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NCT Number: NCT06057675

Tranexamic Acid 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location status: Recruiting

Location contact

Connie Ma, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • No other facial plastic procedure or sinus surgery performed simultaneously.
  • Lack of all the below exclusion criteria.

Exclusion criteria

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

Treatment and study plan

Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine)

Drug

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

Control (1% lidocaine with 1:100,000 epinephrine)

Drug

Subcutaneous injection of local anesthetic (1% lidocaine with 1:100,000 epinephrine)

Other names: Standard of Care

Primary outcomes

  1. Surgical site swelling and bruising (surgeon)

    Time frame: One week

    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.

  2. Surgical site swelling and bruising (patient)

    Time frame: One week

    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.

  3. Intraoperative bleeding

    Time frame: Intraoperative

    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.

  4. Intraoperative bleeding

    Time frame: Intraoperative

    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.

Secondary outcomes

  1. Postoperative pain

    Time frame: One week

    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."

  2. Postoperative pain

    Time frame: One week

    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.

  3. Postoperative patient satisfaction

    Time frame: One week

    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."

Study contacts

Contact information is provided by the study sponsor or research team.

Connie Ma, MD

CONTACT

[email protected]

2815366877

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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