Tranexamic Acid vs Thrombin for Skin Graft Complications
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppression, you cannot participate in the trial.
What data supports the effectiveness of the drug Tranexamic Acid for reducing complications in skin grafts?
Is Tranexamic Acid generally safe for use in humans?
Tranexamic Acid (TXA) is generally considered safe for use in various surgeries, with studies showing it effectively reduces blood loss and transfusion needs. However, it may increase the risk of seizures in cardiac surgery, and there are isolated reports of vascular issues like ulnar artery thrombosis. Overall, TXA has few adverse events, but more research is needed for certain surgical areas.12467
How is the drug Tranexamic Acid different from other treatments for skin graft complications?
Tranexamic Acid (TXA) is unique because it helps prevent bleeding by stopping the breakdown of blood clots, which can be particularly useful in surgeries where bleeding is a concern. Unlike other treatments, TXA is an antifibrinolytic agent, meaning it specifically targets and reduces bleeding, making it a novel option for managing complications in skin grafts.14589
What is the purpose of this trial?
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.
Research Team
Dhaval Bhavsar, MD
Principal Investigator
The University of Kansas Medical Center
Eligibility Criteria
This trial is for English or Spanish speakers with flame or scald burns covering 10% or less of their body. They must have a partial thickness burn and require a skin graft that's either meshed 1:1 or pie crusted if it's a small area, but not more than 5% deep partial/full thickness.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgery with either tranexamic acid or thrombin applied to the wound base during split thickness skin grafting
Post-operative Care
Participants receive routine post-operative care in the burn unit with assessments at 48-72 hours, 7-10 days, and 14 days post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including hematoma occurrence and graft adherence
Treatment Details
Interventions
- Thrombin JMI
- Tranexamic Acid
Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
- Hereditary angioedema
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
- Heavy menstrual bleeding
- Prevention of excessive bleeding during surgeries
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor