Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft
Recruiting
Phase 4Interventional Study
BurnsSkin Graft Complications
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
62 (estimated)
Sponsor
University of Kansas Medical Center · Other
Who this trial is looking for
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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.
Trial Locations
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Status
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…
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
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