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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02766244
Enrollment
3
Registered
2016-05-09
Start date
2014-01-31
Completion date
2014-07-31
Last updated
2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

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.

Interventions

DEVICEICG/SPY

indocyanine green fluorescence imaging

Antibiotic ointment

Sponsors

Texas Tech University Health Sciences Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

* patients with burn less than 15% TBSA

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Perfusion of Burned Area5 daysPerfusion as measured by ICG Fluorescence

Participant flow

Participants by arm

ArmCount
ICG/SPY
Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence. ICG/SPY: indocyanine green fluorescence imaging Antibiotic Ointment: Antibiotic ointment
3
Total3

Baseline characteristics

CharacteristicICG/SPY
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
1 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
1 Participants
Size of burn7 % of body surface area

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 3
serious
Total, serious adverse events
0 / 3

Outcome results

Primary

Perfusion of Burned Area

Perfusion as measured by ICG Fluorescence

Time frame: 5 days

ArmMeasureGroupValue (NUMBER)
Patient 1 SuperficialPerfusion of Burned AreaDay 3250 % perfusion compared to normal skin
Patient 1 SuperficialPerfusion of Burned AreaDay 2300 % perfusion compared to normal skin
Patient 1 SuperficialPerfusion of Burned AreaDay 1200 % perfusion compared to normal skin
Patient 1 SuperficialPerfusion of Burned AreaDay 5205 % perfusion compared to normal skin
Patient 1 SuperficialPerfusion of Burned AreaDay 4180 % perfusion compared to normal skin
Patient 1 Deep TissuePerfusion of Burned AreaDay 3180 % perfusion compared to normal skin
Patient 1 Deep TissuePerfusion of Burned AreaDay 1100 % perfusion compared to normal skin
Patient 1 Deep TissuePerfusion of Burned AreaDay 2200 % perfusion compared to normal skin
Patient 1 Deep TissuePerfusion of Burned AreaDay 4100 % perfusion compared to normal skin
Patient 1 Deep TissuePerfusion of Burned AreaDay 5140 % perfusion compared to normal skin
Patient 2 SuperficialPerfusion of Burned AreaDay 1205 % perfusion compared to normal skin
Patient 2 SuperficialPerfusion of Burned AreaDay 4470 % perfusion compared to normal skin
Patient 2 SuperficialPerfusion of Burned AreaDay 5NA % perfusion compared to normal skin
Patient 2 SuperficialPerfusion of Burned AreaDay 3280 % perfusion compared to normal skin
Patient 2 SuperficialPerfusion of Burned AreaDay 2210 % perfusion compared to normal skin
Patient 2 Deep TissuePerfusion of Burned AreaDay 2110 % perfusion compared to normal skin
Patient 2 Deep TissuePerfusion of Burned AreaDay 3200 % perfusion compared to normal skin
Patient 2 Deep TissuePerfusion of Burned AreaDay 4250 % perfusion compared to normal skin
Patient 2 Deep TissuePerfusion of Burned AreaDay 1180 % perfusion compared to normal skin
Patient 2 Deep TissuePerfusion of Burned AreaDay 5NA % perfusion compared to normal skin
Patient 3 SuperficialPerfusion of Burned AreaDay 4200 % perfusion compared to normal skin
Patient 3 SuperficialPerfusion of Burned AreaDay 2180 % perfusion compared to normal skin
Patient 3 SuperficialPerfusion of Burned AreaDay 1205 % perfusion compared to normal skin
Patient 3 SuperficialPerfusion of Burned AreaDay 3500 % perfusion compared to normal skin
Patient 3 SuperficialPerfusion of Burned AreaDay 5NA % perfusion compared to normal skin
Patient 3 Deep TissuePerfusion of Burned AreaDay 3380 % perfusion compared to normal skin
Patient 3 Deep TissuePerfusion of Burned AreaDay 4150 % perfusion compared to normal skin
Patient 3 Deep TissuePerfusion of Burned AreaDay 2190 % perfusion compared to normal skin
Patient 3 Deep TissuePerfusion of Burned AreaDay 1110 % perfusion compared to normal skin
Patient 3 Deep TissuePerfusion of Burned AreaDay 5NA % perfusion compared to normal skin

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026