Clinical trial NCT05576194: Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Implantable Electronic Device Infection
Keywords: cardiac implantable electronic device infection, taurolidine
Lead sponsor: University of Kiel
Sponsor class: OTHER
Collaborators: name: University of Luebeck
First posted: 2022-10-12
Enrollment: 1417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The intervention group consists of every consecutive patient eligible for any CIED related surgical procedure in the centre of the investigation from January 2020 through February 2022 onwards.

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.

Eligibility criteria: Inclusion Criteria:

CIED procedure, signs PIC

Exclusion Criteria:

PIC not signed, minor

Primary outcomes:
measure: CIED infection
timeFrame: three months
Secondary outcomes:
measure: all cause mortality
timeFrame: three months
measure: adverse events grade 3-5
timeFrame: three months
measure: all cause mortality
timeFrame: 36 months
measure: adverse events grade 3-5
timeFrame: 36 months
Other outcomes:
Locations:
city: Landshut
country: Germany
facility: Lakumed
state: Bavaria
Study officials:
affiliation: Lakumed Landshut, CAU Kiel
name: Stefan Borov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
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.