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Recruiting NCT06057675

Tranexamic Acid in Nasal Mohs Reconstruction

Phase II Interventional Postoperative Bleeding Skin Cancer Face

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine), Control (1% lidocaine with 1:100,000 epinephrine).
Who it may be relevant to
Registry conditions: Postoperative Bleeding, Skin Cancer Face. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Surgical site swelling and bruising (surgeon) [Time frame: One week]
  • Surgical site swelling and bruising (patient) [Time frame: One week]
  • Intraoperative bleeding [Time frame: Intraoperative]
  • Intraoperative bleeding [Time frame: Intraoperative]
Secondary outcome measures (3)
  • Postoperative pain [Time frame: One week]
  • Postoperative pain [Time frame: One week]
  • Postoperative patient satisfaction [Time frame: One week]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT06057675 · 231482

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗