DRKS00014861进行中（未招募）不适用
Post-market clinical follow-up study to evaluate the performance and safety of Suprasorb® A + Ag wound dressing and rope in the treatment of chronic wounds - Suprasorb® A + Ag
ohmann & Rauscher GmbH & Co. KG0 个研究点目标入组 9 人开始时间: 2018年6月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
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
- •Chronic wounds not existing for more than 36 months (ICW clas-sification)
- •Presence of a chronic 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
- •- donor sites or mesh graphs
- •Infected wound or wound with risk of infection (W.A.R. Score = 3*)
- •Heavily exuding wound
- •Wound area between 4 and 100 cm2
- •It must be possible to display the entire wound area on one photo from a distance of 25-30 cm
- •Patient has signed written Informed Consent
排除标准
- •Treatment with Suprasorb® A + Ag silver calcium alginate wound dressing and rope or a similar silver containing alginate dressing during the last 4 weeks
- •Known sensitivity to Suprasorb® A + Ag Antimicrobial Calcium Alginate Wound Dressing and Rope
- •or any of their components
- •Malignant wounds (tumor related wounds)
- •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
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