Comparing tranexamic acid and thrombin for skin grafts in burn patients
The Use of Topical Tranexamic Acid Versus Thrombin Spray for the Management of Split Thickness Skin Graft Recipient Site in Burn Management
This study is testing whether using tranexamic acid instead of thrombin can help burn patients have better skin grafts by reducing swelling at the wound site.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06379724 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy of topical tranexamic acid compared to the standard treatment of thrombin in reducing hematoma formation at the wound base in patients undergoing split thickness skin grafts for burn injuries. Participants will be randomly assigned to receive either tranexamic acid or thrombin during their surgical procedure. The study will assess whether tranexamic acid can serve as a non-inferior, cost-effective alternative to thrombin. The trial will involve informed consent, preoperative preparation, and standardized surgical techniques to ensure consistency in treatment.
Who should consider this trial
Good fit: Ideal candidates include English or Spanish speaking individuals with flame or scald burn injuries covering less than 10% of total body surface area.
Not a fit: Patients with extensive burns, traumatic or chemical burn mechanisms, or those with certain medical conditions such as uncontrolled diabetes or immunosuppression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more cost-effective treatment option for patients undergoing skin grafts after burns, potentially improving healing outcomes.
How similar studies have performed: While this approach is novel in the context of burn treatment, similar studies have explored the use of tranexamic acid in other surgical settings with promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kansas City, Kansas
- The University of Kansas Health System — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Dhaval Bhavsar, MBBS — University of Kansas Medical Center
- Study coordinator: Jessica Reynolds, BSN
- Email: jreynolds11@kumc.edu
- Phone: 913-588-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.