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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Cancer Care Ontario
Information provided by (Responsible Party):
Ralph DaCosta, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01650571
First received: July 23, 2012
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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
Surgical Wounds
Abdominal Wounds

Study Type: Observational
Study Design: 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)

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • providing wound healing status in real time based on collagen fluorescence as an indicator of wound closure [ Time Frame: Upon study completion ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • the ability of the device to provide real-time fluorescence image-guided targeting of swabbing for bacteriology testing [ Time Frame: Upon study completion ] [ Designated as safety issue: No ]
  • utility of PRODIGI™ in guiding intervention [ Time Frame: Upon study completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650571

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Ralph DaCosta, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01650571     History of Changes
Other Study ID Numbers: 12-5024-A
Study First Received: July 23, 2012
Last Updated: October 8, 2014
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on November 24, 2014