Status:
COMPLETED
Swab Sample Collection for the Detection of Bacterial Proteases
Lead Sponsor:
Systagenix Wound Management
Conditions:
Chronic Wounds
Eligibility:
All Genders
18+ years
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT01881815
Start Date
June 1 2013
End Date
June 1 2013
Last Update
July 8 2013
Active Locations (1)
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1
St. John Wound Center
Tulsa, Oklahoma, United States, 74135