrollment in this trial.

- Known MRSA carriers. Beta-lactam allergy (IgE-mediated) precluding the use of
cefazolin

- Participant in another study that may interfere with this trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Antibiotic Prophylaxis

Thoracic Surgery

Intervention(s)

Drug: Cefazolin

Drug: Vancomycin

Primary Outcome(s)

Proportion of patients with complete follow-up, i.e. up to 90 days or death; goal >95% [Time Frame: 3 months post-surgery]

Agreement of blinded outcome assessment based on information from the case report form [Time Frame: 3 months post-surgery]

Proportion of patients receiving antibiotics according to study protocol [Time Frame: 3 months post-surgery]

Secondary Outcome(s)

Deep incisional and organ/space sternal surgical site infection (NHSN/CDC) [Time Frame: 3 months post-surgery]

All types of sternal surgical site infection (superficial, deep, organ; NHSN/CDC) [Time Frame: 3 months post-surgery]

Clostridium difficile infection [Time Frame: 3 months post-surgery]

Mortality [Time Frame: 3 months post-surgery]

Secondary ID(s)

PICS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Physicians' Services Incorporated Foundation