NCT01770067Unknown不适用
Prospective Evaluation of the Efficacy and Safety of Continuous In-situ Ultra High-dose Antibiotics (CITA) and Minimally Invasive Surgery (MIS) Utilizing Regulated Negative Pressure-assisted Wound Therapy (RNPT) in the Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Lack of CIED Infection
研究概览
简要总结
Following previous positive experience with regulated CITA-RNPT of infected CIEDs, we suggest increasing the number of recruited patients and that CITA-RNPT can be administered prophylactically to patients prior to replacement of previously treated CIEDs, immuno-compromised patients, and others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High-risk patients for CIED infections
- •CIED infections
排除标准
- •Systematic infection
研究组 & 干预措施
Infected CIED and Infection-Prone Patients Prior to CIED Implantation
Experimental
Administration of high-dose antibiotics (CITA)
干预措施: CITA-RNPT (Drug)
Infected CIED extraction
Active Comparator
Extraction of infected CIED
干预措施: Extraction of infected CIED (Procedure)
结局指标
主要结局
Lack of CIED Infection
时间窗: One year
次要结局
未报告次要终点
研究者
研究点 (1)
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