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2005年11月25日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Seroma formation in the axilla following axillary dissection of lymphnodes following surgery for breast cancer in women
发起方: Viborg Sygehus
入组人数: 10
状态: 进行中（未招募）
最后更新: 14年前

暂无简介。

注册库

who.int

开始日期

2005年11月25日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

Female

发起方

Viborg Sygehus

•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

•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.