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

Not Applicable

Recruiting

• Conditions: Skin Abnormalities
• Interventions: Other: Adhesive material; Other: Standard adhesive material

• Registration Number: NCT05641168
• Lead Sponsor: Coloplast A/S

Brief Summary

The study investigates different adhesive materials on healthy and peristomal skin

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-28
• Status Verified: 2022-11
• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-29
• Last Update Submitted: 2022-11-29
• Study First Posted: 2022-12-07
• Last Update Posted: 2022-12-07
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ostomy Adhesive material	Adhesive material	Newly designed ostomy adhesive material
comparator adhesive material	Standard adhesive material	Adhesive material already on the market e.g adhesive material from SenSura Mio ostomy product

Primary Outcome Measures

Name	Time	Method
Adherent area	At every material change throughout the study, an average of 1 week	Adherent area (assessed by photos of adhesive materials)

Trial Locations

Locations (1)

Coloplast Research Unit/Userlab; 🇩🇰 Humlebaek, Denmark