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| Name | Class |
|---|---|
| Sorbion Aktiengesellschaft, Germany | UNKNOWN |
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This is a clinical study to evaluate the effects of sorbion sachet s wound dressing on soft tissue edema and wound bioburden in moderately to highly exuding pressure ulcers.
This study is aimed at the participation of subject with moderately to highly exuding pressure ulcers. Each Subject is expected to participate for a period of 4 weeks or until reepithelization, which occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorbion Sachet S | Other | Subject will evaluate Sorbion Sachet S dressing for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorbion Sachet S | Other | Dressing is indicated for moderately to heavily exuding wounds. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to investigate the effect of sachet S reduction on local soft tissue edema (excessive interstitial fluid to a maximum 3cm depth) in pressure ulcers. | To investigate the effect of sachet S reduction on local soft tissue edema in pressure ulcers and the degree to which sachet S influences the wound surface bioburden qualitatively and quantitatively. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objectives are to further investigate whether sorbion sachet s | Generates changes in subjective parameters Generates changes in wound size Leads to clinician satisfaction and patient compliance with sachet s | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall D Wolcott, M.D. | Southwest Regional Wound Care Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Regional Wound Care Center | Lubbock | Texas | 79410 | United States |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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