Clinical trial · Interventional
Tranexamic Acid in Nasal Mohs Reconstruction
Subcutaneous Tranexamic Acid in Nasal Mohs Local Flap Reconstruction: Perioperative Bleeding, Edema, and Ecchymosis
NCT06057675CI-TRIAL-00093814recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postoperative Bleeding | — | UNRESOLVED | — |
| Skin Cancer Face | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control (1% lidocaine with 1:100,000 epinephrine) | Drug | — | UNRESOLVED |
| Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- 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).
- interventionNames
- Drug: Control (1% lidocaine with 1:100,000 epinephrine)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- 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).
- interventionNames
- Drug: Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine)
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.