Clinical trial NCT03290690: Positive Predictive Value (PPV) of Pseudomonas Aeruginosa
Official title: A Prospective, Single-blind Evaluation of the Positive Predictive Value (PPV) of the MolecuLight i:X™ Imaging Device to Predict the Presence of Pseudomonas Aeruginosa in Chronic Wounds
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound
Chronic Leg Ulcer
Wound Contamination
Lead sponsor: MolecuLight Inc.
Sponsor class: INDUSTRY
Collaborators: name: Scarborough Rouge Hospital
First posted: 2017-09-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be treated at the Scarborough and Rouge Hospital as per the standard of care, which includes use of the MolecuLight i:X imaging device and targeted sampling of regions with bacterial fluorescence for microbiological analysis. Patients will be identified as candidates and consented by the study's principle investigator. The images which would be acquired for this study are currently part of the routine clinical wound care assessment process in the principle investigator's wound care clinic. However, during study enrollment subjects will be given as much time as required for their understanding of the basic study, to understand that their participation is optional, to understand that they will receive standard of care wound treatment whether or not they choose to participate, and to have any potential questions addressed.

Brief summary: This is a non-randomized, single-blind post market clinical follow-up study for which 65 patients will be imaged at Rouge Valley Centenary Hospital (Scarborough and Rouge Hospital) who present with a chronic wound and are receiving standard wound care treatment. The MolecuLight i:X imaging device will be used by the study clinician as an adjunctive tool in the assessment of the wound and will be used to guide the targeted sampling of a wound (with curettage scraping), as per current standard of care in the principal investigator's wound care clinic. The acquired tissue sample will then be analysed using conventional gold standard semi-quantitative culture methods to determine bacterial species present, also as per current standard of care in this clinic.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients presenting with a chronic wound (wound duration \> 4 weeks) e.g. diabetic foot ulcer, venous leg ulcer, pressure ulcer, or other acceptable aetiology
2. 18 years or older

Exclusion Criteria:

1. Treatment with an investigational drug within 1 month before study enrolment
2. Inability to consent to medical photography (i.e. inability to understand consent process)
3. Any contra-indication to routine wound care and/or monitoring
4. Prior participation of the patient in this study (for the same wound or a different wound).

Primary outcomes:
measure: Evaluate the ability of the MolecuLight i:X Imaging Device to predicting the presence of Pseudomonas aeruginosa in chronic wounds
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Scarborough
country: Canada
facility: Scarborough and Rouge Hospital
state: Ontario
Study officials:
affiliation: Scarborough Rouge Hospital
name: Rose Raizman
role: PRINCIPAL_INVESTIGATOR
References: