Tranexamic Acid in Gender Mastectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

TXA would be randomized to one side with the other acting as a control

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Tranexamic Acid Irrigation

Intervention Type DRUG

Tranexamic acid (TXA) is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, temporarily inhibiting the degradation of fibrin clots.

Control Side: Saline Irrigation

Contralateral side will serve as a control

Group Type PLACEBO_COMPARATOR

Saline Irrigation

Intervention Type OTHER

Saline will serve as the control.

Interventions

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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.

Intervention Type DRUG

Saline Irrigation

Saline will serve as the control.

Intervention Type OTHER

Other Intervention Names

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TXA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes