Status:
NOT_YET_RECRUITING
Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Infection, Surgical Site
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 wel...
Detailed Description
Although antibiotic prophylaxis is considered the cornerstone of prevention for sternal surgical site infections (s-SSIs), the most effective antimicrobial regimen and optimal duration remain unclear....
Eligibility Criteria
Inclusion
- Adult patients (≥18 years of age) undergoing open-heart surgery (i.e. sternotomy, including minimally-invasive surgical techniques through mini-sternotomies)
Exclusion
- 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
- Participation in other studies that may interfere with this trial.
- Patients undergoing cardiac transplant
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2028
Estimated Enrollment :
38000 Patients enrolled
Trial Details
Trial ID
NCT06567808
Start Date
August 1 2025
End Date
July 30 2028
Last Update
June 13 2025
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