24 Vs 48 Hours of Cefazolin or Cefuroxime as Prophylaxis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-06

Study Completion Date

2022-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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24 hour Cefuroxime arm

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

Group Type ACTIVE_COMPARATOR

Cefuroxime

Intervention Type DRUG

second generation cephalosporin

24 hours

Intervention Type OTHER

Duration of antibiotic therapy

24 hour Cefazolin arm

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

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

First generation cephalosporin

24 hours

Intervention Type OTHER

Duration of antibiotic therapy

48 hour Cefuroxime arm

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

Group Type ACTIVE_COMPARATOR

Cefuroxime

Intervention Type DRUG

second generation cephalosporin

48 hours

Intervention Type OTHER

Duration of antibiotic therapy

48 hour Cefazolin arm

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

Group Type ACTIVE_COMPARATOR

Cefazolin

Intervention Type DRUG

First generation cephalosporin

48 hours

Intervention Type OTHER

Duration of antibiotic therapy

Interventions

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Cefuroxime

second generation cephalosporin

Intervention Type DRUG

Cefazolin

First generation cephalosporin

Intervention Type DRUG

24 hours

Duration of antibiotic therapy

Intervention Type OTHER

48 hours

Duration of antibiotic therapy

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No