Tranexamic Acid in Gender Mastectomy

Surgery Clinical Trial

Official title:

The Role of Tranexamic Acid in Aesthetic and Reconstructive Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04372940
• Other study ID #: 2019-0410-GM
• Secondary ID: A539730SMPH/SURG
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2023
• Est. completion date: January 2024

Study information

• Verified date: January 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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:
• Saline Irrigation
Saline will serve as the control.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days until drain removal		up to 30 days post-op
Secondary	Total drain output in mL for total time drain is in place		up to 30 days post-op
Secondary	Drain fluid output in mL/day		up to 30 days post-op
Secondary	Number of hematomas requiring aspiration or return to the operating room in the 30 days following surgery		up to 30 days post-op
Secondary	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
Secondary	Number of seromas requiring aspiration or return to the operating room in the 30 days following surgery		up to 30 days post-op
Secondary	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
Secondary	Number of Participants requiring transfusion for hemoglobin (Hgb) < 7.0 during postoperative admission		up to 30 days post-op
Secondary	Number of units of blood transfused to maintain Hgb >7.0 in the postoperative admission		up to 30 days post-op