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

Completed

• Conditions: Chronic Wounds With Different Etiologies
• Interventions: Other: Swabs

• Registration Number: NCT01750203
• Lead Sponsor: Systagenix Wound Management

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-12
• Study Start: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-17
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No treatment	Swabs	No cohort as this study is not using a treatment or intervention only swabs are being collected.

Primary Outcome Measures

Name	Time	Method
The biochemical differences between clinically infected and non infected wounds.	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.

Trial Locations

Locations (1)

St. John Wound Center; 🇺🇸 Tulsa, Oklahoma, United States