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

August 24, 2026 updated by: Dhaval Bhavsar, University of Kansas Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Enrolled subjects will be randomized to the control group or the tranexamic acid experimental group. Informed consent for study participation will be obtained by a team member preoperatively and informed consent for split thickness autografting will be obtained by a surgical team member. All questions will be answered and risk/benefits/alternatives will be explained in detail to the study subject. The subject will then be taken back to the operating room and anesthesia will be induced. The surgical timeout will occur verifying subject name, medical record number, planned operation, and surgical site. The subject will be prepped and draped in a sterile manner.
  2. For the control group: The recipient burn site will be excised to healthy, bleeding tissue. The wound base is then sprayed with a film of THROMBIN-JMI® and covered with telfa and pressure applied for 10 minutes to achieve hemostasis while the skin graft is being harvested. The donor site will be marked to determine the size of the autograft. Tumescent solution with a local anesthetic and epinephrine is injected with a cannula and a split thickness skin graft will be taken at 1/12 inch using a Zimmer dermatome. 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. The donor site and recipient site were dressed according to the preference of the attending physician. The patient will then awaken from anesthesia. This procedure will typically take between 60 to 120 minutes.
  3. For the experimental groups: For the first phase of the study, the procedure described above was identical to that performed to the control group with the following exceptions: 100 milligram/milliliter, 10 milliliter vials x2 of injectable tranexamic acid will be filled into a 20 milliliter syringe with a spray tip. The 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.
  4. Post-operatively, subjects will recover from anesthesia and continue routine post-operative care in the burn unit. The first assessment will occur at 48-72 hours after surgery at the first dressing change. Dressings will be changed by the nurse or burn technician who are all well-trained and experienced in burn wound care. Assessment will require documentation of hematoma occurrence, percent graft loss by measuring dimensions of non-adherent graft, and need for reoperation. If the graft is well adherent and the patient does not have barriers to discharge, the patient will be discharged and will return to clinic for follow up at post-operative day 7-10, and at 14 days. A second and third assessment will occur at this time by either the clinic medical provider or study team member. If the patient remains inpatient, the second and third assessment will be made in the hospital.

As part of the study, an objective measured hematoma rate and percent graft take will be measured rather than estimated at the 48-72 hours, 7-10 day, and 14 day follow up period which is the current protocol for this patient population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • The University of Kansas Health System
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dhaval R Bhavsar, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Thrombin JMI
The wound base is then sprayed with a film of Thrombin-JMI
Other Names:
  • Thrombin
Procedure: 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.
Other Names:
  • skin graft, STSG, autograft
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
Procedure: 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.
Other Names:
  • skin graft, STSG, autograft
Drug: Tranexamic acid
100mg/mL 10mL vials x2 of injectable tranexamic acid will be filled into a 20 milliliter syringe with a spray tip.
Other Names:
  • TXA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The number of participants with hematoma occurrence
Time Frame: Post-operative day fourteen, plus or minus two days
dichotomous endpoint
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
continous endpoint
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
dichotomous endpoint
Post-operative day fourteen, plus or minus two days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in cost between two hemostatic agents
Time Frame: during surgery
The cost comparison between two hemostatic agents
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Kansas Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dhaval Bhavsar, MBBS, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 150349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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