Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery
NCT ID: NCT04541303
Last Updated: 2024-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
124 participants
INTERVENTIONAL
2020-10-08
2021-12-30
Brief Summary
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Detailed Description
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Patients meeting inclusion criteria will be randomized into two arms once enrolled in the study on the day of their Mohs micrographic surgery (MMS).
One arm will serve as the control group and will receive normal saline soaked telfa pads to the wound bed upon completion of MMS.
A second arm will receive TXA 25mg/ml at a volume of 1ml/cm2 soaked telfa pads to wound bed upon completion of MMS.
In both arms, the telfa pads will have a standard pressure dressing placed overtop.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Intervention
Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.
Tranexamic acid
tranexamic acid diluted to concentration of 25ml/mg
Placebo
Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.
normal saline
0.9% sodium chloride
Interventions
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Tranexamic acid
tranexamic acid diluted to concentration of 25ml/mg
normal saline
0.9% sodium chloride
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients must not have a known allergic reaction or sensitivity to TXA
* Patient must not have an international normalized ratio (INR) out of therapeutic range if on warfarin.
18 Years
ALL
No
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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Nicholas J Golda
Principal Investigator
Principal Investigators
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Nicholas Golda, MD
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
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University of Missouri-Columbia
Columbia, Missouri, United States
Countries
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References
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Tolkachjov SN, Brodland DG, Coldiron BM, Fazio MJ, Hruza GJ, Roenigk RK, Rogers HW, Zitelli JA, Winchester DS, Harmon CB. Understanding Mohs Micrographic Surgery: A Review and Practical Guide for the Nondermatologist. Mayo Clin Proc. 2017 Aug;92(8):1261-1271. doi: 10.1016/j.mayocp.2017.04.009.
Kimyai-Asadi A, Goldberg LH, Peterson SR, Silapint S, Jih MH. The incidence of major complications from Mohs micrographic surgery performed in office-based and hospital-based settings. J Am Acad Dermatol. 2005 Oct;53(4):628-34. doi: 10.1016/j.jaad.2005.03.023.
Bunick CG, Aasi SZ. Hemorrhagic complications in dermatologic surgery. Dermatol Ther. 2011 Nov-Dec;24(6):537-50. doi: 10.1111/j.1529-8019.2012.01454.x.
Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.
Lin ZX, Woolf SK. Safety, Efficacy, and Cost-effectiveness of Tranexamic Acid in Orthopedic Surgery. Orthopedics. 2016 Mar-Apr;39(2):119-30. doi: 10.3928/01477447-20160301-05. Epub 2016 Mar 4.
Roberts I, Shakur H, Coats T, Hunt B, Balogun E, Barnetson L, Cook L, Kawahara T, Perel P, Prieto-Merino D, Ramos M, Cairns J, Guerriero C. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess. 2013 Mar;17(10):1-79. doi: 10.3310/hta17100.
Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12.
Ausen K, Hagen AI, Ostbyhaug HS, Olafsson S, Kvalsund BJ, Spigset O, Pleym H. Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial. BJS Open. 2020 Apr;4(2):216-224. doi: 10.1002/bjs5.50248. Epub 2019 Dec 26.
de Vasconcellos SJ, de Santana Santos T, Reinheimer DM, Faria-E-Silva AL, de Melo MF, Martins-Filho PR. Topical application of tranexamic acid in anticoagulated patients undergoing minor oral surgery: A systematic review and meta-analysis of randomized clinical trials. J Craniomaxillofac Surg. 2017 Jan;45(1):20-26. doi: 10.1016/j.jcms.2016.10.001. Epub 2016 Oct 13.
Zahed R, Moharamzadeh P, Alizadeharasi S, Ghasemi A, Saeedi M. A new and rapid method for epistaxis treatment using injectable form of tranexamic acid topically: a randomized controlled trial. Am J Emerg Med. 2013 Sep;31(9):1389-92. doi: 10.1016/j.ajem.2013.06.043. Epub 2013 Jul 30.
Teoh WY, Tan TG, Ng KT, Ong KX, Chan XL, Hung Tsan SE, Wang CY. Prophylactic Topical Tranexamic Acid Versus Placebo in Surgical Patients: A Systematic Review and Meta-analysis *. Ann Surg. 2021 Apr 1;273(4):676-683. doi: 10.1097/SLA.0000000000003896.
Ausen K, Pleym H, Liu J, Hegstad S, Nordgard HB, Pavlovic I, Spigset O. Serum Concentrations and Pharmacokinetics of Tranexamic Acid after Two Means of Topical Administration in Massive Weight Loss Skin-Reducing Surgery. Plast Reconstr Surg. 2019 Jun;143(6):1169e-1178e. doi: 10.1097/PRS.0000000000005620.
Eikebrokk TA, Vassmyr BS, Ausen K, Gravastrand C, Spigset O, Pukstad B. Cytotoxicity and effect on wound re-epithelialization after topical administration of tranexamic acid. BJS Open. 2019 Sep 26;3(6):840-851. doi: 10.1002/bjs5.50192. eCollection 2019 Dec.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Ferring Pharmaceuticals Incorporated. Lysteda (tranexamic acid) \[package insert\]. Revised October 2013. Accessed May 2020.
Other Identifiers
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2025444
Identifier Type: -
Identifier Source: org_study_id
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