A Prospective, Single-blind, Clinical Evaluation of the MolecuLight DX in Combination With Biofilm Based Wound Care for the Identification of Biofilm Containing Wounds

This is a prospective, single-blind, controlled trial. There are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (CSB+/CSB-) are allocated in each arm. The primary objective is to evaluate the diagnostic accuracy of MolecuLight fluorescence in identifying biofilm as validated by gold standard SEM imaging.

开始日期2022-02-15

申办/合作机构

Moleculight, Inc.

NCT05183698 / Unknown statusN/A

Spectroscopic Assessment of Autofluorescent Signatures of Tissue in and Around Wounds Identified by MolecuLight i:X Imaging Device

Evaluation and characterization of autofluorescence signals of tissue in and around wounds as identified by MolecuLight fluorescence image.

开始日期2022-01-10

申办/合作机构

Moleculight, Inc.

NCT04185636 / Unknown statusN/A

Prospective, Double-blind Assessment of the Presence of Fluorescence Signature to Predict Graft Failure Using MolecuLight i:X Imaging Device

This study will investigate whether the presence of a bacterial fluorescent signature captured by the MolecuLight i:X can predict a skin graft failure. The MolecuLight i:X is a handheld medical device which enables real-time standard digital imaging and fluorescence imaging of wounds and surrounding healthy skin of patients. When wounds are illuminated in fluorescence mode, collagen and other related proteins in the connective tissue matrix may emit a characteristic green fluorescent signal, while some bacteria may emit a unique red fluorescence signal due to endogenous porphyrin production and others may emit a unique cyan fluorescence signal due to the production of pyoverdine.
This is a non-randomized evaluation for which 20 adult patients will be imaged at University Hospitals Birmingham who present with a wound which has been previously infected and which requires a skin graft. The i:X will be used to take standard and fluorescent (FL) images of each graft site by the study team. The wound will be measured using the measurement application of the i:X, using WoundStickers. The clinician will be blinded to the results of these FL images until the end of the study. In this trial, the device is not intended to guide treatment. The images will be used after a 1-month patient follow up to correlate presence of bacterial fluorescence signature to graft failure. The hypothesis is that the presence of a bacterial fluorescence signature increases the likelihood of graft failure. The ability to predict graft failure would provide clinicians with more information on which to base a patient's suitability for a graft (e.g. determining if there is a heavy bacterial load present). This may lead to selection of appropriate therapies before a graft is applied.

开始日期2021-01-15

申办/合作机构

Moleculight, Inc.

100 项与 Moleculight, Inc. 相关的临床结果

登录后查看更多信息

0 项与 Moleculight, Inc. 相关的专利（医药）

登录后查看更多信息

项与 Moleculight, Inc. 相关的文献（医药）

2020-03-01·Future Microbiology3区 · 生物学

In Vitro Detection of Porphyrin-Producing Wound Bacteria with Real-Time Fluorescence Imaging

3区 · 生物学

Article

作者: DaCosta, Ralph S ; Ng, Herman ; Kirman, Jeffrey ; Keim, Klara C ; Jones, Laura M ; Dunham, Danielle ; Little, William ; Smith, Allie Clinton ; Bourke, Jessica ; Gomez, Andre ; Rennie, Monique Y ; Lopez, Andrea J

Aim: Fluorescence imaging can visualize polymicrobial populations in chronic and acute wounds based on porphyrin fluorescence. We investigated the fluorescent properties of specific wound pathogens and the fluorescence detected from bacteria in biofilm. Methods: Utilizing Remel Porphyrin Test Agar, 32 bacterial and four yeast species were examined for red fluorescence under 405 nm violet light illumination. Polymicrobial biofilms, supplemented with δ-aminolevulinic acid, were investigated similarly. Results: A total of 28/32 bacteria, 1/4 yeast species and polymicrobial biofilms produced red fluorescence, in agreement with their known porphyrin production abilities. Conclusion: These results identify common wound pathogens capable of producing porphyrin-specific fluorescence and support clinical observations using fluorescence imaging to detect pathogenic bacteria in chronic wounds.

2020-02-01·Journal of Wound Care

The safety of punch biopsies on hard-to-heal wounds: a large multicentre clinical trial

作者: Serena, Laura ; Cole, Windy ; Rennie, Monique Y ; Yaakov, Raphael ; Harrell, Khristina ; Serena, Thomas E. ; Coe, Stacey

Objective: Punch biopsy is a simple and effective diagnostic technique used in hard-to-heal wound management. Histologic examination can rule out cancer in the wound bed or diagnose vasculitis in a hard-to-heal or suspicious ulcer. A biopsy can determine the level of bacteria in an ulcer when infection is suspected. Despite its use, health professionals practicing in wound clinics hesitate to perform punch biopsies. The reasons vary from the invasive nature of the procedure to a fear of complications. Methods: A multicentre clinical trial evaluated the addition of fluorescence imaging to clinical examination in determining bacterial burden in hard-to-heal wounds. The protocol required a 6mm punch biopsy of any area (up to three) suspected of having moderate-to-high bacteria levels either on clinical examination or fluorescence image. If clinical examination and fluorescence imaging both did not indicate bacteria, the health professional took a biopsy of the centre of the ulcer. The biopsies were performed under local anaesthesia after cleansing the ulcer bed with sterile normal saline. Haemostasis was achieved with direct pressure and the occasional topical clotting agent. All of the patients were followed for 30 days to monitor for adverse events. Results: A total of 350 patientis with wounds (diabetic foot ulcer n=138; venous leg ulcer n=106; pressure ulcer n=22; surgical site infection n=60; other n=24), enrolled by 20 investigators at 14 sites in the US, underwent a total of 412 punch biopsies. Haemostasis was achieved in all 412 biopsies. No biopsy sites required cautery or suture ligation to control bleeding. No subjects returned to the clinic secondary to bleeding. A patient developed an infection three days post-biopsy that could have been due to the punch biopsy. However, the patient was HIV-positive and the quantitative biopsy was positive for infection, biopsy bacterial load of 106 colony forming units (CFU)/g. Conclusion: This trial used a 6mm punch to obtain tissue for culture, histology and additional biomarker research. In daily wound care practice, a smaller 3mm punch suffices. Adverse events were rare despite the larger biopsy. Punch biopsies are a safe procedure for obtaining tissue for histologic or microbiologic analysis.

2019-12-02·Journal of Wound Care4区 · 医学

Use of a bacterial fluorescence imaging device: wound measurement, bacterial detection and targeted debridement

4区 · 医学

Article

作者: Lindvere-Teene, Liis ; Jones, Laura M ; Raizman, Rose ; Linden, Ron ; Rennie, Monique Y ; Tapang, Kim ; Dunham, Danielle

Objective: Diagnostics which provide objective information to facilitate evidence-based treatment decisions could improve the chance of wound healing. Accurate wound measurements, objective bacterial assessment, and the regular, consistent tracking of these parameters are important aspects of wound care. This study aimed to assess the accuracy, clinical incorporation and documentation capabilities of a handheld bacterial fluorescence imaging device (MolecuLight i:X). Method: Benchtop wound models with known dimensions and clinical wound images were repeatedly measured by trained clinicians to quantify accuracy and intra/inter-user coefficients of variation (COV) of the imaging device measurement software. In a clinical trial of 50 wounds, wound dimensions were digitally measured and fluorescence images were acquired to assess for the presence of bacteria at moderate-to-heavy loads. Finally, fluorescence imaging was implemented into the routine assessment of 22 routine diabetic foot ulcers (DFU) to determine appropriate debridement level and location based on bacterial fluorescence signals. Results: Wound measurement accuracy was >95% (COV <3%). In the clinical trial of 50 wounds, 72% of study wounds demonstrated positive bacterial fluorescence signals. Levine sampling of wounds was found to under-report bacterial loads relative to fluorescence-guided curettage samples. Furthermore, fluorescence documentation of bacterial presence and location(s) resulted in more aggressive, fluorescence-targeted debridement in 17/20 DFUs after standard of care debridement failed to eliminate bacterial fluorescence in 100% of DFU debridements. Conclusion: The bacterial fluorescence imaging device can be readily implemented for objective, evidenced-based wound assessment and documentation at the bedside. Bedside localisation of regions with moderate-to-heavy bacterial loads facilitated improved sampling, debridement targeting and improved wound bed preparation.

项与 Moleculight, Inc. 相关的新闻（医药）

2024-10-17

·PRNewswire

MolecuLight's Fluorescence Imaging: A Game-Changer for Bedside Biofilm Detection

TORONTO, Oct. 17, 2024 /PRNewswire/ -- MolecuLight Inc., the global leader in fluorescence imaging technology for real-time detection of harmful bacteria in wound care, provides the most effective method for bedside biofilm detection as reported in a groundbreaking study "Assessing Biofilm at the Bedside: Exploring Reliable Accessible Biofilm Detection Methods". Published in Diagnostics Journal, this study is the first of its kind to compare various bedside methods for biofilm detection to enable immediate and effective therapeutic action. Continue Reading MolecuLight's Fluorescence Imaging: A Game-Changer for Bedside Biofilm Detection Biofilm is critically linked to various pathophysiological mechanisms that complicate or altogether prevent healing. Accurate biofilm detection is often hindered by the need for specialized techniques, making it impractical for many clinical settings. This study compared promising bedside methods, including clinical signs of biofilm (CSB), biofilm blotting, and fluorescence imaging, against advanced gold standard laboratory-based methods. The results revealed a staggering incidence of biofilm in chronic wounds (62.5%), highlighting its critical relevance in influencing wound healing outcomes. Fluorescence imaging significantly improved the sensitivity and accuracy of biofilm detection over CSB and blotting, offering clinicians a more reliable biofilm detection tool. "Fluorescence imaging demonstrated superior sensitivity (84%) compared to traditional methods of bedside biofilm detection," says Anil Amlani, CEO of MolecuLight Inc. "This underscores the transformative impact of our technology in managing a crucial issue affecting the outcomes of chronic wounds by providing clinicians with real-time, objective data that can significantly enhance patient outcomes." Dr. Perry Mayer, the lead author of the study, commented, "This research represents the first comparative assessment of bedside, actually applicable, bedside methods for detecting wound biofilm for everyday practices. The capability of fluorescence imaging to alert clinicians to the presence of biofilm at the point of care is essential for enhancing therapeutic strategies." He added, "As a clinician, I greatly appreciate the non-invasive and highly practical application of this device. This study reinforces my confidence that I am capturing all relevant bacterial types, allowing me to make objective, evidence-based decisions without having to wait for lab results." The publication of this study further reinforces MolecuLight's commitment to advancing wound care through innovative technology and high-quality research. By delivering actionable insights at the point of care, MolecuLight's fluorescence imaging technology continues to revolutionize wound assessment and healing outcomes. To learn more about how MolecuLight's fluorescence imaging can benefit your practice, please visit our website at . About MolecuLight Inc. MolecuLight Inc. is a privately owned medical imaging company with a global presence that manufactures and commercializes the MolecuLight i:X® and DX™ wound imaging devices. These are the only class II FDA-cleared point-of-care imaging devices for the real-time detection of elevated bacterial burden in wounds. They also provide accurate digital wound measurement for comprehensive wound management, supported by strong clinical evidence including over 100 peer-reviewed publications. Photo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果

2024-10-02

·PRNewswire

10 Clinical Posters Featuring MolecuLight Highlight its Progress Towards Becoming the Standard of Care

TORONTO and LAS VEGAS, Oct. 2, 2024 /PRNewswire/ -- MolecuLight Inc., the global leader in fluorescence imaging technology for real-time detection of harmful bacteria and digital wound measurement, proudly announces the presentation of 10 clinical posters featuring MolecuLight at the Symposium on Advanced Wound Care (SAWC) Fall 2024. This interdisciplinary educational event aimed at improving patient outcomes takes place from October 2–5, 2024 in Las Vegas, Nevada. It stands as one of the largest multidisciplinary meetings of wound care professionals globally. Continue Reading SAWC Fall featuring MolecuLight In addition to the clinical posters at SAWC Fall 2024, the MolecuLight i:X® and DX™ imaging devices will be available for demonstration in the MolecuLight Booth #431 in the Exhibition Hall. MolecuLight's showing at SAWC Fall spans a range of clinical applications and highlights new device features. These include optimized wound bed preparation ahead of skin grafting and cellular and tissue-based product (CTP) application, automatic digital wound depth measurement for streamlined workflow, thermal imaging to detect and better treat pressure injuries, associating fluorescence signals with diabetic ulcer healing, and other innovative approaches to wound care. "We are thrilled to see such a strong representation of MolecuLight research at SAWC Fall, which demonstrates the ever-growing adoption and support of our device. The 10 clinical posters being presented highlight the continuously expanding body of evidence in support of the implementation of our technology as part of the standard of care for wound infection management as this has proven to enhance patient outcomes," says Anil Amlani, CEO of MolecuLight, Inc. "MolecuLight is a unique technology in the field, with integrated multiple functions that provide clinicians with a global overview of the wounds' evolution, documents their interventions and findings and enriches every patent encounter with highly accurate, point-of-care information about bacterial burden and wound size." The clinical posters featuring the MolecuLight at SAWC Fall 2024 are as follows: Poster CR-001, "Imaging Beyond the Wound Bed: Leveraging Fluorescence Imaging of Non-Biologicals to Enhance Bacterial-Infection Management", presented by Dr. Charles Andersen Poster CR-002, "The New Age of Wound Care: Leveraging the Synergy of Multi-modal Fluorescence and Thermal Imaging", presented by Dr. Charles Andersen Poster CR-020, "Validation of a Digital Automatic-Depth Measurement Feature within a Multi-Modal Wound Imaging Device", presented by Dr. Laura Jones Poster CR-029, "Bacterial fluorescence imaging improves chronic wound biofilm detection over standard clinical assessment and blotting", presented by Dr. Laura Jones Poster CR-063, "Bacterial Fluorescence in the Application of Cellular Tissue Products", presented by Dr. Alisha Oropallo Poster CR-064, "Co-localization of High Bacterial Load with Regions of Pain in Venous Leg Ulcers: Fluorescence Imaging Informs Interventions and Validates Patient Self-Reported Pain", presented by Dr. Alisha Oropallo Poster CS-012, "Advancing Pyoderma Gangrenosum Wound Care Through Fluorescence-Guided Debridement", presented by Dr. Charles Andersen Poster CS-115, "The Interface of Cutting-Edge Technology in Mission Sustained Injuries of U.S. Special Operations", presented by Dr. Charles Andersen Poster CS-151, "The Association of Bacterial Autofluorescence Signals with Healing Outcomes in Diabetic Foot Ulcers", presented by Dr. Stephanie Woelfel Poster CS-157, "Update on pressure ulcer diagnosis and management: Leveraging Fluorescence and Thermal Imaging", presented by Dr. Charles Andersen About MolecuLight The MolecuLight i:X® and DX™ are the only Class II FDA cleared imaging devices for real-time detection of elevated levels of bacteria in wounds, surgical sites, and other injuries. With unmatched clinical evidence including 100+ peer-reviewed publications representing over 3500 patients, their innovative devices empower healthcare providers to target bacterial removal and make informed treatment decisions. By detecting bacteria in its early stages, MolecuLight technology improves infection management for exceptional patient outcomes. The multi-modal MolecuLight devices combine bacterial detection, wound measurement, and imaging capabilities into a single tool, streamlining workflows and improving documentation accuracy. Integrating seamlessly with electronic medical records, MolecuLight empowers clinicians to deliver the highest standard of care while optimizing their workflow. For more information, contact: Hunter Zudans, Director of Marketing, Moleculight Inc., T. 416.542.5507, [email protected] Photo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-10-01

·PRNewswire

Auto Depth Digital Wound Measurement Now Available on MolecuLightDX

PITTSBURGH, Oct. 1, 2024 /PRNewswire/ -- MolecuLight Inc., the global leader in fluorescence imaging technology for real-time detection of harmful bacteria and digital wound measurement, announced today that their flagship wound imaging device, MolecuLight DX™, now has the ability to automatically measure wound depth. Continue Reading Auto Depth Digital Wound Measurement Now Available on MolecuLightDX Logo MolecuLight The MolecuLight DX now provides its users with a complete wound measurement solution allowing clinicians to digitally measure wound area, length, width and depth with a single image capture and without the need for calibration stickers. The addition of Auto Depth, made possible with proprietary optics and software, eliminates the need for clinicians to measure depth manually, therefore drastically reducing the steps that are currently necessary to measure a wound via standard of care, while obtaining a higher degree of precision and a global depiction of the wound's anatomy. This exciting new feature will have a positive impact on overall clinical workflow, allowing clinicians to spend more time on patient care and less time on documentation. Standard of care depth measurements, made using a probe and ruler, are often inaccurate with a high degree of variability in measured depths across different clinicians, usually resulting in overestimation. The new MolecuLight DX Auto Depth feature will help to standardize wound measurement across multiple providers. This new feature has been extensively tested and validated to ensure exceptional accuracy and robust reliability within a real clinical environment on real patient wounds. MolecuLight will be showcasing the new Auto Depth feature at the upcoming SAWC Fall 2024, including a poster summarizing the statistically powered accuracy and reproducibility validation testing. "We are thrilled to announce the launch of the Auto Depth feature. Providing customers with a robust, standardized and easily implementable digital wound measurement solution is a top priority at MolecuLight," says Anil Amlani, CEO of MolecuLight Inc. "The MolecuLight DX Auto Depth will have a significant impact on clinical workflow and documentation, allowing wounds to be efficiently measured with a single image capture while obtaining superior accuracy and reliability. The measured Auto Depth is automatically written to the patient record for EHR integrated customers, further reducing the documentation burden experienced by wound care clinicians." About MolecuLight Inc and its wound imaging devices MolecuLight Inc., is a privately owned medical imaging company with a global presence that manufactures and commercializes the MolecuLight i:X® and DX™ wound imaging devices . These are the only class II FDA-cleared point-of-care imaging devices for the real-time detection of elevated bacterial burden in wounds. They also provide accurate digital wound measurement for comprehensive wound management, supported by strong clinical evidence including over 100 peer-reviewed publications. For sales, media or other inquiries or further information, please contact: Hunter Zudans, Director of Marketing, MolecuLight Inc., T. +1.484.682.7580,[email protected], Photo - Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED