Surgical Site Infection
Conditions
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.
Interventions
Sponsors
Saud Al Babtain Cardiac Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
50% of study patients will be assigned to first generation cephalosporin while the other 50% will be assigned to the second generation cephalosporin. 50% of the entire study participants will be assigned to 24 hour therapy while the other 50% will be assigned to 48 hours
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
Saudi Arabia
Outcome results
None listed