Impact of Topical Tranexamic Acid in Breast Reconstruction

Phase 4

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Tranexamic Acid; Other: Saline

• Registration Number: NCT05807074
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

PRIMARY OUTCOMES:

I. To investigate whether topical tranexamic acid may impact rates of seroma, hematoma, severe bruising, and drain output in the post-mastectomy reconstructive population.

II. To evaluate the impact of TXA on seroma rates compared to control.

SECONDARY OUTCOMES:

I. To evaluate the impact of TXA on patient and provider rating of bruising, comparing the TXA side to the control side.

II. To evaluate the impact of TXA on total drain output in the first post operative day.

III. To evaluate the impact of TXA on total drain duration.

OUTLINE:

Participants will only be treated intra-operatively at the time of surgery with topical TXA to one breast pocket. Each participant will serve as own internal control, with one side receiving saline and the other TXA. Participants in this study will be assessed at their regularly scheduled visits up to one year post-operatively.

Study Timeline

• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-04-10
• Study Start: 2023-04-20
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TXA, Saline	Saline	Each participant will have one breast exposed to TXA in the breast pocket and the other to saline only prior to closure. During surgery and prior to wound closure, the wound surface will be moistened on one side with 20 cc of dilute TXA 25mg/ml solution, and the contralateral with 20cc of saline.
TXA, Saline	Tranexamic Acid	Each participant will have one breast exposed to TXA in the breast pocket and the other to saline only prior to closure. During surgery and prior to wound closure, the wound surface will be moistened on one side with 20 cc of dilute TXA 25mg/ml solution, and the contralateral with 20cc of saline.

Primary Outcome Measures

Name	Time	Method
Number of participants with seroma	Up to 3 months	Presence of seroma within 3-month period from time of application in the operating room will be reported
Number of participants with hematoma	Up to 1 month	Presence of hematoma in 30 day period from time of application in the operating room will be reported

Secondary Outcome Measures

Name	Time	Method
Median total drain duration	Up to 1 month	The median time of total drain duration from drain placement in the operating room to removal of the drain will be reported descriptively for the saline only and TXA treated breast.
Number of participants requiring reoperation	Up to 1 year	The number of participants requiring an additional operation related to the bilateral mastectomy will be reported.
Frequency of Ecchymosis	Up to 1 year	Ecchymosis will be measured separately for the right and left breast at each post operative visit and documented. The observer will be blinded to the laterality of TXA. Both participant and provider will be asked to rank which side, the right or left side, has worse bruising. The frequency of ecchymosis for the right and left side will be reported descriptively.
Median total drain output	Up to 1 month	Total drain output over the life of the drain from drain placement in the operating room to discharge on post-operation day 1. Drains will be removed per standard practice at our institution which is when they have produced \< 30cc/day for at least 3 days.
Proportion of participants with reported infection	Up to 1 year	The proportion of participants with demonstrated infection related to the bilateral mastectomy will be reported

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States