Back to resultsSwab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay
Primary Purpose
Chronic Wounds With Different Etiologies
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Swabs
Sponsored by
About this trial
This is an observational trial for Chronic Wounds With Different Etiologies focused on measuring Diabetic foot ulcers, venous leg ulcers, pressure sores, acute wounds
Eligibility Criteria
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.
Sites / Locations
- St. John Wound Center
Arms of the Study
Arm 1
Arm Type
Arm Label
No treatment
Arm Description
No cohort as this study is not using a treatment or intervention only swabs are being collected.
Outcomes
Primary Outcome Measures
The biochemical differences between clinically infected and non infected wounds.
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
Full Information
NCT ID
NCT01750203
First Posted
December 7, 2012
Last Updated
December 19, 2012
Sponsor
Systagenix Wound Management
1. Study Identification
Unique Protocol Identification Number
NCT01750203
Brief Title
Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay
Official Title
Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay
Study Type
Observational
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Systagenix Wound Management
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Wounds With Different Etiologies
Keywords
Diabetic foot ulcers, venous leg ulcers, pressure sores, acute wounds
7. Study Design
Enrollment
135 (Actual)
Biospecimen Retention
None Retained
Biospecimen Description
Swabs will be tested on day on collection. Test is destructive. No swabs will be retained.
8. Arms, Groups, and Interventions
Arm Title
No treatment
Arm Description
No cohort as this study is not using a treatment or intervention only swabs are being collected.
Intervention Type
Other
Intervention Name(s)
Swabs
Intervention Description
There is no intervention only swabs are being used to collect wound fluid samples
Primary Outcome Measure Information:
Title
The biochemical differences between clinically infected and non infected wounds.
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Population Description
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
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Serena, MD
Organizational Affiliation
SerenaGroup, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. John Wound Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay
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