Positive Predictive Value (PPV) of Pseudomonas Aeruginosa

• Conditions: Wound; Chronic Leg Ulcer; Wound Contamination

• Registration Number: NCT03290690
• Lead Sponsor: MolecuLight Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-04
• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-06
• Primary Completion: 2020-07-30
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the ability of the MolecuLight i:X Imaging Device to predicting the presence of Pseudomonas aeruginosa in chronic wounds	1 hour	Primary endpoint: correlation of localized cyan fluorescence signals in device acquired images with microbiological samples indicating Pseudomonas aeruginosa

Trial Locations

Locations (1)

Scarborough and Rouge Hospital; 🇨🇦 Scarborough, Ontario, Canada