Timing of Subcutaneous Tranexamic Acid Injection in Mohs Micrographic Surgery: A Prospective, Multicenter, Two-Arm, Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Quantity of bleeding events 48 hours after surgery measured via documentation in electronic medical record (phone calls, urgent care/office visits for bleeding control)
研究概览
简要总结
This study will compare postoperative bleeding after subcutaneous tranexamic acid (TXA) is administered during Mohs surgery either after tumor clearance and before reconstruction or after reconstruction and before bandage application. TXA is a medication already being administered selectively during Mohs to help lessen bleeding. Enrollment will be enriched for patients taking anticoagulant or antiplatelet therapy and for patients receiving flaps or grafts because these groups have higher bleeding risk; although, any patient receiving Mohs with a linear closure, flap, or graft, may enroll. The primary hypothesis is that pre-reconstruction TXA is no better or worse compared to post-reconstruction TXA when measuring bleeding events within 48 hours and surgical complications within 30 days.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older.
- •Undergoing MMS at a participating site with a planned same-day linear closure, flap reconstruction, or graft reconstruction.
- •Willing and able to provide written informed consent.
- •Able to participate in standard postoperative follow-up and to be reached if follow-up clarification is required.
排除标准
- •Known allergy or hypersensitivity to TXA.
- •Active deep-vein thrombosis, pulmonary embolism, stroke, myocardial infarction, or other active thromboembolic event at the time of surgery.
- •Thromboembolic event within the previous 3 months.
- •Systolic blood pressure greater than 200 mmHg at the time of surgery.
- •Pregnancy or breastfeeding.
- •Planned second-intention healing without reconstruction.
- •History of seizures or current medication judged by the investigator to materially lower seizure threshold.
- •Reported serum creatinine of 5 mg/dL or greater.
- •Unable to complete the 48-hour outcome assessment or standard postoperative follow-up.
- •Prior enrollment in this study.
研究组 & 干预措施
Subcutaneous TXA after reconstruction
Subcutaneous TXA after reconstruction
干预措施: Subcutaneous TXA injection after reconstruction (Drug)
Subcutaneous TXA prior to reconstruction
Subcutaneous TXA prior to reconstruction
干预措施: Subcutaneous TXA injection before reconstruction (Drug)
结局指标
主要结局
Quantity of bleeding events 48 hours after surgery measured via documentation in electronic medical record (phone calls, urgent care/office visits for bleeding control)
时间窗: 48 hours post procedure
Determine whether pre-reconstruction TXA is non-inferior to post-reconstruction TXA for a composite bleeding event within 48 hours after surgery.
次要结局
- Compare wound safety outcomes, including dehiscence, infection, and, where applicable, partial or complete flap/graft necrosis. This will be measured via photograph submission at 7-14 days and chart review for phone calls/office in 30 days(30 days)
- Compare thromboembolic events through 30 days by chart review(30 days)
研究者
Naomi Lawrence
PI
The Cooper Health System