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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750203
First Posted: December 17, 2012
Last Update Posted: December 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Systagenix Wound Management
  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

Resource links provided by NLM:


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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Systagenix Wound Management
ClinicalTrials.gov Identifier: NCT01750203     History of Changes
Other Study ID Numbers: SBIR-001-A
Systagenix ( Other Identifier: Systagenix2012 )
First Submitted: December 7, 2012
First Posted: December 17, 2012
Last Update Posted: December 20, 2012
Last Verified: December 2012

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

Additional relevant MeSH terms:
Wounds and Injuries