Evaluation of MolecuLight i:X as an Adjunctive Fluorescence Imaging Tool to Clinical Signs and Symptoms for the Identification of Bacteria-containing Wounds
NCT ID: NCT03540004
Last Updated: 2020-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
367 participants
OBSERVATIONAL
2018-05-23
2020-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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MolecuLight i:X Imaging Device
The i:X Imaging Device uses built-in light-emitting diodes (LEDs) emitting 405 nm violet excitation light to illuminate the wound during fluorescence imaging in (FL-Mode). The light excites biological components of the wound and surrounding tissues. Non-biological components may also fluoresce although their presence in wounds is less common, provided the wound has been cleaned following standard care protocols. The resulting wound fluorescence wavelengths emitted are typically between 420 - 700 nm in the visible wavelength spectrum. In FL-mode, a customized fluorescence emission filter, which is mechanically placed in front of the built in imaging sensor and allows real-time capture of wound, limits the visualization of fluorescence to wavelengths between 500-545 nm, which typically appears green in color, and 600-665 nm, which typically appears red in color.
Eligibility Criteria
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Inclusion Criteria
* 18 years or older
Exclusion Criteria
* Subjects with recent (\<30 days) biopsy of target wound
* Subjects with wounds that cannot be completely imaged by study device due to anatomic location
* Inability to consent
* Any contra-indication to routine wound care and/or monitoring
18 Years
ALL
No
Sponsors
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SerenaGroup, Inc.
NETWORK
MolecuLight Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tomas E Serena, MD
Role: PRINCIPAL_INVESTIGATOR
Serena Group Research Institute
Locations
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New Hope Podiatry Group
Los Angeles, California, United States
Royal Research Group
Pembroke Pines, Florida, United States
Saint Mary's Center for Wound Healing
Athens, Georgia, United States
The Wound Treatment Center at Opelousas General Health System
Opelousas, Louisiana, United States
Cleveland Foot and Ankle Clinic
Cleveland, Ohio, United States
The Heal Clinic
Tulsa, Oklahoma, United States
Foot and Ankle Center
Bryn Mawr, Pennsylvania, United States
Saint Vincent Health Center
Erie, Pennsylvania, United States
The Foot and Ankle Wellness Center of Western Pennsylvania
Ford City, Pennsylvania, United States
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, United States
Serena Group Research Institute
Pittsburgh, Pennsylvania, United States
Martin Foot and Ankle
York, Pennsylvania, United States
El Campo Memorial Hospital
El Campo, Texas, United States
Texas Gulf Coast Medical Group
Houston, Texas, United States
Countries
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References
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Johnson J, Johnson AR Jr, Andersen CA, Kelso MR, Oropallo AR, Serena TE. Skin Pigmentation Impacts the Clinical Diagnosis of Wound Infection: Imaging of Bacterial Burden to Overcome Diagnostic Limitations. J Racial Ethn Health Disparities. 2024 Apr;11(2):1045-1055. doi: 10.1007/s40615-023-01584-8. Epub 2023 Apr 11.
Serena TE, Gould L, Ousey K, Kirsner RS. Reliance on Clinical Signs and Symptoms Assessment Leads to Misuse of Antimicrobials: Post hoc Analysis of 350 Chronic Wounds. Adv Wound Care (New Rochelle). 2022 Dec;11(12):639-649. doi: 10.1089/wound.2021.0146. Epub 2021 Dec 3.
Other Identifiers
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18-001
Identifier Type: -
Identifier Source: org_study_id
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