Biofilm Correlation and Validation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-11-08

Brief Summary

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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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Detailed Description

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Conditions

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Wound Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ARM 1

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

MolecuLight DX Imaging Device

Intervention Type 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+)

MolecuLight DX Imaging Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No