Tranexamic Acid in Nasal Mohs Reconstruction

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06057675
Phase
PHASE2
Status
Recruiting
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Conditions

  • Postoperative Bleeding
  • Skin Cancer Face

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine) — DRUG
    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) — DRUG
    Subcutaneous injection of local anesthetic (1% lidocaine with 1:100,000 epinephrine)

Study Details

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.

Key Dates

Start date
Mar 19, 2024
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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).

Primary Outcome Measure

Surgical site swelling and bruising (surgeon) [ Time Frame: One week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Connie Ma, MD

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Vanderbilt University Medical Center· Nashville, TN

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