Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection

Prof. Dr. Hendrik Bonnemeier

Status: Completed

Conditions: Cardiac Implantable Electronic Device Infection

Treatments: Device: Hydrogen Peroxide; Drug: Taurolidine; Device: TauroPace

Study type: Observational

Funder types: Other

Identifiers

NCT05576194

19059

Details and patient eligibility

About

From January 1st 2020, any CIED procedure conducted with adjunct TauroPace™ CIED and pocket irrigation is enrolled in a consecutive manner and followed up in one centre. Follow-up is prospectively.

Before that date any CIED procedure conducted with adjunct antispetic pocket and CIED irrigation is evaluated retrospectively to form a comparable group.

Full description

All the hardware (leads, suture sleeves, pulse generator) is washed and the device pocket irrigated with an adjunct antimicrobial solution, which could be 3% hydrogen peroxide (H2O2), taurolidine in a galenic formulation or TauroPace™ (TP, 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 at the authors' institute. Before 01/01/2020, the choice of antimicrobial solution was at the operator's discretion. These procedures were evaluated retrospectively. With change of policy on the first of January 2020, in every consecutive patient and procedure only TP is used. Patients were enrolled and followed consecutively in order of appearance. All CIED procedures performed at the author's institute between 01/01/2017 and 28/02/2022 are included for analysis. Patients who receive the galenic taurolidine formulation were excluded from analysis.

Enrollment: 1,417 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

CIED procedure, signs PIC

Exclusion criteria

PIC not signed, minor

Trial design

1,417 participants in 2 patient groups

TauroPace irrigation group

Description:

every consecutive CIED placement, revision, extraction conducted with TauroPace

Treatment:

Device: TauroPace

antiseptic irrigation group

Description:

every procedure conducted with adjunct antiseptic irrigation, which could be Taurolidine, TauroPace or Hydrogen Peroxide 3%

Treatment:

Device: TauroPace

Drug: Taurolidine

Device: Hydrogen Peroxide