24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

Saud Al Babtain Cardiac Center

Status and phase: Completed; Phase 4

Conditions: Surgical Site Infection

Treatments: Other: 24 hours; Drug: Cefuroxime; Drug: Cefazolin; Other: 48 hours

Study type: Interventional

Funder types: Other

Identifiers

NCT04303390

SBCC-2017-14

Details and patient eligibility

About

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).

Full 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.

Enrollment: 568 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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568 participants in 4 patient groups

24 hour Cefuroxime arm

Active Comparator group

Description:

25% of the entire study participants are assigned to 24 hours and second generation cephalosporin

Treatment:

Drug: Cefuroxime

Other: 24 hours

24 hour Cefazolin arm

Active Comparator group

Description:

25% of the entire study participants are assigned to 24 hours and first generation cephalosporin

Treatment:

Drug: Cefazolin

Other: 24 hours

48 hour Cefuroxime arm

Active Comparator group

Description:

25% of the entire study participants are assigned to 48 hours and second generation cephalosporin

Treatment:

Drug: Cefuroxime

Other: 48 hours

48 hour Cefazolin arm

Active Comparator group

Description:

25% of the entire study participants are assigned to 48 hours and first generation cephalosporin

Treatment:

Drug: Cefazolin

Other: 48 hours