Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06345833
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 1%Tranexamic acid with standard local — DRUG
    1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine with saline as the control.
  • 3% TXA — DRUG
    3% TXA on TXA-soaked pledgets applied for 10 minutes with saline as the control.
  • 1% TXA with local plus 3% TXA-soaked pledgets — DRUG
    1% TXA with local plus 3% TXA-soaked pledgets with saline as the control.

Study Details

Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face. Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.\[12\] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date.

Key Dates

Start date
Jul 1, 2024
Status verified
Aug 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Group 1
    1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine with saline as the control. Each face is treated as a split face and one half gets randomized to a TXA containing treatment group, so that each participant serves as his/her own control.
  • Experimental: Group 2
    3% TXA on TXA-soaked pledgets applied for 10 minutes with saline as the control Each face is treated as a split face and one half gets randomized to a TXA containing treatment group, so that each participant serves as his/her own control.
  • Experimental: Group 3
    1% TXA with local plus 3% TXA-soaked pledgets with saline as the control Each face is treated as a split face and one half gets randomized to a TXA containing treatment group, so that each participant serves as his/her own control.

Primary Outcome Measure

Blood loss [ Time Frame: 2 weeks post-op ]

Central Contacts

  • Jenna Van Beck, MD
    (612) 626-5900

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55414
Jenna Van Beck

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By research site
University of Minnesota· Minneapolis, MN

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