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

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06345833
• Other study ID #: ENT-2024-32847
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Jenna Van Beck, MD
• Phone: (612) 626-5900
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eligible participants will consist of all regular clinic patients who elect and are deemed fit by the surgeon to undergo facelift surgery, including patients undergoing ancillary procedures

• age 18 and older

• English speaking.

Exclusion Criteria:

• younger than 18

• previously had an adverse reaction to tranexamic acid

• non-English speaking

• patients who elect not to participate or withdraw from the study.

Related Conditions & MeSH terms

• Hemophilia
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	measured through post-operative drain output, post-operative edema and ecchymosis.; drain output is believed to be a more accurate representation of blood loss as it directly assesses the area in which TXA was applied as compared to intra-operative blood loss, which would be heavily influenced by bleeding from the skin incision.	2 weeks post-op
Secondary	adverse effects of TXA rates	in the form of flap epidermolysis, hair loss, or abnormal scar formation (e.g. hypertrophic scars) at the incision sites post-operatively.	2 weeks post-op