Actively Recruiting
The Use of Topical Tranexamic Acid Versus Thrombin Spray for the Management of Split Thickness Skin Graft Recipient Site in Burn Management
Led by University of Kansas Medical Center · Updated on 2025-10-20
62
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of topical tranexamic acid compared to the current standard of care, Thrombin-JMI, for managing burn wounds that require a split thickness skin graft. The study aims to show that tranexamic acid is not less effective than thrombin in reducing hematoma formation at the wound site and may provide a lower-cost alternative. This Phase 4 trial focuses on patients with specific types of burn injuries and skin graft procedures. Participants will be randomly assigned to one of two groups. In the control group, the wound base is treated with a spray of Thrombin-JMI before the skin graft is applied. In the experimental group, tranexamic acid solution is sprayed onto the wound base instead, using a syringe with a spray tip. Both groups undergo the same surgical preparation, skin graft harvesting, and application process. After surgery, patients receive standard postoperative care in a burn unit. During the study, participants will be assessed at several time points: 48 to 72 hours, 7 to 10 days, and 14 days after surgery. At these visits, trained staff will check for hematoma occurrence, measure how well the skin graft is adhering, and note if any reoperation is needed. The study also compares the costs of using tranexamic acid versus thrombin during surgery. Overall, the total participation spans from surgery through the 14-day follow-up period with detailed wound evaluations.
CONDITIONS
Brief Title
Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English or Spanish speaking
- Flame or scald burn injury
- 10% or less total body surface area partial thickness burn
- 5% or less total body surface area deep partial or full thickness burn
- Skin graft harvested at 1/12 inch depth, meshed 1:1 or pie crusted if the area is a small functional area
You will not qualify if you...
- More than 10% total body surface area partial thickness burn
- More than 5% total body surface area 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to obtain informed consent and assess eligibility
Duration - Surgery typically takes 60 to 120 minutes with immediate post-operative care continuing until initial recovery
Participants undergo split thickness skin graft surgery where either tranexamic acid or thrombin spray is applied to the wound base to control bleeding, followed by skin graft application and fixation. Participants recover from anesthesia and receive routine post-operative care in the burn unit.
1 surgical visit (in-person)
Duration - 14 days post-surgery
Participants have dressing changes and wound assessments to monitor hematoma occurrence, graft adherence, and need for reoperation. Follow-up visits include measurements at 48 to 72 hours, and clinic visits or hospital assessments at 7 to 10 days and 14 days after surgery.
3 visits (at 48-72 hours, 7-10 days, and 14 days post-surgery)
Trial Site Locations
Total: 1 location
1
The University of Kansas Health System
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
J
Jessica Reynolds, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here