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

NCT06379724 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 150349
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• The number of participants with hematoma occurrence

  dichotomous endpoint

  Post-operative day fourteen, plus or minus two days

• The rate of percentage of graft take adherence amongst participants

  continous endpoint

  Post-operative day fourteen, plus or minus two days

• Comparison of number of participants that require re-operation

  dichotomous endpoint

  Post-operative day fourteen, plus or minus two days

Secondary Outcomes (1)

• Difference in cost between two hemostatic agents

  during surgery

Study Arms (2)

Control

ACTIVE COMPARATOR

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; Procedure: skin graft

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

Drug: Tranexamic acid; Procedure: skin graft

Interventions

Tranexamic acid DRUG

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

Also known as: TXA

Experimental

Thrombin JMI DRUG

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

Also known as: Thrombin

Control

skin graft PROCEDURE

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.

Also known as: skin graft, STSG, autograft

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \>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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

The University of Kansas Health System

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Burns

Interventions

Tranexamic Acid; Thrombin; Skin Transplantation; Transplantation, Autologous

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Dhaval Bhavsar, MBBS

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Reynolds, BSN

CONTACT

913-588-5000; jreynolds11@kumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to their randomization group. Study subject number will be linked to their randomization group. Blinding may be broken if the subject experiences an adverse reaction to the medication utilized for their group so that they are aware that they cannot receive the medication in the future. The research coordinator will have the code to the blind. The surgical team will not be blinded as the overall consistency of the topical agents will differ and may be apparent.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Plastic, Burn and Wound Surgery, Director of Research

Model Details: Prospective, randomized, blinded, non-inferiority study

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: April 23, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)