Trial Outcomes & Findings for Indocyanine Green (ICG) and SPY Imaging for Assessment of Burn Healing (NCT NCT02766244)

Results Overview

Perfusion as measured by ICG Fluorescence

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

5 days

Results posted on

2016-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	ICG/SPY Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence. ICG/SPY: indocyanine green fluorescence imaging Antibiotic Ointment: Antibiotic ointment
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ICG/SPY n=3 Participants Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence. ICG/SPY: indocyanine green fluorescence imaging Antibiotic Ointment: Antibiotic ointment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Size of burn	7 % of body surface area n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Perfusion as measured by ICG Fluorescence

Outcome measures

Outcome measures
Measure	Patient 1 Superficial n=1 Participants Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence. ICG/SPY: indocyanine green fluorescence imaging Antibiotic Ointment: Antibiotic ointment	Patient 1 Deep Tissue n=1 Participants Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence. ICG/SPY: indocyanine green fluorescence imaging Antibiotic Ointment: Antibiotic ointment	Patient 2 Superficial n=1 Participants Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence. ICG/SPY: indocyanine green fluorescence imaging Antibiotic Ointment: Antibiotic ointment	Patient 2 Deep Tissue n=1 Participants Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence. ICG/SPY: indocyanine green fluorescence imaging Antibiotic Ointment: Antibiotic ointment	Patient 3 Superficial n=1 Participants Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence. ICG/SPY: indocyanine green fluorescence imaging Antibiotic Ointment: Antibiotic ointment	Patient 3 Deep Tissue n=1 Participants Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence. ICG/SPY: indocyanine green fluorescence imaging Antibiotic Ointment: Antibiotic ointment
Perfusion of Burned Area Day 4	180 % perfusion compared to normal skin	100 % perfusion compared to normal skin	470 % perfusion compared to normal skin	250 % perfusion compared to normal skin	200 % perfusion compared to normal skin	150 % perfusion compared to normal skin
Perfusion of Burned Area Day 1	200 % perfusion compared to normal skin	100 % perfusion compared to normal skin	205 % perfusion compared to normal skin	180 % perfusion compared to normal skin	205 % perfusion compared to normal skin	110 % perfusion compared to normal skin
Perfusion of Burned Area Day 2	300 % perfusion compared to normal skin	200 % perfusion compared to normal skin	210 % perfusion compared to normal skin	110 % perfusion compared to normal skin	180 % perfusion compared to normal skin	190 % perfusion compared to normal skin
Perfusion of Burned Area Day 3	250 % perfusion compared to normal skin	180 % perfusion compared to normal skin	280 % perfusion compared to normal skin	200 % perfusion compared to normal skin	500 % perfusion compared to normal skin	380 % perfusion compared to normal skin
Perfusion of Burned Area Day 5	205 % perfusion compared to normal skin	140 % perfusion compared to normal skin	NA % perfusion compared to normal skin No data on this day	NA % perfusion compared to normal skin No data on this day	NA % perfusion compared to normal skin No data on this day	NA % perfusion compared to normal skin No data on this day

Adverse Events

ICG/SPY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sharmila Dissanaike

Texas Tech University Health Sciences Center

Phone: 8067435609

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place