A Proof of Concept Cases Series on the Use of the Epidermal Expansion System to Harvest and Place Suction Blister Epidermal Grafts on Hypopigmented Skin and Surgical Wounds
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Wound healing/pigmentation
研究概览
简要总结
This case series will assess the use of suction blister epidermal grafts harvested by a novel device on select patients with hypo pigmented skin or surgical skin wounds.
详细描述
This study evaluates a novel micrografting technique to determine how it will influence the repigmentation of selected areas of hypopigmentation, and how it will influence the healing and pigmentation of surgical skin wounds. The Epidermal Expansion System (designed by MoMelan Technologies) will generate an array of small microblisters and transfer the micrografts to a sterile FDA cleared wound dressing for application to the subject's acute wound or prepared recipient site. The sponsor hypothesizes that applying expanded micrografts to target sites will result in rapid healing of acute wounds and in repigmentation of hypopigmented skin as well as and provide improved cosmetic outcomes.
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
- •Male or female adult subject between 18 and 99 years of age
- •Subject having an area of hypopigmentation or surgical wound considered appropriate by physician to receive epidermal micro grafting
- •Willingness to participate in study by evidence of informed consent
排除标准
- •Female subjects self-reported to be breastfeeding, pregnant or planning to become pregnant during the course of the study.
- •Subject showing clinical signs of infection
- •Subjects currently on immunosuppressive medications, chemotherapy or cytotoxic agents
- •Subject participation in another interventional study with potential exposure to an investigational drug or device within the past 30 days or planned entry into another investigational study within 90 days after entrance into this study
结局指标
主要结局
Wound healing/pigmentation
时间窗: up to 12 weeks
次要结局
- Physician Satisfaction(6-12 weeks)
- Incidence of adverse events(6-12 weeks)
- Patient Satisfaction(6-12 weeks)