Surgery
Conditions
Keywords
gender mastectomy, top surgery
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.
Interventions
DRUGTranexamic 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.
OTHERSaline Irrigation
Saline will serve as the control.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
TXA would be randomized to one side with the other acting as a control
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days until drain removal | up to 30 days post-op |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Total drain output in mL for total time drain is in place | up to 30 days post-op | — |
| Amount of fluid evacuated (mL) - seromas | 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 |
| 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 | — |
| Number of seromas requiring aspiration or return to the operating room in the 30 days following surgery | up to 30 days post-op | — |
Countries
United States
Outcome results
None listed