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24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Cefuroxime
Cefazolin
24 hours
48 hours
Sponsored by
Saud Al Babtain Cardiac Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Site Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Saud AlBabtain Cardiac Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

24 hour Cefuroxime arm

24 hour Cefazolin arm

48 hour Cefuroxime arm

48 hour Cefazolin arm

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

surgical site infection rate is less with Cefuroxime than Cefazolin
that Second Generation Cefalosporin is superior to first generation
surgical site infection rate is less with 48 hours rather than 24 hours
That Longer duration of prophylaxis is better than shorter duration

Secondary Outcome Measures

Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime
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
that 48 hours of cefuroxime will reduce ICU stay
rate of infection with a specific organism following each of the antibiotics used
type of organism following each type of antibiotic used
change from baseline of serum creatinine for each antibiotic used
that 48 hours of cefuroxime will not worsen renal function

Full Information

First Posted
November 3, 2019
Last Updated
April 9, 2023
Sponsor
Saud Al Babtain Cardiac Center
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1. Study Identification

Unique Protocol Identification Number
NCT04303390
Brief Title
24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis
Official Title
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
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2018 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saud Al Babtain Cardiac Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
568 (Actual)

8. Arms, Groups, and Interventions

Arm Title
24 hour Cefuroxime arm
Arm Type
Active Comparator
Arm Description
25% of the entire study participants are assigned to 24 hours and second generation cephalosporin
Arm Title
24 hour Cefazolin arm
Arm Type
Active Comparator
Arm Description
25% of the entire study participants are assigned to 24 hours and first generation cephalosporin
Arm Title
48 hour Cefuroxime arm
Arm Type
Active Comparator
Arm Description
25% of the entire study participants are assigned to 48 hours and second generation cephalosporin
Arm Title
48 hour Cefazolin arm
Arm Type
Active Comparator
Arm Description
25% of the entire study participants are assigned to 48 hours and first generation cephalosporin
Intervention Type
Drug
Intervention Name(s)
Cefuroxime
Intervention Description
second generation cephalosporin
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Description
First generation cephalosporin
Intervention Type
Other
Intervention Name(s)
24 hours
Intervention Description
Duration of antibiotic therapy
Intervention Type
Other
Intervention Name(s)
48 hours
Intervention Description
Duration of antibiotic therapy
Primary Outcome Measure Information:
Title
surgical site infection rate is less with Cefuroxime than Cefazolin
Description
that Second Generation Cefalosporin is superior to first generation
Time Frame
within 3 months from date of surgery
Title
surgical site infection rate is less with 48 hours rather than 24 hours
Description
That Longer duration of prophylaxis is better than shorter duration
Time Frame
within 3 months from date of surgery
Secondary Outcome Measure Information:
Title
Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime
Description
that 48 hours of cefuroxime will reduce hospital stay
Time Frame
within 3 months from date of surgery
Title
Length of ICU Stay will be shorter in the group assigned to 48 hours of cefuroxime
Description
that 48 hours of cefuroxime will reduce ICU stay
Time Frame
within 3 months from date of surgery
Title
rate of infection with a specific organism following each of the antibiotics used
Description
type of organism following each type of antibiotic used
Time Frame
within 3 months from date of surgery
Title
change from baseline of serum creatinine for each antibiotic used
Description
that 48 hours of cefuroxime will not worsen renal function
Time Frame
within 3 months from date of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed S Koudieh, MD
Organizational Affiliation
Saud AlBabtain Cardiac Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shukri M AlSaif, MD
Organizational Affiliation
Saud AlBabtain Cardiac Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saud AlBabtain Cardiac Center
City
Dammam
State/Province
Eastern Province
ZIP/Postal Code
31463
Country
Saudi Arabia

12. IPD Sharing Statement

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24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

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