Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection

Cardiac Implantable Electronic Device Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05576194
• Other study ID #: 19059
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2023
• Source: University of Kiel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1417
• Est. completion date: September 1, 2022
• Est. primary completion date: March 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

CIED procedure, signs PIC

Exclusion Criteria:

PIC not signed, minor

Related Conditions & MeSH terms

• Cardiac Implantable Electronic Device Infection
• Communicable Diseases
• Infections

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Lakumed	Landshut	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dr. Hendrik Bonnemeier	University of Luebeck

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CIED infection	cardiac implantable electronic device infection	three months
Secondary	all cause mortality	death of any cause during the observation	three months
Secondary	adverse events grade 3-5	adverse events related to CIED, procedure or the atiseptic used	three months
Secondary	all cause mortality	death of any cause during all of the follow up period	36 months
Secondary	adverse events grade 3-5	adverse events related to CIED, procedure or the atiseptic used during all of the follow-up period	36 months