DRKS00025394招募中4 期
Multicenter, randomised in parallel groups, non-inferiority study to compare efficacy and safety of the new” Suprasorb® CNP wound foam dressing with the old” Suprasorb® CNP wound foam dressing during negative pressure wound therapy (FOAM”). - FOAM
ohmann & Rauscher GmbH & Co. KG0 个研究点目标入组 114 人开始时间: 2021年9月2日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 114
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
- Randomized controlled 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
- •- Acute or chronic soft-tissue traumatic wound (including soft tissue defects with exposed tendons and/ or non-fractured bones), which is unlikely to heal by a primary intention due to size or other accompanying factors, and for which NPWT seems beneficial as a preparatory stage before skin grafting.
- •- Patient has signed informed consent
排除标准
- •- Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomization and during the whole duration of this study
- •- Wounds with exposed vessels, vascular anastomoses or viscera
- •- Unexplored fistulas in the area of the study wound
- •- Acute bleeding in the area of the study wound
- •- Necrotic wound
- •- Untreated osteomyelitis in the area of the study wound
- •- Wound in the sternum area (except of sternal wound infections after surgical debridement)
- •- Known intolerance or allergy to the product or any of its ingredients
- •- System coagulation disorders (increased risk of bleeding)
- •- Any other medical condition, which may have impact of the success of the study treatment and / or interpretation of the study results (e.g. diabetes, peripheral arterial disease, chronic venous disease).
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