Tranexamic Acid in Gender Mastectomy

The Role of Tranexamic Acid in Aesthetic and Reconstructive Surgery

The goal of this study is to examine the use of tranexamic acid (TXA) in gender mastectomy surgery, specifically looking at volume loss (blood and transudate) postoperatively.

Study Overview

• Status: Withdrawn
• Conditions: Surgery
• Intervention / Treatment: Drug: Tranexamic Acid Irrigation; Other: Saline Irrigation

Detailed Description

Anecdotal data from plastic surgeons around the country suggests that tranexamic acid has decreased patient's drain outputs, swelling, and bruising. Based on these anecdotal reports, many University of Wisconsin (UW) surgeons in Plastic and Reconstructive Surgery became interested in its use. It has a very safe profile and is inexpensive; therefore, many UW plastic surgeons have started using it topically prior to closure in many of procedures. Surgeons notice decreased drain output and bruising; and therefore decided to formally study the effects of tranexamic acid to determine whether there was a statistical difference in outcomes with the use of the drug.

For this sub-study, topical TXA will be applied to the surface of surgical sites and the primary outcome will be days to drain removal postoperatively. Secondary outcomes that would be assessed is total drain fluid output in milliliters, hematoma and seroma rates, and need for transfusion for hemoglobin < 7.0 postoperatively.

The hypothesis is that the use of TXA will result in earlier removal of drains by decreasing total drain fluid output and decreased need for transfusions, thus minimizing the associated complications/risks with drains and transfusions. The overall study is in two-parts, 1) a prospective study with retrospective controls via chart review and 2) a prospective controlled trial in bilateral procedures where participants serve as their own control with one side having tranexamic acid irrigation and the other side having saline irrigation.

This record documents a prospective controlled trial of the use of TXA in gender mastectomy, specifically.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Undergoing gender mastectomy
• English speaking

Exclusion Criteria:

• History of thrombotic event (ie deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction)
• genetic disorder that increases risk of thrombosis
• use of estrogens at time of surgery
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Side: TXA Irrigation; 2.5% tranexamic acid will be applied directly to the wound via bulb irrigation and left in place for 5 minutes in the wound bed	Drug: Tranexamic Acid Irrigation; Tranexamic acid (TXA) is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, temporarily inhibiting the degradation of fibrin clots.; Other Names: TXA
Placebo Comparator: Control Side: Saline Irrigation; Contralateral side will serve as a control	Other: Saline Irrigation; Saline will serve as the control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Days until drain removal	up to 30 days post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total drain output in mL for total time drain is in place		up to 30 days post-op
Drain fluid output in mL/day		up to 30 days post-op
Number of hematomas requiring aspiration or return to the operating room in the 30 days following surgery		up to 30 days post-op
Amount of fluid evacuated (mL) - hematomas	Amount of fluid evacuated (mL) if hematomas require aspiration or return to the operating room in the 30 days following surgery	up to 30 days post-op
Number of seromas requiring aspiration or return to the operating room in the 30 days following surgery		up to 30 days post-op
Amount of fluid evacuated (mL) - seromas	Amount of fluid evacuated (mL) if seromas require aspiration or return to the operating room in the 30 days following surgery	up to 30 days post-op
Number of Participants requiring transfusion for hemoglobin (Hgb) < 7.0 during postoperative admission		up to 30 days post-op
Number of units of blood transfused to maintain Hgb >7.0 in the postoperative admission		up to 30 days post-op

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Katy Gast, MD, MS, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: gender mastectomy; top surgery
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2019-0410-GM; A539730 (Other Identifier: UW Madison); SMPH/SURGERY/DENTL-PLASTC SRGY (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No