Impact of Topical Tranexamic Acid in Breast Reconstruction

Phase 4TerminatedNCT05807074

University of California, San Francisco23 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Breast Pockets That Develop a Hematoma

Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported.

Time frame: Up to 1 month

Number of Breast Pockets That Develop a Seroma

Presence of seroma in the surgical area within 3-month period from time of treatment application in the operating room will be reported.

Time frame: Up to 3 months

Secondary Outcomes

Number of Breast Pockets That Developed Ecchymosis

Ecchymosis will be measured separately for the right and left breast pocket 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.

Time frame: 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 \< 30 cubic centimeters (cc) per day for at least 3 days.

Time frame: Approximately 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.

Time frame: Approximately 1 month

Number of Participants Requiring Reoperation After Completion of Bilateral Mastectomy

The number of participants requiring an additional operation related to the bilateral mastectomy will be reported.

Time frame: Up to 1 year

Proportion of Participants With Reported Infection in Surgical Area Post-mastectomy

The proportion of participants with demonstrated infection in surgical area related to the bilateral mastectomy will be reported.

Time frame: Up to 1 year

Impact of Topical Tranexamic Acid in Breast Reconstruction

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes