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Indocyanine Green (ICG) and SPY Imaging for Assessment of Burn Healing

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ICG/SPY
Antibiotic Ointment
Sponsored by
Texas Tech University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Burns

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with burn less than 15% TBSA

Exclusion Criteria:

  • none

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ICG/SPY

    Arm Description

    Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.

    Outcomes

    Primary Outcome Measures

    Perfusion of Burned Area
    Perfusion as measured by ICG Fluorescence

    Secondary Outcome Measures

    Full Information

    First Posted
    November 13, 2015
    Last Updated
    June 16, 2016
    Sponsor
    Texas Tech University Health Sciences Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02766244
    Brief Title
    Indocyanine Green (ICG) and SPY Imaging for Assessment of Burn Healing
    Official Title
    Indocyanine Green (ICG) and SPY Imaging for Assessment of Burn Healing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Texas Tech University Health Sciences Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Three patients were recruited for assessment of ICG fluorescence in burns.
    Detailed Description
    The early determination of healing potential in indeterminate thickness burns may be difficult to establish by visual inspection alone, even for experienced burn practitioners. This case series explores the use of indocyanine green (ICG) fluorescence using portable bedside assessment as a potential tool for early determination of burn depth. Three subjects with indeterminate thickness burns had daily perfusion assessment using ICG fluorescence assessment using the SPY machine (SPY®, Lifecell Corp., NJ, USA) in addition to standard burn care. The fluorescence was quantified as a percentage of the perfusion of intact skin, and areas of hypo and hyper-perfusion were indicated. The burn surgeon, blinded to the ICG results, made a clinical determination of the need for skin grafting or discharge. The perfusion in areas of differing depth of burn were compared over the entire study period to determine both the magnitude of difference, and the point in the time course of healing when these changes became evident.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burns

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ICG/SPY
    Arm Type
    Experimental
    Arm Description
    Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.
    Intervention Type
    Device
    Intervention Name(s)
    ICG/SPY
    Intervention Description
    indocyanine green fluorescence imaging
    Intervention Type
    Drug
    Intervention Name(s)
    Antibiotic Ointment
    Intervention Description
    Antibiotic ointment
    Primary Outcome Measure Information:
    Title
    Perfusion of Burned Area
    Description
    Perfusion as measured by ICG Fluorescence
    Time Frame
    5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with burn less than 15% TBSA Exclusion Criteria: none

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27602383
    Citation
    Dissanaike S, Abdul-Hamed S, Griswold JA. Variations in burn perfusion over time as measured by portable ICG fluorescence: A case series. Burns Trauma. 2014 Oct 25;2(4):201-5. doi: 10.4103/2321-3868.142397. eCollection 2014.
    Results Reference
    result

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    Indocyanine Green (ICG) and SPY Imaging for Assessment of Burn Healing

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