Echographic Imaging Research to the Anatomical and Physiological Characteristics of the Skin in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novosanis NV
- 入组人数
- 259
- 试验地点
- 3
- 主要终点
- skin thickness (in millimeters) 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 children (aged 8 weeks to 18 years) 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
- 8 Weeks 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children
- •Age: 8 weeks to 18 years
- •Dutch-speaking
- •Caucasian
排除标准
- •Using ointment, crème, gels or oral medication based on corticoids
- •Suffering from skin diseases (psoriasis, burning wounds)
- •Pregnancy or lactating
结局指标
主要结局
skin thickness (in millimeters) of the deltoid region (both left and right)
时间窗: 5-10 minutes
skin thickness (in millimeters) of the proximal dorsal forearm (both left and right)
时间窗: 5-10 minutes
skin thickness (in millimeters) of the proximal ventral forearm (both left and right)
时间窗: 5-10 minutes
skin thickness (in millimeters) of the medial thigh region (both left and right)
时间窗: 5 minutes
次要结局
未报告次要终点