Positive Predictive Value (PPV) of Pseudomonas Aeruginosa

NCT03290690 | Unknown

• 1 other identifier: 16-102
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound; Chronic Leg Ulcer; Wound Contamination

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be treated at the Scarborough and Rouge Hospital as per the standard of care, which includes use of the MolecuLight i:X imaging device and targeted sampling of regions with bacterial fluorescence for microbiological analysis. Patients will be identified as candidates and consented by the study's principle investigator. The images which would be acquired for this study are currently part of the routine clinical wound care assessment process in the principle investigator's wound care clinic. However, during study enrollment subjects will be given as much time as required for their understanding of the basic study, to understand that their participation is optional, to understand that they will receive standard of care wound treatment whether or not they choose to participate, and to have any potential questions addressed.

You may qualify if:

• 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
• years or older

You may not qualify if:

• Treatment with an investigational drug within 1 month before study enrolment
• Inability to consent to medical photography (i.e. inability to understand consent process)
• Any contra-indication to routine wound care and/or monitoring
• Prior participation of the patient in this study (for the same wound or a different wound).

Sponsors & Collaborators

• MolecuLight Inc.: lead
• Scarborough Rouge Hospital: collaborator

Study Sites (1)

Scarborough and Rouge Hospital

Scarborough Village, Ontario, M1E 4B9, Canada

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Rose Raizman

  Scarborough Rouge Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liis Teene

CONTACT

6472551519; lteene@moleculight.com

Rose Raizman

CONTACT

416-886-2328; rraizman@rougevalley.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 25, 2017
• Study Start: August 4, 2017
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)