NCT07807371

Brief Summary

This study will compare postoperative bleeding after subcutaneous tranexamic acid (TXA) is administered during Mohs surgery either after tumor clearance and before reconstruction or after reconstruction and before bandage application. TXA is a medication already being administered selectively during Mohs to help lessen bleeding. Enrollment will be enriched for patients taking anticoagulant or antiplatelet therapy and for patients receiving flaps or grafts because these groups have higher bleeding risk; although, any patient receiving Mohs with a linear closure, flap, or graft, may enroll. The primary hypothesis is that pre-reconstruction TXA is no better or worse compared to post-reconstruction TXA when measuring bleeding events within 48 hours and surgical complications within 30 days.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable healthy

Timeline
24mo left

Started Nov 2026

Typical duration for not_applicable healthy

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 2, 2026

Last Update Submit

September 2, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Quantity of bleeding events 48 hours after surgery measured via documentation in electronic medical record (phone calls, urgent care/office visits for bleeding control)

    Determine whether pre-reconstruction TXA is non-inferior to post-reconstruction TXA for a composite bleeding event within 48 hours after surgery.

    48 hours post procedure

Secondary Outcomes (2)

  • Compare wound safety outcomes, including dehiscence, infection, and, where applicable, partial or complete flap/graft necrosis. This will be measured via photograph submission at 7-14 days and chart review for phone calls/office in 30 days

    30 days

  • Compare thromboembolic events through 30 days by chart review

    30 days

Study Arms (2)

Subcutaneous TXA prior to reconstruction

ACTIVE COMPARATOR

Subcutaneous TXA prior to reconstruction

Drug: Subcutaneous TXA injection before reconstruction

Subcutaneous TXA after reconstruction

ACTIVE COMPARATOR

Subcutaneous TXA after reconstruction

Drug: Subcutaneous TXA injection after reconstruction

Interventions

Subcutaneous TXA injection after reconstructionDRUG

Subcutaneous TXA injection after reconstruction

Subcutaneous TXA after reconstruction
Subcutaneous TXA injection before reconstructionDRUG

Subcutaneous TXA injection before reconstruction

Subcutaneous TXA prior to reconstruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older.
  • Undergoing MMS at a participating site with a planned same-day linear closure, flap reconstruction, or graft reconstruction.
  • Willing and able to provide written informed consent.
  • Able to participate in standard postoperative follow-up and to be reached if follow-up clarification is required.

You may not qualify if:

  • Known allergy or hypersensitivity to TXA.
  • Active deep-vein thrombosis, pulmonary embolism, stroke, myocardial infarction, or other active thromboembolic event at the time of surgery.
  • Thromboembolic event within the previous 3 months.
  • Systolic blood pressure greater than 200 mmHg at the time of surgery.
  • Pregnancy or breastfeeding.
  • Planned second-intention healing without reconstruction.
  • History of seizures or current medication judged by the investigator to materially lower seizure threshold.
  • Reported serum creatinine of 5 mg/dL or greater.
  • Unable to complete the 48-hour outcome assessment or standard postoperative follow-up.
  • Prior enrollment in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Kane Z, Picetti R, Wilby A, Standing JF, Grassin-Delyle S, Roberts I, Shakur-Still H. Physiologically based modelling of tranexamic acid pharmacokinetics following intravenous, intramuscular, sub-cutaneous and oral administration in healthy volunteers. Eur J Pharm Sci. 2021 Sep 1;164:105893. doi: 10.1016/j.ejps.2021.105893. Epub 2021 Jun 1.

    PMID: 34087356RESULT

  • Kumar EA, Morris LM, Michalski-McNeely BM. Tranexamic Acid in Mohs Micrographic Surgery: A Systematic Review. Dermatol Surg. 2025 Jan 1;51(1):17-19. doi: 10.1097/DSS.0000000000004373. Epub 2024 Sep 5.

    PMID: 39235116RESULT

  • Zilinsky I, Barazani TB, Visentin D, Ahuja K, Martinowitz U, Haik J. Subcutaneous Injection of Tranexamic Acid to Reduce Bleeding During Dermatologic Surgery: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. Dermatol Surg. 2019 Jun;45(6):759-767. doi: 10.1097/DSS.0000000000001786.

    PMID: 30640775RESULT

  • Perz AM, Lukowiak TM, Lee MP, Neal D, Aizman L, Miller CJ, Golda N, Albertini JG, Holmes T, Bar A, Leitenberger J, Maher I, Sobanko JF, Chen D, Hollmig T, Aasi S, Sutton A, Higgins HW 2nd, Shin TM, Weinberger C, Mattox A, Wysong A, Etzkorn JR. Postoperative Complications After Interpolated Flap Repair for Mohs Defects of the Nose: A Multicenter Prospective Cohort Study. Dermatol Surg. 2023 Feb 1;49(2):135-139. doi: 10.1097/DSS.0000000000003653. Epub 2022 Dec 22.

    PMID: 36728063RESULT

  • Alam M, Ibrahim O, Nodzenski M, Strasswimmer JM, Jiang SI, Cohen JL, Albano BJ, Batra P, Behshad R, Benedetto AV, Chan CS, Chilukuri S, Crocker C, Crystal HW, Dhir A, Faulconer VA, Goldberg LH, Goodman C, Greenbaum SS, Hale EK, Hanke CW, Hruza GJ, Jacobson L, Jones J, Kimyai-Asadi A, Kouba D, Lahti J, Macias K, Miller SJ, Monk E, Nguyen TH, Oganesyan G, Pennie M, Pontius K, Posten W, Reichel JL, Rohrer TE, Rooney JA, Tran HT, Poon E, Bolotin D, Dubina M, Pace N, Kim N, Disphanurat W, Kathawalla U, Kakar R, West DP, Veledar E, Yoo S. Adverse events associated with mohs micrographic surgery: multicenter prospective cohort study of 20,821 cases at 23 centers. JAMA Dermatol. 2013 Dec;149(12):1378-85. doi: 10.1001/jamadermatol.2013.6255.

    PMID: 24080866RESULT

  • Freeman SC, Heath MS, Neill B, Morris C, Lucero OM, Yu W, Bar A, Leitenberger JJ. Tranexamic Acid Prevention of Hemorrhagic Complications Following Interpolated Flap Repair: A Single-Center, Retrospective, Cohort Study. Dermatol Surg. 2023 Dec 1;49(12):1139-1142. doi: 10.1097/DSS.0000000000003931. Epub 2023 Sep 14.

    PMID: 37712760RESULT

  • Wang W, Lee J, Qin S, Brown MD, Doerr T. Indications and Outcomes of Mohs Micrographic Surgery Using a Multidisciplinary Approach: A Decade of Experience. Dermatol Surg. 2021 Jan 1;47(1):10-15. doi: 10.1097/DSS.0000000000002467.

    PMID: 32541342RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 8, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share