Healthy
Conditions
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.
Interventions
DRUGSubcutaneous TXA injection before reconstruction
Subcutaneous TXA injection before reconstruction
DRUGSubcutaneous TXA injection after reconstruction
Subcutaneous TXA injection after reconstruction
Sponsors
The Cooper Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of bleeding events 48 hours after surgery measured via documentation in electronic medical record (phone calls, urgent care/office visits for bleeding control) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 wound safety outcomes through 30 days, including dehiscence, infection, and, where applicable, partial or complete flap/graft necrosis. |
| Compare thromboembolic events through 30 days by chart review | 30 days | Compare thromboembolic events through 30 days by chart review |
Outcome results
None listed