Timing of Subcutaneous Tranexamic Acid Injection in Mohs Micrographic Surgery: A Prospective, Multicenter, Two-Arm, Non-Inferiority Trial
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials of Subcutaneous TXA injection before reconstruction All trials of Subcutaneous TXA injection after reconstruction
-Summary
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.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Subcutaneous TXA prior to reconstruction | Active comparator | Drug: Subcutaneous TXA injection before reconstruction | Subcutaneous TXA prior to reconstruction |
| Subcutaneous TXA after reconstruction | Active comparator | Drug: Subcutaneous TXA injection after reconstruction | Subcutaneous TXA after reconstruction |
- Subcutaneous TXA injection before reconstruction (Drug): Subcutaneous TXA injection before reconstruction
- Subcutaneous TXA injection after reconstruction (Drug): Subcutaneous TXA injection after reconstruction
+Outcome measures
Primary outcomes
- Quantity of bleeding events 48 hours after surgery measured via documentation in electronic medical record (phone calls, urgent care/office visits for bleeding control) [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.
Secondary outcomes
- 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 wound safety outcomes through 30 days, including dehiscence, infection, and, where applicable, partial or complete flap/graft necrosis.
- Compare thromboembolic events through 30 days by chart review [30 days]: Compare thromboembolic events through 30 days by chart review
+Eligibility
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria:
1. Age 18 years or older.
2. Undergoing MMS at a participating site with a planned same-day linear closure, flap reconstruction, or graft reconstruction.
3. Willing and able to provide written informed consent.
4. Able to participate in standard postoperative follow-up and to be reached if follow-up clarification is required.
Exclusion Criteria:
1. Known allergy or hypersensitivity to TXA.
2. Active deep-vein thrombosis, pulmonary embolism, stroke, myocardial infarction, or other active thromboembolic event at the time of surgery.
3. Thromboembolic event within the previous 3 months.
4. Systolic blood pressure greater than 200 mmHg at the time of surgery.
5. Pregnancy or breastfeeding.
6. Planned second-intention healing without reconstruction.
7. History of seizures or current medication judged by the investigator to materially lower seizure threshold.
8. Reported serum creatinine of 5 mg/dL or greater.
9. Unable to complete the 48-hour outcome assessment or standard postoperative follow-up.
10. Prior enrollment in this study.
+Publications
- Results publication: 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. PMID 34087356
- Results publication: 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. PMID 39235116
- Results publication: 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. PMID 30640775
- Results publication: 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. PMID 36728063
- Results publication: 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. PMID 24080866
- Results publication: 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. PMID 37712760
- Results publication: 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. PMID 32541342