Clinical trial NCT02285140: Prevention of Infections in Cardiac Surgery
Official title: Prevention of Infections in Cardiac Surgery: a Cluster-randomized Factorial Cross-over Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Thoracic Surgery
Antibiotic Prophylaxis
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2014-11-06
Enrollment: 5989
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients receiving antibiotics according to study protocol
timeFrame: 3 months post-surgery
measure: Proportion of patients with complete follow-up, i.e. up to 90 days or death; goal >95%
timeFrame: 3 months post-surgery
measure: Agreement of blinded outcome assessment based on information from the case report form
timeFrame: 3 months post-surgery
Secondary outcomes:
measure: Deep incisional and organ/space sternal surgical site infection (NHSN/CDC)
timeFrame: 3 months post-surgery
measure: All types of sternal surgical site infection (superficial, deep, organ; NHSN/CDC)
timeFrame: 3 months post-surgery
measure: Mortality
timeFrame: 3 months post-surgery
measure: Clostridium difficile infection
timeFrame: 3 months post-surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: Jewish Hospital
state: Quebec
city: Sherbrook
country: Canada
facility: University of Sherbrook
state: Quebec
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Dominik Mertz, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.