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OpenTrials
Completed

NCT Number: NCT05576194

Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection

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.

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Key information

Conditions

Cardiac Implantable Electronic Device Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lakumed

Landshut, Bavaria, 84036, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

CIED procedure, signs PIC

Exclusion criteria

PIC not signed, minor

Treatment and study plan

TauroPace

Device

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

Hydrogen Peroxide

Device

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

taurolidine

Drug

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

Primary outcomes

  1. CIED infection

    Time frame: three months

    cardiac implantable electronic device infection

Secondary outcomes

  1. all cause mortality

    Time frame: three months

    death of any cause during the observation

  2. adverse events grade 3-5

    Time frame: three months

    adverse events related to CIED, procedure or the atiseptic used

  3. all cause mortality

    Time frame: 36 months

    death of any cause during all of the follow up period

  4. adverse events grade 3-5

    Time frame: 36 months

    adverse events related to CIED, procedure or the atiseptic used during all of the follow-up period

Sponsors and collaborators

Lead sponsor

Prof. Dr. Hendrik Bonnemeier

Other

Collaborators

  • University of Luebeck

Registry information

Official study title

Effect of Intraoperative Topical Application of a Taurolidine Solution on CIED Related Infections in the Clinical Setting - a Prospective Observational Study With a Restrospective Historical Control

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2022
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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