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

Not Applicable

Completed

• Conditions: Burns
• Interventions: Device: ICG/SPY; Drug: Antibiotic Ointment

• Registration Number: NCT02766244
• Lead Sponsor: Texas Tech University Health Sciences Center

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-09
• Status Verified: 2016-06
• Results First Submitted: 2016-06-16
• Results First Submitted QC: 2016-06-16
• Last Update Submitted: 2016-06-16
• Results First Posted: 2016-06-17
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• patients with burn less than 15% TBSA

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICG/SPY	Antibiotic Ointment	Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.
ICG/SPY	ICG/SPY	Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.

Primary Outcome Measures

Name	Time	Method
Perfusion of Burned Area	5 days	Perfusion as measured by ICG Fluorescence