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drugset / Trial / NCT05441592

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

NCT05441592 ↗

Phase 4 Completed 107 enrolled University of Michigan
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2022-08-15
Primary completion
2024-10-22
Completion
2024-10-22

Outcome

Missed primary endpoint

registry analysis (superiority test); Irrigation that contains tranexamic acid (TXA) vs No additional irrigation usual care; p = 0.486; Fisher Exact NCT05441592 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 2.67 % Topical
Subject Tranexamic Acid Small molecule 150 ml Topical

Indications

No indication recorded.