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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

St. John Wound Center

Tulsa, Oklahoma, United States, 74135