N/A
Completed N=6
Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture
Stoma Ileostomy
Source: ClinicalTrials.gov NCT03619226 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Resistance (Moisture in the Adhesive) — 0; 0 Number of false positive leaks
Summary
The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resistance (Moisture in the Adhesive) |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have intact skin on the area used in the evaluation
- Have an abdominal area accessible for application of test product (assessed by investigator)
- Negative pregnancy test for fertile women
- Signed document claiming use of safe contraceptives for fertile women
Exclusion Criteria
- Currently receiving or have within the past 2 month received radio- and/or chemo-therapy
- 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 interventional clinical investigations or have previously participated in this evaluation. Exception: Participation in other Coloplast sponsored clinical investigations or evaluations is accepted under the circumstances that the subject has paused the activities in the investigation/evaluation and are otherwise complying with the inclusion and exclusion criteria of this (CP284) Evaluation
Data sourced from ClinicalTrials.gov (NCT03619226). 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.