A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 5
- 主要终点
- Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events.
研究概览
简要总结
The study will collect use data of the Becton Dickinson (BD) PureHub™ Disinfecting Cap in combination with needle-free connectors, which are attached to vascular access devices (VAD).
详细描述
This is a multi-center, prospective observational study of a minimum of 150 study participants who have vascular access devices (VADs) with needle-free connectors as part of their routine medical care.
Patients will be followed from the time of enrollment through the duration of VAD therapy or 45 days post enrollment date, whichever comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has an eligible vascular access device with needle-free connectors in situ or will have one placed Note: This covers all needle-free devices, including central venous catheters, peripheral IV catheters and arterial VADs
- •Is expected to receive VAD therapy for a minimum of 3 days
- •Is expected to be available for regular observation from consent until end of study
- •Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the participant
排除标准
- •BD PureHub™ Disinfecting Cap or any other disinfecting cap in place for more than twelve (12) hours (>12 hours) prior to study participation
- •Presence of any infection, bacteremia, or septicemia is known or suspected
- •Any condition which, in the opinion of the Investigator, precludes the participant from participation in this study
研究组 & 干预措施
General Cohort
All patients who receive a VAD as standard of care in combination with needle-free connectors. A BD PureHub™ Disinfecting Cap will be placed on each eligible needle-free connector and all attachments/removals incl. reason for change will be documented up to 45 days post-enrollment date.
干预措施: BD PureHub™ Disinfecting Cap Placements: Attachments/removals (Device)
结局指标
主要结局
Number of Participants With BD PureHub™ Disinfecting Cap Device-related Adverse Events.
时间窗: Up to 45 days post-enrollment date
Rate of device-related adverse events
Attachment & Removal Success Rate of the BD PureHub Disinfecting Caps to a Needle-free Connector
时间窗: Up to 45 days post-enrollment date
* Attachment success rate of the BD PureHub™ Disinfecting Caps to a needle-free connector (successful attachment/total number of attachments) * Removal success rate of the BD PureHub™ Disinfecting Caps to a needle-free connector (successful removal/ total number of intended removals)
次要结局
未报告次要终点