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Biofilm Correlation and Validation

NCT05196880 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

  • Wound Infection

Interventions

DEVICE

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.

Sponsors & Collaborators

  • MolecuLight Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2022-05-15
Completion
2023-11-08
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05196880 on ClinicalTrials.gov