PUBLICATION_

Point of care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results

ABSTRACT

Background:

Traditionally, chronic wound infection is diagnosed by visual inspection under white light and microbiological sampling, which are subjective and suboptimal, respectively, thereby delaying diagnosis and treatment. To address this, we developed a novel handheld, fluorescence imaging device (PRODIGI) that enables non-contact, real-time, high-resolution visualization and differentiation of key pathogenic bacteria through their endogenous autofluorescence, as well as connective tissues in wounds.

Methods and Findings:

This was a two-part Phase I, single center, non-randomized trial of chronic wound patients (male and female, ≥18 years; UHN REB #09-0015-A for part 1; UHN REB #12-5003 for Part 2; clinicaltrials.gov Identifier: NCT01378728 for Part 1 and NCT01651845 for Part 2). Part 1 (28 patients; 54% diabetic foot ulcers, 46% non-diabetic wounds) established the feasibility of autofluorescence imaging to accurately guide wound sampling, validated against blinded, gold standard swab-based microbiology. Part 2 (12 patients; 83.3% diabetic foot ulcers, 16.7% non-diabetic wounds) established the feasibility of autofluorescence imaging to guide wound treatment and quantitatively assess treatment response. We showed that PRODIGI can be used to guide and improve microbiological sampling and debridement of wounds in situ, enabling diagnosis, treatment guidance and response assessment in patients with chronic wounds. PRODIGI is safe, easy to use and integrates into the clinical workflow. Clinically significant bacterial burden can be detected in seconds, quantitatively tracked over days-to-months and their biodistribution mapped within the wound bed, periphery, and other remote areas.

Conclusions:

PRODIGI represents a technological advancement in wound sampling and treatment guidance for clinical wound care at the point of care.

Trial Registration:

ClinicalTrials.gov NCT01651845; ClinicalTrials.gov NCT01378728.

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References

1Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto Medical Discovery Tower, 15th floor, 101 College St., Toronto, Ontario, M5G 1L7, Canada.

2Techna Institute for Advancement of Technologies for Health, University Health Network, 100 College Street, Rm. 124, Toronto, Ontario, M5G 1L5, Canada.

3Prosserman Center for Health Research, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, 60 Murray Street, Box 18 Room 5–236, Toronto, Ontario, M5T 3L9, Canada.

4Dermatology, Toronto Western Hospital, University Health Network, 399 Bathurst St., Toronto, Ontario, M5T 2S8, Canada.

5The Judy Dan Treatment and Research Center, 555 Finch Avenue West, Toronto,
Ontario, M2R 1N5, Canada.

6Department of Biostatistics, University Health Network, 610 University Avenue, Toronto, Ontario, M5G 2M9, Canada.

7Dalla Lana School of Public Health, University of Toronto, 155 College Street, 6th floor, Toronto, Ontario, M5T 3M7, Canada.