Safety Testing of Hydrogen Peroxide-Generating e-Bandage on Normal Human Skin
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Skin Discoloration
研究概览
简要总结
A novel hydrogen peroxide-generating electrochemical bandage for wound infection treatment and prevention, and wound healing has been developed. The purpose of this research is to gather information on the safety and to confirm lack of toxicity of small hydrogen peroxide-generating e-bandages on normal human skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Intact skin on arms.
- •Able to provide appropriate consent.
排除标准
- •Vulnerable study population.
- •Pregnancy.
- •Children.
- •Skin disease.
- •Non-intact skin on arms.
研究组 & 干预措施
e-Bandages 3 hours
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 3 hours.
干预措施: e-Bandages (Device)
e-Bandages 6 hours
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 6 hours.
干预措施: e-Bandages (Device)
e-Bandages 12 hours
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 12 hours.
干预措施: e-Bandages (Device)
e-Bandages 24 hours
Four subjects will wear the e-Bandage on their skin for 24 hours, with active polarization for 24 hours.
干预措施: e-Bandages (Device)
Control Group
Four subjects will wear the e-Bandage on their skin for 24 hours, with no active polarization.
干预措施: e-Bandages (Device)
结局指标
主要结局
Skin Discoloration
时间窗: Approximately 3 - 24 hours
Skin discoloration from the e-Bandage, graded on a scale of 1-4, with 1 being no reaction, 2 mild reaction, 3 moderate reaction, 4 severe reaction.
e-Bandage Discomfort
时间窗: Approximately 3 - 24 hours
Self-report discomfort with the e-Bandage, graded on a scale of 1-4, with 1 being no reaction, 2 mild reaction, 3 moderate reaction, 4 severe reaction.
Skin irritation/dermatitis
时间窗: Approximately 3 - 24 hours
Skin redness or swelling, graded on a scale of 1-4, with 1 being no reaction, 2 mild reaction, 3 moderate reaction, 4 severe reaction.
Allergic Reaction
时间窗: Approximately 3 - 24 hours
Local/systemic allergic reaction to the e-Bandage, graded on a scale of 1-4, with 1 being no reaction, 2 mild reaction, 3 moderate reaction, 4 severe reaction.
次要结局
未报告次要终点