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NCT Number: NCT07807371

Timing of Subcutaneous Tranexamic Acid Injection in Mohs Micrographic Surgery

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Subcutaneous TXA injection before reconstruction

Drug

Subcutaneous TXA injection before reconstruction

Subcutaneous TXA injection after reconstruction

Drug

Subcutaneous TXA injection after reconstruction

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)

    Time frame: 48 hours post procedure

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

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

    Time frame: 30 days

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

  2. Compare thromboembolic events through 30 days by chart review

    Time frame: 30 days

    Compare thromboembolic events through 30 days by chart review

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Registry information

Official study title

Timing of Subcutaneous Tranexamic Acid Injection in Mohs Micrographic Surgery: A Prospective, Multicenter, Two-Arm, Non-Inferiority Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

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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