Colostomy, Ileostomy
Conditions
Brief summary
This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.
Interventions
DEVICEColoplast Test A
Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
DEVICEColoplast Test B
Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
DEVICESubjects own product
The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Have given written informed consent and in DK: signed a letter of authority 2. Are at least 18 years of age and have full legal capacity 3. Have had their ileostomy or colostomy for at least 3 months 4. Are able to use a baseplate cut-max 15 to 40 mm 5. Are able to handle the product themselves 6. Currently using a 1-piece flat product 8. Willing to use an open bag size maxi during the investigation 9. Are able to use a custom cut (custom fit) product 10. Are suitable for participating in the investigation - this means that the subjects must be able to follow all elements of the study procedures.
Exclusion criteria
1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis) 2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed. 3. Are pregnant or breastfeeding\*\* 4. Are participating in other interventional clinical investigations or have previously participated in this investigation 5. Use irrigation during the investigation (flush the intestines with water, this is mostly for people with a colostomy) 6. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator) 7. Have a loop ostomy (also called double barrel ostomy) 8. Have known hypersensitivity towards any of the products used in the investigation * In DK: women in the child-bearing age will be ask to produce a negative pregnancy test and to sign a form ensuring the use of safe contraception during the investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fit to Body | 14 +/- 2 days | Subjects will evaluate the fit to body for each product by answering the question how was the baseplates ability to fit the body contours in the area around the stoma? The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question. |
Countries
Denmark, Netherlands, United Kingdom, United States
Participant flow
Recruitment details
The subjects were recruited through the Coloplast A/S database and from hospital sites
Participants by arm
| Arm | Count |
|---|---|
| The Study Population This consists of all participants who were enrolled in the study | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Test Period 1 | Adverse Event | 0 | 1 | 0 | 1 | 0 | 0 |
| Test Period 1 | Device deficiency that did not lead to A | 0 | 0 | 1 | 0 | 0 | 0 |
| Test Period 2 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 |
| Test Period 2 | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | The Study Population |
|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 52 | 11 / 54 | 4 / 51 |
| serious Total, serious adverse events | 1 / 52 | 0 / 54 | 0 / 51 |
Outcome results
Primary
Fit to Body
Subjects will evaluate the fit to body for each product by answering the question how was the baseplates ability to fit the body contours in the area around the stoma? The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question.
Time frame: 14 +/- 2 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test A | Fit to Body | 93 percentage of good or very good |
| Test B | Fit to Body | 88 percentage of good or very good |
| Own Product | Fit to Body | 57 percentage of good or very good |