Tranexamic Acid in Nasal Mohs Reconstruction

NCT ID: NCT06057675

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2026-06-30

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.

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.

Conditions

Postoperative Bleeding; Skin Cancer Face

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Other Intervention Names

Tranexamic Acid; Standard of Care

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Priyesh Patel

Asst. Professor of Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Priyesh Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Connie Ma, MD

Role: CONTACT

connie.ma@vumc.org

2815366877

Facility Contacts

Connie Ma, MD

Role: primary

Other Identifiers

231482

Identifier Type: -

Identifier Source: org_study_id