Colostomy Stoma, Ileostomy Stoma
Conditions
Brief summary
The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.
Interventions
DEVICEColoplast Test A
Coloplast Test A is a newly developed ostomy appliance
DEVICEColoplast Test B
Coloplast Test B is a newly developed ostomy appliance.
DEVICEStandard product
Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
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 signed letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Have had their ileostomy/colostomy for at least 3 months 4. Have a stoma with a diameter between 15 and 36 mm 5. Be able to handle the products themselves 6. Be able to use a custom cut product 7. Normally experience faeces under the base plate at least 3 times during 2 weeks 8. Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut 9. Be willing to test the test products without using paste and/or ring 10. Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct 11. Be suitable for participation in the investigation 12. Be able to present a negative result of a pregnancy test - for women of childbearing age
Exclusion criteria
1. Are currently receiving or have within the past 2 months received radio- and/or chemotherapy 2. Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area 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) 6. Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative) 7. Have a loop stoma 8. Have known hypersensitivity towards any of the test products (including adhesive remover)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Leakage | 10 (- 2 days) | The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group. |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Baseline data is summarized for all subjects | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 5 | Adverse Event | 1 | 0 | 1 | 0 | 0 | 0 |
| Period 5 | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 67.0 years STANDARD_DEVIATION 10 |
| Region of Enrollment Denmark | 22 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 19 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 / 22 | 9 / 22 | 3 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Degree of Leakage
The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage). Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.
Time frame: 10 (- 2 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colostomy ,Test A | Degree of Leakage | 3.6 units on a scale | Standard Deviation 5 |
| Colostomy, Training + Test A | Degree of Leakage | 2.4 units on a scale | Standard Deviation 4.2 |
| Colostomy, Test B | Degree of Leakage | 5.5 units on a scale | Standard Deviation 5.5 |
| Colostomy, Training + Test B | Degree of Leakage | 4.8 units on a scale | Standard Deviation 5.1 |
| Colostomy, Standard Care (SenSura Mio) | Degree of Leakage | 3.7 units on a scale | Standard Deviation 6.5 |
| Colostomy, Standard Care (SenSura) | Degree of Leakage | 3.3 units on a scale | Standard Deviation 3.2 |
| Ileostomy, Test A | Degree of Leakage | 9.1 units on a scale | Standard Deviation 5.2 |
| Ileostomy, Training + Test A | Degree of Leakage | 9.7 units on a scale | Standard Deviation 5.7 |
| Ileostomy, Test B | Degree of Leakage | 11.5 units on a scale | Standard Deviation 5.3 |
| Ileostomy, Training + Test B | Degree of Leakage | 12.9 units on a scale | Standard Deviation 5.6 |
| Ileostomy, Standard Care (SenSura) | Degree of Leakage | 8.5 units on a scale | Standard Deviation 5.1 |