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The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.
Six types of patches are tested:
Patch 1: Standard adhesive with own feces
Patch 2: Standard adhesive with own feces mixture
Patch 3: Standard adhesive with simulated feces
Patch 4: Standard adhesive with simulated feces mixture
Patch 5: Standard adhesive with buffer (control)
Patch 6: Standard adhesive with buffer feces mixture (control)
Each subject is randomized to one of two arms testing three patches on the peristomal skin (patch 1, 3 and 5 or patch 2, 4 and 6). Furthermore, within each arm an attempt will be made to randomize each of the three patches on the peristomal skin to one of three locations surrounding the stoma (upper left, upper right, lower). On the healthy contralateral abdominal skin the subjects test all six patches.
A run in period with 2 subjects (healthy volunteers) was conducted to clarify the length of the test period. They were exposed to 4 patches (patch 3-6) on healthy abdominal skin which was removed at 2 different time slots. Based on the results the test period was established
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patch 1, 3 and 5 | Experimental | Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. |
|
| Patch 2, 4 and 6 | Experimental | Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patch 1 | Other | Patch 1:standard adhesive with own feces in sleeve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trans Epidermal Water Loss After Test of Patches. | Trans Epidermal Water Loss is a standardized non-invasive method for describing the barrier function of the skin. Damage to the skin surface (stratum corneum) will lower the barrier of the skin and thereby increase water loss. This can be used as a measure for the damaging effect of the adhesives to the skin. Trans Epidermal Water Loss is measured by applying a probe to the skin surface and is assessed nine times for each patch after applying the patch: three repeated measurements of the skin covered by the center of the patch (Center), as well as three repeated measurements of the skin covered by the adhesive (Under adhesive). | Approximately 7-10 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lene F Nielsen, PhD | Coloplast A/S | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Videncenter for Saarheling | Copenhagen NV | 2400 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peristomal Patches: Patch 1, 3 and 5 | Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. Patch 1: Patch 1:standard adhesive with own feces in sleeve Patch 2: Patch 2:standard adhesive with own feces mixture in sleeve Patch 3: Patch 3: standard adhesive with simulated feces in sleeve Patch 4: Patch 4:standard adhesive with simulated feces mixture in sleeve Patch 5: Patch 5:standard adhesive with buffer in sleeve Patch 6: Patch 6:standard adhesive with buffer mixture in sleeve |
| FG001 | Peristomal Patches: Patch 2, 4 and 6 | Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. Patch 1: Patch 1:standard adhesive with own feces in sleeve Patch 2: Patch 2:standard adhesive with own feces mixture in sleeve Patch 3: Patch 3: standard adhesive with simulated feces in sleeve Patch 4: Patch 4:standard adhesive with simulated feces mixture in sleeve Patch 5: Patch 5:standard adhesive with buffer in sleeve Patch 6: Patch 6:standard adhesive with buffer mixture in sleeve |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peristomal Patches: Patch 1, 3 and 5 | Patch 1, Patch 3 and Patch 5 applied on peristomal skin. Patch 1 - Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. Patch 1: Patch 1:standard adhesive with own feces in sleeve Patch 2: Patch 2:standard adhesive with own feces mixture in sleeve Patch 3: Patch 3: standard adhesive with simulated feces in sleeve Patch 4: Patch 4:standard adhesive with simulated feces mixture in sleeve Patch 5: Patch 5:standard adhesive with buffer in sleeve Patch 6: Patch 6:standard adhesive with buffer mixture in sleeve |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Trans Epidermal Water Loss After Test of Patches. | Trans Epidermal Water Loss is a standardized non-invasive method for describing the barrier function of the skin. Damage to the skin surface (stratum corneum) will lower the barrier of the skin and thereby increase water loss. This can be used as a measure for the damaging effect of the adhesives to the skin. Trans Epidermal Water Loss is measured by applying a probe to the skin surface and is assessed nine times for each patch after applying the patch: three repeated measurements of the skin covered by the center of the patch (Center), as well as three repeated measurements of the skin covered by the adhesive (Under adhesive). | three repeated measurements per participant were performed and used in analysis e.g. 12 participants have 3x12=36 units analysed. | Posted | Mean | Standard Deviation | g/m^2/h | Approximately 7-10 hours | 3 repeated measurements per participant | 3 repeated measurements per participant |
|
17 days
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research
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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 | All Participants | This population also includes the two subject who were included in the screening period. Both AEs were related to the investigational procedures (one to the biopsy and one to the pre-stripping of the skin). Thus the AEs are not reported for each intervention separately as the AEs were unrelated to intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection in biopsies | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Gosk | Scientific and Regulatory affairs | +45 49113568 | dksargo@coloplast.com |
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| ID | Term |
|---|---|
| C000595790 | Sugp2 protein, mouse |
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| Patch 2 | Other | Patch 2:standard adhesive with own feces mixture in sleeve |
|
| Patch 3 | Other | Patch 3: standard adhesive with simulated feces in sleeve |
|
| Patch 4 | Other | Patch 4:standard adhesive with simulated feces mixture in sleeve |
|
| Patch 5 | Other | Patch 5:standard adhesive with buffer in sleeve |
|
| Patch 6 | Other | Patch 6:standard adhesive with buffer mixture in sleeve |
|
| BG001 | Peristomal Patches: Patch 2, 4 and 6 | Patch 2, Patch 4 and Patch 6 applied on peristomal skin. Patch 1- Patch 6 applied on healthy abdominal skin Measurements of skin at three locations of each patch: Center and under adhesive. Patch 1: Patch 1:standard adhesive with own feces in sleeve Patch 2: Patch 2:standard adhesive with own feces mixture in sleeve Patch 3: Patch 3: standard adhesive with simulated feces in sleeve Patch 4: Patch 4:standard adhesive with simulated feces mixture in sleeve Patch 5: Patch 5:standard adhesive with buffer in sleeve Patch 6: Patch 6:standard adhesive with buffer mixture in sleeve |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Measurement on skin (in the center of the patch) exposed to patch 1 (standard adhesive with own feces in sleeve) |
| OG001 | Peristomal Skin Patch 2 Center | Measurement on skin (in the center of the patch) exposed to patch 2 (standard adhesive with own feces mixture in sleeve) |
| OG002 | Peristomal Skin Patch 3 Center | Measurement on skin (in the center of the patch) exposed to patch 3 (standard adhesive with simulated feces in sleeve) |
| OG003 | Peristomal Skin Patch 4 Center | Measurement on skin (in the center of the patch) exposed to patch 4 (standard adhesive with simualted feces mixture in sleeve) |
| OG004 | Peristomal Skin Patch 5 Center | Measurement on skin (in the center of the patch) exposed to patch 5 (standard adhesive with buffer in sleeve) |
| OG005 | Peristomal Skin Patch 6 Center | Measurement on skin (in the center of the patch) exposed to patch 6 (standard adhesive with buffer mixture in sleeve) |
| OG006 | Abdominal Skin Patch 1 Center | Measurement on skin (in the center of the patch) exposed to patch 1 (standard adhesive with own feces in sleeve) |
| OG007 | Abdominal Skin Patch 2 Center | Measurement on skin (in the center of the patch) exposed to patch 2 (standard adhesive with own feces mixture in sleeve) |
| OG008 | Abdominal Skin Patch 3 Center | Measurement on skin (in the center of the patch) exposed to patch 3 (standard adhesive with simulated feces in sleeve) |
| OG009 | Abdominal Skin Patch 4 Center | Measurement on skin (in the center of the patch) exposed to patch 4 (standard adhesive with simulated feces mixture in sleeve) |
| OG010 | Abdominal Skin Patch 5 Center | Measurement on skin (in the center of the patch) exposed to patch 5 (standard adhesive with buffer in sleeve) |
| OG011 | Abdominal Skin Patch 6 Center | Measurement on skin (in the center of the patch) exposed to patch 6 (standard adhesive with buffer mixture in sleeve) |
| OG012 | Peristomal Skin Patch 1 Under Adhesive | Measurement on skin (covered by adhesive after removal of patch) exposed to patch 1 (standard adhesive with own feces in sleeve) |
| OG013 | Peristomal Skin Patch 2 Under Adhesive | Measurement on skin (covered by adhesive after removal of patch) exposed to patch 2 (standard adhesive with own feces mixture in sleeve) |
| OG014 | Peristomal Skin Patch 3 Under Adhesive | Measurement on skin (covered by adhesive after removal of patch) exposed to patch 3 (standard adhesive with simulated feces in sleeve) |
| OG015 | Peristomal Skin Patch 4 Under Patch | Measurement on skin (covered by adhesive after removal of patch) exposed to patch 4(standard adhesive with simulated feces mixture in sleeve) |
| OG016 | Peristomal Skin Patch 5 Under Adhesive | Measurement on skin (covered by adhesive after removal of patch) exposed to patch 5 (standard adhesive with buffer in sleeve) |
| OG017 | Peristomal Skin Patch 6 Under Patch | Measurement on skin (covered by adhesive after removal of patch) exposed to patch 6 (standard adhesive with buffer mixture in sleeve) |
| OG018 | Abdominal Skin Patch 1 Under Adhesive | Measurement on skin (covered by adhesive after removal of patch) exposed to patch 1 (standard adhesive with own feces in sleeve) |
| OG019 | Abdominal Skin Patch 2 Under Adhesive | Measurement on skin (covered by adhesive after removal of patch) exposed to patch 2 (standard adhesive with own feces mixture in sleeve) |
| OG020 | Abdominal Skin Patch 3 Under Adhesive | Measurement on skin (covered by adhesive after removal of patch) exposed to patch 3 (standard adhesive with simulated feces in sleeve) |
| OG021 | Abdominal Skin Patch 4 Under Adhesive | Measurement on skin (covered by adhesive after removal of patch) exposed to patch 4 (standard adhesive with simulated feces mixture in sleeve) |
| OG022 | Abdominal Skin Patch 5 Under Adhesive | Measurement on skin (covered by adhesive after removal of patch) exposed to patch 5 (standard adhesive with buffer in sleeve) |
| OG023 | Abdominal Skin Patch 6 Under Adhesive | Measurement on skin (covered by adhesive after removal of patch) exposed to patch 6 (standard adhesive withbuffer mixture in sleeve) |
|
|
| 0 |
| 24 |
| 2 |
| 24 |
| dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | eczema on the pre-stripped abdominal area |
|
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