NCT02766244

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
1 month until next milestone

Results Posted

Study results publicly available

June 17, 2016

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

November 13, 2015

Results QC Date

June 16, 2016

Last Update Submit

June 16, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perfusion of Burned Area

    Perfusion as measured by ICG Fluorescence

    5 days

Study Arms (1)

ICG/SPY

EXPERIMENTAL

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

Device: ICG/SPYDrug: Antibiotic Ointment

Interventions

ICG/SPYDEVICE

indocyanine green fluorescence imaging

ICG/SPY

Antibiotic ointment

ICG/SPY

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with burn less than 15% TBSA

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
Dr. Sharmila Dissanaike
Organization
Texas Tech University Health Sciences Center

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2015

First Posted

May 9, 2016

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 17, 2016

Results First Posted

June 17, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share