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

Systagenix Wound Management

Status: Completed

Conditions: Chronic Wounds With Different Etiologies

Treatments: Other: Swabs

Study type: Observational

Funder types: Industry

Identifiers

NCT01750203

Systagenix (Other Identifier)

SBIR-001-A

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

135 participants in 1 patient group

No treatment

Description:

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

Treatment:

Other: Swabs