A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Infection outcome
研究概览
简要总结
Research Purpose:
This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter.
Research Design:
This study is designed to be single arm, multi-center, and retrospective. A total of 200 subjects will be retrospectively enrolled. Information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01, 2019 and June 30, 2022.
The following information will be collected from subjects' medical records or hospitals' databases (if any):
- General condition of the subjects (including previous shunting and external drainage operation)
- Intraoperative condition and catheter implantation
- Information on the shunt catheters
- Adverse events of subjects within 2 years after the operation and classification of the adverse events (except anticipated adverse events listed in section 8.1.2)
- Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The informed consent is exempted by the Ethics Committee of a research center. Or a subject or his/her legal representative signed the informed consent form (ICF) prior to the enrollment.
- •A subject had an indication suitable to use Bactiseal Catheter.
- •A subject implanted hydrocephalus shunt catheter for at least 2 years at the time of enrollment.
排除标准
- •A subject didn't have an indication suitable to use the catheter.
- •A subject was known to be allergic to a component or ingredient of the catheter to be implanted, including silicone catheter, rifampicin, and clindamycin.
- •According to the comprehensive judgment of an investigator, a subject had an infection of the implant site when the shunt is implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
- •A subject was simultaneously implanted with another shunt catheter different from Bactiseal Catheter.
- •A subject had a contraindication of the shunt operation.
- •A subject had uncorrected coagulopathy or any bleeding disorder.
结局指标
主要结局
Infection outcome
时间窗: 2 years post catheter implanted.
Incidence of Bactiseal Shunt catheter related infection within 2 years post implant.
Safety outcome
时间窗: 2 years post catheter implanted.
Incidence of adverse events of a subject within 2 years post implant Bactiseal
次要结局
未报告次要终点