Tranexamic Acid in Nasal Mohs Reconstruction

Subcutaneous Tranexamic Acid in Nasal Mohs Local Flap Reconstruction: Perioperative Bleeding, Edema, and Ecchymosis

This study will be a prospective randomized control trial to evaluate the effects of subcutaneously administered TXA among patients undergoing nasal Mohs reconstruction with local flaps at VUMC.

Study Overview

• Status: Recruiting
• Conditions: Skin Cancer Face; Postoperative Bleeding
• Intervention / Treatment: Drug: Control (1% lidocaine with 1:100,000 epinephrine); Drug: Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine)

Detailed Description

Tranexamic acid (TXA) is an antifibrinolytic agent that acts to decrease bleeding by stabilizing the fibrin matrix involved in the clotting cascade. The use of TXA has been extensively described in the literature to prevent exsanguination in trauma and in various surgical procedures, as well as for heavy menstrual bleeding and epistaxis. Studies have suggested administration of TXA may improve outcomes in aesthetic surgery as well, specifically regarding intraoperative bleeding and postoperative ecchymosis and hematoma formation. TXA may be administered systemically, via IV or PO routes, or locally, via topical application or subcutaneous injection. Local administration allows for similar benefits with minimal risk of systemic effects.

Following facial Mohs reconstruction patients often experience surgical site ecchymosis and swelling, which may be distressing, painful, prolong healing, and result in increased healthcare utilization. Other complications include hematoma, wound dehiscence, and suboptimal scarring. Given the growing body of literature demonstrating the benefits of TXA in surgical bleeding outcomes, TXA may also be beneficial in improving postoperative Mohs complications and patient satisfaction.

To date, no studies have investigated the use of perioperative TXA specifically in nasal Mohs reconstruction. This study will be a prospective randomized control trial to evaluate the effects of subcutaneously administered TXA among patients undergoing nasal Mohs reconstruction with local flaps at VUMC.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Connie Ma, MD; Phone Number: 2815366877; Email: connie.ma@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Connie Ma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Adults at least 18 years of age undergoing local flap reconstruction (bilobe flap, note flap dorsal nasal flap, advancement flap) of a nasal defect following Mohs micrographic surgery. Reconstructive procedures will be performed by Drs. Yang or Patel in the division of Facial Plastic Surgery in the Department of Otolaryngology, Head and Neck Surgery at Vanderbilt University Medical Center.
2. No other facial plastic procedure or sinus surgery performed simultaneously.
3. Lack of all the below exclusion criteria.

Exclusion Criteria:

1. Known allergy to TXA
2. Intracranial bleeding
3. Known defective color vision
4. History of venous or arterial thromboembolism
5. History of coagulation disorder
6. Active thromboembolic disease
7. Severe renal impairment (diagnosis of chronic kidney disease)
8. History of acute myocardial infarction
9. History of stroke
10. History of seizure
11. History of liver failure
12. Preoperative lab results indicating thrombocytopenia (platelets <150,000), increased bleeding risk (PT over 45, INR over 1.2).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; The control arm will receive the current standard of care. Before incision, local anesthetic (1% lidocaine with 1:100,000 epinephrine) will be injected subcutaneously into the surgical site. The surgical team will inject approximately 0.8mL per square centimeter of the surgical site area (defect area and undermined tissue area).	Drug: Control (1% lidocaine with 1:100,000 epinephrine); Subcutaneous injection of local anesthetic (1% lidocaine with 1:100,000 epinephrine); Other Names: Standard of Care
Experimental: Experimental; The experimental arm will receive local anesthetic (1% lidocaine with 1:100,000 epinephrine) and TXA (1g/10mL) in a 9:1 volume ratio. This will be injected subcutaneously into the surgical site. The surgical team will inject approximately 0.8mL per square centimeter of the surgical site area (defect area and undermined tissue area).	Drug: Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine); Subcutaneous injection of local anesthetic (1% lidocaine with 1:100,000 epinephrine) and tranexamic acid (1g/10mL), mixed in a 9:1 volume ratio.; Other Names: Tranexamic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site swelling and bruising (surgeon)	Photos will be taken by a research team member at the first postoperative clinic visit and then analyzed and graded by a blinded reviewer for measures including surgical site bruising and swelling. Surgical site swelling and bruising will be graded on a 4 point scale, with 0 indicating no swelling and bruising and 3 indicating significant swelling and bruising.	One week
Surgical site swelling and bruising (patient)	Subjective measures of patient perceived swelling and bruising will be collected via a patient completed survey given at the first postoperative clinic visit. Surgical site swelling and bruising will be graded on a 4 point scale, with 0 indicating no swelling and bruising and 3 indicating significant swelling and bruising.	One week
Intraoperative bleeding	Intraoperative bleeding will be assessed using the validated Boezaart Bleeding scale (6 point scale, with 0 indicating no bleeding/cadaveric conditions and 5 indicating severe bleeding/constant suctioning required). Values will be assigned by the attending surgeon and recorded by the research team.	Intraoperative
Intraoperative bleeding	Attending surgeon will score the approximate percent blood saturation of each surgical sponge used in the case. Values from each sponge will be added together for a total cumulative value, with a higher cumulative value indicating a greater amount of intraoperative bleeding.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Subjective measure of patient perceived pain will be collected via a patient completed survey given at the first postoperative clinic visit. Responses will be graded on a 5 point scale, with 1 indicating "no pain" and 5 indicating "severe pain."	One week
Postoperative pain	Objective measure of pain control will also be collected with an estimate of total amount of opioid pain medication used in the first week after surgery.	One week
Postoperative patient satisfaction	Subjective measure of postoperative patient satisfaction will be collected via a patient completed survey given at the first postoperative clinic visit. Responses will be graded on a 5 point scale, with 1 indicating "very dissatisfied" and 5 indicating "very satisfied."	One week

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Priyesh Patel, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 10, 2023
• First Submitted That Met QC Criteria: September 24, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 17, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Tranexamic Acid; Mohs Reconstruction
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Hemorrhage; Postoperative Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Neurotransmitter Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Tranexamic Acid; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: 231482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no current plans to make IPD available to other researchers. However, if information is made available, to protect patient privacy, patient names will not be released.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes