ileo- of colostomie ileocolostomy stoma
Conditions
Interventions
Use of the investigational stoma product compared in a croos over design with
another usual stoma product.
Sponsors
Coloplast A/S
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Has given written consent to participate by signing the Informed Consent Signature Form 2. Has an ileostomy or colostomy with liquid output (Definition of liquid output: Six-Seven in the Bristol scale (Appendix 5 - Bristol scale) 3. Currently using a flat product 4. Be at least 18 years of age and have full legal capacity 5. Have had their stoma for at least three months (90 days) 6. Can use a product with a max cut size of 40 mm 7. Has experienced leakage* under the baseplate at least three times within the last fourteen days. )*Leakage defined as output seeping under the baseplate (Appendix 6 * Classification of leakage) 8. Has symptoms of peristomal skin complications or has peristomal skin complications defined by at least one of the below a) Has experienced symptoms of skin complications (itching, burning, pain) within the last fourteen days b) Has experienced red skin in the inner circle (within three cm from stoma edge) within the last fourteen days c) Has skin complication (assessed by Principal Investigator, or delegate) in the inner circle (within three cm from stoma edge) of the peristomal area 9. Is able to handle the electronic diary (questionnaire/photo) themselves 10. Is able to handle (apply, remove, cut etc.) the product themselves 11. Is willing to not use barrier film or barrier cream during the investigation 12. Is willing and suitable (determined by Principal Investigator, or delegate) to use a flat custom cut one-piece open or a two-piece open product during the investigation. 13. Is willing to change the product (1pc) or baseplate (2pc) at least every fourth days.
Exclusion criteria
Exclusion criteria: 1. Is currently receiving or have within the past 60 days received radio-and/or chemotherapy; low doses chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer 2. Is currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Low dose systemic steroid treatment (e.g. inhalation) assessed by the Principal Investigator are allowed. Other systemic steroid treatment (e.g. injection, or tablet) are not allowed. 3. Is breastfeeding 4. Is pregnant (based on pregnancy test - urine) 5. Has known hypersensitivity towards any of the products used in the investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to investigate whether a new baseplate comprising of a protective layer can reduce peristomal skin complications induced by output. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to evaluate the psychometric properties of a new clinical assessment tool for the peristomal skin condition. | — |
Countries
Netherlands
Outcome results
None listed