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The MolecuLight i:X instantly visualizes the presence of potentially harmful levels of bacteria through endogenous autofluorescence without the need for contrast agents or contact with the patient. The intended use of the device is to assist health care professionals during the management of patients with wounds by enabling real-time visualization of potentially harmful bacteria. The device is intended to be used as part of routine clinical wound assessment processes which may include examination for characteristic signs and symptoms of infection. Under violet light illumination, the MolecuLight i:X can capture and document images or videos of wounds and surrounding areas where fluorescent bacteria may be present.
The bacterial fluorescence signals detected by the device provide health care professionals with a visual indication of bacterial presence, load, and location within and around wounds. This information can be used to guide health care professionals in their selection, application, and response monitoring of wound therapies.
The indication for use of the device is to instantly visualize the presence of potentially harmful bacteria commonly found within or around wounds including S. aureus, P. aeruginosa, E. coli, Coagulase-negative staphylococci, Enterococcus spp, Proteus spp, Klebsiella pneumonia, Beta-hemolytic streptococci (Group B) and Enterobacter spp during clinical assessment,
treatment, and monitoring of treatment response of wounds.
Easy
Portable, touch-screen device with an intuitive interface.
Safe
No contrast agents and no patient contact required.
Precise
Allows for more targeted treatment protocols by knowing exactly where fluorescent bacteria are.
Efficient
Clinical studies have shown that fluorescent images assist in targeting sampling and debridement, and inform the decision whether or not to use an antimicrobial product
Fast
A clinical study reported that the acquisition of real-time fluorescence images takes less than 30 seconds.
Focused
Allows clinicians to focus on areas that may contain harmful bacteria with the guidance of fluorescence imaging
Incorporating the MolecuLight i:X into standard care helps clinicians measure wounds1,2 and detect fluorescent bacteria3-7 to facilitate evidence-based clinical decisionmaking in these areas of wound management
ASSESSMENT
In a multisite, clinical trial, red fluorescence on MolecuLight i:X images was indicative of bacterial loads of ≥104 CFU/g (moderate/heavy levels) 100% of the time.4 This real-time information, used in conjunction with clinical signs and symptoms, may assist a clinician in their wound assessment and treatment plan.
CLEANING
In case of series, the MolecuLight i:X has been shown to direct clinician focus for cleaning to areas where fluorescent bacteria are located,6,8 thereby optimizing wound bed preparation.
DEBRIDEMENT
In clinical studies and case series, the MolecuLight i:X has been shown to demonstrate the need for debridement, identify the extent of debridement required, and facilitate targeted debridement to areas where fluorescent bacteria are located.
SAMPLING
Guides where to sample;4-6,10 in a clinical trial, fluorescence targeted sampling was more accurate than standard practice in detecting the presence of moderate to heavy bacterial loads.5 A meta-analysis reported an average fluorescence-guided sampling accuracy of 86%.
DOCUMENTATION
Provides objective documentation of the presence of fluorescent bacteria3-7 and the surface area of the wound
TREATMENT SELECTION
In a case series, fluorescence images provided real-time, objective documentation to support skin graft procedures;11 planned grafting procedures were halted when fluorescent bacteria were visualized. Clinical studies have shown that fluorescent images also provide real-time objective feedback on treatment plan effectiveness
ANTIMICROBIAL STEWARDSHIP
In case of series, real-time fluorescence images prevented potentially unnecessary use of systemic and topical antibiotics in wound patients6 and identified asymptomatic wound patients with heavy bacterial burden, prompting antibiotic prescription
PATIENT ENGAGEMENT
In a clinical case study, fluorescence images facilitated patient engagement and were associated with an improvement in patient treatment plan adherence.15 Patients easily understood the bright colors on images in regions where fluorescent bacteria were present
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