DRKS00031365招募中不适用
Prospective, open-label, multicenter, single-arm, post-marketingstudy to assess the performance and safety of Vliwasorb® Pro
ohmann & Rauscher GmbH & Co.KG0 个研究点目标入组 135 人开始时间: 2023年2月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
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
- •Patients with acute and chronic wounds
- •- Wounds with moderate to very high amounts of exudate
- •- Non-infected wounds, wounds at risk of infection, infected
- •- All indications listed in the Vliwasorb® Pro IFU
- •- Arterial-venous (mixed”) leg ulcerations with a relevant, but not
- •critical arterial proportion
- •- Patient over 18 years of age
- •- Patient has signed written Informed Consent Form
- •- Patient agreed to comply with study treatment and planned study
排除标准
- •Use of Vliwasorb® Pro wound dressing is contraindicated according
- •to the current IFU:
- •- Known hypersensitivity to the product or its components.
- •- Not for use in tunnel-forming wound pockets, as the product may
- •expand considerably with the absorption of wound exudate.
- •- Not for use on dry wounds.
- •In addition the following patients shall excluded from this study:
- •- Patients unable to understand the use of the VAS tool.
- •- Pregnant or lactating women
- •- Patients participating in another clinical trial at the time of
- •- Patient not covered by health insurance/social security
- •- Patients not able to give written Informed Consent
- •- Patients not legally capable
研究者
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