Prevention of Infections in Cardiac Surgery

Thoracic Surgery Clinical Trial

— PICS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02285140
• Other study ID #: PICS
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Antibiotic Prophylaxis
• Infections
• Thoracic Surgery

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