Colostomy, Ileostomy
Conditions
Keywords
Ostomy
Brief summary
The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.
Interventions
DEVICEColoplast Test Product
A new 2-piece ostomy appliance developed by Coloplast A/S
DEVICEComparator (Hollister)
Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.
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
* Have given written informed consent and in DK: signed a letter of authority * Be at least 18 years of age and have full legal capacity * Have had their ileostomy or colostomy for at least 3 months * Able to use a baseplate size 15 to 40 mm * Be able to handle the product themselves * Normally experience faeces under the baseplate at least 3 times during 2 weeks * Currently using a 2-piece flat product with mechanical coupling * Willing to test both the Coloplast test product and the comparator product * Willing to use an open bag size maxi during the investigation * Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt) * Willing to use at least 1 baseplate every 3rd day during the investigation * Is able to use a custom cut product * Be suitable for participating in the investigation
Exclusion criteria
* 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) * Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment are allowed * Are pregnant or breastfeeding * Are participating in other interventional clinical investigations or have previously participated in this investigation * Use irrigation during the investigation (flush the intestines with water) * Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator) * Have a loop ostomy * Have known hypersensitivity towards any of the products used in the investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good. | 21 +/- 3 days | Subjects will evaluate the fit to body for each product by answering the question How was the baseplates ability to fit to the body contours in the area around the stoma?. The question is answered with a 5-point scale ranging from very poor to very good. |
Countries
Denmark, Germany, Netherlands, Norway
Participant flow
Pre-assignment details
One subject was a screen failure and was not exposed to any of the test products. This subject was excluded from the safety population, which therefore included 52 subjects.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population All subjects included in the investigation | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Lack of Efficacy | 1 | 0 |
| Period 1 | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age, Continuous | 70.9 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 51 | 17 / 49 |
| serious Total, serious adverse events | 0 / 51 | 3 / 49 |
Outcome results
Primary
Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good.
Subjects will evaluate the fit to body for each product by answering the question How was the baseplates ability to fit to the body contours in the area around the stoma?. The question is answered with a 5-point scale ranging from very poor to very good.
Time frame: 21 +/- 3 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Coloplast Test Product | Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good. | Good | 29.4 percentage of subjects answering |
| Coloplast Test Product | Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good. | Poor | 3.9 percentage of subjects answering |
| Coloplast Test Product | Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good. | Acceptable | 9.8 percentage of subjects answering |
| Coloplast Test Product | Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good. | Very poor | 0 percentage of subjects answering |
| Coloplast Test Product | Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good. | Very good | 56.9 percentage of subjects answering |
| Comparator | Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good. | Very poor | 0 percentage of subjects answering |
| Comparator | Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good. | Very good | 10.6 percentage of subjects answering |
| Comparator | Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good. | Good | 27.7 percentage of subjects answering |
| Comparator | Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good. | Acceptable | 42.6 percentage of subjects answering |
| Comparator | Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good. | Poor | 19.1 percentage of subjects answering |