RecruitingPhase 4NCT07131592

Effect of Intravenous and Topical Tranexamic Acid on Drain Output in Breast Reduction Surgery

The Effect of Tranexamic Acid on Drainage Volume and Time to Drain Removal in Reduction Mammaplasty Patients


Sponsor

Massachusetts General Hospital

Enrollment

160 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate whether tranexamic acid (TXA), a medication that helps reduce bleeding, can decrease fluid drainage after breast reduction surgery. Participants will be randomly assigned to receive either intravenous TXA or no TXA during surgery. Additionally, one breast will receive TXA through the surgical drain, while the other will receive saline. This approach allows to compare the effects of TXA on fluid buildup and healing. The goal is to improve recovery and reduce complications after breast reduction surgery.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • Adults aged 18 years or older
  • Elective bilateral breast reduction
  • Patient understands and is willing to participate in the study
  • Patient willing to and capable of providing informed consent

Exclusion Criteria12

  • Age less than 18 years old
  • Prior radiation to the breast
  • Secondary/Revision breast reduction
  • Known coagulopathy or bleeding disorders
  • Intraoperative coagulopathy
  • History of seizures
  • Active smokers
  • Allergy or contraindication to TXA
  • Pregnant or breastfeeding patients
  • Patient is unable or unwilling to complete the anticipated study follow-up
  • Inability to understand the aims and objectives of the study
  • Inability to or unwilling to provide informed consent

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Interventions

DRUGIV TXA

Patients randomized to the IV TXA group will receive intravenous Tranexamic acid during the procedure. The dose will be 1g IV infused over approx. 10 minutes prior to skin closure (dosing of approx. 15 mg/kg, capped at 1 g, which is within safe limits).

DRUGTopical TXA

Before wound closure, one 15mm round Jackson-Pratt (JP) drain is placed in each breast pocket, exiting through a lateral chest wall stab incision. The randomized topical TXA intervention is then applied through the drain into the breast after skin closure. The drains will then be temporarily clamped for 20 minutes to allow the TXA to dwell in the tissue and exert local effect. After this the clamp is released, the excess fluid sucked off and the drain connected to a drainage bottle.

DRUGTopical saline

Before wound closure, one 15mm round Jackson-Pratt (JP) drain is placed in each breast pocket, exiting through a lateral chest wall stab incision. The randomized saline intervention is then applied through the drain into the breast after skin closure. The drains will then be temporarily clamped for 20 minutes to allow the saline to dwell in the tissue and exert local effect. After this the clamp is released, the excess fluid sucked off and the drain connected to a drainage bottle.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT07131592


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