Timing of Subcutaneous Tranexamic Acid Injection in Mohs Micrographic Surgery
2026年9月2日 更新者:Naomi Lawrence、The Cooper Health System
Timing of Subcutaneous Tranexamic Acid Injection in Mohs Micrographic Surgery: A Prospective, Multicenter, Two-Arm, Non-Inferiority Trial
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.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
500
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Subcutaneous TXA prior to reconstruction
|
Subcutaneous TXA injection before reconstruction
|
|
有源比较器:Subcutaneous TXA after reconstruction
|
Subcutaneous TXA injection after reconstruction
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quantity of bleeding events 48 hours after surgery measured via documentation in electronic medical record (phone calls, urgent care/office visits for bleeding control)
大体时间: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.
|
48 hours post procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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
大体时间:30 days
|
Compare wound safety outcomes through 30 days, including dehiscence, infection, and, where applicable, partial or complete flap/graft necrosis.
|
30 days
|
|
Compare thromboembolic events through 30 days by chart review
大体时间:30 days
|
Compare thromboembolic events through 30 days by chart review
|
30 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kane Z, Picetti R, Wilby A, Standing JF, Grassin-Delyle S, Roberts I, Shakur-Still H. Physiologically based modelling of tranexamic acid pharmacokinetics following intravenous, intramuscular, sub-cutaneous and oral administration in healthy volunteers. Eur J Pharm Sci. 2021 Sep 1;164:105893. doi: 10.1016/j.ejps.2021.105893. Epub 2021 Jun 1.
- Kumar EA, Morris LM, Michalski-McNeely BM. Tranexamic Acid in Mohs Micrographic Surgery: A Systematic Review. Dermatol Surg. 2025 Jan 1;51(1):17-19. doi: 10.1097/DSS.0000000000004373. Epub 2024 Sep 5.
- Zilinsky I, Barazani TB, Visentin D, Ahuja K, Martinowitz U, Haik J. Subcutaneous Injection of Tranexamic Acid to Reduce Bleeding During Dermatologic Surgery: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. Dermatol Surg. 2019 Jun;45(6):759-767. doi: 10.1097/DSS.0000000000001786.
- Perz AM, Lukowiak TM, Lee MP, Neal D, Aizman L, Miller CJ, Golda N, Albertini JG, Holmes T, Bar A, Leitenberger J, Maher I, Sobanko JF, Chen D, Hollmig T, Aasi S, Sutton A, Higgins HW 2nd, Shin TM, Weinberger C, Mattox A, Wysong A, Etzkorn JR. Postoperative Complications After Interpolated Flap Repair for Mohs Defects of the Nose: A Multicenter Prospective Cohort Study. Dermatol Surg. 2023 Feb 1;49(2):135-139. doi: 10.1097/DSS.0000000000003653. Epub 2022 Dec 22.
- Alam M, Ibrahim O, Nodzenski M, Strasswimmer JM, Jiang SI, Cohen JL, Albano BJ, Batra P, Behshad R, Benedetto AV, Chan CS, Chilukuri S, Crocker C, Crystal HW, Dhir A, Faulconer VA, Goldberg LH, Goodman C, Greenbaum SS, Hale EK, Hanke CW, Hruza GJ, Jacobson L, Jones J, Kimyai-Asadi A, Kouba D, Lahti J, Macias K, Miller SJ, Monk E, Nguyen TH, Oganesyan G, Pennie M, Pontius K, Posten W, Reichel JL, Rohrer TE, Rooney JA, Tran HT, Poon E, Bolotin D, Dubina M, Pace N, Kim N, Disphanurat W, Kathawalla U, Kakar R, West DP, Veledar E, Yoo S. Adverse events associated with mohs micrographic surgery: multicenter prospective cohort study of 20,821 cases at 23 centers. JAMA Dermatol. 2013 Dec;149(12):1378-85. doi: 10.1001/jamadermatol.2013.6255.
- Freeman SC, Heath MS, Neill B, Morris C, Lucero OM, Yu W, Bar A, Leitenberger JJ. Tranexamic Acid Prevention of Hemorrhagic Complications Following Interpolated Flap Repair: A Single-Center, Retrospective, Cohort Study. Dermatol Surg. 2023 Dec 1;49(12):1139-1142. doi: 10.1097/DSS.0000000000003931. Epub 2023 Sep 14.
- Wang W, Lee J, Qin S, Brown MD, Doerr T. Indications and Outcomes of Mohs Micrographic Surgery Using a Multidisciplinary Approach: A Decade of Experience. Dermatol Surg. 2021 Jan 1;47(1):10-15. doi: 10.1097/DSS.0000000000002467.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年11月1日
初级完成 (估计的)
2028年11月1日
研究完成 (估计的)
2028年11月1日
研究注册日期
首次提交
2026年9月2日
首先提交符合 QC 标准的
2026年9月2日
首次发布 (实际的)
2026年9月8日
研究记录更新
最后更新发布 (实际的)
2026年9月8日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 26-226
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
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