An observational study in Wound, Chronic Leg Ulcer and Wound Contamination, sponsored by MolecuLight Inc.. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-06.
Sponsored by MolecuLight Inc. · Observational
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.
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.
Exclusion Criteria:
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
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
Time frame: 1 hour
Plan to share: No
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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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MolecuLight Inc.