Positive Predictive Value (PPV) of Pseudomonas Aeruginosa

MolecuLight Inc.65 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Wound Chronic Leg Ulcer Wound Contamination

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Evaluate the ability of the MolecuLight i:X Imaging Device to predicting the presence of Pseudomonas aeruginosa in chronic wounds

Primary endpoint: correlation of localized cyan fluorescence signals in device acquired images with microbiological samples indicating Pseudomonas aeruginosa

Time frame: 1 hour