Stoma Ileostomy
Conditions
Keywords
ileostomy, Subjects
Brief summary
The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.
Detailed description
The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters.
Interventions
DEVICEColoplast Adhesive baseplate A
Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
DEVICEColoplast Adhesive baseplate B
Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
DEVICEColoplast Adhesive baseplate C
Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance
DEVICESenSura 1-Piece
SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .
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 bags themselves. 4. Have an ileostomy with a diameter between 15 and 40 mm. 5. Have had their ostomy for at least three months. 6. Currently use a 1-piece flat ostomy appliance with open bag. 7. Use minimum 1 ostomy appliance every second day. 8. Be suitable for participation in the investigation and for using standard adhesive, flat base plate. 9. Must be able to use a custom cut ostomy appliance. 10. Accept to test three 1-piece ostomy appliances in the investigation. 11. Negative result of a pregnancy test for women of childbearing age (only DK).
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 months 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. Currently using ostomy belt. 7. Currently using extended wear product. 8. Known hypersensitivity towards any of the test products 9. 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 | one week | The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change. The subjects had to tick off one of the following choices: 1. No leakage 2. Starting to leak 3. Leakage 4. Sudden Leakage |
Countries
Denmark
Participant flow
Recruitment details
Recruitment was performed primarily via Coloplast own subject database. In Norway recruitment also took place through medical clinics and hospitals.
Pre-assignment details
65 participants were recruited. However, one participant was a screen failure and was not randomized and did not try any products.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Test Period 1 (1 Week) | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Test Period 1 (1 Week) | Convex product user | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 36 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 | 18 / 42 | 12 / 42 | 11 / 42 | 13 / 62 |
| serious Total, serious adverse events | 1 / 42 | 1 / 42 | 0 / 42 | 0 / 62 |
Outcome results
Primary
Degree of Leakage
The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change. The subjects had to tick off one of the following choices: 1. No leakage 2. Starting to leak 3. Leakage 4. Sudden Leakage
Time frame: one week
Population: The subjects were randomized to one of nine possible treatment groups. Each group consisted of three equal periods in which the subjects tested two test products and the comparator product (SenSura 1-piece). An equal distribution among the three arms and nine different treatment groups was aimed for. The ITT population was used for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test A | Degree of Leakage | 50 percentage of baseplates with no leakage |
| Test B | Degree of Leakage | 44 percentage of baseplates with no leakage |
| Test C | Degree of Leakage | 41 percentage of baseplates with no leakage |
| SenSura | Degree of Leakage | 60 percentage of baseplates with no leakage |