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This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ostomy device 1 | Experimental | In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film |
|
| Ostomy device 2 | Experimental | In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film |
|
| Ostomy device 3 | Experimental | In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ostomy device 1 | Device | This device consists of a known adhesive and a new top film |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Trans Epidermal Water Loss | The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are in grams of water per square meter per hour (g/m^2/h). | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birte P Jakosen, MD | Medial director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ostomy Device 1 | In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film Ostomy device 1: This device consists of a known adhesive and a new top film |
| FG001 | Ostomy Device 2 | In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film Ostomy device 2: This device consists of a new adhesive and a known top film |
| FG002 | Ostomy Device 3 | In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film Ostomy device 3: This device consists of a known adhesive and a new top film |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ostomy Device 1 | In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film |
| BG001 | Ostomy Device 2 | In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film |
| 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 | The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are in grams of water per square meter per hour (g/m^2/h). | Posted | Least Squares Mean | 95% Confidence Interval | g/m^2/h | 7 days |
|
42 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 | Ostomy Device 1 | In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film Ostomy device 1: This device consists of a known adhesive and a new top film |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peristomal skin complications | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Peristomal skin complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Medical Writing and Biostatistics | Coloplast | 49113143 | +45 | dkpen@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 | May 1, 2018 | Oct 2, 2023 | Prot_SAP_000.pdf |
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| Ostomy device 2 |
| Device |
This device consists of a new adhesive and a known top film |
|
| Ostomy device 3 | Device | This device consists of a known adhesive and a new top film |
|
| BG002 | Ostomy Device 3 | In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ostomy Device 2 |
In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film Ostomy device 2: This device consists of a new adhesive and a known top film |
| OG002 | Ostomy Device 3 | In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film Ostomy device 3: This device consists of a known adhesive and a new top film |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | Ostomy Device 2 | In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film Ostomy device 2: This device consists of a new adhesive and a known top film | 0 | 15 | 0 | 15 | 1 | 15 |
| EG002 | Ostomy Device 3 | In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film Ostomy device 3: This device consists of a known adhesive and a new top film | 0 | 10 | 0 | 10 | 1 | 10 |
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| Male |
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