Positive Predictive Value (PPV) of Pseudomonas Aeruginosa

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03290690

Enrollment

Registered

2017-09-25

Start date

2017-08-04

Completion date

2020-07-30

Last updated

2020-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Leg Ulcer, Wound, Wound Contamination

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Canada

Contacts

Primary ContactLiis Teene

lteene@moleculight.com6472551519

Backup ContactRose Raizman

rraizman@rougevalley.ca416-886-2328

Outcome results