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| ID | Type | Description | Link |
|---|---|---|---|
| LUHSC IRB #: 205654091813 | Other Identifier | Hollister Incorporated |
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| Name | Class |
|---|---|
| Loyola University | OTHER |
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This purpose of this study is to look at three commercially available ostomy barriers on peristomal (around the stoma) skin. Repeated barrier application and removal over years causes changes to the skin that the investigators wish to investigate. The primary objective is to measure peel force on normal skin and peel force on peristomal skin, with the intent of determining if differences occur. The study hypotheses is that no differences exist.
This is a single center, non-invasive exploratory study utilizing a sample of convenience. This study compares three commercially available barrier materials on peristomal skin and normal abdominal skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Abdominal Skin | Apply SoftFlex (standard wear commercial skin barrier), FlexWear (standard wear commercial skin barrier), and FlexTend (extended wear commercial skin barrier), material to non-peristomal abdominal skin. |
| |
| Peristomal Abdominal Skin | Apply SoftFlex, FlexWear and FlexTend barrier material to peristomal abdominal skin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Abdominal Skin | Device | Three barrier materials will be peeled from abdominal skin after a set period at a set rate. |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin Barrier Peel Force | Peel force of barrier materials, comparing peristomal skin to abdominal skin. A portable peel force analyser, previously validated, was used in the clinic to measure peel at 90 degrees to the plane of the body. Peel force was measured on peristomal skin and ipsilateral abdominal skin in the same subject. | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Ostomates with a normal peristomal skin and normal ipsilateral abdominal skin
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| Name | Affiliation | Role |
|---|---|---|
| James Swan, MD | Loyola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Grange Center for Health | La Grange Park | Illinois | 60526 | United States |
All 17 participants wore all three barrier types on control area AND peristomal area NOT 34 participants in study only 17 participants in study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abdominal Skin Barrier Peel Force | Barrier materials were attached and peeled off control and peristomal abdominal skin. Three commercial barrier materials (SoftFlex, FlexWear and FlexTend) were peeled from control or peristomal abdominal skin after a set period at a set rate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Must have ostomy of any type.
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| ID | Title | Description |
|---|---|---|
| BG000 | Abdominal Skin Barrier Peel Force | Three commerical barrier materials, SoftFlex, FlexWear and FlexTend barrier were peeled from control or peristomal abdominal skin after a set period at a set rate. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Skin Barrier Peel Force | Peel force of barrier materials, comparing peristomal skin to abdominal skin. A portable peel force analyser, previously validated, was used in the clinic to measure peel at 90 degrees to the plane of the body. Peel force was measured on peristomal skin and ipsilateral abdominal skin in the same subject. | Posted | Mean | Standard Deviation | grams | 4 hours |
|
5 months. Period from Sept 1, 2013 to Jan 31, 2014.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Abdominal Skin Barrier Peel Force | Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate. |
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Small sample size may not be generalizable to the population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr James Swan, MD | Loyola University of Chicago | 708-485-1271 | jswan@lumc.edu |
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| Peristomal Abdominal Skin | Device | Three barrier materials will be peeled from abdominal skin after a set period at a set rate. |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Peristomal Skin Barrier Peel Force | Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate. | 0 | 17 | 0 | 17 |
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