24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

Surgical Site Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04303390
• Other study ID #: SBCC-2017-14
• Status: Completed
• Phase: Phase 4
• Start date: February 6, 2018
• Est. completion date: May 31, 2022

Study information

• Verified date: April 2023
• Source: Saud Al Babtain Cardiac Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Cefuroxime
second generation cephalosporin
• Cefazolin
First generation cephalosporin

Other:
• 24 hours
Duration of antibiotic therapy
• 48 hours
Duration of antibiotic therapy

Locations

Country	Name	City	State
Saudi Arabia	Saud AlBabtain Cardiac Center	Dammam	Eastern Province

Sponsors (1)

Lead Sponsor	Collaborator
Saud Al Babtain Cardiac Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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