A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin

NCT ID: NCT05641168

Last Updated: 2025-09-04

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

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-28

Study Completion Date

2024-05-30

Brief Summary

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The study investigates different adhesive materials on healthy and peristomal skin

Detailed Description

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Conditions

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Skin Abnormalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Ostomy Adhesive material

Newly designed ostomy adhesive material

Group Type EXPERIMENTAL

Adhesive material

Intervention Type OTHER

Newly developed adhesive material

comparator adhesive material

Adhesive material already on the market e.g adhesive material from SenSura Mio ostomy product

Group Type OTHER

Standard adhesive material

Intervention Type OTHER

Standard adhesive material

Interventions

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Adhesive material

Newly developed adhesive material

Intervention Type OTHER

Standard adhesive material

Standard adhesive material

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Has given written consent
* Be at least 18 years of age and have full legal capacity
* Have had a colostomy/ileostomy/urostomy for more than one year (for stoma patients) Have suitable peristomal skin area (assessed by investigator) (for stoma patients)

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 abdominal skin area or systemic steroid (tablet/injection) treatment
* Are pregnant or breastfeeding
* Having dermatological problems in the abdominal area (assessed by investigator)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coloplast A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Coloplast Research Unit/Userlab

Humlebæk, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CP333

Identifier Type: -

Identifier Source: org_study_id

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