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| ID | Type | Description | Link |
|---|---|---|---|
| Systagenix | Other Identifier | Systagenix2012 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment | No cohort as this study is not using a treatment or intervention only swabs are being collected. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swabs | Other | There is no intervention only swabs are being used to collect wound fluid samples |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Tom Serena, MD | SerenaGroup, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John Wound Center | Tulsa | Oklahoma | 74135 | United States |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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Swabs will be tested on day on collection. Test is destructive. No swabs will be retained.
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |