Impact of Topical Tranexamic Acid in Breast Reconstruction

• Status: Recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: Female

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. The proposed prospective study will evaluate the utility of topical tranexamic acid in decreasing hematoma and seroma rates, drain output, and ecchymosis in post-mastectomy breast reconstruction patients. TXA in breast surgery may provide a simple, cost-effective, and safe way to improve outcomes and satisfaction for breast cancer patients.

Participants will be recruited from patients undergoing bilateral mastectomy at University of California, San Francisco.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

1. Histologically confirmed breast malignancy OR increased risk for breast cancer

2. Age >= 18 years

3. Scheduled to undergo bilateral mastectomy with plastic surgery closure or reconstruction

4. Ability to understand a written informed consent document, and the willingness to sign it

5. At least 4 weeks post-completion of chemotherapy or radiation therapy

Exclusion Criteria:

1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study

2. Any history of thromboembolic disease

3. Current anticoagulant use

4. Current use of chlorpromazine due to label contraindication

5. Current use of any prothrombotic medical products due to label contraindication

6. Documented or reported allergic reaction to tranexamic acid

7. Male participants