RecruitingPhase 4NCT06379724

Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft

The Use of Topical Tranexamic Acid Versus Thrombin Spray for the Management of Split Thickness Skin Graft Recipient Site in Burn Management

Sponsor

University of Kansas Medical Center

Enrollment

62 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

Burns Skin Graft Complications

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria11

\>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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Interventions

DRUGTranexamic acid

100mg/mL 10mL vials x2 of injectable tranexamic acid will be filled into a 20 milliliter syringe with a spray tip.

DRUGThrombin JMI

The wound base is then sprayed with a film of Thrombin-JMI

PROCEDUREskin graft

Skin is taken from uninjured part of the participant's body and used to surgically cover a wound or injured area with skin that contains the epidermis and a portion of the dermis.