MedTrace Logo

Use of Tranexamic Acid in Reduction Mammoplasty

NCT04947514 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-04-10

Study results available
· View outcomes & findings →

Summary

Breast reduction mammoplasty (BRM) is among the most commonly performed procedures in plastic surgery. However, postoperative hematoma is one of the most common complications following BRM. Hematoma-related complications include unplanned surgery, need for blood transfusion, wound healing issues, and unfavorable surgical outcomes.

Tranexamic acid has emerged in the literature as a promising agent that reduces perioperative blood loss and need for transfusion. However, despite its consistently reported efficacy, low cost, and favorable safety profile, tranexamic acid remains underutilized in plastic surgery.

The investigators propose a prospective, double-blinded randomized controlled study of the efficacy of tranexamic acid in reducing hematoma development in patients undergoing reduction mammoplasty. The investigators hope to contribute to the growing body of literature supporting tranexamic acid to reduce unwanted surgical bleeding.

Conditions

  • Hematoma Postoperative
  • Venous Thromboembolism

Interventions

DRUG

Tranexamic acid

Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.

OTHER

Placebo (topical saline)

The untreated breast will receive topical saline.

Sponsors & Collaborators

  • The Plastic Surgery Foundation

    collaborator OTHER

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Joseph A Ricci, MD · Montefiore Medical Center/Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-29
Primary Completion
2022-07-13
Completion
2022-07-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04947514 on ClinicalTrials.gov