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

Study Overview

• Status: Completed
• Conditions: Surgical Wounds

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

20 patients with wounds resulting from general abdominal surgery will be entered into this trial, based on statistical power-based calculations for sample size determined in collaboration with the UHN Biostatistics Group (assuming one wound per patient).

Description

Inclusion Criteria:

1. > 18 years of age
2. males and females
3. receiving care as in-patient at St. Michael's Hospital
4. presenting with abdominal wounds resulting from general surgery with known or unknown infection status.

Exclusion Criteria:

1. treatment with an investigational drug within 1 month before study enrolment
2. any contra-indication to routine wound care and/or monitoring
3. inability to consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
providing wound healing status in real time based on collagen fluorescence as an indicator of wound closure	Upon study completion

Secondary Outcome Measures

Outcome Measure	Time Frame
detecting bacterial contamination and infection in wounds that is occult to conventional wound assessment methods (white light visualization and clinical signs and symptoms of wound infection)	Upon study completion
the ability of the device to provide real-time fluorescence image-guided targeting of swabbing for bacteriology testing	Upon study completion
utility of PRODIGI™ in guiding intervention	Upon study completion

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Cancer Care Ontario
• Investigators: Principal Investigator: Ralph S DaCosta, PhD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 12-5024-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No