Topical Tranexamic Acid Use on Granulating Wounds Following Mohs Micrographic Surgery

NCT04541303 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: 2025444
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Bleeding after Mohs micrographic surgery for skin cancer is a low risk complication that can occur. This study aims to determine the effect of a drug, often used to reduce bleeding, called tranexamic acid when applied topically to the skin wound after surgery.

Conditions

Postoperative Wound Haemorrhage

Keywords

tranexamic acid; hemostasis; hemorrhagic complication; bleeding complication; Mohs micrographic surgery; granulating wound; granulating defect

Outcome Measures

Primary Outcomes (3)

• Frequency of Postoperative Hemorrhagic Complications

  Number of patients who call to report postoperative bleeding

  three days

• Rate of Clinic Evaluations of Postoperative Hemorrhagic Complications

  The number of patients who return to clinic with postoperative bleeding

  three days

• Rate of Treatment Interventions for Postoperative Hemorrhagic Complications

  The number of patients who are treated for postoperative bleeding

  three days

Secondary Outcomes (1)

• Types of Postoperative Hemorrhagic Complications

  three days

Study Arms (2)

Intervention

EXPERIMENTAL

Topical application of tranexamic acid to granulating wound defect status post Mohs micrographic surgery.

Drug: Tranexamic acid

Placebo

PLACEBO COMPARATOR

Topical application of normal saline to granulating wound defect status post Mohs micrographic surgery.

Drug: normal saline

Interventions

Tranexamic acid DRUG

tranexamic acid diluted to concentration of 25ml/mg

Also known as: Lysteda, Cyclokapron

Intervention

normal saline DRUG

0.9% sodium chloride

Also known as: 0.9% sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult (18 years or older) patients presenting for Mohs micrographic surgery (MMS) for the treatment of melanoma or nonmelanoma skin cancer (NMSC) with a wound that will be healing by granulation

You may not qualify if:

• Patients must not be pregnant or breastfeeding.
• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

Related Publications (13)

• 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.

  PMID: 28778259 BACKGROUND

• 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.

  PMID: 16198783 BACKGROUND

• 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.

  PMID: 22515669 BACKGROUND

• 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.

  PMID: 10400410 BACKGROUND

• 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.

  PMID: 26942474 BACKGROUND

• 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.

  PMID: 23477634 BACKGROUND

• 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.

  PMID: 19007970 BACKGROUND

• 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.

  PMID: 32207575 BACKGROUND

• 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.

  PMID: 27840121 BACKGROUND

• 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.

  PMID: 23911102 BACKGROUND

• 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.

  PMID: 32282377 BACKGROUND

• 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.

  PMID: 31136475 BACKGROUND

• 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.

  PMID: 31832591 BACKGROUND

Related Links

• Ferring Pharmaceuticals Incorporated. Lysteda (tranexamic acid) \[package insert\]. Revised October 2013. Accessed May 2020.

MeSH Terms

Interventions

Tranexamic Acid; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Brianna Castillo MD
• Organization: Univ of Mo

briannacastillo.md@gmail.com

813-765-1619

Study Officials

• Nicholas Golda, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Physician/surgeon, nurses, patient, and patient family will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One arm will receive topical application of tranexamic acid (intervention). Other arm with receive topical application of normal saline (placebo).

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 9, 2020
• Study Start: October 8, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-10

Locations

US (1)