Swab Sample Collection for the Detection of Bacterial Proteases
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ClinicalTrials.gov Identifier: NCT01881815 |
Recruitment Status :
Completed
First Posted : June 20, 2013
Last Update Posted : July 8, 2013
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Condition or disease | Intervention/treatment |
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Chronic Wounds | Other: Swabs |
Study Type : | Observational |
Actual Enrollment : | 141 participants |
Official Title: | Swab Sample Collection for the Detection of Bacterial Proteases in Wounds Assay |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Group/Cohort | Intervention/treatment |
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No treatment
No cohort as this study is not using a treatment or intervention only swabs are being collected.
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Other: Swabs
There is no intervention only swabs are being used to collect wound fluid samples |
- 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.
- 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.
Biospecimen Retention: None Retained

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881815
United States, Oklahoma | |
St. John Wound Center | |
Tulsa, Oklahoma, United States, 74135 |
Principal Investigator: | Tom Serena, MD | SerenaGroup, Inc. |
Responsible Party: | Systagenix Wound Management |
ClinicalTrials.gov Identifier: | NCT01881815 History of Changes |
Other Study ID Numbers: |
SBIR-001-B Systagenix ( Other Identifier: Systagenix ) |
First Posted: | June 20, 2013 Key Record Dates |
Last Update Posted: | July 8, 2013 |
Last Verified: | June 2013 |
Chronic wounds with different etiologies Diabetic foot ulcers venous leg ulcers pressure sores acute wounds |
Wounds and Injuries |