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The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New moldable user | Subjects presenting with peristomal lesions with a traditional barrier and for whom a ConvaTec Moldable Technologyâ„¢ Skin Barrier is used as a replacement. | ||
| New osomate | Subjects for whom a ConvaTec Moldable Technologyâ„¢ Skin Barrier is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin. |
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| Measure | Description | Time Frame |
|---|---|---|
| Peristomal skin condition | Change in peristomal skin condition from baseline as assessed with the SACS Instrument | At day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Peristomal skin condition | Change in peristomal skin condition from baseline as assessed with the SACS instrument | at 1 month |
| Level of satisfaction | Subjects satisfaction as measured with a satisfaction survey |
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Inclusion Criteria:
OR
Exclusion Criteria:
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colostomates, ileostomates, urostomates in acute care settings or community at large.
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| Name | Affiliation | Role |
|---|---|---|
| Qing Li, Ph.D, MD | ConvaTec Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Independent Nurse Consultant | Tucson | Arizona | 85742 | United States | ||
| John Muir Health Concord Campus |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 19, 2014 | |
| Reset | Apr 22, 2014 | |
| Release | Mar 30, 2016 | |
| Reset | May 3, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 19, 2014 | Apr 22, 2014 | |||
| Mar 30, 2016 |
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| At 2 months |
| Accessory usage | Subjects use of additional products in stoma care. | Up to 2 months |
| Peristomal Skin Condition | Change in peristomal skin condition from baseline as assessed with the SACS instrument | At 2 months |
| Level of satisfaction | Subjects level of satisfaction as measured by a satisfaction survey | At 12 days |
| Level of satisfaction | Subjects level of satisfaction as measured with a satisfaction survey | At 1 month |
| Concord |
| California |
| 94520 |
| United States |
| Conn. Clinical Nursing Associate, LLC | Plymoth | Connecticut | 06782 | United States |
| Baptist Home Health | Jacksonville | Florida | 32207 | United States |
| Porter Hospital | Valparaiso | Indiana | 46383 | United States |
| Serena Group - Dr. Thomas Serena MD | Cambridge | Massachusetts | 02140 | United States |
| Henry Ford Macomb Hospital | Clinton Township | Michigan | 48038 | United States |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| St. Anthony's Medical Center | St Louis | Missouri | 63128 | United States |
| ID Med Inc. | Columbus | Ohio | 43222 | United States |
| RI Colorectal Clinic, LLC | Pawtucket | Rhode Island | 02860 | United States |
| San Jacinto Methodist Hospital | Baytown | Texas | 77521 | United States |
| NW Pavillion Ostomy Clinic | Renton | Washington | 98055 | United States |
| May 3, 2016 |