Examination of therapeutical effects of different types of armsleeves in treating lymphatic diseases after breast cancer surgery during maintenance phase 1. thesis: \- all types should be equal regarding volume reduction 2. thesis: armsleeves manufactured with microfibre yarn are expected to be * better in wearing comfort and * better in handling features.
1. 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) 2. 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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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.
Landeskrankenhaus Wolfsberg
Wolfsberg, Carinthia, Austria
RECRUITINGUniversitaire Ziekenhuizen
Leuven, Belgium
RECRUITINGKlinik und Poliklinik für Hautkrankheiten, Sauerbruchstraße
Greifswald, Mecklenburg-Vorpommern, Germany
RECRUITINGchange 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.
Time frame: 6 weaks per patient
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
Time frame: 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
Time frame: 6 weeks per patient
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Nij Smellinghe Hosptial
Drachten, Netherlands
RECRUITING