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Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection

NCT ID: NCT05576194

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1417 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-09-01

Brief Summary

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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

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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.

Conditions

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Cardiac Implantable Electronic Device Infection

Keywords

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cardiac implantable electronic device infection, taurolidine

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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TauroPace irrigation group

every consecutive CIED placement, revision, extraction conducted with TauroPace

TauroPace

Intervention Type 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

antiseptic irrigation group

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

Hydrogen Peroxide

Intervention Type 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

Intervention Type 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

TauroPace

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

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

Intervention Type DRUG

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

CIED procedure, signs PIC

Exclusion Criteria

PIC not signed, minor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role collaborator

Prof. Dr. Hendrik Bonnemeier

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Hendrik Bonnemeier

Coordinating principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Stefan Borov, MD

Role: PRINCIPAL_INVESTIGATOR

Lakumed Landshut, CAU Kiel

Locations

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Lakumed

Landshut, Bavaria, Germany

Site Status

Countries

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Germany

References

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Borov, S., Baldauf, B., Lau, E.W. et al. Salvage of infected cardiac implantable electronic device with taurolidine-a case report. Cardiothorac Surg 30, 7 (2022). https://doi.org/10.1186/s43057-022-00068-5

Reference Type BACKGROUND

Giaccardi M, Baldauf B, Lau EW, Borov S, Bonnemeier H. Salvage of Cardiac Implantable Electronic Device Pocket Infection with Skin Erosion in Frail 92-Year-Old. J Cardiovasc Dev Dis. 2022 Mar 10;9(3):81. doi: 10.3390/jcdd9030081.

Reference Type BACKGROUND
PMID: 35323629 (View on PubMed)

Weichsel J, Baldauf B, Bonnemeier H, Lau EW, Dittrich S, Cesnjevar R. Eradication of Ventricular Assist Device Driveline Infection in Paediatric Patients with Taurolidine. J Cardiovasc Dev Dis. 2022 Jan 10;9(1):18. doi: 10.3390/jcdd9010018.

Reference Type BACKGROUND
PMID: 35050228 (View on PubMed)

Borov S, Baldauf B, Henke J, Pavaci H, Perani A, Zrenner B, Dietl J, Mehilli J, Lau EW, Vonthein R, Bonnemeier H. Use of a taurolidine containing antimicrobial wash to reduce cardiac implantable electronic device infection. Europace. 2023 Oct 5;25(10):euad306. doi: 10.1093/europace/euad306.

Reference Type DERIVED
PMID: 37831737 (View on PubMed)

Other Identifiers

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19059

Identifier Type: -

Identifier Source: org_study_id