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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

Must not have

Known MRSA carriers

Patients on antibiotics at the time of surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-surgery

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and will have open-heart surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a known carrier of MRSA.

Select...

I am taking antibiotics during my surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Combination therapy, short courseExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vancomycin

2020

Completed Phase 4

~7920

Cefazolin

2017

Completed Phase 4