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.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThuasne

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MOBIDERM Autofit Armsleeve
  • Self-bandages

Treatment groups

16 Participants
are divided into 2 treatment groups

Sponsors and collaborators