Tranexamic Acid in Gender Mastectomy

Study Overview
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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.

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.

Official Title
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The Role of Tranexamic Acid in Aesthetic and Reconstructive Surgery

Conditions
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Surgery

Intervention / Treatment
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* Drug: Tranexamic Acid Irrigation
* Other: Saline Irrigation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: TXA would be randomized to one side with the other acting as a control
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Side: TXA Irrigation<br>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<br>* Tranexamic acid (TXA) is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, temporarily inhibiting the degradation of fibrin clots.<br>* Other names: TXA;|
| Placebo Comparator: Control Side: Saline Irrigation<br>Contralateral side will serve as a control | Other: Saline Irrigation<br>* Saline will serve as the control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gender mastectomy, top surgery