Comparison of the Effectiveness of a Precast Adjustable Compression Wrap With the Multilayer Compression Bandage in Upper Limb Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 6
- 主要终点
- Change in the excess of volume of upper limb
研究概览
简要总结
Treatment of lymphedema is based on a combined program called complex decongestive therapy. The components of the complex decongestive therapy are skin care, kinesiotherapy, manual lymphatic drainage and compression. The compression with multilayer bandage has proved to be the most effective of these therapies when analyzed separately.The multilayer bandage produces a gradient compression on the limb where distal pressure is higher than proximal pressure. Several materials are needed for the multilayer bandage, including tubular bandage lining, digit bandages, foam under-cast padding and multiple layers of short-stretch bandages to cover the entire limb. The Precast Adjustable Compression Wrap fits each patient through a Velcro system.
The aim is to compare the effectiveness of a precast adjustable compression wrap (Circaid) with the multilayer compression bandages in the treatment of the upper limb lymphedema.
详细描述
The gold standard of the treatment of lymphedema is based on a combined program called complex decongestive therapy. The components of the complex decongestive therapy are skin care, kinesiotherapy, manual lymphatic drainage and compression. The compression with multilayer bandage has proved to be the most effective of these therapies when analyzed separately. With the multilayer compression bandage the upper limb lymphedema volume decreased a 37.2%.
The multilayer bandage produces a gradient compression on the limb where distal pressure is higher than proximal pressure. Several materials are needed for the multilayer bandage, including tubular bandage lining, digit bandages, foam under-cast padding and multiple layers of short-stretch bandages to cover the entire limb. The Precast Adjustable Compression Wrap fits each patient through a Velcro system.
Decreasing compression is achieved by controlling the tension applied to each Velcro through a visual color guide. The Precast Adjustable Compression Wrap has proved to be safe and effective to treat lower limb lymphedema, but there is little information about its effectiveness in the treatment of the upper limb lymphedema.
The aim is to compare the effectiveness of a precast adjustable compression wrap (Circaid) with the multilayer compression bandages in the treatment of the upper limb lymphedema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Upper limb lymphedema after axillary lymph node dissection for breast cancer.
- •Lymphedema must affect at least the arm or the forearm.
- •The lymphedema volume excess must be at least 10%
- •The lymphedema must have not been previously treated or have been at least 1 year without treatment.
排除标准
- •Bilateral upper limb lymphedema
- •Cognitive or sensorial impairments which could interfere collaboration
- •Plexopathy post radiotherapy
- •Breast cancer in progression Pregnancy or Lactation
结局指标
主要结局
Change in the excess of volume of upper limb
时间窗: Baseline to 3 months (10 sessions of treatment)
Change in the excess of volume of the affected upper limb. The excess of volume is the difference in volume between the affected and the unaffected upper limb. The upper limb volumes will be obtained from the perimeters of the upper limbs and applying the truncate cone formula. Baseline to 2 weeks (10 sessions of treatment). A follow up at 3 months
次要结局
- Changes in pain, heaviness, tightness and hardness(Baseline to 3 months (10 sessions of treatment))
- Changes in skin and lymphedema condition(Baseline to 3 months (10 sessions of treatment))
- Number of Participants with Serious and Non-Serious Adverse Events(Baseline to 3 months (10 sessions of treatment))
研究者
Roser Belmonte
PhD
Parc de Salut Mar