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
About this trial
This is an interventional diagnostic trial for Burns
Eligibility Criteria
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
NCT ID
NCT02766244
First Posted
November 13, 2015
Last Updated
June 16, 2016
Sponsor
Texas Tech University Health Sciences Center
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
Learn more about this trial
Indocyanine Green (ICG) and SPY Imaging for Assessment of Burn Healing
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