A Clinimetric Research to Test the Validity of the MoistureMeterD, Conducted by the Local Edema (Urticaria Acuta) Into the Administering of Intradermal Histamine.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- amount of edema formation measured with a moisturemeterD of histamin reaction
研究概览
简要总结
In lymphedema there is increase in water content of the tissue. We studied a device (MoistureMeterD) which is suitable to detect water contact in the tissue. Although the apparatus is commercially available, no validation study had been performed in vivo with local edema.
We designed a validation study for inter- and intra observer variability and the reproducibility in vivo by histamin induced local edema
详细描述
The multiprobe Delfin MoistureMeterD is a unique and compact water-specific instrument for the measurement of water content of biological tissues. It measures the dielectric constant values of the skin and subcutaneous tissues non-invasively and locally in a few seconds. The dielectric constant value is directly proportional to the amount of water in the tissue.
As lymphedema produces local water content increase, we are interested if the device is suitable for daily use in lymphedema patients. Therefore we designed a protocol to measure the results with a moisturemeter in a standardized edema formation by histamin induced scratch test edema. This method is well known in type I allergy testing.
The aim of the study is:
- research the inter- and intra observer variability
- measure the reproducibility of edema formation in a standardized edema formation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18 years or older;
- •Coming for intra-cutaneous allergy scratch test;
- •Gender: male and female.
排除标准
- •Patients who have a pacemaker or other inbuilt stimulator;
- •Lymphoedema;
- •Patients who have an infection;
- •Patients with skin problems in research area.
- •No use of anti-histamines medication
结局指标
主要结局
amount of edema formation measured with a moisturemeterD of histamin reaction
时间窗: october 2013
At various moments and regions around the scratch location the dielectric constant values of the skin is measured in all patients. we try to see if there is a reproducibility of edema with a standardized edema formation method.
次要结局
- validation of a Moisturemeter device for inter- and intra observer variability(october 2013)
研究者
R.J. Damstra
dermatologist MD PhD
Nij Smellinghe Hosptial