NCT05447559

Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study

Name: Clinical Trial NCT05447559
Creator: Monash University
Keywords: Surgical Site Infection, Cefazolin, Phase 4, drug, clinical trial

Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery

Monash University·Phase 4·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Surgical Site Infection
Drug/Device/Intervention: Cefazolin
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Monash University

Timeline & enrollment

Phase: Phase 4
Start date: Sep 01, 2022
End date: Jun 01, 2027
Enrollment: 9000 participants

Primary outcome

Incidence of surgical site infection

Summary

This multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial will compare the incidence of surgical site infection and other healthcare associated infections, health economic and microbiological impact after intraoperative only (Arm A), to 24 hours (Arm B) and, to 48 hours (Arm C) of IV cefazolin and placebo postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery

ICD-10 classifications

Infection following a procedure, not elsewhere classifiedBacterial infection of unspecified siteOther bacterial infections of unspecified siteInfection of obstetric surgical woundOther specified local infections of skin and subcutaneous tissue

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05447559
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05447559 through Pure Global AI's free database. This Phase 4 trial is sponsored by Monash University and is currently Not yet recruiting. The study focuses on Surgical Site Infection. Target enrollment is 9000 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.