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The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.
The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.
The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.
Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.
The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.
100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care base plate | Active Comparator | Standard care are the participants own product and can have several manufacture and brand names |
|
| New ostomy base plate (SS) | Experimental | SS = New ostomy base plate. Due to company confidentiality the product is called SS and this is not short for any name |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New ostomy base plate (SS) | Device | The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Output Under the Base Plate (Leakage). | Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage). | Each test product was assessed for 2 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sygehus Sønderjylland i Aabenraa | Aabenraa | 6200 | Denmark | |||
| Bispebjerg Hospital |
A total of 33 subjects were enrolled in the trial. Of these, 6 discontinued during the New ostomy base plate run-in period prior to period 1 and were excluded from the Intention-To-Treat analysis set (no performance data obtained). 27 subjects comprised the intention-to-treat population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care - New Ostomy Base Plate | Subjects first test Standard Care then New ostomy base plate. |
| FG001 | New Ostomy Base Plate - Standard Care | Subjects first test New ostomy base plate then Standard Care. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Standard Care base plate | Device | The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate. |
|
| Copenhagen |
| 2400 |
| Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Odense Universitetshospital | Odense | 5000 | Denmark |
| Hôpital Nord | Marseille | 13015 | France |
| Hôpital Hôtel Dieu de Nantes | Nantes | 44093 | France |
| Hôpital Lariboisière | Paris | 75475 | France |
| CHRU La Milétrie | Poitiers | 86021 | France |
| Hôpital de Pontchaillou, CHRU de Rennes | Rennes | 35033 | France |
| Sanitätshaus Fürst GmbH | Passau | 94032 | Germany |
| Landspitali University Hospital | Reykjavik | 108 | Iceland |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intention-to-treat Analysis Set |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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 | Degree of Output Under the Base Plate (Leakage). | Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage). | Posted | Mean | Standard Deviation | units on a scale | Each test product was assessed for 2 weeks. | Baseplates | Participants |
|
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|
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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 Care Base Plate | Safety population includes subjects allocated to test period (no run-in period) | 0 | 21 | 0 | 21 | ||
| EG001 | New Ostomy Base Plate | Safety population includes subjects allocated to run-in period and test period. | 1 | 30 | 13 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection in parastomal prosthetic mesh | Infections and infestations | Systematic Assessment | Not related to the product |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peristomal skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse event related or possibly related to the product |
| |
| Adhesive issue | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse event related to the product |
| |
| Lack of effectiveness | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse event related to the product |
|
Early termination leading to small number of subjects analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tonny Karlsmark | Bispebjerg Hospital | tkar0002@bbh.regionh.dk |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| E.g. study termination |
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| Iceland |
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| Germany |
|