NCT06379724 Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft
| NCT ID | NCT06379724 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Kansas Medical Center |
| Condition | Burns |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2024-07-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 62 participants in total. It began in 2024-07-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Dhaval Bhavsar, MBBS
PRINCIPAL INVESTIGATOR
University of Kansas Medical Center
Frequently Asked Questions
Who can join the NCT06379724 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Burns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06379724 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06379724 currently recruiting?
Yes, NCT06379724 is actively recruiting participants. Contact the research team at jreynolds11@kumc.edu for enrollment information.
Where is the NCT06379724 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT06379724 clinical trial?
NCT06379724 is sponsored by University of Kansas Medical Center. The principal investigator is Dhaval Bhavsar, MBBS at University of Kansas Medical Center. The trial plans to enroll 62 participants.