NCT05618496已完成不适用
Multi-centre, Open-label, First-in-man Study With Epipad Used in Adult Patients
Contipro Pharma a.s.4 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年10月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Change in the wound dimensions (width x length)
研究概览
简要总结
The main objective of the trial is to confirm safety of a new product - Epipad. The main impact of the device is to provide good environment for the healing of chronic wounds and wounds in the last healing phase (granulation and epithelisation).
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
- •Patient suffered from superficial wound of different etiology
- •Wounds in terminal phase of healing
- •Wounds without visible sign of infection
- •Max. size of the wound: 10 x 20 cm (i.e. two pieces of the product)
- •Duration of wound treatment of at least 6 weeks
- •Subject willing and able to provide written informed consent
- •Ability to communicate well with the investigator in local language, and to understand and comply with the requirements of the study
排除标准
- •Sloughy or necrotic wound bed
- •Severely contaminated or infected wound
- •Age < 18 years
- •Pregnant or lactating woman
- •Subject in terminal stage of living
- •Subject with cancer disease
- •Subject with known hypersensitivity or allergy to any component of the investigational device
- •Subject participating in other interventional clinical trial
- •Alcohol and/or drug abuse
结局指标
主要结局
Change in the wound dimensions (width x length)
时间窗: Week 3
Change in the wound dimensions from baseline
次要结局
未报告次要终点
研究者
研究点 (4)
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