About this trial
The goal of this pragmatic, multi-centre factorial cluster randomized cross-over trial is to assess the efficacy of a combination of cefazolin plus vancomycin compared to cefazolin monotherapy, as well as a comparison of short versus long-term prophylaxis with four study arms: 1) cefazolin short-term, 2) cefazolin long-term, 3) cefazolin plus vancomycin short-term and 4) cefazolin plus vancomycin long-term.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
On systemic antibiotics or with an active bacterial infection at the time of surgery
Previously enrolled in this trial
Known to be colonized with methicillin-resistant staphylococcus aureus (MRSA). Where it is unethical to not administer glycopeptides.
Beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively
Trial design
Factorial
Treatments tested in this trial
Cefazolin
Drugadministration as outlined
Vancomycin
Drugadministered as outlined
Treatment groups
Trial outcomes
Primary outcomes
Deep incisional or organ/space (complex) sternal surgical site infection (CDC/NHSN)
Sternal surgical site infections are defined by clinical and microbiological criteria of infection at the surgical site that are associated with the operative procedure occurring within 90 days after surgery.
Secondary outcomes
All types of sternal surgical site infections (superficial, deep, organ; (CDC/NHSN)
Sternal surgical site infections are defined by clinical and microbiological criteria of infection at the surgical site that are associated with the operative procedure occurring within 90 days after surgery.
Clostridium difficile infection
Laboratory confirmed
Mortality
Mortality in participants with an active infection
Number of patients with acute kidney injury
Acute kidney injury following the Acute Kidney Injury Network definition
Locations
Sponsors and contacts
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Hamilton Health Sciences Corporation
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
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