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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02766244
• Other study ID #: 003 NCT02028520
• Status: Completed
• Phase: N/A
• First received: November 13, 2015
• Last updated: June 16, 2016
• Start date: January 2014
• Est. completion date: July 2014

Study information

• Verified date: June 2016
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Three patients were recruited for assessment of ICG fluorescence in burns.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• patients with burn less than 15% TBSA

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• ICG/SPY
indocyanine green fluorescence imaging

Drug:
• Antibiotic Ointment
Antibiotic ointment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

References & Publications (1)

Dissanaike S, Abdul-Hamed S, Griswold JA.Variations in burn perfusion over time as measured by portable ICG flourescence: A case series Burnes& Trauma, 2(4):201-205, 2014

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfusion of Burned Area	Perfusion as measured by ICG Fluorescence	5 days	No