Tranexamic Acid for Breast Reduction Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether tranexamic acid (TXA), a medication that reduces bleeding, can aid healing after breast reduction surgery by decreasing fluid buildup. Participants will join different groups to test TXA's effect on recovery, with some receiving the medication through an IV during surgery and/or directly into the surgical site. The study aims to determine if TXA can make recovery smoother and reduce complications. It suits adults planning an elective breast reduction who haven't had previous radiation to the breast and don't have bleeding disorders. As a Phase 4 trial, TXA is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.
What is the safety track record for tranexamic acid?
Research has shown that tranexamic acid (TXA) is generally safe for surgeries such as breast reduction. Studies have found that TXA lowers the risk of bleeding without causing major side effects. Administering TXA through an IV significantly reduces the chance of a hematoma, where blood collects outside blood vessels. This method has not been linked to a higher risk of blood clots, despite a few reports suggesting otherwise.
Topical TXA, applied directly to the surgical area, also reduces the risk of blood and fluid buildup. It helps prevent seroma, which is fluid collecting under the skin, and has no major side effects.
Both intravenous and topical TXA improve outcomes in breast surgery, making them promising for reducing complications like excessive bleeding or fluid drainage after surgery.12345Why are researchers enthusiastic about this study treatment?
Tranexamic acid (TXA) is unique in breast reduction surgery because it can be administered both intravenously and topically to potentially reduce blood loss and postoperative bleeding. Unlike traditional methods that mainly focus on intravenous administration, this trial explores the effectiveness of topical application directly through surgical drains. Researchers are excited because using TXA topically is thought to enhance clot stability right at the surgical site, potentially improving recovery times and outcomes. This dual approach could offer a more targeted and efficient way to manage bleeding, setting it apart from the current standard care options.
What evidence suggests that this trial's treatments could be effective for reducing fluid drainage after breast reduction surgery?
Research has shown that tranexamic acid (TXA) reduces bleeding and fluid buildup in breast surgeries. In this trial, participants will receive TXA in different ways. One arm administers TXA through an IV during surgery, which studies have shown lowers the chances of blood clots and shortens the time surgical drains are needed, aiding recovery after breast reduction surgery. Another arm applies TXA directly to the surgery area, significantly reducing blood clots and fluid drainage. This trial tests both methods—IV and direct application—to improve surgical outcomes by reducing bleeding problems.12678
Are You a Good Fit for This Trial?
This trial is for adults over 18 who understand and agree to participate, can give informed consent, and are scheduled for elective bilateral breast reduction surgery. It's not specified who cannot join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo bilateral breast reduction surgery with randomization to receive intravenous TXA or no TXA, and each breast receives either TXA or saline via the surgical drain.
Postoperative Monitoring
Participants are monitored for drain output, fluid color change, and other postoperative outcomes until drain removal.
Follow-up
Participants are monitored for safety and effectiveness, including seroma rate, infection rate, and patient-reported outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- Tranexamic Acid
Trial Overview
The study tests if tranexamic acid (TXA), a drug that reduces bleeding, can lower fluid drainage after breast reduction surgery. Participants will get either IV TXA or none during surgery; one breast will be treated with topical TXA and the other with saline to compare effects.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Participants in this arm receive no intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with TXA administered through the surgical drain.
Participants in this arm receive a single dose of intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with topical TXA administered through the surgical drain.
Participants in this arm receive a single dose of intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with saline administered through the surgical drain.
Participants in this arm receive no intravenous tranexamic acid (TXA) during surgery. After skin closure, one breast is treated with saline administered through the surgical drain.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
The Usage of Intravenous Tranexamic Acid in Reduction ...
The use of IV TXA is a safe and effective way to reduce hematoma rates in patients receiving reduction mammoplasty. Keywords: breast reduction, hematoma, TXA ...
Tranexamic Acid in Breast Surgery – A Systematic Review ...
Both topical and intravenous TXA in breast surgery significantly reduce hematoma and reduce drain output and time upon drain removal.
3.
clinicaltrials.gov
clinicaltrials.gov/study/NCT07131592?locStr=United+States&country=United+States&aggFilters=status%3AEffect of Intravenous and Topical Tranexamic Acid on Drain ...
This study aims to evaluate whether tranexamic acid (TXA), a medication that helps reduce bleeding, can decrease fluid drainage after breast reduction ...
Intravenous Tranexamic Acid Reduces Perioperative Blood ...
This randomized, triple-blinded, placebo-controlled trial demonstrated that a single pre-incisional intravenous dose of TXA (10 mg/kg) significantly reduced ...
Plastic and Reconstructive Surgery – Global Open
CONCLUSION: Intravenous TXA use in reduction mammoplasty confers lower rates of wound dehiscence and hospital readmission, building upon the expanding support ...
The Use of Tranexamic Acid in Breast Reduction and ...
Most studies have supported the conclusion that there is no increased risk of VTE conferred with its use,33,34 although a few other publications have suggested ...
The Use of Tranexamic Acid in Breast Reduction and ...
Results: No significant differences in the rates or risks of hematoma, seroma, or the need for procedural drainage between patients administered ...
8.
unboundmedicine.com
unboundmedicine.com/medline/citation/36729851/The_Usage_of_Intravenous_Tranexamic_Acid_in_Reduction_Mammaplasty_Safely_Reduces_Hematoma_Rates_The Usage of Intravenous Tranexamic Acid in Reduction ...
The use of IV TXA is a safe and effective way to reduce hematoma rates in patients receiving reduction mammoplasty. Links. PMC Free PDF ...
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