NCT01650571

Evaluation of a 'Hand-Held' Fluorescence Digital Imaging Device for Real-Time Advanced Wound Care Monitoring (SMH/UHN)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Surgical Wounds

Timeline

• Start date: 2012-10-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2012-07-26
• Last updated: 2017-08-28

Locations

1 site across 1 country: Canada