Clinical trial NCT05807074: Impact of Topical Tranexamic Acid in Breast Reconstruction
Official title: The Impact of Tranexamic Acid in Reducing Hematoma and Seroma Formation in Reconstructive Post-oncologic Breast Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Breast Reconstruction
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with hematoma
timeFrame: Up to 1 month
measure: Number of participants with seroma
timeFrame: Up to 3 months
Secondary outcomes:
measure: Frequency of Ecchymosis
timeFrame: Up to 1 year
measure: Median total drain output
timeFrame: Up to 1 month
measure: Median total drain duration
timeFrame: Up to 1 month
measure: Number of participants requiring reoperation
timeFrame: Up to 1 year
measure: Proportion of participants with reported infection
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Merisa Piper, MD
role: PRINCIPAL_INVESTIGATOR
References: