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

Coloplast

Status: Completed

Conditions: Skin Abnormalities

Treatments: Other: Standard adhesive material; Other: Adhesive material

Study type: Interventional

Funder types: Industry

Identifiers

NCT05641168

CP333

Details and patient eligibility

About

The study investigates different adhesive materials on healthy and peristomal skin

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Ostomy Adhesive material

Experimental group

Description:

Newly designed ostomy adhesive material

Treatment:

Other: Adhesive material

comparator adhesive material

Other group

Description:

Adhesive material already on the market e.g adhesive material from SenSura Mio ostomy product

Treatment:

Other: Standard adhesive material