Reduce Driveline Trauma Through Stabilization and Exit Site Management (RESIST) Pilot Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Demonstration of the wearability and usability of the Percutaneous Lead Management Kit
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of a Percutaneous Lead Management Kit for HeartMate II driveline stabilization and exit site management.
详细描述
The Percutaneous Lead Management Kit is a combination of commercially available components that are packaged together in a kit to be used for HeartMate II driveline exit site cleaning, dressing and stabilization. The RESIST study is a prospective, non-randomized study to evaluate the wearability and usability of the Percutaneous Lead Management Kit. Evaluation of the Percutaneous Lead Management Kit for wearability and usability will be performed for 30 days from enrollment. Study patients will also be followed for up to 6 months for any evidence of driveline infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •16 years of age or older
- •Supported by HeartMate II LVAD continuously for at least 6 months and not currently hospitalized
- •Will continue on LVAD support for at least another 30 days
- •No driveline or systemic infection
- •Willing and able to perform kit dressing changes at least once every 7 days for 30 days
- •Can fill out study forms
- •Can use a digital camera
- •Willing to return to clinic for final study visit in 30 days
排除标准
- •High risk for non-compliance
- •Ongoing mechanical circulatory support other than HeartMate II LVAD
- •Sensitivity to kit components
- •Skin condition that may react to kit component adhesives
- •Already using all components of Percutaneous Lead Management Kit
结局指标
主要结局
Demonstration of the wearability and usability of the Percutaneous Lead Management Kit
时间窗: Up to 30 days
次要结局
- Durability of the Percutaneous Lead Management Kit's infection mitigation and stabilization(Up to 7 days continuous kit use)
- Incidence of adverse reactions to any Percutaneous Lead Management Kit components(Up to 6 months)
- Evidence of driveline infection(Up to 6 months)