Swab Sample Collection for the Detection of Bacterial Proteases

• ClinicalTrials.gov Identifier: NCT01881815
• Recruitment Status: Completed
• First Posted: June 20, 2013
• Last Update Posted: July 8, 2013
• Sponsor: Systagenix Wound Management
• Information provided by (Responsible Party): Systagenix Wound Management

Study Description

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 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 or disease	Intervention/treatment
Chronic Wounds	Other: Swabs

Study Design

• Study Type: Observational
• Actual Enrollment: 141 participants
• Official Title: Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay
• Study Start Date: June 2013
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. The determination of the protease levels in clinically infected and non infected chronic wounds from swabs by enzyme techniques. [ Time Frame: 3 days ]
   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.

Secondary Outcome Measures :

1. to determine the bacteria present in infected and non infected wounds by microbiological techniques [ Time Frame: 3 days ]
   The difference in the microbial flora will be determine by analysis of the swabs from infected and non infected wounds.

Biospecimen Retention:   None Retained

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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: NCT01881815 History of Changes
• Other Study ID Numbers: SBIR-001-B; Systagenix ( Other Identifier: Systagenix )
• First Posted: June 20, 2013
• Last Update Posted: July 8, 2013
• Last Verified: June 2013

Keywords provided by Systagenix Wound Management:

Chronic wounds with different etiologies; Diabetic foot ulcers; venous leg ulcers; pressure sores; acute wounds

Additional relevant MeSH terms:

Wounds and Injuries