Status:
COMPLETED
Prevention of Infections in Cardiac Surgery (PICS) Prevena Study
Lead Sponsor:
Population Health Research Institute
Conditions:
Surgical Site Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 prophyla...
Detailed Description
Despite the routine use of antibiotics before and after cardiac surgery, infections of the chest wound remain a common life threatening complication of heart surgery that is preventable. Antibiotic pr...
Eligibility Criteria
Inclusion
- \- ≥18 years of age undergoing open-heart surgery (sternotomy, including minimally-invasive sternotomies)
Exclusion
- 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
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2024
Estimated Enrollment :
4107 Patients enrolled
Trial Details
Trial ID
NCT03402945
Start Date
March 5 2018
End Date
October 17 2024
Last Update
February 28 2025
Active Locations (2)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
2
London Health Sciences Centre & Lawson Health Research Institute
London, Ontario, Canada, N6A 5A5