This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
107
The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.
There will be no additional irrigation after the standard surgical procedure.
University of Michigan
Ann Arbor, Michigan, United States
Hematomas
Results reflect the number of hematomas that occurred during the trial, requiring operative washout or aspiration in participants who received TXA versus participants who did not receive TXA.
Time frame: Up to approximately 4 weeks after surgery
Participants Who Experienced a Major Thromboembolic Event Related to the Study Drug
Results reflect the number of participants who experienced any major thromboembolic event during the trial. Major thromboembolic events included, but were not limited to, deep vein thrombosis, pulmonary embolism, and stroke.
Time frame: Up to approximately 4 weeks after surgery
Participants Who Experienced Major Complications Other Than Hematoma
Results reflect the number of participants who experienced any major complication other than a hematoma. Major complications included, but were not limited to, infection, seroma, hypersensitivity reaction to TXA, and renal impairment.
Time frame: Up to approximately 4 weeks after surgery
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