Swab Sample Collection for the Detection of Bacterial Proteases

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.

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Key information

Conditions

Chronic Wounds Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. John Wound Center

Tulsa, Oklahoma, 74135, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Swabs

Other

There is no intervention only swabs are being used to collect wound fluid samples

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Systagenix Wound Management

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jun 20, 2013
Registry last updated: Jul 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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