Positive Predictive Value (PPV) of Pseudomonas Aeruginosa

NCT03290690 — Unknown, 65 participants, MolecuLight Inc.

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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

Registry	NCT03290690
Status	Unknown
Study type	Observational
Enrollment	65 (Estimated)
Sponsor	MolecuLight Inc. (Industry); collaborators: Scarborough Rouge Hospital
Conditions	Wound, Chronic Leg Ulcer, Wound Contamination
Dates	start 2017-08-04, primary completion 2020-07-30 (estimated), completion 2020-07-30 (estimated), first posted 2017-09-25, last updated 2020-03-06
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
All Subjects			All subjects in this study will have their wounds imaged and assessed in the following manner: Capture and save ST-image Capture and save FL-image Identify discrete locations of cyan (blue/green) fluorescent bacteria (FL_C) Acquire sample of tissue where cyan fluorescent bacteria are present (using curette method) Consent patient for inclusion in this study Note location of sample acquisition by annotating FL-image obtained in step 2 Send sample for microbiology analysis Note naming of microbiology sample on Case Report Form

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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).

+Locations (1)

Facility	City	Country	Status
Scarborough and Rouge Hospital	Scarborough Village, Ontario	Canada	Recruiting

+Investigators

Rose Raizman, Principal investigator, Scarborough Rouge Hospital

My Notes

Public

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