Trial | NCT04303390  Report issue

Title

24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis
24 Versus 48 Hours of First Generation or Second Generation Cephalosporin as Prophylaxis to Reduce Surgical Site Infection in Adult Cardiac Surgery Patients: a Randomized Controlled Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    568
A randomized control trial studying the effect of prophylactic antibiotics to reduce surgical site infections following cardiac surgery in adults using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime).
A prospective randomized controlled patient blinded study with 2x2 factional design. It aims to study optimal duration of antibiotic to reduce surgical site infections following cardiac surgery in adults 24 or 48 hours using 1st generation cephalosporin (Cefazolin) or 2nd generation cephalosporin (Cefuroxime). Patients shall remain on either medicines for 24 or 48 hours. The primary endpoints of the study are:(1) 48 hours antibiotic prophylaxis is superior to 24 hours in adult cardiac surgery (2) Cefuroxime is superior to Cafazolin as a prophylactic antibiotic in adult cardiac surgery. Secondary endpoints include; organisms causing surgical site infections, length of hospital and ICU stay, and worsening in renal function.
Study Started
Feb 06
2018
Primary Completion
May 31
2022
Study Completion
May 31
2022
Last Update
Apr 11
2023

Drug Cefuroxime

second generation cephalosporin

Drug Cefazolin

First generation cephalosporin

Other 24 hours

Duration of antibiotic therapy

Other 48 hours

Duration of antibiotic therapy

24 hour Cefuroxime arm Active Comparator

25% of the entire study participants are assigned to 24 hours and second generation cephalosporin

24 hour Cefazolin arm Active Comparator

25% of the entire study participants are assigned to 24 hours and first generation cephalosporin

48 hour Cefuroxime arm Active Comparator

25% of the entire study participants are assigned to 48 hours and second generation cephalosporin

48 hour Cefazolin arm Active Comparator

25% of the entire study participants are assigned to 48 hours and first generation cephalosporin

Criteria 

Inclusion Criteria:

Ability to provide informed consent
Planned to undergo a cardiac surgical procedure

Exclusion Criteria:

Patients on antibiotics on the day of surgery or those who received any within 7 days for any reason
Patients taken to operating room as salvage
Patients who are allergic to either cefuroxime or cefazolin
Patients for LVAD or ECMO
Patients who are known MRSA carriers
Patients receiving steroid therapy
No Results Posted