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Evaluation of the Performance of a New Adhesive Strip

NCT ID: NCT03257787

Last Updated: 2017-11-08

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-08

Study Completion Date

2017-09-23

Brief Summary

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This study investigates the performance of a new adhesive strip when impacted by output.

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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Test of a new adhesive strip

A new adhesive strip has been developed and will be tested in this investigation.

Group Type EXPERIMENTAL

new adhesive strip

Intervention Type OTHER

This is a strip made of a newly developed adhesive

Interventions

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new adhesive strip

This is a strip made of a newly developed adhesive

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 a stoma for more than one year
4. Have intact skin on the area used in the evaluation
5. Has a stoma with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of 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. Actively participating in other interventional clinical investigations or have previously participated in this investigation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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 preclinical department

Locations

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Coloplast A/S

Humlebæk, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CP265_15

Identifier Type: -

Identifier Source: org_study_id