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Antibiotic
Vancomycin + Cefazolin for Surgical Site Infections (PICS Trial)
N/A
Waitlist Available
Led By Dominik Mertz, MD, MSc
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All adult patients (≥18 years of age) undergoing open-heart surgery (sternotomy, including minimally-invasive surgical techniques)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-surgery
Awards & highlights
PICS Trial Summary
This trial will test whether adding vancomycin to cefazolin can reduce surgical site infections, and whether short-term prophylaxis is as effective as long-term prophylaxis.
Who is the study for?
Adults (18+) needing open-heart surgery can join this trial. It's not for those already on antibiotics, previous participants, known MRSA carriers, people allergic to beta-lactams that prevent cefazolin use, or anyone in another interfering study.Check my eligibility
What is being tested?
The trial is testing if adding vancomycin to standard cefazolin before heart surgery prevents infections better and whether short-term antibiotic use is as good as long-term. It's a pilot study to see if a larger trial would work.See study design
What are the potential side effects?
Possible side effects include infections with C. difficile or the emergence of resistant bacteria due to exposure to the antibiotics vancomycin and cefazolin.
PICS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and will have open-heart surgery.
PICS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Agreement of blinded outcome assessment based on information from the case report form
Proportion of patients receiving antibiotics according to study protocol
Proportion of patients with complete follow-up, i.e. up to 90 days or death; goal >95%
Secondary outcome measures
All types of sternal surgical site infection (superficial, deep, organ; NHSN/CDC)
Clostridium difficile infection
Deep incisional and organ/space sternal surgical site infection (NHSN/CDC)
+1 morePICS Trial Design
4Treatment groups
Experimental Treatment
Group I: Combination therapy, short courseExperimental Treatment2 Interventions
One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered. In addition, one dose of vancomycin 60-90min pre-op will be administered.
Group II: Combination therapy, long courseExperimental Treatment2 Interventions
One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered followed by additional five doses every eight hours postoperatively (last dose 44 hours after the first dose). In addition, one dose of vancomycin 60-90min pre-op will be administered followed by 3 post-op doses every 12 hours (last dose 36 hours after first dose)
Group III: Cefazolin monotherapy, short courseExperimental Treatment1 Intervention
One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered
Group IV: Cefazolin monotherapy, long courseExperimental Treatment1 Intervention
One pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered followed by additional five doses every eight hours postoperatively (last dose 44 hours after the first dose).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
2005
Completed Phase 4
~7930
Cefazolin
2017
Completed Phase 4
~4720
Find a Location
Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
297,993 Total Patients Enrolled
1 Trials studying Antibiotic Prophylaxis
84 Patients Enrolled for Antibiotic Prophylaxis
The Physicians' Services Incorporated FoundationOTHER
162 Previous Clinical Trials
23,755 Total Patients Enrolled
Dominik Mertz, MD, MScPrincipal InvestigatorHamilton Health Sciences Corporation
Frequently Asked Questions
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