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

NCT06379724 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-10-17

No results posted yet for this study

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

Interventions

DRUG

Tranexamic acid

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

DRUG

Thrombin JMI

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

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.

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Dhaval Bhavsar, MBBS · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06379724 on ClinicalTrials.gov