An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture

NCT ID: NCT02818257

Last Updated: 2019-02-01

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-10-13

Brief Summary

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The aim is to investigate the impact that water absorption properties in adhesives has on adhesion.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Strip A (wet)

Six strips of Strip A are applied on skin wetted with two different buffers (3 strips each)

Group Type EXPERIMENTAL

Strip A

Intervention Type OTHER

Adhesive strip A

Strip A (dry)

Six strips of Strip A are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)

Group Type EXPERIMENTAL

Strip A

Intervention Type OTHER

Adhesive strip A

Strip B (wet)

Six strips of Strip B are applied on skin wetted with two different buffers (3 strips each)

Group Type EXPERIMENTAL

Strip B

Intervention Type OTHER

Adhesive strip B

Strip B (dry)

Six strips of Strip B are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)

Group Type EXPERIMENTAL

Strip B

Intervention Type OTHER

Adhesive strip B

Strip C (wet)

Six strips of Strip C are applied on skin wetted with two different buffers (3 strips each)

Group Type EXPERIMENTAL

Strip C

Intervention Type OTHER

Adhesive strip C

Strip C (dry)

Six strips of Strip C are applied on skin that is either dry (3 strips) or wetted with buffer (3 strips)

Group Type EXPERIMENTAL

Strip C

Intervention Type OTHER

Adhesive strip C

Interventions

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Strip A

Adhesive strip A

Intervention Type OTHER

Strip B

Adhesive strip B

Intervention Type OTHER

Strip C

Adhesive strip C

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Have intact skin on the area used in the investigation

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 abdominal skin area or systemic steroid (tablet/injection) treatment.
* Are pregnant or breastfeeding
* Having dermatological problems in the abdominal area (assessed by investigator)
* Participate in other clinical investigations or have previously participated in this investigation
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

Humlebæk, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CP263

Identifier Type: -

Identifier Source: org_study_id

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