Biofilm Correlation and Validation

MolecuLight

Status: Completed

Conditions: Wound Infection

Treatments: Device: MolecuLight DX Imaging Device

Study type: Observational

Funder types: Industry

Identifiers

NCT05196880

21-002

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

ARM 1

Description:

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

Treatment:

Device: MolecuLight DX Imaging Device

ARM 2

Description:

Patients with positive clinical suspicion of Biofilm containing wounds(CSB+)

Treatment:

Device: MolecuLight DX Imaging Device