Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

NCT ID: NCT03619226

Last Updated: 2025-07-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-02

Study Completion Date

2018-07-04

Brief Summary

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

Detailed Description

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Conditions

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Stoma Ileostomy

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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test patch

two adhesive patches are applied to the abdominal area

Group Type EXPERIMENTAL

test patch

Intervention Type OTHER

the test patch consists of an adhesive patch

Interventions

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test patch

the test patch consists of an adhesive patch

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 intact skin on the area used in the evaluation
4. Have an abdominal area accessible for application of test product (assessed by investigator)
5. Negative pregnancy test for fertile women
6. Signed document claiming use of safe contraceptives for fertile women

Exclusion Criteria

1. Currently receiving or have within the past 2 month received radio- and/or chemo-therapy
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 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

Principal Investigators

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Lene F Nielsen

Role: PRINCIPAL_INVESTIGATOR

Head of the pre-clinical department

Locations

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Coloplast A/S

Humlebæk, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CP284_1

Identifier Type: -

Identifier Source: org_study_id

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