Evaluation of the Influence of Output on Skin Covered by Adhesives (Round 5)

This study investigates the impact real output has on peristomal skin covered by an adhesive

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Other: Standard adhesive strip; Other: Experimental adhesive strip

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark, 3050
    • Coloplast A/S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 5; This is a sub-study testing the effect of real output applied under two adhesive strips on the skin after 8 hours. There is one visit: Two adhesive strips (standard adhesive strip and Experimental adhesive strip)are applied on the peristomal skin and allowed to sit for 8hours before being removed.	Other: Standard adhesive strip; This is a standard adhesive strip (hydrocolloid); Other: Experimental adhesive strip; This is a strip of a newly developed adhesive.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trans epidermal water loss	The skins barrier function is measured using trans epidermal water loss after removing the adhesive from the skin	4 - 24 hours

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Lene Feldskov, M. Sci, Senior R&D Scientist

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimated): December 14, 2016

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CP265_05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO