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This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test product 1 first | Experimental | own product (baseline) - test product 1 - test product 2 test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1 |
|
| test product 2 first | Experimental | own product (baseline) - test product 2 - test product 1 test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| test product 1: new ostomy base plate with Coloplast as manufacturer | Device | test product 1 is tested first |
|
| Measure | Description | Time Frame |
|---|---|---|
| Leakage Under the Base Plate Using a 24-point Scale | Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome) | Each product will be tested 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | Denmark | 3050 | Denmark |
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The subjects were recruited through the Coloplast database.
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| ID | Title | Description |
|---|---|---|
| FG000 | Own Product (Baseline) - Test Product 1 - Test Product 2 | own product (baseline) - test product 1 - test product 2 test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1 |
| FG001 | Own Product (Baseline) - Test Product 2 - Test Product 1 | own product (baseline) - test product 2 - test product 1 test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Period |
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| Test Period 1 |
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| Test Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study |
| 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, 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 | Leakage Under the Base Plate Using a 24-point Scale | Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome) | Posted | Mean | Standard Deviation | units on a scale | Each product will be tested 2 weeks | degree of leakage on the baseplate | Participants |
|
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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 | Test Product 1 | own product (baseline) - test product 1 - test product 2 test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenterit | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation (peristomal) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marianne Raff | Coloplast A7S | +45 4911 2562 | dkmr@oloplast.com |
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| test product 2: new ostomy base plate with Coloplast as manufacturer | Device | test product 2 is tested first |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG002 | Baseline | Data collected on own product- All subjects collected baseline data on own product in the first period. |
|
|
| 0 |
| 20 |
| 8 |
| 19 |
| EG001 | Test Product 2 | own product (baseline) - test product 2 - test product 1 test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2 | 0 | 20 | 6 | 18 |
| EG002 | Baseline | Data collected on own product- All subjects collected baseline data on own product in the first period. | 1 | 20 | 1 | 20 |
| Bleeding peristomal skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Itchy peristomal skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Gastroenterit | Gastrointestinal disorders | Systematic Assessment | Not related to the testproducts |
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| Urin retension | Renal and urinary disorders | Systematic Assessment | Not related to the testproducts |
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| Cystitis | Renal and urinary disorders | Systematic Assessment | Not related to the testproducts |
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| febrilia | Infections and infestations | Systematic Assessment | Not related to the testproducts |
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| pain in bladder/Tenesmi | Renal and urinary disorders | Systematic Assessment | Not related to the testproducts |
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| Nausea | General disorders | Systematic Assessment | Not related to the testproducts |
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| elevated prostataspecific antigen | Reproductive system and breast disorders | Systematic Assessment | Not related to the testproducts |
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| skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Not related to the testproducts |
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| cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Not related to the testproducts |
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| sclerose attack | Nervous system disorders | Systematic Assessment | Not related to the testproducts |
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| Herpes on the back of the thigh | Infections and infestations | Systematic Assessment | Not related to the testproducts |
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| candidiacis on labia | Infections and infestations | Systematic Assessment | candidadiacis |
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