title: 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.
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01651845; ClinicalTrials.gov NCT01378728.
authors: Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto Medical Discovery Tower, 15th floor, 101 College St., Toronto, Ontario, M5G 1L7, Canada; Techna Institute for Advancement of Technologies for Health, University Health Network, 100 College Street, Rm. 124, Toronto, Ontario, M5G 1L5, Canada.
authors: Ralph S
authors: RS
authors: DaCosta
authors: Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto Medical Discovery Tower, 15th floor, 101 College St., Toronto, Ontario, M5G 1L7, Canada.
authors: Iris
authors: I
authors: Kulbatski
authors: Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto Medical Discovery Tower, 15th floor, 101 College St., Toronto, Ontario, M5G 1L7, Canada.
authors: Liis
authors: L
authors: Lindvere-Teene
authors: Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto Medical Discovery Tower, 15th floor, 101 College St., Toronto, Ontario, M5G 1L7, Canada.
authors: Danielle
authors: D
authors: Starr
authors: Prosserman Center for Health Research, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, 60 Murray Street, Box 18 Room 5-236, Toronto, Ontario, M5T 3L9, Canada.
authors: Kristina
authors: K
authors: Blackmore
authors: Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto Medical Discovery Tower, 15th floor, 101 College St., Toronto, Ontario, M5G 1L7, Canada.
authors: Jason I
authors: JI
authors: Silver
authors: The Judy Dan Treatment and Research Center, 555 Finch Avenue West, Toronto, Ontario, M2R 1N5, Canada.
authors: Julie
authors: J
authors: Opoku
authors: Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto Medical Discovery Tower, 15th floor, 101 College St., Toronto, Ontario, M5G 1L7, Canada.
authors: Yichao Charlie
authors: YC
authors: Wu
authors: Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto Medical Discovery Tower, 15th floor, 101 College St., Toronto, Ontario, M5G 1L7, Canada.
authors: Philip J
authors: PJ
authors: Medeiros
authors: Department of Biostatistics, University Health Network, 610 University Avenue, Toronto, Ontario, M5G 2M9, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, 6th floor, Toronto, Ontario, M5T 3M7, Canada.
authors: Wei
authors: W
authors: Xu
authors: Dalla Lana School of Public Health, University of Toronto, 155 College Street, 6th floor, Toronto, Ontario, M5T 3M7, Canada.
authors: Lizhen
authors: L
authors: Xu
authors: Princess Margaret Cancer Centre, University Health Network and University of Toronto, Toronto Medical Discovery Tower, 15th floor, 101 College St., Toronto, Ontario, M5G 1L7, Canada.
authors: Brian C
authors: BC
authors: Wilson
authors: Dermatology, Toronto Western Hospital, University Health Network, 399 Bathurst St., Toronto, Ontario, M5T 2S8, Canada.
authors: Cheryl
authors: C
authors: Rosen
authors: The Judy Dan Treatment and Research Center, 555 Finch Avenue West, Toronto, Ontario, M2R 1N5, Canada.
authors: Ron
authors: R
authors: Linden
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001419:Bacteria / Q000302:isolation & purification; D003646:Debridement; D017719:Diabetic Foot / Q000382:microbiology; D005260:Female; D005453:Fluorescence; D006801:Humans; D008297:Male; D008875:Middle Aged; D061848:Optical Imaging / Q000295:instrumentation* / Q000379:methods; D019095:Point-of-Care Systems; D014946:Wound Infection / Q000175:diagnosis* / Q000382:microbiology / Q000628:therapy; D055815:Young Adult