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NCT05196880 Clinical Trial

Biofilm Correlation and Validation

Wound Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05196880
Other study ID # 21-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2022
Est. completion date November 8, 2023

Study information
Verified date March 2024
Source MolecuLight Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date November 8, 2023
Est. primary completion date May 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Canada The Mayer Institute Hamilton Ontario

Sponsors (1)
Lead Sponsor Collaborator
MolecuLight Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load 3 months
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