Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

June 23, 2025 updated by: Coloplast A/S
The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

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 A/S

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

Description

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)
  5. Participating in interventional clinical investigations or have previously participated in this evaluation. Exception: Participation in other Coloplast sponsored clinical investigations or evaluations is accepted under the circumstances that the subject has paused the activities in the investigation/evaluation and are otherwise complying with the inclusion and exclusion criteria of this (CP284) Evaluation

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: test patch
two adhesive patches are applied to the abdominal area
Other: test patch
the test patch consists of an adhesive patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistance (Moisture in the Adhesive)
Time Frame: 3 days

The outcome measure is described as number of events where the sensor system reacted to a false positive leak.

Moisture in adhesive is measured using a sensor system. Moisture influences the resistance of the sensor system. Intense moisture/sweat does not result in false positive leak signals. The signal response to moisture/sweat is different to the response to leaks.
3 days

Collaborators and Investigators

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

Sponsor

Coloplast A/S

Investigators

  • Principal Investigator: Lene F Nielsen, Head of the pre-clinical department

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)

July 2, 2018

Primary Completion (Actual)

July 4, 2018

Study Completion (Actual)

July 4, 2018

Study Registration Dates

First Submitted

July 13, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CP284_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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