N/A N=6 Basic Science

Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

Stoma Ileostomy

Bottom Line

View on ClinicalTrials.gov: NCT03619226 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Resistance (Moisture in the Adhesive) — 0; 0 Number of false positive leaks

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: test patch (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Coloplast A/S
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Resistance (Moisture in the Adhesive)	0; 0	—

Summary

The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.

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

View full record on ClinicalTrials.gov →

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.