Swab Sample Collection for the Detection of Bacterial Proteases

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Wounds
• Intervention / Treatment: Other: Swabs

• Study Type: Observational
• Enrollment (Actual): 141

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • St. John Wound Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Systagenix Wound Management
• Investigators: Principal Investigator: Tom Serena, MD, SerenaGroup, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (Estimate): June 20, 2013

Study Record Updates

• Last Update Posted (Estimate): July 8, 2013
• Last Update Submitted That Met QC Criteria: July 4, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Diabetic foot ulcers; venous leg ulcers; pressure sores; acute wounds; Chronic wounds with different etiologies
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: SBIR-001-B; Systagenix (Other Identifier: Systagenix)