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Biofilm Correlation and Validation
Sponsor: MolecuLight Inc.
Summary
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.
Official title: A Prospective, Single-blind, Clinical Evaluation of the MolecuLight DX in Combination With Biofilm Based Wound Care for the Identification of Biofilm Containing Wounds
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2022-02-15
Completion Date
2023-11-08
Last Updated
2026-06-25
Healthy Volunteers
No
Conditions
Interventions
MolecuLight DX Imaging Device
The MolecuLight DX Imaging Device is a fluorescence imaging device intended to acquire images from wounds. This will not alter the participant's standard of care treatment.
Locations (1)
The Mayer Institute
Hamilton, Ontario, Canada