Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cefazolin, Vancomycin.
- Who it may be relevant to
- Registry conditions: Infection, Surgical Site. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Cefazolin
administration as outlined - Drug Vancomycin
administered as outlined
Primary outcome measures
- Deep incisional or organ/space (complex) sternal surgical site infection (CDC/NHSN) [Time frame: 3 months post-surgery]
Secondary outcome measures (6)
- All types of sternal surgical site infections (superficial, deep, organ; (CDC/NHSN) [Time frame: 3 months post-surgery]
- Clostridium difficile infection [Time frame: 3 months post-surgery]
- Mortality [Time frame: 3 months post-surgery]
- Number of patients with acute kidney injury [Time frame: 7 days post surgery]
- Number of patients with sternal revision surgery [Time frame: 3 months post surgery]
- Rate of antimicrobial resistant organisms causing sternal wound infections [Time frame: 3 months post-surgery]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06567808 · PICS