Swab Sample Collection for the Detection of Bacterial Proteases
NCT ID: NCT01881815
Last Updated: 2013-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
141 participants
OBSERVATIONAL
2013-06-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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No treatment
No cohort as this study is not using a treatment or intervention only swabs are being collected.
Swabs
There is no intervention only swabs are being used to collect wound fluid samples
Interventions
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Swabs
There is no intervention only swabs are being used to collect wound fluid samples
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Systagenix Wound Management
INDUSTRY
Responsible Party
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Principal Investigators
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Tom Serena, MD
Role: PRINCIPAL_INVESTIGATOR
SerenaGroup, Inc.
Locations
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St. John Wound Center
Tulsa, Oklahoma, United States
Countries
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Other Identifiers
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Systagenix
Identifier Type: OTHER
Identifier Source: secondary_id
SBIR-001-B
Identifier Type: -
Identifier Source: org_study_id
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