Antibiotic Prophylaxis, Thoracic Surgery
Conditions
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
Interventions
DRUGCefazolin
administration as outlined
DRUGVancomycin
administration as outlined
Sponsors
The Physicians' Services Incorporated Foundation
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients receiving antibiotics according to study protocol | 3 months post-surgery | Co-Primary outcome of pilot study |
| Proportion of patients with complete follow-up, i.e. up to 90 days or death; goal >95% | 3 months post-surgery | Co-Primary outcome of pilot study |
| Agreement of blinded outcome assessment based on information from the case report form | 3 months post-surgery | Co-Primary outcome of pilot study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Deep incisional and organ/space sternal surgical site infection (NHSN/CDC) | 3 months post-surgery | Primary outcome of eventual full trial |
| Clostridium difficile infection | 3 months post-surgery | Secondary outcome of eventual full trial |
| All types of sternal surgical site infection (superficial, deep, organ; NHSN/CDC) | 3 months post-surgery | Secondary outcome of eventual full trial |
| Mortality | 3 months post-surgery | Secondary outcome of eventual full trial |
Countries
Canada
Outcome results
None listed