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Insufficient subject accrual rate
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The study goal is to evaluate the ability of the V.A.C. ULTAâ„¢ Negative Pressure Wound Therapy System and V.A.C. VERAFLO CLEANSE CHOICE â„¢ (VFCC) dressing system with saline as an irrigant in increasing viable tissue in full thickness wounds (such as chronic, acute, traumatic, sub-acute, and dehisced wounds and/or ulcers) with difficult to manage bioburden and slough.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V.A.C. VERAFLO CLEANSE CHOICEâ„¢ with Normal Saline | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V.A.C. VERAFLO CLEANSE CHOICEâ„¢ dressing with Normal Saline | Device | -125mmHg, 10 minute soak time, 3.5 hours of negative pressure therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in wound bed surface area (cm2) of clean, healthy, viable tissue | Baseline to Day 6-9 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in total wound volume (cm3) | Baseline to Day 6-9 | |
| Percent change in total wound area (cm2) | Baseline to Day 6-9 | |
| Physician assessment of the need for surgical debridement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph M. Still Research Foundation | Augusta | Georgia | 30909 | United States |
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This will be a subjective assessment made by the Investigator of Yes or No |
| Day 6-9 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 26, 2023 | Oct 18, 2023 | 7 | ||
| Sep 27, 2024 | Oct 21, 2024 | 8 |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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