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

NCT01650571 | Completed

• 1 other identifier: 12-5024-A
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wounds

Outcome Measures

Primary Outcomes (1)

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

  Upon study completion

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• \> 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Cancer Care Ontario: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Ralph S DaCosta, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 26, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CA (1)