N/A
Completed N=22
An Exploratory Study Investigating Human Skin Reaction to Output
Source: ClinicalTrials.gov NCT02351791 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Trans Epidermal Water Loss After Test of Patches. — 45.8; 22.9; 36.8; 19.6 g/m^2/h
Summary
The primary purpose of the study is to investigate the impact that feces mixtures have on the peristomal skin when using a standard adhesive.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trans Epidermal Water Loss After Test of Patches. |
45.8; 22.9; 36.8; 19.6; 15.7; 13.3 | — |
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had an ileostomy for more than one year
- Have normal to slightly red skin on the area used in the evaluation
- Has an ileostomy with a diameter up to (≤) 35 mm
- Have a peristomal area accessible for applied patches (assessed by investigator)
Exclusion Criteria
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
- Are pregnant or breastfeeding
- Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
- Participating in other interventional clinical investigations or have previously participated in this investigation
Data sourced from ClinicalTrials.gov (NCT02351791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.