Post Market Clinical Followup of MolecuLight i:X's PPV to Predict Presence of Bacteria in Wounds
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|ClinicalTrials.gov Identifier: NCT03091361|
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
|Condition or disease||Intervention/treatment|
|Wounds and Injuries||Other: imaging, no intervention|
MolecuLight Inc. (Toronto, Canada) has recently introduced to the Canadian market an innovative imaging device, the MolecuLight i:X™ Imaging Device, that offers real-time detection of important biological and molecular information of a chronic wound, and could have significant impact on improving conventional wound care and management. The MolecuLight i:X Imaging Device is intended to assist clinicians during care and management of patients with chronic wounds by screening for the presence of potentially harmful bacteria levels. The device can capture and document either an image or video of the chronic wound where the presence of fluorescent bacteria appears under violet light illumination. This information can be used to guide a clinician to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present. Though the MolecuLight i:X Imaging Device has been shown to be effective in controlled settings, this study is deploying the device in a larger population and evaluating the ability of the MolecuLight i:X device to positively predict the presence of bacteria in chronic wounds.
The overall objective of this work is to evaluate the MolecuLight i:X Imaging Device in screening of chronic wounds for the presence of bacteria. The device is intended to guide the clinician to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present.
All imaging will be performed with the MolecuLight i:X Imaging Device at an appropriate distance from the wound of interest (8 - 12 cm), which is indicated by the range finder LED. Illumination is provided by two violet (405 nm) LEDs that produce a bright, but clinically safe, uniform illumination. Fluorescence imaging is performed on the camera in real-time while the device is in fluorescence mode and the room lights are turned off. If room ambient light cannot be eliminated to an acceptable level (indicated by the ambient light sensor), the MolecuLight drape must be used to achieve a dark environment. A standard measurement sticker will be placed adjacent to the wound within the field of view to act as a reference for size.
All microbiological analysis will be performed as per clinic standard practice. Tissue samples will be analyzed for culture and sensitivity, yielding the species of bacteria present in the sample (if any), the susceptibility to various antibiotics and a measure of the bacterial load.
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|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 Bacteria in Chronic Wounds|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||February 2017|
All patients (imaging/no intervention)
There is only one group in this study, the imaging/no intervention group. These patients will meet all enrollment criteria and bacterial (red or cyan) fluorescence will be visualized within or around their wound with the MolecuLight i:X imaging device. A targeted curettage sample will be taken from the site of fluorescence and sent for microbiological analysis. There will be no intervention or followup.
Other: imaging, no intervention
- Correlation of localized red fluorescence signals in acquired images with microbiological samples [ Time Frame: 1 hour ]
- Correlation of localized cyan fluorescence signals in acquired images with microbiological samples indicating pseudomonas aeruginosa [ Time Frame: 1 hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091361
|Judy Dan Research and Treatment Centre|
|North York, Ontario, Canada, M2R 1N5|
|Principal Investigator:||Ron Linden, MD||Judy Dan Research and Treatment Center|