Evaluation of the Influence of Output on Skin Covered by Adhesives

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03000881

Enrollment

Registered

2016-12-22

Start date

2016-12-31

Completion date

2017-04-04

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileostomy - Stoma

Brief summary

The study investigates the impact real output has on peristomal skin covered by two different adhesives

Interventions

OTHERstandard adhesive

This is a standard adhesive (hydrocolloid)

OTHERNew adhesive strip

This is a newly developed adhesive strip

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 intact skin on the area used in the evaluation * Has an ileostomy with a diameter up to 35 mm * Have a peristomal area accessible for application of adhesive strips

Exclusion criteria

* Currently receiving or have within the past 2 month 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 investigating scientist) * Participating in other interventional clinical investigations or have previously participated in this evaluation -

Design outcomes

Primary

Measure	Time frame
Trans Epidermal Water Loss	8 hours

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026