← Back to all trials
Completed
NCT05196880
Biofilm Correlation and Validation
Conditions: Wound Infection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 40
Sponsor: MolecuLight Inc.
Location: The Mayer Institute Hamilton Ontario
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05196880). StuddyBuddy aggregates publicly available trial information.
