Evaluation of the Influence of Output on a Newly Develop Adhesive

August 31, 2016 updated by: Coloplast A/S
The study investigates the impact real output has on the adhesion of adhesives.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

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
      • Humlebaek, 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Have given written informed consent
  2. Be at least 18 years of age and have full legal capacity
  3. Have had an ileostomy for more than one year
  4. Have intact skin on the area used in the evaluation
  5. Has an ileostomy with a diameter up to (≤) 35 mm
  6. Have a peristomal area accessible for application of patches/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. Participating in other interventional clinical investigations or have previously participated in this 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: Cohort 02

This is a sub-study testing how the adhesion of two adhesives is influenced by exposure to real output.

There are two visits:

The first visit:

Two adhesive strips (standard adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not.

The second visit:

Two adhesive strips (new adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not.
Other: Standard adhesive strip
A standard adhesive strip (hydrocolloid)
Other: New adhesive strip
A newly developed adhesive strip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peel force used to removed the adhesive from the skin
Time Frame: 12 hours
12 hours

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, Msc, R&D scientist

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

November 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 1, 2016

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • CP265_02

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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