Swab Sample Collection for the Detection of Bacterial Proteases

Sponsor

Systagenix Wound Management (Industry)

Overall Status

Completed

CT.gov ID

NCT01881815

Collaborator

(none)

141

Enrollment

Location

Study Details

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	Phase
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 :

Jun 1, 2013

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	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

Arm

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

The determination of the protease levels in clinically infected and non infected chronic wounds from swabs by enzyme techniques. [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.