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
|Condition or disease||Intervention/treatment|
|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|
No cohort as this study is not using a treatment or intervention only swabs are being collected.
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
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.|