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Tranexamic Acid in Gender Mastectomy

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ClinicalTrials.gov Identifier: NCT04372940
Recruitment Status : Suspended (Suspended due to COVID)
First Posted : May 4, 2020
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Surgery Drug: Tranexamic Acid Irrigation Other: Saline Irrigation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: TXA would be randomized to one side with the other acting as a control
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: The Role of Tranexamic Acid in Aesthetic and Reconstructive Surgery
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

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 Name: TXA

Placebo Comparator: Control Side: Saline Irrigation
Contralateral side will serve as a control
Other: Saline Irrigation
Saline will serve as the control.




Primary Outcome Measures :
  1. Days until drain removal [ Time Frame: up to 30 days post-op ]

Secondary Outcome Measures :
  1. Total drain output in mL for total time drain is in place [ Time Frame: up to 30 days post-op ]
  2. Drain fluid output in mL/day [ Time Frame: up to 30 days post-op ]
  3. Number of hematomas requiring aspiration or return to the operating room in the 30 days following surgery [ Time Frame: up to 30 days post-op ]
  4. Amount of fluid evacuated (mL) - hematomas [ Time Frame: up to 30 days post-op ]
    Amount of fluid evacuated (mL) if hematomas require aspiration or return to the operating room in the 30 days following surgery

  5. Number of seromas requiring aspiration or return to the operating room in the 30 days following surgery [ Time Frame: up to 30 days post-op ]
  6. Amount of fluid evacuated (mL) - seromas [ Time Frame: up to 30 days post-op ]
    Amount of fluid evacuated (mL) if seromas require aspiration or return to the operating room in the 30 days following surgery

  7. Number of Participants requiring transfusion for hemoglobin (Hgb) < 7.0 during postoperative admission [ Time Frame: up to 30 days post-op ]
  8. Number of units of blood transfused to maintain Hgb >7.0 in the postoperative admission [ Time Frame: up to 30 days post-op ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   transgender males
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04372940


Locations
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United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Katy Gast, MD, MS University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04372940    
Other Study ID Numbers: 2019-0410-GM
A539730 ( Other Identifier: UW Madison )
SMPH/SURGERY/DENTL-PLASTC SRGY ( Other Identifier: UW Madison )
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Wisconsin, Madison:
gender mastectomy
top surgery
Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants