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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT01650571
Collaborator
Cancer Care Ontario (Other)
7
Enrollment
1
Location
48
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    7 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of a 'Hand-Held' Fluorescence Digital Imaging Device for Real-Time Advanced Wound Care Monitoring (SMH/UHN)
    Actual Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Oct 1, 2016
    Actual Study Completion Date :
    Oct 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. providing wound healing status in real time based on collagen fluorescence as an indicator of wound closure [Upon study completion]

    Secondary Outcome Measures

    1. 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]

    2. the ability of the device to provide real-time fluorescence image-guided targeting of swabbing for bacteriology testing [Upon study completion]

    3. utility of PRODIGI™ in guiding intervention [Upon study completion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Michael's Hospital Toronto Ontario Canada M5B 1W8

    Sponsors and Collaborators

    • University Health Network, Toronto
    • Cancer Care Ontario

    Investigators

    • Principal Investigator: Ralph S DaCosta, PhD, University Health Network, Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT01650571
    Other Study ID Numbers:
    • 12-5024-A
    First Posted:
    Jul 26, 2012
    Last Update Posted:
    Aug 28, 2017
    Last Verified:
    Aug 1, 2017
    Additional relevant MeSH terms:
    Wounds and Injuries
    Surgical Wound

    Study Results

    No Results Posted as of Aug 28, 2017