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Recruiting Phase 4 NCT06379724

Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft

Trial Parameters

Condition Burns
Sponsor University of Kansas Medical Center
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 62
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-07-11
Completion 2026-12
Interventions
Tranexamic acidThrombin JMIskin graft

Brief Summary

Investigators hypothesize that topical tranexamic acid will have better or comparable efficacy to topical thrombin in reducing hematoma formation at the wound base. The purpose of the study is to demonstrate that topical tranexamic acid will be a non-inferior alternative medication to the current standard of care,THROMBIN-JMI® , and at a lower cost to the health system.

Eligibility Criteria

Inclusion Criteria: * English or Spanish speaking * Flame or scald burn injury * \<=10% total body surface area (TBSA) partial thickness * \<= 5% total body surface area (TBSA) deep partial or full thickness * Skin graft harvested at 1/12 inch depth, meshed 1:1 or pie crusted if the area is a small functional area Exclusion Criteria: * \>10% total body surface area (TBSA) partial thickness burn * \>5% total body surface area (TBSA )surgical area of burn injury (deep partial or full thickness injury) * Traumatic or chemical burn mechanism * Patients on immunosuppression * Uncontrolled diabetes * Known diagnosis of peripheral vascular disease or diagnosis at time of injury * Pregnant women * Patients with acquired defective color vision * Patients with subarachnoid hemorrhage * Patients with active intravascular clotting or known hypersensitivity reactions to tranexamic acid * Inability to give informed consent

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