RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: University of Kansas Medical Center • ClinicalTrials.gov ID: NCT06379724

Registry updated: 2026-08-27

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Description

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.

Interventions

Tranexamic acid (Drug)
100mg/mL 10mL vials x2 of injectable tranexamic acid will be filled into a 20 milliliter syringe with a spray tip.
Thrombin JMI (Drug)
The wound base is then sprayed with a film of Thrombin-JMI
skin graft (Procedure)
Skin is taken from uninjured part of the participant's body and used to surgically cover a wound or injured area with skin that contains the epidermis and a portion of the dermis.

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

Conditions

Burns Skin Graft Complications

Locations

The University of Kansas Health System — Kansas City, Kansas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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