Biofilm Correlation and Validation

NCT05196880 | Completed FDA Device

• 1 other identifier: 21-002
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Infection

Outcome Measures

Primary Outcomes (1)

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

  3 months

Study Arms (2)

ARM 1

Patients with negative clinical suspicion of Biofilm containing wounds(CSB-).

Device: MolecuLight DX Imaging Device

ARM 2

Patients with positive clinical suspicion of Biofilm containing wounds(CSB+)

Device: MolecuLight DX Imaging Device

Interventions

MolecuLight DX Imaging Device 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.

ARM 1; ARM 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female subjects presenting with acute or chronic wounds

You may qualify if:

• Patients presenting with acute or chronic wounds
• years or older
• Willing to consent

You may not qualify if:

• Treatment with an investigational drug within 1 month of enrolment
• Any contra-indication to regular wound care
• Inability or unwillingness to consent

Sponsors & Collaborators

• MolecuLight Inc.: lead

Study Sites (1)

The Mayer Institute

Hamilton, Ontario, L8R 2R3, Canada

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 19, 2022
• Study Start: February 15, 2022
• Primary Completion: May 15, 2022
• Study Completion: November 8, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CA (1)