Health TrialsbyHealthPanel

Timing of Subcutaneous Tranexamic Acid Injection in Mohs Micrographic Surgery

ConditionHealthy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cooper Health System

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Subcutaneous TXA injection before reconstruction

    Drug

    Subcutaneous TXA injection before reconstruction

  • Subcutaneous TXA injection after reconstruction

    Drug

    Subcutaneous TXA injection after reconstruction

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Subcutaneous TXA prior to reconstructionActive comparator 1 intervention
Group B: Subcutaneous TXA after reconstructionActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cooper Health System

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: