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| ID | Type | Description | Link |
|---|---|---|---|
| A539730 | Other Identifier | UW Madison | |
| SMPH/SURGERY/DENTL-PLASTC SRGY | Other Identifier | UW Madison |
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due to COVID
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Side: TXA Irrigation | Experimental | 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 |
|
| Control Side: Saline Irrigation | Placebo Comparator | Contralateral side will serve as a control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid Irrigation | Drug | Tranexamic acid (TXA) is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, temporarily inhibiting the degradation of fibrin clots. |
| Measure | Description | Time Frame |
|---|---|---|
| Days until drain removal | up to 30 days post-op |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
transgender males
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| Name | Affiliation | Role |
|---|---|---|
| Katy Gast, MD, MS | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
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TXA would be randomized to one side with the other acting as a control
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| Saline Irrigation | Other | Saline will serve as the control. |
|
| 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 |