The Impact of Tranexamic Acid in Reducing Hematoma and Seroma Formation in Reconstructive Post-oncologic Breast Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Breast Pockets That Develop a Hematoma
研究概览
简要总结
Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operative bleeding (hematomas) and fluid collections (seromas) in women undergoing surgery to remove both breasts (bilateral mastectomy) immediately followed by surgery to rebuild the breast (reconstruction). The formation of hematomas and seromas, a common post-mastectomy complication, can interfere with breast reconstruction and increase the risk of infection and wound healing and can potentially delay cancer treatments. TXA is a synthetic molecule that pushes the body's clotting cascade toward clot formation to improve blood clotting. Applying TXA topically to the surgical site before closing the incision may prevent hematoma and seroma formation in post-mastectomy breast reconstruction patients.
Participants will be recruited from patients undergoing bilateral mastectomy at University of California, San Francisco.
详细描述
PRIMARY OUTCOMES:
I. To investigate whether topical tranexamic acid may impact rates of seroma, hematoma, severe bruising, and drain output in the post-mastectomy reconstructive population.
II. To evaluate the impact of TXA on seroma rates compared to control.
SECONDARY OUTCOMES:
I. To evaluate the impact of TXA on patient and provider rating of bruising, comparing the TXA side to the control side.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Histologically confirmed breast malignancy OR increased risk for breast cancer
- •Age >= 18 years
- •Scheduled to undergo bilateral mastectomy with plastic surgery closure or reconstruction
- •Ability to understand a written informed consent document, and the willingness to sign it
- •At least 4 weeks post-completion of chemotherapy or radiation therapy
排除标准
- •Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study
- •Any history of thromboembolic disease
- •Current anticoagulant use
- •Current use of chlorpromazine due to label contraindication
- •Current use of any prothrombotic medical products due to label contraindication
- •Documented or reported allergic reaction to tranexamic acid
- •Male participants
研究组 & 干预措施
All participants
Each participant will have one breast pocket exposed to TXA and the other to saline only prior to closure. During surgery and prior to wound closure, the wound surface will be moistened on one side with 20 cc of dilute TXA 25mg/ml solution, and the contralateral with 20cc of saline.
干预措施: Tranexamic Acid (Drug)
All participants
Each participant will have one breast pocket exposed to TXA and the other to saline only prior to closure. During surgery and prior to wound closure, the wound surface will be moistened on one side with 20 cc of dilute TXA 25mg/ml solution, and the contralateral with 20cc of saline.
干预措施: Saline (Other)
结局指标
主要结局
Number of Breast Pockets That Develop a Hematoma
时间窗: Up to 1 month
Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported.
Number of Breast Pockets That Develop a Seroma
时间窗: Up to 3 months
Presence of seroma in the surgical area within 3-month period from time of treatment application in the operating room will be reported.
次要结局
- Number of Breast Pockets That Developed Ecchymosis(Up to 1 year)
- Median Total Drain Duration(Approximately 1 month)
- Number of Participants Requiring Reoperation After Completion of Bilateral Mastectomy(Up to 1 year)
- Median Total Drain Output(Approximately 1 month)
- Proportion of Participants With Reported Infection in Surgical Area Post-mastectomy(Up to 1 year)