The Effect of Topical Administration of Tranexamic Acid on Postoperative Bleeding and Seroma Formation in Patients Undergoing Mastectomy: A Prospective Placebo-controlled Double Blinded Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- bleeding as defined by drain production per hour the first 24 hours
研究概览
简要总结
After surgical procedures, interventions to reduce postoperative bleeding are of great importance. In this study, the effect will be investigated of smearing tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. The researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether topically applicated tranexamic acid reduces bleeding after breast surgery for breast cancer.
After surgery for breast cancer patients may also experience problems with long lasting seroma. Therefore it will at the same time be investigated whether topical tranexamic acid reduces the development of seroma in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •breast cancer
- •undergoing unilateral mastectomy with or without axillary node dissection
- •received adequate oral and written information about the study and signed an informed-consent form
排除标准
- •pregnant or breastfeeding
- •known thromboembolic disease or with high risk of thromboembolism, warranting extra anticoagulation in connection with the procedure
- •known allergy to tranexamic acid/Cyklokapron®
研究组 & 干预措施
topical tranexamic acid
tranexamic acid to be smeared on surgical wounds before closure
干预措施: Tranexamic Acid (Drug)
placebo control
saline to be smeared on surgical wounds before closure
干预措施: saline (Drug)
结局指标
主要结局
bleeding as defined by drain production per hour the first 24 hours
时间窗: 24 hours postoperatively
Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml
次要结局
- Daily drain production up to drain removal - cumulative volume(3 weeks)
- number of patients having surgical bleeding in need of re-operation(3 weeks)
- number of postoperative aspirations of clinical seroma(up to 3 months)
- chronic seroma (lasting more than three months)(3 months)