Tranexamic Acid in Nasal Mohs Reconstruction

NCT06057675 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 231482
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Bleeding; Skin Cancer Face

Keywords

Tranexamic Acid; Mohs Reconstruction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Postoperative pain

  One week

• Postoperative pain

  One week

• Postoperative patient satisfaction

  One week

Study Arms (2)

Control

ACTIVE COMPARATOR

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)

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)

Interventions

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.

Also known as: Tranexamic Acid

Experimental

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

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

Also known as: Standard of Care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Therapeutics; Tranexamic Acid; Lidocaine; Epinephrine; Standard of Care

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Priyesh Patel, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Connie Ma, MD

CONTACT

2815366877; connie.ma@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient participants will be blinded to the study arm to which they belong. Additionally, the independent reviewer of postoperative photos will be blinded to the study arm to which patients belong. Participation will end at the 7-day follow up appointment, at which time data collection will cease and treatment group will be disclosed to participants. Provisions for breaking blinding would include a rare thromboembolic event or anaphylactic event of unknown cause in the immediate postoperative period, or patient desire to terminate involvement in the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor of Otolaryngology

Model Details: In this study, patients undergoing Mohs reconstruction of the nose with local flap techniques will be randomized to receive either standard of care (subcutaneous injection of local anesthetic, 1% lidocaine with 1:100,000 epinephrine) or TXA treatment (subcutaneous injection of local anesthetic, 1% lidocaine with 1:100,000 epinephrine and TXA 1g/10mL, in 9:1 volume ratio) pre-operatively. Outcomes will include intraoperative bleeding and postoperative swelling and bruising.

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 28, 2023
• Study Start: March 19, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)