Product Evaluation for the Effectiveness of the ClearGuard® HD End Cap
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,902
- 试验地点
- 2
- 主要终点
- Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days
研究概览
简要总结
To assess blood stream infections in participants using two FDA-cleared devices: ClearGuard HD end caps compared to the Tego® connector with the CurosTM for Tego disinfecting port protector.
详细描述
Prospective, cluster-randomized, open-label, post market, comparative effectiveness evaluation with facilities participating for up to 13 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •All patients dialyzing with a central venous catheter
排除标准
- •Known allergy to chlorhexidine
研究组 & 干预措施
Treatment
ClearGuard HD End Cap
干预措施: ClearGuard HD End Cap (Device)
Control
Tego® connector with the CurosTM for Tego disinfecting port protector
结局指标
主要结局
Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days
时间窗: Through the 13-month intervention period.
This was calculated by dividing the cumulative number of PBCs by cumulative time at-risk as follows. The National Healthcare Safety Network (NHSN) Center for Disease Control (CDC) 21-day outpatient hemodialysis patient rule is as follows: A PBC is considered a new event and counted only if it occurred 21 days or more after a previously reported PBC in the same patient; new PBC events are based on blood cultures drawn as an outpatient or within one calendar day after a hospital admission. Following a PBC additional same-type events were counted beginning 21 days following the initial event; the CVC-days were counted during this period. The CVC-days were calculated by summing the number of days each patient was at-risk of accruing a PBC. This analysis included all subjects that participated in the study that were not otherwise censored to more accurately count CVC-days.
次要结局
未报告次要终点