---
title: Biofilm Correlation and Validation
nct_id: NCT05196880
overall_status: COMPLETED
sponsor: MolecuLight Inc.
study_type: OBSERVATIONAL
primary_condition: Wound Infection
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05196880.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05196880"
ct_last_update_post_date: 2024-03-15
last_seen_at: "2026-05-12T06:12:51.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Biofilm Correlation and Validation

**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

**NCT ID:** [NCT05196880](https://clinicaltrials.gov/study/NCT05196880)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** MolecuLight Inc.
- **Conditions:** Wound Infection
- **Start Date:** 2022-02-15
- **Completion Date:** 2023-11-08
- **CT.gov Last Update:** 2024-03-15

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **ARM 1** — Patients with negative clinical suspicion of Biofilm containing wounds(CSB-).
- **ARM 2** — Patients with positive clinical suspicion of Biofilm containing wounds(CSB+)

## Interventions

- **MolecuLight DX Imaging Device** (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.

## Primary Outcomes

- **Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load** _(time frame: 3 months)_

## Locations (1)

- The Mayer Institute, Hamilton, Ontario, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the mayer institute|hamilton|ontario|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05196880.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05196880*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*