NCT01004055已完成2 期
Efficacy of the PROCELLERA Wound Dressing in the Healing of Wounds After Curettage and Electrodesiccation of Skin Lesions
Vomaris Innovations1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Wound healing over time
研究概览
简要总结
The purpose of this study is to determine whether a bioelectric wound dressing, a silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds resulting from curettage and electrodesiccation of skin lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If female, must either be not of childbearing potential or if they are of childbearing potential must have a negative urine pregnancy test
- •Wound size greater than 1x1cm
- •Wound must be ≥5 cm away from all other wounds
- •Wound size must not be diminished in size greater than 10% between enrollment in study and the prescreening
- •Participant agrees to participate in follow-up evaluation
- •Participant must be able to read and understand informed consent, and sign the informed consent
排除标准
- •Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study
- •Participant is to receive another topical antimicrobial agent other than the study dressing
- •Participant with sensitivity or adverse reactions to silver or zinc
- •Pregnancy or nursing an infant or child
- •Immunosuppression
- •Active or systemic infection
- •Collagen vascular disease
- •Venous stasis ulcers
- •Participant undergoing active cancer chemotherapy
- •Chronic steroid use
- •Decision impairment
研究组 & 干预措施
Procellera™ Wound Dressing
Experimental
干预措施: Procellera™ Antimicrobial Wound Dressing (Device)
ACTICOAT™
Active Comparator
干预措施: ACTICOAT™ Antimicrobial Barrier Dressing (Drug)
Mepilex® Ag
Active Comparator
干预措施: Mepilex® Ag Silver Foam Dressing (Drug)
结局指标
主要结局
Wound healing over time
时间窗: July 2008-October 2009
次要结局
- Comparing three FDA cleared products for pain reduction and incidence of infection(July 2008-October 2009)
研究者
研究点 (1)
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