A Pilot Evaluation Exploring New Adhesive Materials and Their Ability to Adhere to Abdominal and Peristomal Skin

The study investigates different adhesive materials on healthy and peristomal skin

Study Overview

• Status: Completed
• Conditions: Skin Abnormalities
• Intervention / Treatment: Other: Adhesive material; Other: Standard adhesive material

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Humlebæk, Denmark
    • Coloplast Research Unit/Userlab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Has given written consent
• Be at least 18 years of age and have full legal capacity
• Have had a colostomy/ileostomy/urostomy for more than one year (for stoma patients) Have suitable peristomal skin area (assessed by investigator) (for stoma patients)

Exclusion Criteria:

• Currently receiving or have within the past 2 months 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. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ostomy Adhesive material; Newly designed ostomy adhesive material	Other: Adhesive material; Newly developed adhesive material
Other: comparator adhesive material; Adhesive material already on the market e.g adhesive material from SenSura Mio ostomy product	Other: Standard adhesive material; Standard adhesive material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherent area	Adherent area (assessed by photos of adhesive materials)	At every material change throughout the study, an average of 1 week

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Skin Abnormalities; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture; Specialty Uses of Chemicals; Adhesives
• Other Study ID Numbers: CP333

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No