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Tranexamic Acid in Gender Mastectomy

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status and phase

Withdrawn
Phase 4

Conditions

Surgery

Treatments

Other: Saline Irrigation
Drug: Tranexamic Acid Irrigation

Study type

Interventional

Funder types

Other

Identifiers

NCT04372940
2019-0410-GM
A539730 (Other Identifier)
SMPH/SURGERY/DENTL-PLASTC SRGY (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

Intervention Side: TXA Irrigation
Experimental group
Description:
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
Treatment:
Drug: Tranexamic Acid Irrigation
Control Side: Saline Irrigation
Placebo Comparator group
Description:
Contralateral side will serve as a control
Treatment:
Other: Saline Irrigation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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