Biofilm Correlation and Validation

N/ACompletedNCT05196880

MolecuLight Inc.40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Wound Infection

Interventions

MolecuLight DX Imaging DeviceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients presenting with acute or chronic wounds 2. 18 years or older 3. Willing to consent Exclusion Criteria: 1. Treatment with an investigational drug within 1 month of enrolment 2. Any contra-indication to regular wound care 3. Inability or unwillingness to consent

Locations (1)

The Mayer Institute

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.