Use of the Epidermal Expansion System to Harvest and Place Suction Blister Epidermal Grafts on Wounds in Patients After Mohs or Excisional Surgery for Skin Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Wound healing/scarring
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 that have wounds from Mohs or excisional surgery.
详细描述
This study evaluates a novel micrografting technique to determine how it will influence the healing and cosmetic result of selected post surgical wounds in 12 subjects. The Epidermal Expansion System (designed by MoMelan Technologies) will generate an array of small microblisters and transfer the micrografts to a sterile wound dressing for application to the subject's surgical area. The sponsor hypothesizes that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possibly reduce scarring.
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
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females between 35 and 90 years of age
- •Status post skin cancer removal on the scalp, ear or leg with a wound that would otherwise be allowed to heal by secondary intention or grafting
- •Wound considered appropriate by physician to receive epidermal grafting
- •Willingness to participate in study by evidence of informed consent
排除标准
- •Female patients reported to be breastfeeding, pregnant or planning to become pregnant
- •Clinical signs of infection
- •Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
- •Participation in another interventional study with potential exposure to an investigational drug or device within the past 30 days or planned study entry within 90 days after study entrance.
研究组 & 干预措施
Micrografting
干预措施: Momelan Technologies Epidermal Graft Harvesting System (Device)
结局指标
主要结局
Wound healing/scarring
时间窗: 6 weeks
次要结局
- Subject global satisfaction(6 weeks)
- Incidence of adverse events(6 weeks)
- Physician global satisfaction(6 weeks)