EUCTR2005-004429-25-DK进行中（未招募）不适用
A single cohort, open trial to evaluate the efficacy and safety of TachoSil in prevention of seroma formation following axillary lymph node dissection in women following surgery for breast cancer. A pilot study. - Prevention of seroma formation following axillary lymph node dissection due to breast cancer.
Viborg Sygehus0 个研究点目标入组 10 人开始时间: 2005年11月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Patients with breast cancer who require exaresis of the axillary lymph nodes with or without mastectomy.
- •Planned removeal of lymp nodes from level I or II
- •Axilla must be macroscopically tumour free after dissection of lymph nodes
- •Age over 18 years of age
- •Signed informed consent before any trial related activities
- •Negative pregnancy test
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who have previously undergone any surgery on the breast or axilla at the planned site
- •Previous radiation therapy
- •Previous chemotherapy
- •Final stage patients with a life expectancy of less than 3 months
- •Patients with diabetes
- •Patients with a history of disturbances in wound healing
- •Known or suspected allergy to any of the components in TachoSil
- •Pregnancy or breast feeding.
研究者
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