Impact of Topical Tranexamic Acid in Breast Reconstruction (NCT05807074) | Clinical Trial Compass
TerminatedPhase 4
Impact of Topical Tranexamic Acid in Breast Reconstruction
Stopped: Slow Accrual
United States23 participantsStarted 2023-04-20
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Histologically confirmed breast malignancy OR increased risk for breast cancer
✓. Age \>= 18 years
✓. Scheduled to undergo bilateral mastectomy with plastic surgery closure or reconstruction
✓. Ability to understand a written informed consent document, and the willingness to sign it
✓. At least 4 weeks post-completion of chemotherapy or radiation therapy
Exclusion criteria
✕. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study
✕. Any history of thromboembolic disease
✕. Current anticoagulant use
✕. Current use of chlorpromazine due to label contraindication
✕. Current use of any prothrombotic medical products due to label contraindication