A Phase 4 interventional study of Cefuroxime and Cefazolin in Surgical Site Infection, sponsored by Saud Al Babtain Cardiac Center. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-11.
Sponsored by Saud Al Babtain Cardiac Center · Phase 4, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 568 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Saud Al Babtain Cardiac Center is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
25% of the entire study participants are assigned to 24 hours and second generation cephalosporin
Drug: Cefuroxime · Other: 24 hours
25% of the entire study participants are assigned to 24 hours and first generation cephalosporin
Drug: Cefazolin · Other: 24 hours
25% of the entire study participants are assigned to 48 hours and second generation cephalosporin
Drug: Cefuroxime · Other: 48 hours
25% of the entire study participants are assigned to 48 hours and first generation cephalosporin
Drug: Cefazolin · Other: 48 hours
second generation cephalosporin
First generation cephalosporin
Duration of antibiotic therapy
Duration of antibiotic therapy
surgical site infection rate is less with Cefuroxime than Cefazolin
that Second Generation Cefalosporin is superior to first generation
Time frame: within 3 months from date of surgery
surgical site infection rate is less with 48 hours rather than 24 hours
That Longer duration of prophylaxis is better than shorter duration
Time frame: within 3 months from date of surgery
Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime
that 48 hours of cefuroxime will reduce hospital stay
Time frame: within 3 months from date of surgery
Length of ICU Stay will be shorter in the group assigned to 48 hours of cefuroxime
that 48 hours of cefuroxime will reduce ICU stay
Time frame: within 3 months from date of surgery
rate of infection with a specific organism following each of the antibiotics used
type of organism following each type of antibiotic used
Time frame: within 3 months from date of surgery
change from baseline of serum creatinine for each antibiotic used
that 48 hours of cefuroxime will not worsen renal function
Time frame: within 3 months from date of surgery
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Saud Al Babtain Cardiac Center