Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications

Study Overview
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Brief Summary
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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 better in wearing comfort and better in handling features.

Detailed Description
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thesis: measuring of arm volume by inverse water-volumetry (see later) measuring of circumference cD measuring of circumference cG photodocumentation in 2 positions(during each round) thesis questionaire for patients in the beginning after 1 week after 2 weeks (at the end of a wearing period) questionaire for study nurse (at the end of a wearing period)

Official Title
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Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications (Therapeutische Bewertung Von Armkompressionsstrümpfen für Lymphatische Indikationen BF09-PH-01)

Conditions
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Lymphedema

Intervention / Treatment
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* Other: Compression Armsleeves


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with a secondary arm-lymphedema for at least 3 months willingness to wear compression arm-sleeves for at least 12 hours per day maintenance phase, where no significant further reduction of arm-volume can be achieved lymphedema in stadium 1 or 2 age: at least 18 years signed consent form by the patient sufficient knowledge in national language Exclusion Criteria: edema not completely reduced to maintenance phase immobilized patient acute deep vein thrombosis in arm directly after arm-vein-thrombosis acute arm erysipelas malignant edema existent lipedema arterial occlusion distinctive neuropathy in upper limbs neurinoma in upper limbs chronic pain after plastic surgery in upper limbs, shoulder or breast change in drug treatment, that can influence edema situation during the study pregnant women breast giving mothers not signed consent form participation in a second clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Compression ArmsleevesType A<br>Product A: armsleeves of type SoraLife KKl. 2 according to RAL GZ 387 | Other: Compression Armsleeves<br>* 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.<br>* Other names: Jobst Elvarex;|
| Active Comparator: Compression Armsleeves Type B<br>Product B: armsleeves of type Elvarex KKl. 2 according to RAL GZ 387 | Other: Compression Armsleeves<br>* 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.<br>* Other names: Jobst Elvarex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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secondary arm-lymphedema, breast cancer related arm-lymphedema