24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Drug: Cefuroxime
* Drug: Cefazolin
* Other: 24 hours
* Other: 48 hours


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 24 hour Cefuroxime arm<br>25% of the entire study participants are assigned to 24 hours and second generation cephalosporin | Drug: Cefuroxime<br>* second generation cephalosporin<br>Other: 24 hours<br>* Duration of antibiotic therapy<br>|
| Active Comparator: 24 hour Cefazolin arm<br>25% of the entire study participants are assigned to 24 hours and first generation cephalosporin | Drug: Cefazolin<br>* First generation cephalosporin<br>Other: 24 hours<br>* Duration of antibiotic therapy<br>|
| Active Comparator: 48 hour Cefuroxime arm<br>25% of the entire study participants are assigned to 48 hours and second generation cephalosporin | Drug: Cefuroxime<br>* second generation cephalosporin<br>Other: 48 hours<br>* Duration of antibiotic therapy<br>|
| Active Comparator: 48 hour Cefazolin arm<br>25% of the entire study participants are assigned to 48 hours and first generation cephalosporin | Drug: Cefazolin<br>* First generation cephalosporin<br>Other: 48 hours<br>* Duration of antibiotic therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical site infection rate is less with Cefuroxime than Cefazolin | that Second Generation Cefalosporin is superior to first generation | 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 | within 3 months from date of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime | that 48 hours of cefuroxime will reduce hospital stay | 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 | 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 | 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 | within 3 months from date of surgery |