NCT04146883

Post-procedure Antibiotic Prophylaxis for Cardiac Electrical Device Implantation: ABxFREE Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center open-label randomized study, and we sought to investigate the redundancy of post-procedural prophylactic antibiotics in cardiac implantable electronic device implantation. There are 2 arms in this study. One arm will receive pre-procedural intravenous antibiotics only. The other arm will receive both pre-procedural intravenous antibiotics and post-procedural 3-day oral antibiotics.

Detailed description

There is general agreement on the benefits of preoperative prophylactic antibiotics which had been documented in previous studies. Concerns of bacterial resistance and unnecessary cost, our prospective observational case-control study had suggested the redundancy of post-procedural antibiotics. In this well-designed study, we sought to investigate the efficacy of post-procedural antibiotics and confirm the hypothesis.

Conditions

• Post Procedural Infection
• Pacemaker Electrode Infection
• Antibiotics
• Implantable Defibrillator User

Interventions

Type	Name	Description
DRUG	Antibiotics	Post-procedural one-day iv cefazolin then 3-day prophylactic cephalexin

Timeline

• Start date: 2019-08-20
• Primary completion: 2020-08-19
• Completion: 2021-12-31
• First posted: 2019-10-31
• Last updated: 2019-10-31

Locations

1 site across 1 country: Taiwan