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临床试验/NCT05576194
NCT05576194已完成不适用

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

Prof. Dr. Hendrik Bonnemeier1 个研究点 分布在 1 个国家目标入组 1,417 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,417
试验地点
1
主要终点
CIED infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CIED procedure, signs PIC

排除标准

  • PIC not signed, minor

研究组 & 干预措施

TauroPace irrigation group

every consecutive CIED placement, revision, extraction conducted with TauroPace

干预措施: TauroPace (Device)

antiseptic irrigation group

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

干预措施: TauroPace (Device)

antiseptic irrigation group

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

干预措施: Hydrogen Peroxide (Device)

antiseptic irrigation group

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

干预措施: Taurolidine (Drug)

结局指标

主要结局

CIED infection

时间窗: three months

cardiac implantable electronic device infection

次要结局

  • all cause mortality(36 months)
  • adverse events grade 3-5(36 months)

研究者

发起方
Prof. Dr. Hendrik Bonnemeier
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. Hendrik Bonnemeier

Coordinating principal investigator

University of Kiel

研究点 (1)

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