The aim of this cross-over, randomized study is to assess the efficacy and pressure maintenance of MOBIDERM Autofit versus bandages in the management of Breast Cancer Related Lymphedema (BCRL) in night-time maintenance phase.
Age ≥ 18 years
Unilateral upper limb lymphedema of stage I, II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
Patient in maintenance phase of lymphedema treatment
Affected arm that fits with one of the standard sizes of the Auto- Adjustable MOBIDERM Autofit provided.
Active cellulitis / Infectious dermo-hypodermatitis
Lymphedema associated with active cancer needing acute chemotherapy
Motor and sensitive neurological deficiency / psychiatric or addictive disorders
Patients for whom compression is contraindicated, such as untreated infections, skin irritation, thrombosis: presence of skin lesions on the sleeve placement
Crossover
MOBIDERM Autofit Armsleeve
DeviceThe MOBIDERM Autofit Armsleeve will be worn by the patients at night for one month.
Self-bandages
DeviceSelf-bandages will be worn by the patients at night for one month.
Volume excess variation
The primary endpoint of this study is to compare the volume excess variation of the upper limb between both conditions: MOBIDERM Autofit and self-bandages after one month of treatment, using the SCANECA 3D scanner.
Evolution of affected upper limb volume:
Evolution of affected upper limb volume between baseline and 1 month of treatment with MOBIDERM Autofit and self-bandages in patients with upper limb lymphedema.
Device pressure:
The level of pressure under the devices will be measured with Picopress during the 3 patient visits for each patient.
Evolution of hand lymphedema:
The volume of the hand related to healthy and to affected upper limb will be measured at baseline and the volume of the hand related to affected upper limb after one month of treatment with MOBIDERM Autofit and bandages with a digital measure device and/or tape measurement to check and compare the absence of migration of lymphedema towards the hand between both conditions.
Comfort / Ease of use / satisfaction:
A self-questionnaire will be completed by the patient at the end of the study when the patient tested each of the devices and is able to compare comfort, ease of use and satisfaction. A qualitative follow-up interview will be proposed to a dozen of patients at the end of the study to obtain their feed-back about their study treatments (overall experience, benefits of self-management, experience when putting on, taking off and adjusting the device).
This trial is not recruiting at the moment. You can still explore other options:
