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OpenTrials
Completed

NCT Number: NCT02766244

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

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

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Key information

Conditions

Burns Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with burn less than 15% TBSA

Exclusion criteria

  • none

Treatment and study plan

ICG/SPY

Device

indocyanine green fluorescence imaging

Antibiotic Ointment

Drug

Antibiotic ointment

Primary outcomes

  1. Perfusion of Burned Area

    Time frame: 5 days

    Perfusion as measured by ICG Fluorescence

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 9, 2016
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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