drugset / Trial / NCT05807074

Impact of Topical Tranexamic Acid in Breast Reconstruction

NCT05807074 ↗

Phase 4 Terminated 23 enrolled University of California, San Francisco
NaSingle-groupOpen-labelSupportive care

Summary

Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operative bleeding (hematomas) and fluid collections (seromas) in women undergoing surgery to remove both breasts (bilateral mastectomy) immediately followed by surgery to rebuild the breast (reconstruction). The formation of hematomas and seromas, a common post-mastectomy complication, can interfere with breast reconstruction and increase the risk of infection and wound healing and can potentially delay cancer treatments. TXA is a synthetic molecule that pushes the body's clotting cascade toward clot formation to improve blood clotting. Applying TXA topically to the surgical site before closing the incision may prevent hematoma and seroma formation in post-mastectomy breast reconstruction patients. Participants will be recruited from patients undergoing bilateral mastectomy at University of California, San Francisco.

Timeline

Start
2023-04-20
Primary completion
2024-11-30
Completion
2024-11-30

Outcome

Outcome not reported

Stopped (Enrollment): “Slow Accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 25 mg/ml Topical

Indications