Assessement of the Peal Force Needed to Peel New Adhesives From the Skin

NCT ID: NCT03289013

Last Updated: 2018-02-01

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

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-11

Study Completion Date

2017-12-21

Brief Summary

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This study investigates the adhesion of new adhesives to the skin.

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

OTHER

Blinding Strategy

NONE

Study Groups

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Testing of new adhesive strips

Each subject will test six adhesive strips on pre-stripped skin.

1. Standard adhesive 1
2. Standard adhesive 2
3. LT-2
4. LT-21
5. LT-25
6. 33-20

The six strips are applied on the abdominal skin. The order of the adhesive strips on the skin is randomized. The subjects will change the adhesive strips at home and the adhesion of adhesive strips will be measured at 5 visits.

Group Type EXPERIMENTAL

Standard adhesive 1

Intervention Type OTHER

This strip consists of a standard hydrocolloid adhesive found in ostomy devices

Standard adhesive 2

Intervention Type OTHER

This strip consists of a standard hydrocolloid adhesive found in ostomy devices

LT-2

Intervention Type OTHER

Newly developed adhesive

LT-21

Intervention Type OTHER

Newly developed adhesive

LT-25

Intervention Type OTHER

Newly developed adhesive

33-20

Intervention Type OTHER

Newly developed adhesive

Interventions

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Standard adhesive 1

This strip consists of a standard hydrocolloid adhesive found in ostomy devices

Intervention Type OTHER

Standard adhesive 2

This strip consists of a standard hydrocolloid adhesive found in ostomy devices

Intervention Type OTHER

LT-2

Newly developed adhesive

Intervention Type OTHER

LT-21

Newly developed adhesive

Intervention Type OTHER

LT-25

Newly developed adhesive

Intervention Type OTHER

33-20

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 intact skin on the area used in the investigation

Exclusion Criteria

1. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
2. Currently receiving or have within the past months received topical steroid treatment in the abdominal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Have 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

Principal Investigators

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Lene Feldskov

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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CP267_02

Identifier Type: -

Identifier Source: org_study_id

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