Subjects With an Ileostomy
Conditions
Keywords
stoma ileostomy
Brief summary
The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
Detailed description
The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.
Interventions
DEVICEColoplast A
Coloplast A is a newly developed 2-piece ostomy appliance
DEVICEColoplast B
Coloplast B is a newly developed 2-piece ostomy appliance
DEVICEColoplast C
Coloplast C is a newly developed 2-piece ostomy appliance
DEVICESenSura Click
The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.
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 form. 2. Be at least 18 years of age and have full legal capacity. 3. Be able to handle the appliances themselves 4. Have an ileostomy with a diameter between 15 and 40 mm. 5. Have had their ostomy for at least three months. 6. Use minimum 1 baseplate every third day. 7. Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included) 8. Must be able to use custom cut product 9. Accept to test three 2-piece products within the study. 10. Negative result of a pregnancy test for women of childbearing age.
Exclusion criteria
1. Use irrigation during the study (flush the stoma with water). 2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy. 3. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area. 4. Are pregnant or breastfeeding. 5. Participating in other interventional clinical investigations or have previously participated in this investigation. 6. More than three days wear time as usual change pattern. 7. Currently using ostomy belt 8. Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive) 9. Have a loop ileostomy 10. Known hypersensitivity towards any of the test products 11. Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Leakage | 10 days | The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S. The 4-point leakage scale has four choices 1. No leakage 2. Starting to leakage 3. Leakage 4. Sudden leakage Leakage was assessed at every baseplate change |
Countries
Denmark
Participant flow
Recruitment details
The subject were recruited through the Coloplast user data base.
Pre-assignment details
Thirty-one subjects signed the informed consent, but 2 subjects were screen failures and did not test any products. These two subjects are not included in the participant flow below.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population baseline data is given for subjects in the ITT population | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 19 | 8 / 19 | 4 / 19 | 6 / 28 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 19 | 1 / 28 |
Outcome results
Primary
Degree of Leakage
The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S. The 4-point leakage scale has four choices 1. No leakage 2. Starting to leakage 3. Leakage 4. Sudden leakage Leakage was assessed at every baseplate change
Time frame: 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coloplast Test Product A | Degree of Leakage | 1.8 units on a scale | Standard Deviation 0.7 |
| Coloplast Test Product B | Degree of Leakage | 1.8 units on a scale | Standard Deviation 0.7 |
| Coloplast Test Product C | Degree of Leakage | 1.9 units on a scale | Standard Deviation 0.9 |
| SenSura | Degree of Leakage | 1.7 units on a scale | Standard Deviation 0.8 |