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

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06379724
Phase
PHASE4
Status
Recruiting
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Conditions

  • Burns
  • Skin Graft Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Thrombin JMI — DRUG
    The wound base is then sprayed with a film of Thrombin-JMI
  • 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.

Study Details

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.

Key Dates

Start date
Jul 11, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

The number of participants with hematoma occurrence [ Time Frame: Post-operative day fourteen, plus or minus two days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Kansas Health SystemKansas CityKansas66160
Jessica Reynolds, BSN
[email protected]
913-588-0044
Dhaval Bhavsar, MBBS
[email protected]
913-588-2000
Dhaval R Bhavsar, MBBS (PRINCIPAL_INVESTIGATOR)

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