Using Tranexamic Acid to Reduce Bleeding in Nasal Reconstruction

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

This study is testing whether giving tranexamic acid can help reduce bleeding and improve recovery for patients having nasal reconstruction surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06057675 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of tranexamic acid (TXA) administered subcutaneously in patients undergoing nasal Mohs reconstruction with local flaps at Vanderbilt University Medical Center. TXA is an antifibrinolytic agent that helps stabilize the fibrin matrix in the clotting process, potentially reducing postoperative complications such as bleeding, ecchymosis, and hematoma formation. The study is a prospective randomized control trial, comparing TXA treatment to a control group receiving only lidocaine with epinephrine. The goal is to improve surgical outcomes and patient satisfaction following nasal reconstruction.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older undergoing local flap reconstruction of nasal defects after Mohs micrographic surgery.

Not a fit: Patients with a history of thromboembolic disease, severe renal impairment, or known allergies to TXA may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery for patients undergoing nasal reconstruction.

How similar studies have performed: While TXA has been shown to be beneficial in various surgical contexts, this specific application in nasal Mohs reconstruction is novel and has not been previously studied.

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.
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).

Where this trial is running

Nashville, Tennessee

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Priyesh Patel, MD — Vanderbilt University Medical Center
• Study coordinator: Connie Ma, MD

Conditions Postoperative Bleeding; Skin Cancer Face; Tranexamic Acid; Mohs Reconstruction