Tranexamic Acid in Nasal Mohs Reconstruction

Postoperative Bleeding Clinical Trial

Official title:

Subcutaneous Tranexamic Acid in Nasal Mohs Local Flap Reconstruction: Perioperative Bleeding, Edema, and Ecchymosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057675
• Other study ID #: 231482
• Status: Recruiting
• Phase: Phase 2
• Start date: March 19, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Vanderbilt University Medical Center
• Contact: Connie Ma, MD
• Phone: 2815366877
• Email: connie.ma[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Tranexamic acid (TXA) is an antifibrinolytic agent that acts to decrease bleeding by stabilizing the fibrin matrix involved in the clotting cascade. The use of TXA has been extensively described in the literature to prevent exsanguination in trauma and in various surgical procedures, as well as for heavy menstrual bleeding and epistaxis. Studies have suggested administration of TXA may improve outcomes in aesthetic surgery as well, specifically regarding intraoperative bleeding and postoperative ecchymosis and hematoma formation. TXA may be administered systemically, via IV or PO routes, or locally, via topical application or subcutaneous injection. Local administration allows for similar benefits with minimal risk of systemic effects.

Following facial Mohs reconstruction patients often experience surgical site ecchymosis and swelling, which may be distressing, painful, prolong healing, and result in increased healthcare utilization. Other complications include hematoma, wound dehiscence, and suboptimal scarring. Given the growing body of literature demonstrating the benefits of TXA in surgical bleeding outcomes, TXA may also be beneficial in improving postoperative Mohs complications and patient satisfaction.

To date, no studies have investigated the use of perioperative TXA specifically in nasal Mohs reconstruction. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hemorrhage
• Postoperative Bleeding
• Postoperative Hemorrhage
• Skin Cancer Face

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site swelling and bruising (surgeon)	Photos will be taken by a research team member at the first postoperative clinic visit and then analyzed and graded by a blinded reviewer for measures including surgical site bruising and swelling. Surgical site swelling and bruising will be graded on a 4 point scale, with 0 indicating no swelling and bruising and 3 indicating significant swelling and bruising.	One week
Primary	Surgical site swelling and bruising (patient)	Subjective measures of patient perceived swelling and bruising will be collected via a patient completed survey given at the first postoperative clinic visit. Surgical site swelling and bruising will be graded on a 4 point scale, with 0 indicating no swelling and bruising and 3 indicating significant swelling and bruising.	One week
Primary	Intraoperative bleeding	Intraoperative bleeding will be assessed using the validated Boezaart Bleeding scale (6 point scale, with 0 indicating no bleeding/cadaveric conditions and 5 indicating severe bleeding/constant suctioning required). Values will be assigned by the attending surgeon and recorded by the research team.	Intraoperative
Primary	Intraoperative bleeding	Attending surgeon will score the approximate percent blood saturation of each surgical sponge used in the case. Values from each sponge will be added together for a total cumulative value, with a higher cumulative value indicating a greater amount of intraoperative bleeding.	Intraoperative
Secondary	Postoperative pain	Subjective measure of patient perceived pain will be collected via a patient completed survey given at the first postoperative clinic visit. Responses will be graded on a 5 point scale, with 1 indicating "no pain" and 5 indicating "severe pain."	One week
Secondary	Postoperative pain	Objective measure of pain control will also be collected with an estimate of total amount of opioid pain medication used in the first week after surgery.	One week
Secondary	Postoperative patient satisfaction	Subjective measure of postoperative patient satisfaction will be collected via a patient completed survey given at the first postoperative clinic visit. Responses will be graded on a 5 point scale, with 1 indicating "very dissatisfied" and 5 indicating "very satisfied."	One week