Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Thermal damage threshold
研究概览
简要总结
This clinical study has been initiated to assess the effect of laser exposure on human skin and determine the threshold for tissue damage. The tissue specific effects will be evaluated through histological evaluation. Excess skin from corrective surgery (gastric bypass or similar) will be donated for this study. Skin samples will be subjected to titrating laser treatment with varying laser intensity and exposure time.
详细描述
The dosimetry of laser induced hyperthermia and threshold for tissue damage will be evaluated. A dose escalation study will be performed by varying irradiance (mW) and time (minutes). Surface temperature will be monitored concurrently. Acute lesions occurring within 5 minutes of irradiation will be assessed and histological damage will be observed microscopically in slice sections of punch biopsies and qualitative assessed. Irradiation regimes above the anticipated threshold will be employed to properly titrate the irradiation necessary to elicit a thermal damage response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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 and female subject 18 years of age or older
- •Gastric bypass operated or similar
- •Excess abdominal skin to be removed surgically
- •Abdominal skin tone 4 or below
排除标准
- •Extensive skin changes, tattoos or diseases on skin explant to be donated
- •Medical history or any condition that may in investigator's opinion compromise the subject's ability to participate.
研究组 & 干预措施
Laser irradiation regimes
Non-ionising radiation intervention will be applied to skin explants
干预措施: Non-ionising radiation (Radiation)
结局指标
主要结局
Thermal damage threshold
时间窗: Within 3 months
Quantitative evaluation of laser induced damage by histological lesion in epidermis and dermis.
次要结局
未报告次要终点