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

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).

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: Cefuroxime; Other: 24 hours; Drug: Cefazolin; Other: 48 hours

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.

• Study Type: Interventional
• Enrollment (Actual): 568
• Phase: Phase 4

Contacts and Locations

Study Locations

• Saudi Arabia
  • Eastern Province
    • Dammam, Eastern Province, Saudi Arabia, 31463
      • Saud AlBabtain Cardiac Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saud Al Babtain Cardiac Center
• Investigators: Principal Investigator: Mohammed S Koudieh, MD, Saud AlBabtain Cardiac Center; Principal Investigator: Shukri M AlSaif, MD, Saud AlBabtain Cardiac Center

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2018
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: November 3, 2019
• First Submitted That Met QC Criteria: March 8, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 9, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wound Infection; Infections; Surgical Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin; Cefuroxime; Cefuroxime axetil
• Other Study ID Numbers: SBCC-2017-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No