Tranexamic Acid in Nasal Mohs Reconstruction

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06057675

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Bleeding Skin Cancer Face	Drug: Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine) Drug: Control (1% lidocaine with 1:100,000 epinephrine)	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Patient participants will be blinded to the study arm to which they belong. Additionally, the independent reviewer of postoperative photos will be blinded to the study arm to which patients belong. Participation will end at the 7-day follow up appointment, at which time data collection will cease and treatment group will be disclosed to participants. Provisions for breaking blinding would include a rare thromboembolic event or anaphylactic event of unknown cause in the immediate postoperative period, or patient desire to terminate involvement in the study.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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).	Drug: Control (1% lidocaine with 1:100,000 epinephrine) Subcutaneous injection of local anesthetic (1% lidocaine with 1:100,000 epinephrine) Other Names: Standard of Care
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).	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. Other Names: Tranexamic Acid

Arm

Intervention/Treatment

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).

Drug: Control (1% lidocaine with 1:100,000 epinephrine)

Subcutaneous injection of local anesthetic (1% lidocaine with 1:100,000 epinephrine)

Other Names:

Standard of Care

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).

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.

Other Names:

Tranexamic Acid

Outcome Measures

Primary Outcome Measures

Surgical site swelling and bruising (surgeon) [One week]
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.
Surgical site swelling and bruising (patient) [One week]
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.
Intraoperative bleeding [Intraoperative]
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 bleeding [Intraoperative]
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.

Secondary Outcome Measures

Postoperative pain [One week]
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."
Postoperative pain [One week]
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.
Postoperative patient satisfaction [One week]
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."

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.
No other facial plastic procedure or sinus surgery performed simultaneously.
Lack of all the below exclusion criteria.

Exclusion Criteria:

Known allergy to TXA
Intracranial bleeding
Known defective color vision
History of venous or arterial thromboembolism
History of coagulation disorder
Active thromboembolic disease
Current use of anticoagulant medication
Severe renal impairment (diagnosis of chronic kidney disease)
Uncontrolled diabetes preventing use of dexamethasone in the perioperative period
Cardiac arrhythmia
History of acute myocardial infarction
History of stroke
History of seizure
History of liver failure
Preoperative lab results indicating thrombocytopenia (platelets <150,000), increased bleeding risk (PT over 45, INR over 1.2).