Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Upper Limb LYMphedema in Maintenance Phase

Launched by THUASNE · Dec 17, 2019

Keywords

ClinConnect Summary

The gold standard treatment to achieve volume reduction of lymphedema is based on a Decongestive Lymphedema Therapy (DLT).that consists in 2 consecutive phases: the initial intensive phase which aim is to obtain maximal reduction of lymphedema volume and a second, the maintenance phase which aim is to maintain the initial volumetric reduction achieved during phase 1 as long as possible. The second maintenance phase mostly based on patient self-management of his treatment, is not strictly codified, but includes compression therapy, nutritional recommendations, skin cares, physical exercises ...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women responding positively to the lymphedema reduction phase defined by a ≥ 20% decrease in lymphedema volume at the end of DLT
• • Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer
• • Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® Autofit armsleeve provided
• • Signed informed consent prior to any study-mandated procedure
• • Affiliated to the General regime of the Social Security or covered by a similar health insurance system
• Non-inclusion criteria :
• • Stage I lymphedema or located in several places
• • Active cellulitis / Infectious dermo-hypodermatitis
• • Lymphedema associated with active cancer needing acute chemotherapy
• • Motor and sensitive neurological deficiency / psychiatric or addictive disorders
• • Post-operative edema (i.e acute edema occurring during the days following breast cancer-related surgery)
• • Patients for whom compression is contraindicated, such as untreated infections, skin irritation, thrombosis, presence of skin lesions on the armsleeve placement
• • Pregnant or breastfeeding patient
• • Previous history of hypersensitivity to MOBIDERM® technology or lymphatrex garment General conditions
• • Participation to any other clinical study which has an impact on the different endpoints
• • Unlikely to be followed up to 3 months with clinical assessment as per investigator's judgment
• • Vulnerable patient according to the article L.1121-6 of the French Public Health Code, the adults being the object of a legal protective measure or enable to express their consent according to the article L.1121-8 of French Public Health Code