NCT05494450终止不适用
An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds
Molnlycke Health Care AB4 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds
研究概览
简要总结
An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds
详细描述
The overall objective of this post market clinical follow-up (PMCF) investigation is to confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds, with Mepilex Border Flex as the secondary dressing, when used in accordance with the Instructions for Use.
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
- •Signed Informed Consent Form
- •Patient aged ≥18 years old
- •Patient with moderate to high exuding chronic wound (PU (stage II-IV), VLU or DFU)
- •Patient with target wound that is a shallow to deep wound or cavity
- •Patient with target wound that is ≥ 4 weeks in age
- •Patient with target wound that is ≥ 8 cm2
排除标准
- •Patient is contraindicated for the dressing according to product labeling
- •Known allergy/hypersensitivity to any of the components of the investigation products
- •Pregnancy/lactating female
- •Patient with spreading soft tissue infection/cellulitis in the wound (as judged by the Investigator)
- •Patient with known immunodeficiency
- •Patient taking systemic antibiotics
- •Patient with the target wound located on an infected limb and/or interfered by minimal blood flow in the opinion of the Investigator.
- •Patient with the target wound with an unexplored enteric fistula
- •Patient requiring treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide
- •Patient who, in the opinion of the Investigator, is not expected to comply with the investigation due to physical and/or mental conditions
- •Patient who was previously enrolled in this investigation
- •Patient participating in other investigations that would preclude the subject from participating in this investigation as judged by the Investigator
- •Patient involved in the planning and conduct of the clinical investigation (applies to all Mölnlycke staff, investigational site staff, and third party vendor)
结局指标
主要结局
evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds
时间窗: 28 Days
open, non-comparative, multicenter investigation
次要结局
未报告次要终点
研究者
研究点 (4)
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