NCT04303390

24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 568 (actual)
• Sponsor: Saud Al Babtain Cardiac Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Cefuroxime	second generation cephalosporin
DRUG	Cefazolin	First generation cephalosporin
OTHER	24 hours	Duration of antibiotic therapy
OTHER	48 hours	Duration of antibiotic therapy

Timeline

• Start date: 2018-02-06
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2020-03-11
• Last updated: 2023-04-11

Locations

1 site across 1 country: Saudi Arabia