Infection, Surgical SitePhase 4PICSNCT06567808
Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial
A Phase 4 study testing Cefazolin and Vancomycin in people with Infection, Surgical Site, run by Hamilton Health Sciences Corporation.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Surgical Site
- What is being tested?
- Cefazolin and Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 30 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years of age) undergoing open-heart surgery (i.e. sternotomy, including minimally-invasive surgical techniques through mini-sternotomies)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ingrid Copland contact
About this study
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.
Read the 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.
- Conditions
- Infection, Surgical Site
- Being tested
- Cefazolin, Vancomycin
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolinDrug
Also called Kefzol, Ancef
administration as outlined
VancomycinDrug
Also called Vancocin, Firvanq
administered as outlined
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Cefazolin; Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-surgery
Secondary outcomes (6)
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.
Measured: 3 months post-surgery
Clostridium difficile infection
Laboratory confirmed
Measured: 3 months post-surgery
Mortality
Mortality in participants with an active infection
Measured: 3 months post-surgery
Number of patients with acute kidney injury
Acute kidney injury following the Acute Kidney Injury Network definition
Measured: 7 days post surgery
Number of patients with sternal revision surgery
For suspected sternal surgical site infection
Measured: 3 months post surgery
Rate of antimicrobial resistant organisms causing sternal wound infections
including relevant susceptibilities and stratified by study arm
Measured: 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Mar 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Surgical SiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Factorial Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Dominik Mertz, MD, MSc, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567808
- Sponsor's protocol ID
- PICS
- Acronym
- PICS
- Status last verified
- Dec 2025
- First submitted
- 20 Aug 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial
- ClinicalTrials.gov ID
- NCT06567808
- Acronym / sponsor ID
- PICS / PICS
- Conditions
- Infection, Surgical Site
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38,000 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Factorial Assignment
| Arm | Type | Receives |
|---|---|---|
| cefazolin short-term | Experimental | Drug: CefazolinCefazolin 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). |
| cefazolin long-term | Experimental | Drug: CefazolinCefazolin 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. |
| cefazolin plus vancomycin short-term | Experimental | Drug: Cefazolin, Drug: VancomycinCefazolin 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. |
| cefazolin plus vancomycin long-term | Experimental | Drug: Cefazolin, Drug: VancomycinCefazolin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (≥18 years of age) undergoing open-heart surgery (i.e. sternotomy, including minimally-invasive surgical techniques through mini-sternotomies)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefazolinAlso: Kefzol, Ancefadministration as outlined | Drug | cefazolin long-term, cefazolin plus vancomycin long-term, cefazolin plus vancomycin short-term, cefazolin short-term |
| VancomycinAlso: Vancocin, Firvanqadministered as outlined | Drug | cefazolin plus vancomycin long-term, cefazolin plus vancomycin short-term |
Primary outcome
Deep incisional or organ/space (complex) sternal surgical site infection (CDC/NHSN)
Time frame: 3 months post-surgery
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ingrid Copland contact
Dominik Mertz, MD, MSc principal investigator
Hamilton Health Sciences Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefazolin and Vancomycin in people with Infection, Surgical Site, run by Hamilton Health Sciences Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominik Mertz, MD, MSc (905-521-2100 ext. 43952, mertz@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep incisional or organ/space (complex) sternal surgical site infection (CDC/NHSN) (time frame: 3 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.