Swab Sample Collection for the Detection of Bacterial Proteases

NCT01881815 | Completed DMC

• 2 other identifiers: SBIR-001-BSystagenix
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Wounds

Keywords

Chronic wounds with different etiologies; Diabetic foot ulcers; venous leg ulcers; pressure sores; acute wounds

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• to determine the bacteria present in infected and non infected wounds by microbiological techniques

  3 days

Study Arms (1)

No treatment

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

Other: Swabs

Interventions

Swabs OTHER

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

No treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Systagenix Wound Management: lead

Study Sites (1)

St. John Wound Center

Tulsa, Oklahoma, 74135, United States

Location

Biospecimen

Retention: NONE RETAINED

Swabs will be tested on day on collection. Test is destructive. No swabs will be retained.

MeSH Terms

Conditions

Diabetic Foot; Pressure Ulcer

Condition Hierarchy (Ancestors)

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

Study Officials

• Tom Serena, MD

  SerenaGroup, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 20, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 8, 2013

Record last verified: 2013-06

Locations

US (1)