Swab Sample Collection for the Detection of Bacterial Proteases

Study Overview
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Brief Summary
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The objective of this study is to collect wound exudate (fluid) swab samples from Subjects who have wounds that show clinical signs of infection, as well as from Subjects who have wounds that do not show clinical signs of infection. Swab samples will be collected from acute and chronic wounds of different etiologies and these will be analysed for bacteria types and markers of infection.

Official Title
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Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay

Conditions
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Chronic Wounds

Intervention / Treatment
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* Other: Swabs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has presented to participating study site with a wound(s) suspected to be infected, as determined by the Investigator and/ or study staff - defined as one that through clinical judgment has questionable infection status, and /or shows three or more of the NERDS or STONES signs of infection); Subject has presented to participating study site with a wound(s) suspected not to be infected, as determined by the Investigator and/ or study staff - defined as one that does not show three or more of the NERDS or STONES signs of infection. Subject is 18 years of age or older. Subject agrees to complete all aspects of the study and provides Informed Consent Exclusion Criteria: Subject is less than 18 years of age. Target wound contains a malignancy Subject has hypersensitivity of the wound or painful wound surface which prevents touching/swabbing of the wound surface. Subject is confirmed to be positive for HIV or hepatitis. Subject is unable or unwilling to provide informed consent. Subjects deemed inappropriate for the study by the site's Principal Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br>No cohort as this study is not using a treatment or intervention only swabs are being collected. | Other: Swabs<br>* There is no intervention only swabs are being used to collect wound fluid samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The determination of the protease levels in clinically infected and non infected chronic wounds from swabs by enzyme techniques. | Wound exudate (fluid) swab samples from different etiologies of wounds will be collected. Subjects who have wounds that do not show clinical signs of infection, as well as Subjects who have wounds that do show clinical signs of infection will be enrolled. a maximum of four (4) swab sample from Subjects from whom Informed Consent has been obtained. The swabs will be subjected to various tests methods that may include, but are not limited to, the following: 1) quantitative bacterial cultures (for aerobic and / or anaerobic bacteria), 2) for research use only testing on test formats currently in development by the sponsor (note: this data will not be used to support regulatory filings, such as CE marking or FDA submissions for U.S. market clearance), 3) molecular microbiology, and 4) protease analysis. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine the bacteria present in infected and non infected wounds by microbiological techniques | The difference in the microbial flora will be determine by analysis of the swabs from infected and non infected wounds. | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic wounds with different etiologies, Diabetic foot ulcers, venous leg ulcers, acute wounds, pressure sores