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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02285140
Other study ID # PICS
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date November 7, 2026

Study information

Verified date September 2023
Source Hamilton Health Sciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3000
Est. completion date November 7, 2026
Est. primary completion date August 7, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All adult patients (=18 years of age) undergoing open-heart surgery (sternotomy, including minimally-invasive surgical techniques). Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cefazolin
administration as outlined
Vancomycin
administration as outlined

Locations

Country Name City State
Canada Hamilton Health Sciences Hamilton Ontario
Canada Jewish Hospital Montréal Quebec
Canada University of Sherbrook Sherbrook Quebec
Canada St. Michael's Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Hamilton Health Sciences Corporation The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients receiving antibiotics according to study protocol Co-Primary outcome of pilot study 3 months post-surgery
Primary Proportion of patients with complete follow-up, i.e. up to 90 days or death; goal >95% Co-Primary outcome of pilot study 3 months post-surgery
Primary Agreement of blinded outcome assessment based on information from the case report form Co-Primary outcome of pilot study 3 months post-surgery
Secondary Deep incisional and organ/space sternal surgical site infection (NHSN/CDC) Primary outcome of eventual full trial 3 months post-surgery
Secondary All types of sternal surgical site infection (superficial, deep, organ; NHSN/CDC) Secondary outcome of eventual full trial 3 months post-surgery
Secondary Mortality Secondary outcome of eventual full trial 3 months post-surgery
Secondary Clostridium difficile infection Secondary outcome of eventual full trial 3 months post-surgery
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