Vancomycin + Cefazolin for Surgical Site Infections

(PICS Trial)

Recruiting at 3 trial locations

Overseen By Dominik Mertz, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hamilton Health Sciences Corporation

Must not be taking: Antibiotics

Disqualifiers: MRSA, Beta-lactam allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2-3 days

5989 Participants Needed

Trial Summary

What is the purpose of this trial?

There is clinical equipoise about the question of whether antibiotic prophylaxis should be given for a short period or an extended period of time as reflected by inconsistencies in major guidelines, current practices at Canadian centers, and as concluded in the three systematic reviews. There also is clinical equipoise on whether the addition of vancomycin to routine cefazolin prophylaxis can further reduce s-SSI rates. A short duration of combined antimicrobial prophylaxis can reduce side effects of exposure to antimicrobials such as infections with C. difficile or emergence of resistance, but may also reduce the incidence of s-SSIs. The objective of the eventual full scale study is to determine whether adding vancomycin to cefazolin can reduce SSIs as well as whether short-term prophylaxis is as effective as long-term prophylaxis. The rationale to conduct the proposed pilot study is to assess the feasibility to conduct this factorial cluster randomized cross-over trial, the adherence to the study protocol at each pilot site, the length of time to fill out the case report forms, and to get reliable estimates of event rates for sample size calculation for the main study

Research Team

Dominik Mertz, MD

Principal Investigator

Hamilton Health Sciences Corporation

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

Beta-lactam allergy (IgE-mediated) precluding the use of cefazolin

I am a known carrier of MRSA.

Previous enrollment in this trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cefazolin monotherapy or combination therapy with vancomycin, with short or long course regimens administered around the time of surgery

2-3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of surgical site infections and other outcomes

3 months

Treatment Details

Interventions

• Cefazolin
• Vancomycin

Trial Overview 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.

Participant Groups

Group I: Combination therapy, short course Experimental Treatment 2 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 course Experimental Treatment 2 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 course Experimental Treatment 1 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 course Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

The Physicians' Services Incorporated Foundation

Collaborator

Trials

165

Recruited

31,700+