Echographic Measurement of Skin Thickness at the Deltoid and Proximal Forearm in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novosanis NV
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- skin thickness (in milimeters) of the deltoid region (both left and right)
研究概览
简要总结
To optimize a medical device for intradermal injection, knowledge concerning the thickness of epidermis and dermis at the proximal forearm is required. Since scientific knowledge is lacking, the investigators will examine the skin thickness (epidermis and dermis) of adults using imaging technology (High Frequency Ultrasound). The investigators hypothesize that they are able to correlate the thickness of the (epi)dermis to a specific combination of parameters age, gender, and BMI.
Based on these results, the investigators can define which needle type and length is needed to correctly perform injections into the dermal layer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
- •Age: 18-65 years
- •Dutch-speaking
- •Caucasian
排除标准
- •Pregnancy or lactating
- •Using ointment, crème, or gels based on corticoids
- •Suffering from skin diseases (psoriasis, burning wounds)
结局指标
主要结局
skin thickness (in milimeters) of the deltoid region (both left and right)
时间窗: 10 minutes
skin thickness (in milimeters) of the proximal forearm dorsal (both left and right)
时间窗: 10 minutes
skin thickness (in milimeters) of the proximal forearm ventral (both left and right)
时间窗: 10 minutes
次要结局
- Body Mass Index(at the moment of entering the study)
- Age(at the moment of entering the study)
- sex(at the moment of entering the study)