Wound Infection
Conditions
Brief 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.
Interventions
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
MolecuLight Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load | 3 months |
Countries
Canada
Outcome results
None listed