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| Name | Class |
|---|---|
| ConvaTec Inc. | INDUSTRY |
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A comparison of two skin barriers on healthy volunteers with a colostomy, ileostomy or urostomy.
Endpoints of comparison include the ability to maintain a secure fit around the stoma, skin protection, wear-time, ease of use, ease of teaching, and comfort.
Study to include 60 subjects, three centers, total of 4 weeks, 2 weeks in each product. Subjects recruited from a population of persons who have had an existing fecal or urinary stoma for a duration of at least three months. There is no restriction on primary diagnosis for ostomy surgery. Subjects must be of legal consenting age, must currently be managing their own stoma with a two piece pouching system, either a pre-cut, cut to fit, moldable or stretch-to-fit, any manufacturer. Subjects may not require convexity and be willing to not to use any accessory products during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sur-Fit Natura/FormaFlex | Active Comparator | Subject will be on Surfit Moldable for 2 weeks then crossover to Formaflex |
|
| FormaFlex/Sur-Fit Natura | Active Comparator | Subject will be on Formaflex for 2 weeks then crossover to Surfit Moldable |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sur-Fit Natura | Device | ConvaTec Moldable Skin Barrier for ostomy patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability to maintain secure (snug) fit around stoma |
| Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Protection |
| Two weeks |
| Wear Time | 1. Time of barrier change recorded |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann M Durnal, RN BSN WOCN | Independent Nurse Consultants LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Independent Nurse Consultants LLC | Tucson | Arizona | 85742 | United States |
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| FormaFlex | Device | Hollister skin barrier for ostomy patients |
|
|
| Two weeks |
| Ease of use | 1. Assessment by subject response to questionnaire | Two weeks |
| Ease of teaching | 1. Assessment by nurse of ability to teach subject to use barrier | Two weeks |
| Comfort | 1. Subject assessment of comfort of barrier at each change | Two weeks |