NCT01831596终止不适用
Evaluation of a Novel Post-Surgical Dressing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- KCI USA, Inc
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Frequency of Complaints About Device Use and Operation
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Surgically closed incision.
- •Subject is 18 years of age or older.
- •Subject consents to follow-up per protocol.
- •Willing and able to sign informed consent.
排除标准
- •Subject is allergic to wound care products used in this study.
- •Subject has wounds with exposed blood vessels not suitable for negative pressure therapy.
- •Pregnant or pregnancy-suspected subject.
- •Subject actively participating in other clinical trials that conflict with the current study.
- •Subject is unable or unwilling to comply with protocol requirements.
结局指标
主要结局
Frequency of Complaints About Device Use and Operation
时间窗: 30 days
Frequency of complaints about device use and operation
次要结局
未报告次要终点
研究者
研究点 (2)
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