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

• ClinicalTrials.gov Identifier: NCT01650571
• Recruitment Status: Completed
• First Posted: July 26, 2012
• Last Update Posted: August 28, 2017
• Sponsor: University Health Network, Toronto
• Collaborator: Cancer Care Ontario
• Information provided by (Responsible Party): University Health Network, Toronto

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
Surgical Wounds

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: October 2012
• Actual Primary Completion Date: October 2016
• Actual Study Completion Date: October 2016

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. providing wound healing status in real time based on collagen fluorescence as an indicator of wound closure [ Time Frame: 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) [ 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT01650571
• Other Study ID Numbers: 12-5024-A
• First Posted: July 26, 2012
• Last Update Posted: August 28, 2017
• Last Verified: August 2017

Additional relevant MeSH terms:

Wounds and Injuries; Surgical Wound