Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection

CompletedOBSERVATIONAL
Enrollment

1,417

Participants

Timeline

Start Date

January 1, 2020

Primary Completion Date

March 1, 2022

Study Completion Date

September 1, 2022

Conditions
Cardiac Implantable Electronic Device Infection
Interventions
DEVICE

TauroPace

All the hardware (leads, suture sleeves, pulse generator) is washed and the device pocket irrigated with an adjunct antimicrobial solution containing Taurolidine (TauroPace™, Tauropharm, Bavaria, Germany), during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system since January 2019

DEVICE

Hydrogen Peroxide

All the hardware (leads, suture sleeves, pulse generator) was washed and the device pocket irrigated with an adjunct antimicrobial solution containing 3% hydrogen peroxide (H2O2) during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system at the authors' institute before 01/01/2020

DRUG

Taurolidine

All the hardware (leads, suture sleeves, pulse generator) was washed and the device pocket irrigated with an adjunct antimicrobial solution containing taurolidine in a galenic formulation during any invasive procedure (new implantation, pulse generator replacement, lead repositioning or insertion, system upgrade or downgrade, revision) involving a CIED system at the authors' institute before 01/01/2019

Trial Locations (1)

84036

Lakumed, Landshut

All Listed Sponsors
collaborator

University of Luebeck

OTHER

lead

Prof. Dr. Hendrik Bonnemeier

OTHER

NCT05576194 - Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection | Biotech Hunter | Biotech Hunter