Clinical Study 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.

Cross-over, Randomized, Open Label Study 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.

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.

In order to optimize treatment of lymphedema efficacy, THUASNE developed the standard Auto-Adjustable Armsleeve using the MOBIDERM technology, named MOBIDERM Autofit.

The device has already been evaluated in several clinical studies as an adjuvant treatment to daily compressive garment during night-time maintenance phase in women with Breast cancer related lymphedema.

The possibility to use this category of devices during both phases of lymphedema treatment has been reinforced recently by studies that showed a similar reduction in lymphedema volume with wraps versus conventional multilayer bandages [Ochalek et al., 2023,Borman et al., 2021].

The global objective of the MOBISCAN study is to reinforce the efficacy of MOBIDERM Autofit garment by assessing its efficacy and pressure maintenance versus bandages in the management of upper limb Lymphedema in night-time maintenance phase.

Inclusion Criteria:

1. Age ≥ 18 years
2. Unilateral upper limb lymphedema of stage I, II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
3. Patient in maintenance phase of lymphedema treatment
4. Affected arm that fits with one of the standard sizes of the Auto- Adjustable MOBIDERM Autofit provided.
5. Signed informed consent prior to any study-mandated procedure.

Exclusion Criteria:

1. Active cellulitis / Infectious dermo-hypodermatitis
2. Lymphedema associated with active cancer needing acute chemotherapy
3. Motor and sensitive neurological deficiency / psychiatric or addictive disorders
4. Patients for whom compression is contraindicated, such as untreated infections, skin irritation, thrombosis: presence of skin lesions on the sleeve placement
5. Pregnant or breastfeeding patient
6. Participation to any other clinical study which has an impact on the different endpoints
7. Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.