Advertisement

Topics

Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds

2016-02-16 21:38:24 | BioPortfolio

Summary

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).

Description

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Conditions

Wounds

Intervention

MolecuLight i:X Imaging Device

Status

Not yet recruiting

Source

MolecuLight Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-02-16T21:38:24-0500

Clinical Trials [1006 Associated Clinical Trials listed on BioPortfolio]

Post Market Clinical Followup of MolecuLight i:X's PPV to Predict Presence of Bacteria in Wounds

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...

Moleculight i:X™ in Wound Healing

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...

Bioelectric Field Imaging Near Human Skin Wounds

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 ...

Provant Therapy of Venous Stasis Ulcer Trial

This pilot study hypothesizes that use of the Regenesis Provant Wound Therapy System (a radiofrequency device) twice daily over venous stasis ulcers (wounds thought to occur due to imprope...

Feasibility Study of a Novel Device for Chronic Wounds

The purpose of this study is to evaluate the feasibility and usability of a new portable and compact wound dressing device for the treatment of small chronic skin wounds.

PubMed Articles [8583 Associated PubMed Articles listed on BioPortfolio]

Efficacy of an imaging device at identifying the presence of bacteria in wounds at a plastic surgery outpatients clinic.

Current standard diagnostic practice of bacterial infections by visual inspection under white light is subjective, and microbiological sampling is suboptimal due to high false negative rates and the l...

Long-term Live Imaging Device for Improved Experimental Manipulation of Zebrafish Larvae.

The zebrafish larva is an important model organism for both developmental biology and wound healing. Further, the zebrafish larva is a valuable system for live high-resolution microscopic imaging of d...

Open vs Closed Negative Pressure Wound Therapy for Contaminated and Dirty Surgical Wounds: A Prospective Randomized Comparison.

A new proprietary negative pressure wound device has been developed to apply negative pressure therapy to closed wounds (Closed-NPWT). We postulated that Closed-NPWT management of contaminated and dir...

Candida parapsilosis isolates from burn wounds can penetrate an acellular dermal matrix.

We isolated and identified yeasts from burn wounds and evaluated the ability of Candida parapsilosis isolates from burn wounds to penetrate an acellular dermal matrix (ADM). A prospective study was co...

Time Heals All Wounds … But Wounds Heal Faster with Lactobacillus.

Chronic nonhealing wounds represent a significant clinical problem and cost the healthcare system $19 billion annually. Recently, Vågesjö et al. (2018) demonstrated a promising therapeutic approach...

Medical and Biotech [MESH] Definitions

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.

More From BioPortfolio on "Positive Predictive Value of the MolecuLight i:X Imaging Device to Predict the Presence of Bacteria in Chronic Wounds"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Wound management
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
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...


Searches Linking to this Trial