Biofilm Correlation and Validation

Completed

• Conditions: Wound Infection
• Interventions: Device: MolecuLight DX Imaging Device

• Registration Number: NCT05196880
• Lead Sponsor: MolecuLight Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-19
• Study Start: 2022-02-15
• Primary Completion: 2022-05-15
• Study Completion: 2023-11-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARM 1	MolecuLight DX Imaging Device	Patients with negative clinical suspicion of Biofilm containing wounds(CSB-).
ARM 2	MolecuLight DX Imaging Device	Patients with positive clinical suspicion of Biofilm containing wounds(CSB+)

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Mayer Institute; 🇨🇦 Hamilton, Ontario, Canada