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

Surgical Wounds Clinical Trial

— SMH/UHN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01650571
• Other study ID #: 12-5024-A
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: August 25, 2017
• Start date: October 2012
• Est. completion date: October 2016

Study information

• Verified date: August 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Wounds
• Wounds and Injuries

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Cancer Care Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	providing wound healing status in real time based on collagen fluorescence as an indicator of wound closure		Upon study completion
Secondary	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
Secondary	the ability of the device to provide real-time fluorescence image-guided targeting of swabbing for bacteriology testing		Upon study completion
Secondary	utility of PRODIGI™ in guiding intervention		Upon study completion