Ileostomy - Stoma
Conditions
Keywords
stoma ileostomy
Brief summary
The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
Interventions
DEVICETest product
The test product consists of an adhesive with a new top film
DEVICESenSura
SenSura is the CE-marked and commercially available comparator product
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 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 55 mm 5. Have had their ileostomy for at least 3 months 6. Currently use a 1-piece flat ostomy appliance with open bag 7. Use minimum 1 product every second day, i.e. maximum 2 days wear time 8. Be suitable for participation in the study and for using a standard adhesive, flat base plate 9. Must be able and willing to use custom cut products 10. Accept to test two 1-piece products within the study period
Exclusion criteria
1. Use irrigation during the study period (flush the intestines with water) 2. Currently receiving or have within the past 2 months received chemotherapy or radiation therapy 3. Currently receiving or have within the past month received systematic steroid or local 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 a ostomy belt 7. Currently using extended wear product 8. Have a loop ileostomy 9. Known hypersensitivity towards any of the test products 10. Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Leakage (Percentage of All Baseplates With Leakage) | After each baseplate change over a period, of 7 days | leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate. The subjects tick of one of the four possible answers: 1. No leakage 2. Starting to leak (leakage under the baseplate) 3. Leakage (seepage of faeces resulting in leakage on clothes) 4. Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate) |
Countries
Sweden
Participant flow
Recruitment details
The subjects were recruited from hospital sites in Sweden and in Germany subjects were recruit from the Coloplast database and from hospital sites.
Pre-assignment details
The investigation was designed as a cross-over study where subjects that did not complete the 1 period as planned were allowed to continue to the next test period.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Describing baseline data for all subjects in the ITT population | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (7 Days) | Lack of Efficacy | 1 | 0 |
| Period 1 (7 Days) | Protocol Violation | 0 | 1 |
| Period 1 (7 Days) | Withdrawal by Subject | 2 | 0 |
| Period 2 (7 Days) | Protocol Violation | 1 | 0 |
| Period 2 (7 Days) | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 15.7 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 32 | 1 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Leakage (Percentage of All Baseplates With Leakage)
leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate. The subjects tick of one of the four possible answers: 1. No leakage 2. Starting to leak (leakage under the baseplate) 3. Leakage (seepage of faeces resulting in leakage on clothes) 4. Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)
Time frame: After each baseplate change over a period, of 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Product | Leakage (Percentage of All Baseplates With Leakage) | 34 percentage baseplates with leakage |
| SenSura | Leakage (Percentage of All Baseplates With Leakage) | 35 percentage baseplates with leakage |