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Not yet recruitingNCT07807371Updated Sep 8, 2026

Timing of Subcutaneous Tranexamic Acid Injection in Mohs Micrographic Surgery

An interventional study of Subcutaneous TXA injection before reconstruction and Subcutaneous TXA injection after reconstruction in Healthy, sponsored by The Cooper Health System. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by The Cooper Health System · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Known allergy or hypersensitivity to TXA.
  2. Active deep-vein thrombosis, pulmonary embolism, stroke, myocardial infarction, or other active thromboembolic event at the time of surgery.
  3. Thromboembolic event within the previous 3 months.
  4. Systolic blood pressure greater than 200 mmHg at the time of surgery.
  5. Pregnancy or breastfeeding.
  6. Planned second-intention healing without reconstruction.
  7. History of seizures or current medication judged by the investigator to materially lower seizure threshold.
  8. Reported serum creatinine of 5 mg/dL or greater.
  9. Unable to complete the 48-hour outcome assessment or standard postoperative follow-up.
  10. Prior enrollment in this study.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
500 participants (estimated)

Study arms

  • Active comparator
    Subcutaneous TXA prior to reconstruction

    Subcutaneous TXA prior to reconstruction

    Drug: Subcutaneous TXA injection before reconstruction

  • Active comparator
    Subcutaneous TXA after reconstruction

    Subcutaneous TXA after reconstruction

    Drug: Subcutaneous TXA injection after reconstruction

Interventions

  • DrugSubcutaneous TXA injection before reconstruction

    Subcutaneous TXA injection before reconstruction

  • DrugSubcutaneous TXA injection after reconstruction

    Subcutaneous TXA injection after reconstruction

05

What researchers measure

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.

    Time frame: 48 hours post procedure

Secondary outcomes

  1. 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

    Compare wound safety outcomes through 30 days, including dehiscence, infection, and, where applicable, partial or complete flap/graft necrosis.

    Time frame: 30 days

  2. Compare thromboembolic events through 30 days by chart review

    Compare thromboembolic events through 30 days by chart review

    Time frame: 30 days

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 34087356 ↗
  • 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. PubMed 39235116 ↗
  • 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. PubMed 30640775 ↗
  • 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. PubMed 36728063 ↗
  • 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. PubMed 24080866 ↗
  • 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. PubMed 37712760 ↗
  • 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. PubMed 32541342 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07807371
Lead sponsor
The Cooper Health System
Responsible party
Naomi Lawrence (PI, The Cooper Health System) — Principal investigator
First posted
Sep 8, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 1, 2028 (estimated)
Completion
Nov 1, 2028 (estimated)
Last update
Sep 8, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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