Track topics on Twitter Track topics that are important to you
This is a non-randomized evaluation for which 50 patients will be imaged at clinics associated with the Advanced Research Institute of Miami Florida, who present with a chronic wound and are receiving standard treatment. The MolecuLight i:X Imaging Device will be used as an adjunctive tool in the assessment of the wound and will be used to guide the targeted sampling of a wound (punch biopsy method).
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 standard practice at each local clinic. 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.
Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
MolecuLight i:X Imaging Device
Not yet recruiting
Published on BioPortfolio: 2016-02-16T21:38:24-0500
This is a non-randomized evaluation for which 160 adult patients will be imaged at outpatient wound care clinics who present with a wound of unknown infection diagnostic status and are rec...
This is a non-randomized, single-blind post market clinical follow-up study for which 50 patients will be imaged at the Judy Dan Research and Treatment Centre who present with a chronic an...
Diabetic foot disease is a global health problem. Diabetes affects over 450million people worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their feet an...
The investigators have developed a new non-invasive medical device called the Bioelectric Field Imager. They plan to use this device to measure the electric field near small lancet wounds ...
Patients with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-i...
The complexity and severity of traumatic wounds in military and civilian trauma demands improved wound assessment, before, during, and after treatment. Here, we explore the potential of 3 charge-coupl...
The Food and Drug Administration (FDA or we) is classifying the extracorporeal shock wave device for treatment of chronic wounds into class II (special controls). The special controls that apply to th...
Critical limb ischemia (CLI) is a leading cause of lower extremity amputation. When CLI is identified, revascularization should be performed if possible. When options for revascularization do not exis...
Traumatic wounds (wounds caused by injury) range from abrasions and minor skin incisions or tears, to wounds with extensive tissue damage or loss as well as damage to bone and internal organs. Two key...
The urgent need to eliminate unnecessary use of antibiotics in wound patients has been hampered by diagnostic uncertainty and the time required to obtain culture results. The authors evaluated bedside...
The use of molecularly targeted imaging probes to localize and/or monitor biochemical and cellular processes via various imaging modalities that include RADIONUCLIDE IMAGING; ULTRASONOGRAPHY; MAGNETIC RESONANCE IMAGING; fluorescence imaging; and MICROSCOPY.
Head injuries which feature compromise of the skull and dura mater. These may result from gunshot wounds (WOUNDS, GUNSHOT), stab wounds (WOUNDS, STAB), and other forms of trauma.
Penetrating wounds caused by a pointed object.
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
The use of combination of imaging techniques or platforms (e.g., MRI SCAN and PET SCAN) encompassing aspects of anatomical, functional, or molecular imaging methods.
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...
Biological therapy involves the use of living organisms, substances derived from living organisms, or laboratory-produced versions of such substances to treat disease. Some biological therapies for cancer use vaccines or bacteria to stimulate the body&rs...