Surgical Site Infection
Conditions
Keywords
Cardiac surgery
Brief summary
This multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial will compare the incidence of surgical site infection and other healthcare associated infections, health economic and microbiological impact after intraoperative only (Arm A), to 24 hours (Arm B) and, to 48 hours (Arm C) of IV cefazolin and placebo postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery
Detailed description
This trial will evaluate the clinical effectiveness, health-economic outcomes and microbiological impact of intraoperative (only) compared with intraoperative plus postoperative prophylaxis durations in patients undergoing cardiac surgery. CALIPSO, a multicentre, adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial will examine the incidence proportion of SSI following cardiac surgery. Our three-intervention trial will compare: Arm A Administration of prophylaxis in intraoperative period only Arm B Administration of prophylaxis in intraoperative plus for 24 hours postoperatively Arm C Administration of prophylaxis in intraoperative plus for 48 hours postoperatively
Interventions
DRUGCefazolin
Intravenous administration of 2 g cefazolin
Intravenous administration of 10mL sterile water for injection
Sponsors
Monash University
ANZCA CTN
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, treating clinicians, all members of the research team including the study statistician will be blinded to treatment arm allocation. Active treatment will consist of 2-grams cefazolin powder for injection. Placebo will consist of an identical empty vial. The commercial labels will be removed and a sheath placed over the vial. Amber-tinted syringes will be provided for drawing up and administration of cefazolin/placebo to mask study arm. The vial containing cefazolin or placebo will be reconstituted in a minimum of 10 mL of sterile water for injections and administered in keeping with product information for cefazolin and / or local guidelines.
Intervention model description
Adaptive, double-blind, three-arm, placebo-controlled, phase IV, noninferiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Adult patients undergoing cardiac surgery involving a median sternotomy
Exclusion criteria
* Age \<18 years * American Society of Anesthesiology (ASA) 5 * Subjects with GFR \<40mL/min/1.73m2 or those requiring continuous renal replacement therapy, haemodialysis or peritoneal dialysis * Surgery for suspected or proven endocarditis or deep sternal wound infection * Documented cefazolin hypersensitivity * Documented methicillin resistant Staphylococcus aureus (MRSA) colonisation or infection in the 12-months prior to index surgery * Cardiac transplantation * Procedures involving insertion ventricular assist device or mechanical circulatory support device * Procedures not involving a median sternotomy * Patients previously enrolled and randomised to the CALIPSO trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgical site infection | 90 days from index surgery | Surgical site infection according to CDC / NHSN definition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Clostridioides difficile infection | 30 days from index surgery | Clostridioides difficile infection according the CDC definitions |
| Incidence of other health care association infections | From date of randomization until the date of discharge from the acute healthcare facility or date of death from any cause, whichever came first, assessed up to 30 days from index surgery | Composite of all other HCAIs (pneumonia, blood stream infection and urinary tract infection) |
Countries
Australia, Canada, Malaysia, New Zealand, United States
Contacts
CONTACTPaige Druce, MSc(Epi)
CONTACTSarah Astbury
PRINCIPAL_INVESTIGATORTrisha Peel, MBBS GradCertRes FRACP PhD
Monash University
Outcome results
None listed