Swab Sample Collection for the Detection of Bacterial Proteases

Chronic Wounds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881815
• Other study ID #: SBIR-001-B
• Secondary ID: Systagenix
• Status: Completed
• Phase: N/A
• First received: June 11, 2013
• Last updated: July 4, 2013
• Start date: June 2013
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Systagenix Wound Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Chronic Wounds

Intervention

Other:
• Swabs
There is no intervention only swabs are being used to collect wound fluid samples

Locations

Country	Name	City	State
United States	St. John Wound Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Systagenix Wound Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The determination of the protease levels in clinically infected and non infected chronic wounds from swabs by enzyme techniques.	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.	3 days	No
Secondary	to determine the bacteria present in infected and non infected wounds by microbiological techniques	The difference in the microbial flora will be determine by analysis of the swabs from infected and non infected wounds.	3 days	No