Limb Lymphoedema
Conditions
Keywords
Lymphedema of upper limb, Compression garments, Lymphedema management
Brief summary
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.
Detailed description
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.
Interventions
The MOBIDERM Autofit Armsleeve will be worn by the patients at night for one month.
DEVICESelf-bandages
Self-bandages will be worn by the patients at night for one month.
Sponsors
Thuasne
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cross-over, randomized, open label study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume excess variation | 2 months (Inclusion, first month and second month visit) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of affected upper limb volume: | 2 months (Inclusion, first month and second month visit) | 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: | 2 months (Inclusion, first month and second month visit) | The level of pressure under the devices will be measured with Picopress during the 3 patient visits for each patient. |
| Evolution of hand lymphedema: | 2 months (Inclusion, first month and second month visit) | 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: | 2 month visit | 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). |
| Compliance: | 2 months | The patient will complete a diary during the study to report the compliance with each device at night (Wear/not wear, number of hours). |
| Patient's safety | 2 months | The Number and type of serious and non-serious Adverse Device Effects (ADE) with a focus on the cutaneous ADE will be collected during the study. |
Countries
Germany
Contacts
CONTACTStéphanie Villet, Dr
CONTACTAlyssia Marques
PRINCIPAL_INVESTIGATORChristina Lindemann, Physician
Ödemzentrum Bad Berleburg Klinik "Haus am Schloßpark" Hochstr. 7 D 57319 Bad Berleburg
Outcome results
None listed