ClinicalTrials.gg
CompletedNCT05196880Updated Jun 25, 2026

Biofilm Correlation and Validation

An observational study in Wound Infection, sponsored by MolecuLight Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by MolecuLight Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Wound Infection with a site in Canada — 2 open to participants now, 2 under way, none of them phase 3. Wound Infection · Canada.

Started
2022
the only one that year
Observational
2 of 11
none open now
Registered
9th of 11
by date
Lead sponsor
1 of 11
MolecuLight Inc.

Among the 11 studies in Wound Infection with a site in Canada, this one is the only one that started in 2022, is one of 2 observational ones, and was the 9th registered.

Wound Infection

270 studies on the registry are indexed under Wound Infection; 33 are open to participants now.

Browse Wound Infection studies →

Open to participants now

2 of the 11 studies in Wound Infection with a site in Canada are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 23 Wound Infection studies recruiting now, 17 (74%) set no upper age limit and 1 (4%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Wound Infection

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Male and female subjects presenting with acute or chronic wounds

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients presenting with acute or chronic wounds
  2. 18 years or older
  3. Willing to consent

Exclusion criteria

Exclusion Criteria:

  1. Treatment with an drug within 1 month of enrolment
  2. Any to regular wound care
  3. Inability or unwillingness to consent
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Target follow-up
01 Days
Patient registry
Yes

Groups and cohorts

  • ARM 1

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

    Device: MolecuLight DX Imaging Device

  • ARM 2

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

    Device: MolecuLight DX Imaging Device

Interventions

  • DeviceMolecuLight 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.

06

What researchers measure

Primary outcomes

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

    Time frame: 3 months

07

Study locations

1 site
  • The Mayer Institute
    Hamilton, Ontario L8R 2R3, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2022 to primary completion in May 2022, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2021
First posted
Jan 19, 2022
StartActual
Feb 15, 2022
Primary completionActual
May 15, 2022
CompletionActual
Nov 8, 2023
Last update
Jun 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05196880
Lead sponsor
MolecuLight Inc.
Responsible party
Sponsor
First posted
Jan 19, 2022
Start date
Feb 15, 2022
Primary completion
May 15, 2022
Completion
Nov 8, 2023
Last update
Jun 25, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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