AzTrials
AzTrials

Thoracic SurgeryPICSNCT02285140

Prevention of Infections in Cardiac Surgery

A study testing Cefazolin and Vancomycin in people with Thoracic Surgery and Antibiotic Prophylaxis, run by Hamilton Health Sciences Corporation at 4 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

There is clinical equipoise about the question of whether antibiotic prophylaxis should be given for a short period or an extended period of time as reflected by inconsistencies in major guidelines, current practices at Canadian centers, and as concluded in the three systematic reviews. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thoracic Surgery, Antibiotic Prophylaxis
What is being tested?
Cefazolin and Vancomycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,989 participants
Where
4 sitesCanada
Study dates
Apr 2015to 10 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • All adult patients (≥18 years of age) undergoing open-heart surgery (sternotomy, including minimally-invasive surgical techniques).

Who cannot join

  • Patients on antibiotics at the time of surgery.
  • Previous enrollment in this trial.
  • Known MRSA carriers. Beta-lactam allergy (IgE-mediated) precluding the use of cefazolin
  • Participant in another study that may interfere with this trial.

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2

  • Jewish Hospital

    Montreal, Quebec, H3T 1E2

  • University of Sherbrook

    Sherbrook, Quebec, J1H 5N4

  • St. Michael's Hospital

    Toronto, Ontario, M5B1W8

Other trials in Canada

About this study

Official title: Prevention of Infections in Cardiac Surgery: a Cluster-randomized Factorial Cross-over Trial

There is clinical equipoise about the question of whether antibiotic prophylaxis should be given for a short period or an extended period of time as reflected by inconsistencies in major guidelines, current practices at Canadian centers, and as concluded in the three systematic reviews. There also is clinical equipoise on whether the addition of vancomycin to routine cefazolin prophylaxis can further reduce s-SSI rates. A short duration of combined antimicrobial prophylaxis can reduce side effects of exposure to antimicrobials such as infections with C. difficile or emergence of resistance, but may also reduce the incidence of s-SSIs. The objective of the eventual full scale study is to determine whether adding vancomycin to cefazolin can reduce SSIs as well as whether short-term prophylaxis is as effective as long-term prophylaxis. The rationale to conduct the proposed pilot study is to assess the feasibility to conduct this factorial cluster randomized cross-over trial, the adherence to the study protocol at each pilot site, the length of time to fill out the case report forms, and to get reliable estimates of event rates for sample size calculation for the main study

Being tested
Cefazolin, Vancomycin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CefazolinDrug

    administration as outlined

  • VancomycinDrug

    administration as outlined

Study groups in NCT02285140
Study groupRoleWhat they receive
Cefazolin monotherapy, short courseExperimentalOne pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered
Receives: Drug: Cefazolin
Cefazolin monotherapy, long courseExperimentalOne pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered followed by additional five doses every eight hours postoperatively (last dose 44 hours after the first dose).
Receives: Drug: Cefazolin
Combination therapy, short courseExperimentalOne pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered. In addition, one dose of vancomycin 60-90min pre-op will be administered.
Receives: Drug: Cefazolin; Drug: Vancomycin
Combination therapy, long courseExperimentalOne pre-op dose of cefazolin 30-60 minutes prior to surgery followed by a second dose either four hours after the first dose or upon wound closure (whatever comes first) will be administered followed by additional five doses every eight hours postoperatively (last dose 44 hours after the first dose). In addition, one dose of vancomycin 60-90min pre-op will be administered followed by 3 post-op doses every 12 hours (last dose 36 hours after first dose)
Receives: Drug: Cefazolin; Drug: Vancomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients receiving antibiotics according to study protocol

    Co-Primary outcome of pilot study

    Measured: 3 months post-surgery

  2. Proportion of patients with complete follow-up, i.e. up to 90 days or death; goal >95%

    Co-Primary outcome of pilot study

    Measured: 3 months post-surgery

  3. Agreement of blinded outcome assessment based on information from the case report form

    Co-Primary outcome of pilot study

    Measured: 3 months post-surgery

Secondary outcomes (4)

  1. Deep incisional and organ/space sternal surgical site infection (NHSN/CDC)

    Primary outcome of eventual full trial

    Measured: 3 months post-surgery

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

    Secondary outcome of eventual full trial

    Measured: 3 months post-surgery

  3. Mortality

    Secondary outcome of eventual full trial

    Measured: 3 months post-surgery

  4. Clostridium difficile infection

    Secondary outcome of eventual full trial

    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.

  1. First posted6 Nov 2014 (estimated)
  2. Study startApr 2015
  3. Primary completion10 Mar 2025
  4. Study completion10 Mar 2025

Why it stopped: Funding received for eventual full trial, and data rolled over into full trial. Full trial registered under NCT06567808.

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5,989 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02285140
Sponsor's protocol ID
PICS Vanguard
Acronym
PICS
Status last verified
Mar 2025
First submitted
4 Nov 2014
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No

Publications

  • van Oostveen RB, Romero-Palacios A, Whitlock R, Lee SF, Connolly S, Carignan A, Mazer CD, Loeb M, Mertz D. Prevention of Infections in Cardiac Surgery study (PICS): study protocol for a pragmatic cluster-randomized factorial crossover pilot trial. Trials. 2018 Dec 17;19(1):688. doi: 10.1186/s13063-018-3080-y.

    PubMed 30558680

Questions about this trial

What is this clinical trial studying?

A study testing Cefazolin and Vancomycin in people with Thoracic Surgery and Antibiotic Prophylaxis, run by Hamilton Health Sciences Corporation at 4 sites in Canada.

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 4 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: stopped early, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study was stopped early (reason given: Funding received for eventual full trial, and data rolled over into full trial. Full trial registered under NCT06567808.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients receiving antibiotics according to study protocol (time frame: 3 months post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02285140, which also lists 1 linked publication.

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 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in