Clinical trial NCT06567808: Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial
Official title: Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Infection, Surgical Site
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-08-23
Enrollment: 38000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Factorial Assignment
Primary purpose: PREVENTION

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.

Detailed description: Although antibiotic prophylaxis is considered the cornerstone of prevention for sternal surgical site infections (s-SSIs), the most effective antimicrobial regimen and optimal duration remain unclear. There is a pressing need to determine how best to prevent sternal surgical site infections and at the same time reduce adverse events from unnecessary antibiotic exposure. Currently, due to the lack of evidence, unproven approaches prevail and adherence to guidelines is poor. Rigorous randomized controlled trials data are needed for improved patient care.

A factorial cluster randomized cross-over trial, a design not used previously in this field, will address these gaps. To date, we have successfully enrolled close to 6,000 eligible patients in the vanguard study, and have shown that the trial as planned is feasible and operationally highly cost-effective.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. On systemic antibiotics or with an active bacterial infection at the time of surgery
2. Previously enrolled in this trial
3. Known to be colonized with methicillin-resistant staphylococcus aureus (MRSA). Where it is unethical to not administer glycopeptides.
4. Beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively
5. Participation in other studies that may interfere with this trial.
6. Patients undergoing cardiac transplant

Primary outcomes:
measure: Deep incisional or organ/space (complex) sternal surgical site infection (CDC/NHSN)
timeFrame: 3 months post-surgery
Secondary outcomes:
measure: All types of sternal surgical site infections (superficial, deep, organ; (CDC/NHSN)
timeFrame: 3 months post-surgery
measure: Clostridium difficile infection
timeFrame: 3 months post-surgery
measure: Mortality
timeFrame: 3 months post-surgery
measure: Number of patients with acute kidney injury
timeFrame: 7 days post surgery
measure: Number of patients with sternal revision surgery
timeFrame: 3 months post surgery
measure: Rate of antimicrobial resistant organisms causing sternal wound infections
timeFrame: 3 months post-surgery
Other outcomes:
Locations:
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Dominik Mertz, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: