The Influence of Output on Skin Covered by Adhesive With Topfilm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-16

Study Completion Date

2017-05-10

Brief Summary

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The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive with topfilm and a standard adhesive with a topfilm.

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Detailed Description

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Conditions

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Ileostomy - Stoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 8

This is a sub-study testing the effect of real output on the skin applied under two adhesive strips.

New adhesive strip Standard adhesive strip

Group Type EXPERIMENTAL

New adhesive strip

Intervention Type OTHER

This is a newly developed adhesive strip that in the future might be part of an ostomy device

Standard adhesive strip

Intervention Type OTHER

This is a standard adhesive strip (hydrocolloid). The adhesive is a part of an ostomy device

Interventions

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New adhesive strip

This is a newly developed adhesive strip that in the future might be part of an ostomy device

Intervention Type OTHER

Standard adhesive strip

This is a standard adhesive strip (hydrocolloid). The adhesive is a part of an ostomy device

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No