Comparison of a self-adjusting compression arm sleeve with conventional bandages for lymphedema following breast cancer

Breast cancer-related lymphedema (BCRL) often develops as a result of surgery or radiation therapy as part of breast cancer treatment, since these therapies can damage lymphatic vessels and lymph nodes. This causes lymph fluid to accumulate in the tissue, usually in the arm on the affected side, which can lead to swelling, a feeling of tightness, limited range of motion, and an increased risk of infection. Treatment consists of two phases: In the first phase (decongestive phase), the volume of the lymphedema is reduced through intensive measures such as manual lymphatic drainage and compression bandages. In the subsequent maintenance phase, the goal is to preserve and stabilize the treatment’s success, with the regular use of compression garments playing a central role. Until now, self-applied bandages have frequently been used at night during the maintenance phase; however, these can be cumbersome to use. MOBIDERM Autofit is a self-adjusting compression arm sleeve that uses special technology to apply uniform pressure to the affected arm and automatically adapts to the arm’s circumference, which is intended to make nighttime use easier.

The aim of this study is to investigate the efficacy and pressure retention of the self-adjusting compression arm sleeve compared to conventional self-applied bandages during overnight use in the maintenance phase. All patients use both treatments sequentially for one month each, with the order determined at random (randomized, crossover design). In the study arm, patients first wear the MOBIDERM Autofit arm stocking overnight during the first month, while in the control arm, they wear the self-adhesive bandages during the first month. In the second month, the other method is used. The study is open-label (not blinded), meaning that the patients and study physicians know which treatment is currently being administered. The primary objective of the study is to compare the change in volume of the affected upper arm between the two treatments after one month each, as measured by a 3D scanner. In addition, the study will evaluate pressure, comfort, ease of use, and safety.

Women aged 18 and older with unilateral upper-arm lymphedema following breast cancer treatment who are in the maintenance phase of lymphedema treatment are eligible to participate in this study. At the time of study enrollment, participants must not have any active cancer requiring chemotherapy. Patients with active skin inflammation/cellulitis, thrombosis, or skin irritation in the area where the bandages will be applied are also ineligible to participate in the study.