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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Volume excess variation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •Signed informed consent prior to any study-mandated procedure.
排除标准
- •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
- •Pregnant or breastfeeding patient
- •Participation to any other clinical study which has an impact on the different endpoints
- •Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.
研究组 & 干预措施
Group 1:
Night-time MOBIDERM Autofit for the 1st month (1st phase) and self-bandages at night for the 2nd month (2nd phase).
干预措施: MOBIDERM Autofit Armsleeve (Device)
Group 1:
Night-time MOBIDERM Autofit for the 1st month (1st phase) and self-bandages at night for the 2nd month (2nd phase).
干预措施: Self-bandages (Device)
Group 2:
Self-bandages at night for the 1st month (1st phase) then Night-time MOBIDERM Autofit for the 2nd month (2nd phase).
干预措施: MOBIDERM Autofit Armsleeve (Device)
Group 2:
Self-bandages at night for the 1st month (1st phase) then Night-time MOBIDERM Autofit for the 2nd month (2nd phase).
干预措施: Self-bandages (Device)
结局指标
主要结局
Volume excess variation
时间窗: 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.
次要结局
- Evolution of affected upper limb volume:(2 months (Inclusion, first month and second month visit))
- Device pressure:(2 months (Inclusion, first month and second month visit))
- Evolution of hand lymphedema:(2 months (Inclusion, first month and second month visit))
- Comfort / Ease of use / satisfaction:(2 month visit)
- Compliance:(2 months)
- Patient's safety(2 months)