24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 5, 2021

Detailed Description

A prospective randomized controlled patient blinded study with 2×2 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.

Interventions

  • Drug: Cefuroxime
    • second generation cephalosporin
  • Drug: Cefazolin Injection
    • First generation cephalosporin
  • Other: 24 hours
    • Duration of antibiotic therapy
  • Other: 48 hours
    • Duration of antibiotic therapy

Arms, Groups and Cohorts

  • Active Comparator: 24 hour Cefuroxime arm
    • 25% of the entire study participants are assigned to 24 hours and second generation cephalosporin
  • Active Comparator: 24 hour Cefazolin arm
    • 25% of the entire study participants are assigned to 24 hours and first generation cephalosporin
  • Active Comparator: 48 hour Cefuroxime arm
    • 25% of the entire study participants are assigned to 48 hours and second generation cephalosporin
  • Active Comparator: 48 hour Cefazolin arm
    • 25% of the entire study participants are assigned to 48 hours and first generation cephalosporin

Clinical Trial Outcome Measures

Primary Measures

  • surgical site infection rate is less with Cefuroxime than Cefazolin
    • Time Frame: within 3 months from date of surgery
    • that Second Generation Cefalosporin is superior to first generation
  • surgical site infection rate is less with 48 hours rather than 24 hours
    • Time Frame: within 3 months from date of surgery
    • That Longer duration of prophylaxis is better than shorter duration

Secondary Measures

  • Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime
    • Time Frame: within 3 months from date of surgery
    • that 48 hours of cefuroxime will reduce hospital stay
  • Length of ICU Stay will be shorter in the group assigned to 48 hours of cefuroxime
    • Time Frame: within 3 months from date of surgery
    • that 48 hours of cefuroxime will reduce ICU stay
  • rate of infection with a specific organism following each of the antibiotics used
    • Time Frame: within 3 months from date of surgery
    • type of organism following each type of antibiotic used
  • change from baseline of serum creatinine for each antibiotic used
    • Time Frame: within 3 months from date of surgery
    • that 48 hours of cefuroxime will not worsen renal function
  • Mortality rate associated with use of each antibiotic used
    • Time Frame: within 3 months from date of surgery
    • that 48 hours of cefuroxime might reduce mortality
  • rate of infection other than surgical site following each of the antibiotics used
    • Time Frame: within 3 months from date of surgery
    • that this will not be affected by the antibiotic used

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Saud Al Babtain Cardiac Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mohammed S Koudieh, MD, Principal Investigator, Saud AlBabtain Cardiac Center
    • Shukri M AlSaif, MD, Principal Investigator, Saud AlBabtain Cardiac Center
  • Overall Contact(s)
    • Dina F AlBiliwi, RN, +966138517569, dina.albiliwi@yahoo.com

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