NCT05441592

A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hematoma Postoperative

Interventions

Type	Name	Description
DRUG	Tranexamic acid injection	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.
OTHER	No additional irrigation	There will be no additional irrigation after the standard surgical procedure.

Timeline

• Start date: 2022-08-15
• Primary completion: 2024-10-22
• Completion: 2024-10-22
• First posted: 2022-07-01
• Last updated: 2025-11-26
• Results posted: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study