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Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection

NCT05576194 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1417

Last updated 2023-12-06

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • University of Luebeck

    collaborator OTHER

  • Prof. Dr. Hendrik Bonnemeier

    lead OTHER

Principal Investigators

  • Stefan Borov, MD · Lakumed Landshut, CAU Kiel

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-03-01
Completion
2022-09-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05576194 on ClinicalTrials.gov