Tranexamic Acid in Nasal Mohs Reconstruction

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Sep 24, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Tranexamic Acid in Nasal Mohs Reconstruction," is studying the effects of a medication called tranexamic acid (TXA) to help reduce bleeding after surgery for skin cancer on the nose. The trial is taking place at Vanderbilt University Medical Center and involves patients who are having a specific type of surgery called nasal Mohs reconstruction. The goal is to see if giving TXA as an injection under the skin can help patients recover with less bleeding after their surgery.

To participate in this study, you need to be at least 18 years old and scheduled for a local flap reconstruction on your nose after Mohs micrographic surgery. However, you won’t be eligible if you have certain health conditions, like a known allergy to TXA or a history of serious blood disorders. If you join the study, you can expect to receive either the TXA injection or a placebo (a substance with no active medicine) and be monitored closely during your recovery. This research aims to improve surgical outcomes and help patients heal better after their procedures.

Gender

ALL

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).