Clinical trial NCT06057675: Tranexamic Acid in Nasal Mohs Reconstruction
Official title: Subcutaneous Tranexamic Acid in Nasal Mohs Local Flap Reconstruction: Perioperative Bleeding, Edema, and Ecchymosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Postoperative Bleeding
Skin Cancer Face
Keywords: Tranexamic Acid
Mohs Reconstruction
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, patients undergoing Mohs reconstruction of the nose with local flap techniques will be randomized to receive either standard of care (subcutaneous injection of local anesthetic, 1% lidocaine with 1:100,000 epinephrine) or TXA treatment (subcutaneous injection of local anesthetic, 1% lidocaine with 1:100,000 epinephrine and TXA 1g/10mL, in 9:1 volume ratio) pre-operatively. Outcomes will include intraoperative bleeding and postoperative swelling and bruising.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Surgical site swelling and bruising (surgeon)
timeFrame: One week
measure: Surgical site swelling and bruising (patient)
timeFrame: One week
measure: Intraoperative bleeding
timeFrame: Intraoperative
measure: Intraoperative bleeding
timeFrame: Intraoperative
Secondary outcomes:
measure: Postoperative pain
timeFrame: One week
measure: Postoperative pain
timeFrame: One week
measure: Postoperative patient satisfaction
timeFrame: One week
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Priyesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: