Positive Predictive Value (PPV) of Pseudomonas Aeruginosa

Wound Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03290690
• Other study ID #: 16-102
• Status: Recruiting
• Start date: August 4, 2017
• Est. completion date: July 30, 2020

Study information

• Verified date: March 2020
• Source: MolecuLight Inc.
• Contact: Liis Teene
• Phone: 6472551519
• Email: lteene[@]moleculight.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Leg Ulcer
• Leg Ulcer
• Wound
• Wound Contamination
• Wounds and Injuries

Locations

Country	Name	City	State
Canada	Scarborough and Rouge Hospital	Scarborough	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
MolecuLight Inc.	Scarborough Rouge Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 hour