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The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Standard Care, then SenSura Mio | Experimental | Subjects first test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) and after cross-over SenSura Mio |
|
| First SenSura Mio, then Standard Care | Experimental | Subjects first test SenSura Mio and after cross-over Standard Care(Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SenSura Mio | Device | Ostomy product - 1 piece closed bag |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage) | Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenche Sundberg, stoma nurse | Diakonhjemmet Sykhus, Oslo | Principal Investigator |
| Merete Bjørke, Stoma Nurse | St. Olavs Hopsital | Principal Investigator |
| Vigids Dagsland, Stoma Nurse | Haugesund Sykhus | Principal Investigator |
| Randi Melum, Stoma Nurse | St. Olavs Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Publicare | Cologne | Køln | Germany |
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The subjects were recruited via sites and user data-bases in Denmark, Norway, Germany and France.
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| ID | Title | Description |
|---|---|---|
| FG000 | First SenSura Mio, Then Standard Care | The subjects first test SenSura Mio : Ostomy product - 1 piece closed bag and thereafter cross-over and test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima) |
| FG001 | First Standard Care, Then SenSura Mio | The subjects first test Standard Care Ostomy product 1 piece closed bags (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)and after cross-over test SenSura Mio 1-piece closed bags. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SenSura Mio First, |
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| |||||||||||||||||||||
| Standard Care First, |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Entire study population = all participants enrolled in the study |
| 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 | Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage) | Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage. | Posted | Mean | Standard Deviation | points on a scale | 14 days | baseplates | 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 | SenSura Mio | SenSura Mio : Ostomy product - 1 piece closed bag |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Coloplast A/S | +45 4911 3595 | dkbir@coloplast.com |
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| Standard Care | Device | Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima. |
|
| Withdrawal by Subject |
|
| Other |
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| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima. |
|
|
| 0 |
| 120 |
| 10 |
| 120 |
| EG001 | Standard Care | Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima. | 0 | 118 | 10 | 118 |
| Peristomal skin redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Peristomal skin erosion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Peristomal allergic contact dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Not clinically verified allergic contact dermatitis.1 subject tested 21 Nova baseplates before the AE -allergic dermatitis.1 subject tested 8 SenSura Mio baseplates during 3 days before the AE -contact dermatitis because of allergic reaction occured. |
|
| Peristomal burns | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
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| Infected toe | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Consumption of food leading to skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Granulation in the peristomal area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Pain in the peristomal area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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