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
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
- 否
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
Prof. Dr. Hendrik Bonnemeier
Coordinating principal investigator
University of Kiel
