Health TrialsbyHealthPanel

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

ConditionsBurnsSkin Graft Complications
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

>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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 2 interventions
Group B: ExperimentalExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The number of participants with hematoma occurrence

dichotomous endpoint

Time frame
Post-operative day fourteen, plus or minus two days
2

The rate of percentage of graft take adherence amongst participants

continous endpoint

Time frame
Post-operative day fourteen, plus or minus two days
3

Comparison of number of participants that require re-operation

dichotomous endpoint

Time frame
Post-operative day fourteen, plus or minus two days

Secondary outcomes

1

Difference in cost between two hemostatic agents

The cost comparison between two hemostatic agents

Time frame
during surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Kansas Medical Center

Lead sponsor

Source ClinicalTrials.gov
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