Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamilton Health Sciences Corporation

About this trial

The goal of this pragmatic, multi-centre factorial cluster randomized cross-over trial is to assess the efficacy of a combination of cefazolin plus vancomycin compared to cefazolin monotherapy, as well as a comparison of short versus long-term prophylaxis with four study arms: 1) cefazolin short-term, 2) cefazolin long-term, 3) cefazolin plus vancomycin short-term and 4) cefazolin plus vancomycin long-term.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

On systemic antibiotics or with an active bacterial infection at the time of surgery

Previously enrolled in this trial

Known to be colonized with methicillin-resistant staphylococcus aureus (MRSA). Where it is unethical to not administer glycopeptides.

Beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively

Trial design

Design model

Factorial

Treatments tested in this trial

  • Cefazolin

    Drug

    administration as outlined

  • Vancomycin

    Drug

    administered as outlined

Treatment groups

38,000 Participants
are divided into 4 treatment groups
Group A: cefazolin short-termExperimental treatment 1 intervention
Group B: cefazolin long-termExperimental treatment 1 intervention
Group C: cefazolin plus vancomycin short-termExperimental treatment 2 interventions
Group D: cefazolin plus vancomycin long-termExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Deep incisional or organ/space (complex) sternal surgical site infection (CDC/NHSN)

Sternal surgical site infections are defined by clinical and microbiological criteria of infection at the surgical site that are associated with the operative procedure occurring within 90 days after surgery.

Time frame
3 months post-surgery

Secondary outcomes

1

All types of sternal surgical site infections (superficial, deep, organ; (CDC/NHSN)

Sternal surgical site infections are defined by clinical and microbiological criteria of infection at the surgical site that are associated with the operative procedure occurring within 90 days after surgery.

Time frame
3 months post-surgery
2

Clostridium difficile infection

Laboratory confirmed

Time frame
3 months post-surgery
3

Mortality

Mortality in participants with an active infection

Time frame
3 months post-surgery
4

Number of patients with acute kidney injury

Acute kidney injury following the Acute Kidney Injury Network definition

Time frame
7 days post surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Hamilton Health Sciences Corporation

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

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