An Investigation Exploring Adhesive Materials and Their Ability to Handle Moisture

January 31, 2019 updated by: Coloplast A/S
The aim is to investigate the impact that water absorption properties in adhesives has on adhesion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Humlebæk, Denmark, 3050
        • Coloplast

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strip A (wet)
Six strips of Strip A are applied on skin wetted with two different buffers (3 strips each)
Other: Strip A
Adhesive strip A
Experimental: Strip A (dry)
Six strips of Strip A are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)
Other: Strip A
Adhesive strip A
Experimental: Strip B (wet)
Six strips of Strip B are applied on skin wetted with two different buffers (3 strips each)
Other: Strip B
Adhesive strip B
Experimental: Strip B (dry)
Six strips of Strip B are applied on skin that is dry (3 strips) and wetted with buffer (3 strips)
Other: Strip B
Adhesive strip B
Experimental: Strip C (wet)
Six strips of Strip C are applied on skin wetted with two different buffers (3 strips each)
Other: Strip C
Adhesive strip C
Experimental: Strip C (dry)
Six strips of Strip C are applied on skin that is either dry (3 strips) or wetted with buffer (3 strips)
Other: Strip C
Adhesive strip C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peel force used to removed adhesive
Time Frame: 60 min

The three strips applied to skin that has received the same treatment (either buffer 1, buffer 2 or dry) are removed at three different time points (max 60 min) and the peel force is measured.

Peel force (90 degree angle from skin) The tensile tester was mounted on a tripod under which the subject was lying. In this way the tensile tester measures the force (Newton), which was needed to remove the adhesive from the skin with a constant speed and with a mean angel of 90°
60 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

October 13, 2018

Study Completion (Actual)

October 13, 2018

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CP263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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