24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis
- Conditions
- Surgical Site Infection
- Interventions
- Registration Number
- NCT04303390
- Lead Sponsor
- Saud Al Babtain Cardiac Center
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 568
- Ability to provide informed consent
- Planned to undergo a cardiac surgical procedure
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 48 hour Cefuroxime arm 48 hours 25% of the entire study participants are assigned to 48 hours and second generation cephalosporin 24 hour Cefuroxime arm 24 hours 25% of the entire study participants are assigned to 24 hours and second generation cephalosporin 24 hour Cefazolin arm 24 hours 25% of the entire study participants are assigned to 24 hours and first generation cephalosporin 48 hour Cefuroxime arm Cefuroxime 25% of the entire study participants are assigned to 48 hours and second generation cephalosporin 24 hour Cefuroxime arm Cefuroxime 25% of the entire study participants are assigned to 24 hours and second generation cephalosporin 48 hour Cefazolin arm 48 hours 25% of the entire study participants are assigned to 48 hours and first generation cephalosporin 24 hour Cefazolin arm Cefazolin 25% of the entire study participants are assigned to 24 hours and first generation cephalosporin 48 hour Cefazolin arm Cefazolin 25% of the entire study participants are assigned to 48 hours and first generation cephalosporin
- Primary Outcome Measures
Name Time Method surgical site infection rate is less with 48 hours rather than 24 hours within 3 months from date of surgery That Longer duration of prophylaxis is better than shorter duration
surgical site infection rate is less with Cefuroxime than Cefazolin within 3 months from date of surgery that Second Generation Cefalosporin is superior to first generation
- Secondary Outcome Measures
Name Time Method Length of ICU Stay will be shorter in the group assigned to 48 hours of cefuroxime within 3 months from date of surgery that 48 hours of cefuroxime will reduce ICU stay
Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime within 3 months from date of surgery that 48 hours of cefuroxime will reduce hospital stay
rate of infection with a specific organism following each of the antibiotics used within 3 months from date of surgery type of organism following each type of antibiotic used
change from baseline of serum creatinine for each antibiotic used within 3 months from date of surgery that 48 hours of cefuroxime will not worsen renal function
Trial Locations
- Locations (1)
Saud AlBabtain Cardiac Center
🇸🇦Dammam, Eastern Province, Saudi Arabia