Surgical Wounds Clinical Trial
Official title:
Evaluation of a 'Hand-Held' Fluorescence Digital Imaging Device for Real-Time Advanced Wound Care Monitoring (SMH/UHN)
Currently, standard wound care practice is suboptimal at assessing wound remodeling and
bacterial infection in real-time. An alternative and complimentary means of providing
real-time imaging of connective tissue re-modeling and bacterial infection may greatly
increase the early detection of infection thus leading to rapid therapeutic intervention. Our
new device, PRODIGI(TM), images tissue and bacterial autofluorescence (without agents) and
may provide this clinically-important capability.
In preliminary preclinical testing, the investigators have discovered that when wounds are
illuminated by violet/blue light, endogenous collagen in the connective tissue matrix emit a
characteristic green fluorescent signal, while most pathogenic bacterial species emit a
unique red fluorescence signal due to the production of endogenous porphyrins. Therefore,
with autofluorescence imaging, no exogenous contrast agents are needed during imaging, making
this approach particularly appealing as a diagnostic imaging method for clinical use.
The investigators hypothesize that real-time imaging of tissue autofluorescence signals
emanating from endogenous connective tissue (e.g. collagen) and pathogenic bacteria within
complex wounds can be used to determine healing status (i.e., collagen re-modeling and wound
closure), detect wound bacterial contamination and/or infection that is occult under standard
clinical white light evaluation, and guide intervention and wound care.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02604251 -
Evaluation of the KLOX BioPhotonic WoundGel System in the Treatment of Surgical Wounds
|
N/A | |
Completed |
NCT03070925 -
Prospective PuraPly™ AM Case Series Study
|
N/A | |
Completed |
NCT03286452 -
The RESPOND Registry
|