NCT01061502已完成1 期
Efficacy of the PROCELLERA Wound Dressing in the Healing of Skin Graft Donor Sites
Vomaris Innovations2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- To compare epithelialization over time
研究概览
简要总结
The purpose of this study is to determine whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Wounds resulting from skin graft
- •Split thickness wound
- •Wound size greater than 2x2 cm
- •Wounds must be ≥5 cm away from all other wounds
- •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
- •Participant undergoing active cancer chemotherapy
- •Chronic steroid use
- •Decision impairment
结局指标
主要结局
To compare epithelialization over time
时间窗: 3 months
次要结局
- To compare patient reported perception of pain(3 months)
- To compare scarring(3 months)
研究者
研究点 (2)
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