Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection

Completed

• Conditions: Cardiac Implantable Electronic Device Infection
• Interventions: Device: TauroPace; Device: Hydrogen Peroxide; Drug: Taurolidine

• Registration Number: NCT05576194
• Lead Sponsor: Prof. Dr. Hendrik Bonnemeier

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-09-01
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-08
• Study First Posted: 2022-10-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1417

Inclusion Criteria

CIED procedure, signs PIC

Exclusion Criteria

PIC not signed, minor

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
antiseptic irrigation group	Hydrogen Peroxide	every procedure conducted with adjunct antiseptic irrigation, which could be Taurolidine, TauroPace or Hydrogen Peroxide 3%
antiseptic irrigation group	TauroPace	every procedure conducted with adjunct antiseptic irrigation, which could be Taurolidine, TauroPace or Hydrogen Peroxide 3%
TauroPace irrigation group	TauroPace	every consecutive CIED placement, revision, extraction conducted with TauroPace
antiseptic irrigation group	Taurolidine	every procedure conducted with adjunct antiseptic irrigation, which could be Taurolidine, TauroPace or Hydrogen Peroxide 3%

Primary Outcome Measures

Name	Time	Method
CIED infection	three months	cardiac implantable electronic device infection

Secondary Outcome Measures

Name	Time	Method
all cause mortality	36 months	death of any cause during all of the follow up period
adverse events grade 3-5	36 months	adverse events related to CIED, procedure or the atiseptic used during all of the follow-up period

Trial Locations

Locations (1)

Lakumed; 🇩🇪 Landshut, Bavaria, Germany