24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

NCT04303390 | Completed Phase 4 DMC

• 1 other identifier: SBCC-2017-14
• Study Type: interventional
• Target: 568
• Locations: 1 country
• Sites: 1

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).

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Length of actual Hospital Stay in the group assigned to 48 hours of cefuroxime

  within 3 months from date of surgery

• Length of ICU Stay will be shorter in the group assigned to 48 hours of cefuroxime

  within 3 months from date of surgery

• rate of infection with a specific organism following each of the antibiotics used

  within 3 months from date of surgery

• change from baseline of serum creatinine for each antibiotic used

  within 3 months from date of surgery

Study Arms (4)

24 hour Cefuroxime arm

ACTIVE COMPARATOR

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

Drug: Cefuroxime; Other: 24 hours

24 hour Cefazolin arm

ACTIVE COMPARATOR

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

Drug: Cefazolin; Other: 24 hours

48 hour Cefuroxime arm

ACTIVE COMPARATOR

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

Drug: Cefuroxime; Other: 48 hours

48 hour Cefazolin arm

ACTIVE COMPARATOR

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

Drug: Cefazolin; Other: 48 hours

Interventions

Cefuroxime DRUG

second generation cephalosporin

24 hour Cefuroxime arm; 48 hour Cefuroxime arm

Cefazolin DRUG

First generation cephalosporin

24 hour Cefazolin arm; 48 hour Cefazolin arm

24 hours OTHER

Duration of antibiotic therapy

24 hour Cefazolin arm; 24 hour Cefuroxime arm

48 hours OTHER

Duration of antibiotic therapy

48 hour Cefazolin arm; 48 hour Cefuroxime arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent
• Planned to undergo a cardiac surgical procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Saud Al Babtain Cardiac Center: lead

Study Sites (1)

Saud AlBabtain Cardiac Center

Dammam, Eastern Province, 31463, Saudi Arabia

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefuroxime; Cefazolin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mohammed S Koudieh, MD

  Saud AlBabtain Cardiac Center

  PRINCIPAL INVESTIGATOR

• Shukri M AlSaif, MD

  Saud AlBabtain Cardiac Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: March 11, 2020
• Study Start: February 6, 2018
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

SA (1)