Artificial opening for faeces
Conditions
Interventions
After informed consent (V0) has been obtained, there will be a screening visit
(V1) lasting up to 6 hours.
The study consist of four test periods:
Test period 1: Subjects use SenSura Mio® (1-piece/2
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 .Must be able to use custom cut product 5. Can use a product with max cut size 45 mm 6. Self-reported problems with leakage (3 x within 14 days) 7. Can handle the Clinical App. and product themselves 8. Users get red skin after exposure to output (screening visit)
Exclusion criteria
Exclusion criteria: 1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis) 2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed. 3. Are participating in other interventional clinical investigations or have previously participated in this investigation. Participation in other Coloplast in-house clinical investigations are accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP264) protocol. 4. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator) 5. Have known hypersensitivity towards any of the products used in the investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trans epidermal water loss (TEWL) (30 min) in the inner circle around the stoma. Each TEWL measurement will be repeated three times. | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin measurements and assessments * TEWL (in the outer circle of the peristomal area) (Three repeated measurements) (30 min) * pH (0 min and 30 min) in the inner circle around the stoma and outer circle of the peristomal area. Each pH measurement will be repeated three times. * Potentially thermography pic (0 min and 30 min) * Hydration (0 min and 30 min) in the inner circle around the stoma and outer circle of the peristomal area. Each hydration measurement will be repeated three times at each point. * Erythema (0 min and 30 min) in the inner circle around the stoma and outer circle of the peristomal area. Each erythema measurement will be repeated three times at each point. * Potentially take picture with light box (potentially assess the DET score) (0 min and 30 min) * Picture of the skin with the Clinical Trial App (at every baseplate change) * Collection of used baseplates for analysis of the neutralizing layer (from visit 3, 4 and 5) Leakage assessments * Leakage area (assessed by picture from app) (at each baseplate change) * Leakage distance (assessed by picture from app) (at each baseplate change) * Leakage outside the baseplate (at each baseplate change in clinical trial App) * Leakage scale questionnaire (at each visit) Baseline assessments registered at inclusion (visit 0) by the investigator * Gender * Age * Weight * Height * Age of stoma (year when created) * Cause of the stoma (Crohn's disease/Colitis ulcerosa/Cancer/Other) * Size of the stoma (diameter on widest place and height) * Current product (brand, product name, item number, size, product type (1-piece or 2-piece) * Is the subject used to cut the baseplate? (Yes/No) * If yes, how much is cut off from the baseplate (template of the baseplate where the cut is drawn up-on, max cut in mm) * How often do skin complications occur? (Daily, Every 2-3 days, Once a week, Once every second week, More rarely) * Why do you usually change your baseplate? (I change at the | — |
Countries
Netherlands
Outcome results
None listed