Validation of the MoistureMeterD in Local Edema by Histamine

Nij Smellinghe Hosptial

Status: Completed

Conditions: Lymphedema

Treatments: Device: MoistureMeterD

Study type: Interventional

Funder types: Other

Identifiers

NCT01833156

NS5NL

Details and patient eligibility

About

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

Full description

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:

1. research the inter- and intra observer variability
2. measure the reproducibility of edema formation in a standardized edema formation

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients 18 years or older;
• Coming for intra-cutaneous allergy scratch test;
• Gender: male and female.

Exclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

patient with local edema by histamin

Experimental group

Description:

Measuring at 3 locations (on the histmin spot, at 5 cm and 10 cm border (is the control) at 7 times: T0 - T10 minutes - T20 - T30 - T45 - T60 - T75

Treatment:

Device: MoistureMeterD