Tranexamic Acid in Nasal Mohs Reconstruction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Known allergy to TXA
Intracranial bleeding
Known defective color vision
History of venous or arterial thromboembolism
Trial design
Design model
Parallel
Treatments tested in this trial
Treatment (tranexamic acid and 1% lidocaine with 1:100,000 epinephrine)
DrugSubcutaneous 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)
DrugSubcutaneous injection of local anesthetic (1% lidocaine with 1:100,000 epinephrine)
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
One week2
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.
Time frame
One week3
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.
Time frame
Intraoperative4
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.
Time frame
IntraoperativeSecondary outcomes
1
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."
Time frame
One week2
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.
Time frame
One week3
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."
Time frame
One weekSponsors and contacts
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Source ClinicalTrials.gov