Recruiting
Phase 2

Tranexamic Acid

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06057675

Conditions

Postoperative Bleeding

Skin Cancer Face

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

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

Study Details

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

Study ID

NCT06057675

Start date

Mar 19, 2024

Status verified date

Aug, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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).

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).

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.

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

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Connie Ma, MD

2815366877connie.ma@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Aug 19, 2025

Last verified

Aug, 2025

Keywords

  • Tranexamic Acid
  • Mohs Reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-08-19.