NCT04699305招募中不适用
An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Nature, frequency, and severity of adverse events in the intent to treat population
研究概览
简要总结
Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Subject is ≥18 years of age
- •Subject has an exuding cutaneous wound
- •Subject agrees to the use of his health data, including photos of his wound in analysis and publications
- •Subject/LAR must be able to read and understand English and/or Spanish
排除标准
- •Subject/LAR is unable to read and understand English or Spanish.
结局指标
主要结局
Nature, frequency, and severity of adverse events in the intent to treat population
时间窗: 1 year
Nature, frequency, and severity (by CTCAE5) of adverse events
Percentage area reduction (PAR) at 4 weeks
时间窗: 4 weeks
Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).
次要结局
- Percentage area reduction at 8 and 12 weeks(12 weeks)
研究者
研究点 (1)
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