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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Systagenix Wound Management
ClinicalTrials.gov Identifier:
NCT01750203
First received: December 7, 2012
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Chronic Wounds With Different Etiologies
Other: Swabs

Study Type: Observational
Official Title: Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay

Further study details as provided by Systagenix Wound Management:

Primary Outcome Measures:
  • The biochemical differences between clinically infected and non infected wounds. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   None Retained

Swabs will be tested on day on collection. Test is destructive. No swabs will be retained.


Enrollment: 135
Study Start Date: December 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No treatment
No cohort as this study is not using a treatment or intervention only swabs are being collected.
Other: Swabs
There is no intervention only swabs are being used to collect wound fluid samples

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult subjects (greater than 18 years old), presenting at participating clinical sites with wounds of different etiologies, who are willing to provide informed consent and who meet the inclusion / exclusion criteria, will be prospectively enrolled

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750203

Locations
United States, Oklahoma
St. John Wound Center
Tulsa, Oklahoma, United States, 74135
Sponsors and Collaborators
Systagenix Wound Management
Investigators
Principal Investigator: Tom Serena, MD SerenaGroup, Inc.
  More Information

No publications provided

Responsible Party: Systagenix Wound Management
ClinicalTrials.gov Identifier: NCT01750203     History of Changes
Other Study ID Numbers: SBIR-001-A, Systagenix
Study First Received: December 7, 2012
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Systagenix Wound Management:
Diabetic foot ulcers, venous leg ulcers, pressure sores, acute wounds

ClinicalTrials.gov processed this record on November 24, 2014