Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Location contact
Connie Ma, MD
CONTACT
NCT Number: NCT06057675
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Connie Ma, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Subcutaneous injection of local anesthetic (1% lidocaine with 1:100,000 epinephrine)
Other names: Standard of Care
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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.
Time frame: 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."
Contact information is provided by the study sponsor or research team.
Vanderbilt University Medical Center
Other
Subcutaneous Tranexamic Acid in Nasal Mohs Local Flap Reconstruction: Perioperative Bleeding, Edema, and Ecchymosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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