Impact of Topical Tranexamic Acid in Breast Reconstruction

Study Overview
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Brief Summary
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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
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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 will be followed up for assessments weekly for the first 4 weeks to assess for development of any of the outcomes of interest and assess for drain removal, 6 weeks, 3 months and 1 year after surgery for study outcomes.

Official Title
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The Impact of Tranexamic Acid in Reducing Hematoma and Seroma Formation in Reconstructive Post-oncologic Breast Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Tranexamic Acid
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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 Documented or reported allergic reaction to tranexamic acid Male participants

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TXA, Saline<br>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. | Drug: Tranexamic Acid<br>* Applied intraoperatively<br>* Other names: Lysteda;Other: Saline<br>* Applied intraoperatively<br>* Other names: Sodium Chloride 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with hematoma | Presence of hematoma in 30 day period from time of application in the operating room will be reported | Up to 1 month | 
| Number of participants with seroma | Presence of seroma within3 month period from time of application in the operating room will be reported | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Ecchymosis | 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. | Up to 1 year | 
| Median total drain output | 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. | Up to 1 month | 
| Median total drain duration | 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. | Up to 1 month | 
| Number of participants requiring reoperation | The number of participants requiring an additional operation related to the bilateral mastectomy will be reported. | Up to 1 year | 
| Proportion of participants with reported infection | The proportion of participants with demonstrated infection related to the bilateral mastectomy will be reported | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Reconstruction