NCT00816101已完成2 期
Efficacy of the PROCELLERA™ Wound Dressing in the Healing of Wounds After a Curettage and Electrodesiccation of Skin Lesions
Vomaris Innovations2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2008年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Number of Patients Who Experienced 50% or Greater Wound Healing
研究概览
简要总结
The purpose of this pilot clinical study is to compare healing rates, pain levels, and incidence of wound complications including infection with the use of a moist PROCELLERA™ Antimicrobial Wound Dressing when compared to a standard dressing, Mepilex® Border Lite, following 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 1x1 cm
- •Wounds 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
- •Peripheral vascular occlusive disease
- •Collagen vascular disease
- •Connective tissue disease
- •Venous stasis ulcers
- •Participant undergoing active cancer chemotherapy
- •Chronic steroid use
- •Decision impairment
结局指标
主要结局
Number of Patients Who Experienced 50% or Greater Wound Healing
时间窗: 3 Weeks
Participants were assessed to see whether or not the wound area was reduced by at least 50%, and the number of such participants is reported
次要结局
- Number of Patients Reporting Pain(3 Weeks)
- Erythema at Week 3(3 Weeks)
研究者
研究点 (2)
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