A Randomized Noninferiority Study of the TYRX-A Antibacterial Envelope Alone Versus Envelope Plus Intraoperative Antibacterial Irrigant and Postoperative Oral Antibiotics to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Patients
Objective
To test the hypothesis that the use of the TYRX antibacterial envelope alone is noninferior to a strategy using the antibacterial envelope and intraoperative antibacterial irrigant and postoperative oral antibiotics for the reduction of cardiac implantable device infections in patients with ≥2 risk factors for infection.
Eligibility
At least 2 of the following risk factors for infection:
- Diabetes mellitus
- Chronic kidney disease (estimated creatinine clearance <30 ml/min)
- Therapeutic anticoagulation
- Chronic heart failure
- Chronic use of corticosteroids
- Fever ≥38° C or leukocytois (≥11,000 cells/mm3) within 24 hrs of implant
- Device revision (including generator change, or extraction)
- ≥3 leads in situ (CRT system or abandoned leads)
- Early reoperation (pocket re-entry <2 weeks)
- Previous CIED infection
NCT ID
NCT02809131
