DRKS00015648已完成4 期
Prospective Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of Vliwaktiv® Ag
ohmann & Rauscher GmbH & Co. KG0 个研究点目标入组 58 人开始时间: 2018年10月9日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age = 18 years
- •Patient is legally capable
- •Presence of a wound according to the instruction for use:
- •- venous leg ulcer or
- •- arterial ulcer (ABPI < 0,5) or
- •- arterial and venous leg ulcer (ABPI > 0,5) or
- •- pressure ulcer (category II – IV) or
- •- diabetic foot ulcer or
- •- post-operative wound healing disturbance or
- •- exulcerating tumors
- •Infected wound or wound with risk of infection (W.A.R. Score = 3)
- •Estimated survival time > 8 weeks
- •Wound area between 4 und 20 cm2
- •Patient has signed written Informed Consent
排除标准
- •Treatment with Vliwaktiv® Ag Activated Charcoal Dressing and Rope with Silver or a similar dressing during the last 4 weeks prior to study start
- •Known sensitivity to Vliwaktiv® Ag Activated Charcoal Dressing and Rope with Silver or any of their components
- •Critical limb ischemia
- •Planned amputation in the next 2 months
- •A planned surgical operation in the region of the study wound in the next 8 weeks following inclusion
- •Patient is not compliant regarding treatment of the underlying disease (e.g. compression)
- •Dry wound
- •Pregnancy or breast feeding
- •Reliable severe malnutrition
- •Patient is analphabet
- •Participation in a therapeutic trial in the last 3 months and during participation in this study
研究者
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