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

Mass General Brigham

Status and phase: Not yet enrolling; Phase 4

Conditions: Breast Reductions; Drain Output After Breast Reduction Surgery

Treatments: Drug: Topical saline; Drug: Topical TXA; Drug: IV TXA

Study type: Interventional

Funder types: Other

Identifiers

NCT07131592

2025P001908

Details and patient eligibility

About

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.

Full description

This single-center, prospective, randomized controlled trial investigates the effect of tranexamic acid (TXA) on postoperative drain output and recovery following bilateral reduction mammaplasty. While TXA is widely utilized to minimize intraoperative blood loss, its role in optimizing postoperative wound healing and fluid management in plastic surgery remains underexplored.

Participants undergoing bilateral breast reduction will be randomized to receive either intravenous TXA or no TXA at the time of surgery. In addition, each breast will be independently randomized to receive TXA or saline via the closed-suction drain after skin closure. This split-body design enables a controlled intra-individual comparison of local TXA effects, while concurrently assessing systemic administration in a parallel fashion.

Primary outcomes include total drain output per breast and time to drain removal. Secondary endpoints include the incidence of postoperative hematoma and patient reported outcomes. All outcome measures will be recorded using standardized protocols and assessed by blinded evaluators where applicable.

Participants will be followed until 30 days postoperatively.

Given the established safety profile of TXA and the relatively low-risk nature of the intervention, no independent data monitoring committee has been appointed. The study has been approved by the local IRB and will adhere to institutional standards for adverse event monitoring and reporting.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 4 patient groups, including a placebo group

IV TXA + Topical TXA

Experimental group

Description:

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.

Treatment:

Drug: IV TXA

Drug: Topical TXA

IV TXA + Topical Saline

Active Comparator group

Description:

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.

Treatment:

Drug: IV TXA

Drug: Topical saline

No IV TXA + Topical TXA

Experimental group

Description:

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.

Treatment:

Drug: Topical TXA

No IV TXA + Topical Saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Topical saline