Prospective, Randomized Controlled Trial Comparing the Effect of 3M Coban 2 Layer Compression System Versus Trico Bandages in the Treatment of Leg Lymphedema.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- volume decrease in relation to interface pressure after application of two types of bandages.
研究概览
简要总结
The purpose of this trial is to study the effect of the 3M Coban 2 Layer Compression System (hereafter C2L) in the treatment of leg lymphedema compared to the traditional treatment with Trico bandages.
详细描述
The goal of this prospective, randomized, controlled trial with CE marked product is to study the effectiveness (volume reduction) of 24-hour compression therapy for lymphedema, comparing C2L and Trico bandaging. Therefore 30 patients with leg lymphedema are included.
Application of marketed compression bandages (C2L or Trico bandages) used for treatment by trained specialists with assessment of the subbandage pressure and volume reduction.
Measurements are carried out at:
Volumetry:
Measurements after 0h, 2h and 24 h by using classic water displacement apparatus.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: male or female
- •More than 18 years of age
- •Patients with distal lymphedema of the leg requiring multilayer lymphedema bandaging of the leg
- •The patient is able to understand the study and is willing to give written informed consent to the study
排除标准
- •Allergy against one of the used materials
- •Proximal lymphedema (involvement of thigh, genitalia)
- •Severe systemic diseases causing peripheral oedema
- •Acute superficial or deep vein thrombosis
- •Arterial occlusive disease (stadium II, III or IV) or arm/leg blood pressure index (ALPI)<0,8
- •Local infection in the therapy area
- •Auto-immunological disorders or vasculitis
- •Use of systemic corticosteroids
结局指标
主要结局
volume decrease in relation to interface pressure after application of two types of bandages.
时间窗: enrollment of 30 patients
次要结局
- Pressure drop after 2 hours and 24 hours of bandaging(after application, at 2 hours and 24 hours after application of bandage)
研究者
R.J. Damstra
MD PhD
Nij Smellinghe Hosptial