Biofilm Correlation and Validation

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.

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Key information

Conditions

Wound Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Mayer Institute

Hamilton, Ontario, L8R 2R3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

MolecuLight Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Jan 19, 2022
Registry last updated: Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed