Antimicrobial Strategy for Device Implantation

Not yet recruitingOBSERVATIONAL
Enrollment

1,000

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

December 31, 2027

Conditions
CIED-related Infections
Interventions
DRUG

TauroPace Cohort

"After sterile opening of the vial, the entire content of TauroPace™ will be poured into single-use sterile trays. Following skin incision, the surgical site will be irrigated with 5 mL of TauroPace™ solution.~The leads, device generator, and fixation sutures will then be thoroughly wiped using sterile gauze soaked in the solution. Once the leads are connected to the generator, the entire system will be treated again with TauroPace™ before being inserted into the pocket.~At the end of the procedure, the final surgical site will be irrigated once more with an additional 5 mL of TauroPace™ using a sterile syringe. A full 100 mL vial of the solution will be used for each patient, ensuring continuous antimicrobial coverage throughout the procedure.~Excess solution will be gently removed prior to surgical wound closure."

All Listed Sponsors
lead

University of Calabria

OTHER

NCT07158502 - Antimicrobial Strategy for Device Implantation | Biotech Hunter | Biotech Hunter