An interventional study of Coloplast Test product 1 and Coloplast Test product 2 in Ileostomy - Stoma, sponsored by Coloplast A/S. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-27.
Sponsored by Coloplast A/S · Not applicable and Interventional
To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured
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:
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Coloplast Test product 1 are randomised to secondly test either: 1. Coloplast Test product 2 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) 2. Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2
Device: Coloplast Test product 1 · Device: Coloplast Test product 2 · Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Coloplast Test product 2 are randomised to secondly test either: 1. Coloplast Test product 1 and thereafter Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) 2. Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 1
Device: Coloplast Test product 1 · Device: Coloplast Test product 2 · Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) are randomised to secondly test either: 1. Coloplast Test product 1 and thereafter Coloplast Test product 2 2. Coloplast Test product 2 and thereafter Coloplast Test product 1
Device: Coloplast Test product 1 · Device: Coloplast Test product 2 · Device: Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)
Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.
Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S
Standard Care was the subject usual ostomy appliance and had to be one of the following: * Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut, * Dansac: Nova 1 \& Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate * Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate * ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate * B. Braun: Flexima Active \& Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate
Degree of Leakage
The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S
Time frame: Up to 14 days per test product
The subjects were recruited through the Coloplast database in Denmark
| Milestone | First Test Product 1, Then Test Product 2;Then Standard Care | First Test Product 1, Then Standard Care, Then Test Product 2 | First Test Product 2, Then Test Product 1, Then Standard Care | First Test Product 2; Then Standard Care, Then Test Product 1 | First Standard Care, Then Test Product 1, Then Test Product 2 | First Standard Care, Then Test Product 2, Then Test Product 1 |
|---|---|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 | 3 | 3 |
| Completed | 4 | 4 | 4 | 4 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | First Test Product 1, Then Test Product 2;Then Standard Care | First Test Product 1, Then Standard Care, Then Test Product 2 | First Test Product 2, Then Test Product 1, Then Standard Care | First Test Product 2; Then Standard Care, Then Test Product 1 | First Standard Care, Then Test Product 1, Then Test Product 2 | First Standard Care, Then Test Product 2, Then Test Product 1 |
|---|---|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 | 3 | 3 |
| Completed | 4 | 4 | 4 | 4 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | First Test Product 1, Then Test Product 2;Then Standard Care | First Test Product 1, Then Standard Care, Then Test Product 2 | First Test Product 2, Then Test Product 1, Then Standard Care | First Test Product 2; Then Standard Care, Then Test Product 1 | First Standard Care, Then Test Product 1, Then Test Product 2 | First Standard Care, Then Test Product 2, Then Test Product 1 |
|---|---|---|---|---|---|---|
| Started | 4 | 4 | 4 | 4 | 3 | 3 |
| Completed | 4 | 4 | 4 | 4 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S
| units on a scale | Coloplast Test Product 1 | Coloplast Test Product 2 | Standard Care |
|---|---|---|---|
| Degree of Leakage | 4 ± 5 | 4.6 ± 5.6 | 2.6 ± 3.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Coloplast Test Product 1 | — | 1/22 (4.5%) | 5/22 (22.7%) |
| Coloplast Test Product 2 | — | 0/22 (0%) | 6/22 (27.3%) |
| Standard Care | — | 0/22 (0%) | 3/22 (13.6%) |
| Event | Coloplast Test Product 1 | Coloplast Test Product 2 | Standard Care |
|---|---|---|---|
| GastroenteritGastrointestinal disorders | 1/22 | 0/22 | 0/22 |
| Event | Coloplast Test Product 1 | Coloplast Test Product 2 | Standard Care |
|---|---|---|---|
| Peristomal skin problemSkin and subcutaneous tissue disorders | 3/22 | 1/22 | 0/22 |
| DiarreGastrointestinal disorders | 2/22 | 1/22 | 0/22 |
| Bleeding from stomaSkin and subcutaneous tissue disorders | 0/22 | 1/22 | 0/22 |
| respirational tract infectionInfections and infestations | 0/22 | 1/22 | 0/22 |
| infection of the operational wound on the back/ haemtom in operational woundInfections and infestations | 0/22 | 1/22 | 0/22 |
| inflammation in rectumGastrointestinal disorders | 0/22 | 0/22 | 1/22 |
| Pain in collapsed forefootGeneral disorders | 0/22 | 0/22 | 1/22 |
| GastroenteritGastrointestinal disorders | 0/22 | 0/22 | 1/22 |
| short term dizzinessGeneral disorders | 0/22 | 1/22 | 0/22 |
| stinging skin around the stomaSkin and subcutaneous tissue disorders | 0/22 | 0/22 | 1/22 |
Two subjects were screening failiures and did not test any test product, but did contribute with baseline data. These subjects are not inclæuded in the participant flow (as the did not test products) but contributed with baseline data.
| Age, Continuous(years) | All Subjects |
|---|---|
| Mean | 28.4 ± 10.9 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 8 |
| Male | 16 |
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Coloplast A/S