Skip to main content
OpenTrials
Completed

NCT Number: NCT01650571

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. providing wound healing status in real time based on collagen fluorescence as an indicator of wound closure

    Time frame: Upon study completion

Secondary outcomes

  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)

    Time frame: Upon study completion

  2. the ability of the device to provide real-time fluorescence image-guided targeting of swabbing for bacteriology testing

    Time frame: Upon study completion

  3. utility of PRODIGI™ in guiding intervention

    Time frame: Upon study completion

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Cancer Care Ontario

Registry information

Acronym: SMH/UHN

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 26, 2012
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.