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

NCT06567808 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: PICS
• Study Type: interventional
• Target: 38,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infection, Surgical Site

Outcome Measures

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.

  3 months post-surgery

Secondary Outcomes (6)

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

  3 months post-surgery

• Clostridium difficile infection

  3 months post-surgery

• Mortality

  3 months post-surgery

• Number of patients with acute kidney injury

  7 days post surgery

• Number of patients with sternal revision surgery

  3 months post surgery

Study Arms (4)

cefazolin short-term

EXPERIMENTAL

Cefazolin 2g (or 3g if greater than 120kg body weight) will be given within an hour of surgery. The intraoperative dose at 4 hours after the first dose or upon wound closure (whatever comes first).

Drug: Cefazolin

cefazolin long-term

EXPERIMENTAL

Cefazolin 2g (or 3g if greater than 120kg body weight) will be given within an hour of surgery. The intraoperative dose at 4 hours after the first dose or upon wound closure (whatever comes first) and the five post-operative doses in the long-term arms will be 2g every 8 hours.

Drug: Cefazolin

cefazolin plus vancomycin short-term

EXPERIMENTAL

Cefazolin 2g (or 3g if greater than 120kg body weight) will be given within an hour of surgery. The intraoperative dose at 4 hours after the first dose or upon wound closure (whatever comes first). Vancomycin will be dosed at roughly 15mg/kg body weight intravenously, i.e. 1g or 1.5g if greater than 85kg body weight and is to be administered within 60-90 minutes of the surgical procedure.

Drug: Cefazolin; Drug: Vancomycin

cefazolin plus vancomycin long-term

EXPERIMENTAL

Cefazolin 2g (or 3g if greater than 120kg body weight) will be given within an hour of surgery. The intraoperative dose at 4 hours after the first dose or upon wound closure (whatever comes first) and the five post-operative doses in the long-term arms will be 2g every 8 hours. Vancomycin will be dosed at roughly 15mg/kg body weight intravenously, i.e. 1g or 1.5g if greater than 85kg body weight and is to be administered within 60-90 minutes of the surgical procedure. The same dose will be used for the 3 post-operative doses in the long-term arm.

Drug: Cefazolin; Drug: Vancomycin

Interventions

Cefazolin DRUG

administration as outlined

Also known as: Kefzol, Ancef

cefazolin long-term; cefazolin plus vancomycin long-term; cefazolin plus vancomycin short-term; cefazolin short-term

Vancomycin DRUG

administered as outlined

Also known as: Vancocin, Firvanq

cefazolin plus vancomycin long-term; cefazolin plus vancomycin short-term

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years of age) undergoing open-heart surgery (i.e. sternotomy, including minimally-invasive surgical techniques through mini-sternotomies)

You may not qualify if:

• 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
• Participation in other studies that may interfere with this trial.
• Patients undergoing cardiac transplant

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefazolin; Vancomycin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dominik Mertz, MD, MSc

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik Mertz, MD, MSc

CONTACT

905-521-2100; mertz@hhsc.ca

Ingrid Copland

CONTACT

pics@phri.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Factorial Assignment

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 23, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: March 12, 2026

Record last verified: 2025-12