RecruitingPhase 2

Tranexamic Acid in Nasal Mohs Reconstruction

United States100 participantsStarted 2024-03-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. No other facial plastic procedure or sinus surgery performed simultaneously.

Exclusion criteria

. Known allergy to TXA
. Intracranial bleeding
. Known defective color vision
. History of venous or arterial thromboembolism
. History of coagulation disorder
. Active thromboembolic disease
. Severe renal impairment (diagnosis of chronic kidney disease)
. History of acute myocardial infarction

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Surgical site swelling and bruising (surgeon)

Timeframe: One week

Surgical site swelling and bruising (patient)

Timeframe: One week

Intraoperative bleeding

Timeframe: Intraoperative

Intraoperative bleeding

Timeframe: Intraoperative

Trial details

NCT IDNCT06057675

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Connie Ma, MD

2815366877 connie.ma@vumc.org

View on ClinicalTrials.gov More Postoperative Bleeding trials