Biofilm Correlation and Validation

Sponsor

MolecuLight Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05196880

Collaborator

(none)

Enrollment

5.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wound Infection	Device: MolecuLight DX Imaging Device

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Feb 15, 2022

Anticipated Primary Completion Date :

May 15, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
ARM 1 Patients with negative clinical suspicion of Biofilm containing wounds(CSB-).	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.
ARM 2 Patients with positive clinical suspicion of Biofilm containing wounds(CSB+)	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.

Arm

Intervention/Treatment

ARM 1

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

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.

ARM 2

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

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

MolecuLight Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MolecuLight Inc.

ClinicalTrials.gov Identifier:

NCT05196880

Other Study ID Numbers:

21-002

First Posted:

Jan 19, 2022

Last Update Posted:

Jan 19, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Wound Infection

Study Results

No Results Posted as of Jan 19, 2022