A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put

January 19, 2016 updated by: Coloplast A/S
The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

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

18 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 01a

This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions:

Buffer Own output Simulated output (digestive enzymes)

All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously.
Other: Buffer
The sleeve contains phosphate buffered saline buffer
Other: Own output
The sleeve contains the subject own ileal effluent
Other: simulated output
The sleeve contains simulated output

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remaining adhesive area of adhesive
Time Frame: 30 hours
The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area.
30 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 Principal 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)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • CP265_01

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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