Biofilm Correlation and Validation

A Prospective, Single-blind, Clinical Evaluation of the MolecuLight DX in Combination With Biofilm Based Wound Care for the Identification of Biofilm Containing Wounds

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 Overview

• Status: Completed
• Conditions: Wound Infection
• Intervention / Treatment: Device: MolecuLight DX Imaging Device

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

• Study Contact: Name: Liis Teene, M.Sc; Phone Number: 416.542.5530; Email: lteene@moleculight.com
• Study Contact Backup: Name: Divya Bhardwaj, M.Sc.; Phone Number: 416.542.5531; Email: divyab@moleculight.com

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8R 2R3
      • The Mayer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Male and female subjects presenting with acute or chronic wounds

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ARM 1; Patients with negative clinical suspicion of Biofilm containing wounds(CSB-).	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.
ARM 2; Patients with positive clinical suspicion of Biofilm containing wounds(CSB+)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load	3 months

Collaborators and Investigators

• Sponsor: MolecuLight Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): May 15, 2022
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wound Infection
• Other Study ID Numbers: 21-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes