Recruiting

Tranexamic Acid vs. ThrombinBurn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft

Sponsor:

University of Kansas Medical Center

Code:

NCT06379724

Conditions

Burns

Skin Graft Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tranexamic acid

Thrombin JMI

skin graft

Study Details

Brief 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.

Conditions

Burns

Skin Graft Complications

Study ID

NCT06379724

Start date

Jul 11, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

Prior to application of the skin graft, a thin layer of thrombin is sprayed onto the wound base. The skin graft is then applied to the recipient site and fixated in standard fashion.

experimental: Experimental

Tranexamic acid solution will be sprayed onto the wound base after excision and prior to skin graft appliance in the same manner as the thrombin spray in the control group

Interventions

Tranexamic acid

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

Thrombin JMI

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

skin 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.

Primary outcome measure

The number of participants with hematoma occurrence [ Time Frame: Post-operative day fourteen, plus or minus two days ]
The rate of percentage of graft take adherence amongst participants [ Time Frame: Post-operative day fourteen, plus or minus two days ]
Comparison of number of participants that require re-operation [ Time Frame: Post-operative day fourteen, plus or minus two days ]

Central Contacts and Locations

Central contacts

Jessica Reynolds, BSN

913-588-5000 jreynolds11@kumc.edu

Locations

The University of Kansas Health System

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Jessica Reynolds, BSN

913-588-0044 jreynolds11@kumc.edu

Dhaval Bhavsar, MBBS

913-588-2000 dbhavsar@kumc.edu

Principal Investigator:

Dhaval R Bhavsar, MBBS

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-08-27.