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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1 | Patients with negative clinical suspicion of Biofilm containing wounds(CSB-). |
| |
| ARM 2 | Patients with positive clinical suspicion of Biofilm containing wounds(CSB+) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of fluorescence signature to predict presence or absence of wound biofilm measured by moderate/ heavy bacterial load | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female subjects presenting with acute or chronic wounds
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mayer Institute | Hamilton | Ontario | L8R 2R3 | Canada |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
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