1,000
Participants
Start Date
September 1, 2025
Primary Completion Date
September 30, 2027
Study Completion Date
December 31, 2027
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."
University of Calabria
OTHER