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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient with local edema by histamin | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MoistureMeterD | Device | measuring erythema size and the dielectric constant values |
|
| Measure | Description | Time Frame |
|---|---|---|
| amount of edema formation measured with a moisturemeterD of histamin reaction | 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. | october 2013 |
| Measure | Description | Time Frame |
|---|---|---|
| validation of a Moisturemeter device for inter- and intra observer variability | The researchers are randomized in investigator A and B. In several patients at one time three measures are made: A1 and A2 and B. By collecting these data we can calculate the intra-observer variability (A1 versus A2) and the inter observer variability (A1/2 versus B) | october 2013 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Damstra, MD PhD | Nij Smellinghe Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital | Drachten | Provincie Friesland | 9202 NN | Netherlands |
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| Label | URL |
|---|---|
| General website from the Nij Smellinghe hospital | View source |
| The foundation related to the expert centre organizing research | View source |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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