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This study investigates the impact and adhesion of new adhesives to the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testing of 6 adhesive strips | Experimental | Each subject tests six adhesive strips on pre-striped skin.
The six strips are applied on abdominal skin. The order to which the adhesive strips are located on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of the adhesive strips will be measured at 5 visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard adhesive 1 | Other | This strip consists of a standard hydrocolloid adhesive found in ostomy products |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peel Force | The peel force (N) needed to peel off adhesive strips from the skin | 30 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Adhesive 1 | This strip consists of a standard hydrocolloid adhesive found in ostomy products |
| FG001 | Standard Adhesive 2 | This strip consists of a standard hydrocolloid adhesive found in ostomy products |
| FG002 | Standard Adhesive 3 | This strip consists of a standard hydrocolloid adhesive found in ostomy products |
| FG003 | P-4 Adhesive | Newly developed adhesive |
| FG004 | P-15 Adhesive | Newly developed adhesive |
| FG005 | P-16 Adhesive | Newly developed adhesive |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not different from the assignment in Participant Flow
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| ID | Title | Description |
|---|---|---|
| BG000 | Testing of 6 Adhesive Strips | Each subject tests six adhesive strips on pre-striped skin.
The six strips are applied on abdominal skin. The order to which the adhesive strips are located on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of the adhesive strips will be measured at 5 visits. Standard adhesive 1: This strip consists of a standard hydrocolloid adhesive found in ostomy products Standard adhesive 2: This strip consists of a standard hydrocolloid adhesive found in ostomy products Standard adhesive 3: This strip consists of a standard hydrocolloid adhesive found in ostomy products P-4: Newly developed adhesive P-4 P-15: Newly developed adhesive P-14 P-16: Newly developed adhesive P-8 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Peel Force | The peel force (N) needed to peel off adhesive strips from the skin | All participants were analysed | Posted | Median | Full Range | Newton | 30 min |
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Adverse event data were collected over 4 weeks
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 | Standard Adhesive 1 | This strip consists of a standard hydrocolloid adhesive found in ostomy products |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Pre-Clinical Research | Coloplast A/S | 49111111 | +45 | dklfn@coloplast.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2021 | Apr 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050762 | Cyclin-Dependent Kinase Inhibitor p15 |
| D019941 | Cyclin-Dependent Kinase Inhibitor p16 |
| ID | Term |
|---|---|
| D050756 | Cyclin-Dependent Kinase Inhibitor Proteins |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Standard adhesive 2 | Other | This strip consists of a standard hydrocolloid adhesive found in ostomy products |
|
| Standard adhesive 3 | Other | This strip consists of a standard hydrocolloid adhesive found in ostomy products |
|
| P-4 | Other | Newly developed adhesive P-4 |
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| P-15 | Other | Newly developed adhesive P-14 |
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| P-16 | Other | Newly developed adhesive P-8 |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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This strip consists of a standard hydrocolloid adhesive found in ostomy products
| OG003 | P-4 Adhesive | Newly developed adhesive |
| OG004 | P-15 Adhesive | Newly developed adhesive |
| OG005 | P-16 Adhesive | Newly developed adhesive |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Standard Adhesive 2 | This strip consists of a standard hydrocolloid adhesive found in ostomy products | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Standard Adhesive 3 | This strip consists of a standard hydrocolloid adhesive found in ostomy products | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | P-4 Adhesive | Newly developed adhesive | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | P-15 Adhesive | Newly developed adhesive | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | P-16 Adhesive | Newly developed adhesive | 0 | 6 | 0 | 6 | 0 | 6 |
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| D018797 | Cell Cycle Proteins |
| D011506 | Proteins |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |