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| Name | Class |
|---|---|
| KABEG Management | OTHER |
| Nij Smellinghe Hosptial | OTHER |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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Examination of therapeutical effects of different types of armsleeves in treating lymphatic diseases after breast cancer surgery during maintenance phase
thesis:
- all types should be equal regarding volume reduction
thesis: armsleeves manufactured with microfibre yarn are expected to be
thesis:
thesis
questionaire for patients
questionaire for study nurse (at the end of a wearing period)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compression ArmsleevesType A | Active Comparator | Product A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387 |
|
| Compression Armsleeves Type B | Active Comparator | Product B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression Armsleeves | Other | Type: Compression Class II (according to RAL) The study is designed in a way, that per product after a one weak resting (preparing) cycle a 2 weeks wearing period will follow. Herewith the whole duration of the study is 6 weeks per patient. |
| Measure | Description | Time Frame |
|---|---|---|
| change of volume (arm and hand together) | During a 2-weeks-phase the volume of patients arm and hand together is measured once a week, e.g. 3 times (beginning, after 1 week, at the end). This is done with armsleeves of the first type. After one week of sedation the test will be repeated with the second product. Randomization is given by chance, that during first phase product of type A or type B can be applied. During second phase then vice versa. The measurements were performed by an "inverse water plethysmography device" (later: inverse watervolumetry) desinged by R. Damstra. | 6 weaks per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical judgement of skin status | clinical judgement of skin status with photo documentation, clinical finding (as palpation,check on fibrosclerosis, skin clour, skin surface, edema, tenderness, tissue consistency...), check of skin contamination | 6 weaks per patient |
| Wearing comfort and handling features of armsleeves |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Jünger, Prof. Dr. | Contact | +493834-866770 | juenger@uni-greifswald.de | |
| Claudia Eggert, Study Nurse | Contact | +493834-866770 | claudia.eggert@uni-greifswald.de |
| Name | Affiliation | Role |
|---|---|---|
| Michael Jünger, Prof. Dr. | Klinik und Poliklinik für Hautkrankheiten der Universität Greifswald | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Wolfsberg | Recruiting | Wolfsberg | Carinthia | 9400 | Austria |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D000072656 | Breast Cancer Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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For both types of products questionaires are prepared to find out how patients are feeling with their armsleeves.It is asked for problems during donning procedure as well as during wearing period. This will be done in the beginning after 1 week and after 2 weeks for both types. At the end the study nurses are asked to their impression regarding patients acceptance of the armsleeves. Method: VAS score |
| 6 weeks per patient |
| Universitaire Ziekenhuizen | Recruiting | Leuven | 3000 | Belgium |
|
| Klinik und Poliklinik für Hautkrankheiten, Sauerbruchstraße | Recruiting | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
|
| Nij Smellinghe Hosptial | Recruiting | Drachten | 9202 | Netherlands |
|
| D013568 | Pathological Conditions, Signs and Symptoms |