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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02028520
Other study ID # 003
Secondary ID
Status Completed
Phase N/A
First received January 3, 2014
Last updated May 11, 2015
Start date January 2014
Est. completion date August 2014

Study information

Verified date May 2015
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

Hypothesis: Higher levels of perfusion on indocyanine green (ICG) fluoroscopy indicate higher likelihood of burns healing whole lower levels of perfusion correlate with lower likelihood of healing

Consented patients with burn injuries will be evaluated daily and along with continued wound care will receive 5 mg of ICG (FDA approved dose) and their burns assessed fluoroscopically. Perfusion will be quantified numerically as a percentage of normally perfused skin. No changes to the actual care of the burn patient will be made as a result of the fluoroscopic examination.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria:

- Subjects aged 18-89 with indeterminate thickness burn wounds to trunk or extremities

- Anticipated admission of greater than 3 days

- Admission to the Timothy J Harner Burn Center

- Informed consent

Exclusion Criteria:

- Known allergy for ICG, iodine or shellfish

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
SPY imaging


Locations

Country Name City State
United States Texas Tech University Health Sciences Center/University Medical Center Lubbock Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perfusion rate and burn wound healing The use of ICG fluoroscopic imaging and perfusion rates to anticipate wound healing will be assessed 48-72 hrs. post admission to patient discharge No