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

NCT ID: NCT02766244

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-07-31

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.

Conditions

Burns

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ICG/SPY

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

Group Type: EXPERIMENTAL

ICG/SPY

Intervention Type: DEVICE

indocyanine green fluorescence imaging

Antibiotic Ointment

Intervention Type: DRUG

Antibiotic ointment

Interventions

ICG/SPY

indocyanine green fluorescence imaging

Intervention Type: DEVICE

Antibiotic Ointment

Antibiotic ointment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients with burn less than 15% TBSA

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Sharmila Dissanaike

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 27602383 (View on PubMed)

Other Identifiers

003 NCT02028520

Identifier Type: -

Identifier Source: org_study_id

NCT02028520

Identifier Type: -

Identifier Source: nct_alias