Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial
- Conditions
- Infection, Surgical Site
- Registration Number
- NCT06567808
- Lead Sponsor
- Hamilton Health Sciences Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 38000
Inclusion Criteria:<br><br>Adult patients (=18 years of age) undergoing open-heart surgery (i.e. sternotomy,<br>including minimally-invasive surgical techniques through mini-sternotomies)<br><br>Exclusion Criteria:<br><br> 1. On systemic antibiotics or with an active bacterial infection at the time of surgery<br><br> 2. Previously enrolled in this trial<br><br> 3. Known to be colonized with methicillin-resistant staphylococcus aureus (MRSA). Where<br> it is unethical to not administer glycopeptides.<br><br> 4. Beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin,<br> respectively<br><br> 5. Participation in other studies that may interfere with this trial.<br><br> 6. Patients undergoing cardiac transplant
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Deep incisional or organ/space (complex) sternal surgical site infection (CDC/NHSN)
- Secondary Outcome Measures
Name Time Method All types of sternal surgical site infections (superficial, deep, organ; (CDC/NHSN);Clostridium difficile infection;Mortality;Acute kidney injury;Sternal revision surgery;Microbiology of sternal surgical site infections