An interventional study of test product 1: new ostomy base plate with Coloplast as manufacturer and test product 2: new ostomy base plate with Coloplast as manufacturer in Leakage, sponsored by Coloplast A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-10.
Sponsored by Coloplast A/S · Not applicable and Interventional
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.
Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Device: test product 1: new ostomy base plate with Coloplast as manufacturer
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
Device: test product 2: new ostomy base plate with Coloplast as manufacturer
test product 1 is tested first
test product 2 is tested first
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)
Time frame: Each product will be tested 2 weeks
The subjects were recruited through the Coloplast database.
| Milestone | Own Product (Baseline) - Test Product 1 - Test Product 2 | Own Product (Baseline) - Test Product 2 - Test Product 1 |
|---|---|---|
| Started | 11 | 9 |
| Completed | 11 | 8 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Milestone | Own Product (Baseline) - Test Product 1 - Test Product 2 | Own Product (Baseline) - Test Product 2 - Test Product 1 |
|---|---|---|
| Started | 11 | 8 |
| Completed | 10 | 8 |
| Not completed | 1 | 0 |
| Withdrew: Adverse event | 1 | 0 |
| Milestone | Own Product (Baseline) - Test Product 1 - Test Product 2 | Own Product (Baseline) - Test Product 2 - Test Product 1 |
|---|---|---|
| Started | 10 | 8 |
| Completed | 10 | 7 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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)
| units on a scale | Test Product 1 | Test Product 2 | Baseline |
|---|---|---|---|
| Leakage Under the Base Plate Using a 24-point Scale | 4.5 ± 5.3 | 3.3 ± 4.3 | 4.4 ± 4.7 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Product 1 | — | 0/20 (0%) | 8/19 (42.1%) |
| Test Product 2 | — | 0/20 (0%) | 6/18 (33.3%) |
| Baseline | — | 1/20 (5%) | 1/20 (5%) |
| Event | Test Product 1 | Test Product 2 | Baseline |
|---|---|---|---|
| GastroenteritGastrointestinal disorders | 0/20 | 0/20 | 1/20 |
| Event | Test Product 1 | Test Product 2 | Baseline |
|---|---|---|---|
| Skin irritation (peristomal)Skin and subcutaneous tissue disorders | 3/19 | 2/18 | 0/20 |
| Itchy peristomal skinSkin and subcutaneous tissue disorders | 3/19 | 1/18 | 0/20 |
| coldRespiratory, thoracic and mediastinal disorders | 0/19 | 2/18 | 0/20 |
| Bleeding peristomal skinSkin and subcutaneous tissue disorders | 0/19 | 1/18 | 0/20 |
| CystitisRenal and urinary disorders | 1/19 | 0/18 | 1/20 |
| sclerose attackNervous system disorders | 1/19 | 0/18 | 0/20 |
| Herpes on the back of the thighInfections and infestations | 1/19 | 0/18 | 0/20 |
| candidiacis on labiaInfections and infestations | 1/19 | 0/18 | 0/20 |
| GastroenteritGastrointestinal disorders | 0/19 | 0/18 | 1/20 |
| Urin retensionRenal and urinary disorders | 0/19 | 0/18 | 1/20 |
| Age, Continuous(years) | Overall Study |
|---|---|
| Mean | 64 ± 10.8 |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 12 |
| Male | 8 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Coloplast A/S