NCT02431741已完成不适用
Title: A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds
Molnlycke Health Care AB2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Infection in the Wound (Signs of Clinical Infection)
研究概览
简要总结
This is a prospective, open, non-controlled clinical investigation to evaluate the performance and safety of using Mepilex Transfer Ag on a malignant wound. Approximately ten to fifteen (10-15) subjects from one to three centers in Europe, presenting with a malignant (fungating) wound will be enrolled into the study. Eligible subjects will have one malignant (fungating) wound selected as a "study site". Subjects will be followed for a one-week observation period with their existing product followed by a 4-week investigation period using Mepilex Transfer Ag.
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
- •Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment
- •Both genders with an age ≥ 18 years at randomization
- •Subjects with a suspected survival time of > 3 months
- •Signed informed consent
排除标准
- •Any known or suspected systemic infection
- •Use of metronidazole is not allowed during the investigation period
- •Any known sensitivity to silver or other components/products used in this study.
- •Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
- •Participation in another investigational study while participating in this study.
结局指标
主要结局
Infection in the Wound (Signs of Clinical Infection)
时间窗: weekly, for 5 weeks
Weekly Visual inspection of the wounds by the investigators.
次要结局
未报告次要终点
研究者
研究点 (2)
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