Ileostomy
Conditions
Interventions
For 42 days, the subject will test 3 different stoma products. In this period,
the subject will not use its regular stoma product. After the investigation the
subject will use its regular stoma prod
Sponsors
Coloplast A/S
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Have given written informed consent 2. Be at least 18 years of age and have full legal capacity 3. Have had their ileostomy for at least 3 months 4. Have a stoma with a diameter between 15 and 43 mm 5. Have a stoma placed on an outward area (including hernia) sized minimum 6 cm. and maximum 20 cm. in diameter 6. Have an outward area which is at least 2 cm high with a stoma placed on the bulge 7. Be able to handle the product themselves 8. Be able to use a custom cut product 9. Normally experience faeces under the adhesive wafer at least 3 times during 2 weeks 10.Currently using Sensura 1-piece flat, open bag, pre-cut or custom cut or Assura 1-piece flat, open bag, pre-cut or custom cut or other 1-piece flat Standard of care 11.Be willing to test products with open bag size maxi 12.If usual SenSura/Assura user: be willing to test Moderma Flex or Confidence® Natural, Draina- ble as well as test product A and B OR If usually using other flat standard of care: be willing to test SenSura as well as test product A and B during the study period 13.Be willing to test the test products without using paste, ring(s) and/or ostomy tape 14.Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per product 15.Be suitable for participating in the investigation 16.Be willing to take/have taken pictures of the stoma before, during and after application of product
Exclusion criteria
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 topical steroid treatment in the peri-stomal skin area or systemic steroid (tablet/injection) treatment 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 peri-stomal skin problems i.e. bleeding and/or broken skin (assessed by the study nurse) 7. Have a loop stoma 8. Have known hypersensitivity towards any of the test products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| People with outward abdominal ostomy have despite development of better ostomy appliances still problems with leakage and peristomal skin disorders which influence their quality of life negatively. As the frequency of leakage correlates to the degree of peristomal skin complications, ostomy appliances with a better fit to body and better leakage performance have the potential of improving the peristomal skin condition and quality of life. Hence body fit is the primary end point in this investigation and will be recorded after test period 1, 2, 3 and Termination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Leakage is considered to be one of the greatest concerns for people with an ostomy. The frequency of leakage correlates to the degree of peristomal skin complications; therefore ostomy appliances with better leakage performance have the potential of improving the peristomal skin condition and quality of life [2,3]. Constant evaluation and development of new ostomy appliances with good leakage performance is therefore of high importance and clinically relevant. Further secondary end points have been chosen in this exploratory investigation to gain knowledge regarding the effect of base plate shape and adhesive type on aspects such as comfort, preference and Quality of Life. | — |
Countries
Netherlands
Outcome results
None listed