Clinical trial NCT04372940: Tranexamic Acid in Gender Mastectomy
Official title: The Role of Tranexamic Acid in Aesthetic and Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Surgery
Keywords: gender mastectomy
top surgery
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: TXA would be randomized to one side with the other acting as a control
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Days until drain removal
timeFrame: up to 30 days post-op
Secondary outcomes:
measure: Total drain output in mL for total time drain is in place
timeFrame: up to 30 days post-op
measure: Drain fluid output in mL/day
timeFrame: up to 30 days post-op
measure: Number of hematomas requiring aspiration or return to the operating room in the 30 days following surgery
timeFrame: up to 30 days post-op
measure: Amount of fluid evacuated (mL) - hematomas
timeFrame: up to 30 days post-op
measure: Number of seromas requiring aspiration or return to the operating room in the 30 days following surgery
timeFrame: up to 30 days post-op
measure: Amount of fluid evacuated (mL) - seromas
timeFrame: up to 30 days post-op
measure: Number of Participants requiring transfusion for hemoglobin (Hgb) < 7.0 during postoperative admission
timeFrame: up to 30 days post-op
measure: Number of units of blood transfused to maintain Hgb >7.0 in the postoperative admission
timeFrame: up to 30 days post-op
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Katy Gast, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: