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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefuroxime | Drug | second generation cephalosporin |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed S Koudieh, MD | Saud AlBabtain Cardiac Center | Principal Investigator |
| Shukri M AlSaif, MD | Saud AlBabtain Cardiac Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saud AlBabtain Cardiac Center | Dammam | Eastern Province | 31463 | Saudi Arabia |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D002444 | Cefuroxime |
| D002437 | Cefazolin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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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
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| Cefazolin | Drug | First generation cephalosporin |
|
| 24 hours | Other | Duration of antibiotic therapy |
|
| 48 hours | Other | Duration of antibiotic therapy |
|
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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |