Clinical Investigation Exploring a Newly Developed Ostomy Baseplate.

NCT07316530 | Completed

• 1 other identifier: CP381
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, which affect their quality of life negatively. Among the main reasons for developing PSCs are that the peristomal skin is exposed to stomal output either due to leakage of output under the baseplate and/or imperfect cutting of the hole in the baseplate, and incorrect application creating a gap between the hole in the baseplate and the stoma. To seal this gap, Coloplast has developed a new ostomy baseplate and the aim of the investigation is to explore the investigational device 's ability to help protect the peristomal skin.

Conditions

Stoma Ileostomy

Outcome Measures

Primary Outcomes (1)

• Maximum itching

  Maximum itching score between hour 4-6 after application of the investigational device and the comparator (scale from 0-10)

  6 hours

Study Arms (2)

Investigational device

EXPERIMENTAL

1 day treatment with investigational device

Device: CP381

Comparator

ACTIVE COMPARATOR

1 day treatment with comparator

Device: CP381

Interventions

CP381 DEVICE

All subjects will test the investigational device and the comparator for 6 hours during two different test days, with at least 14 days between the test days. Before the application of the investigational device as well as comparator, the stoma will be measured by the test personal and the baseplate will be pre-cut too big, leaving an approximately 5 mm distance from the edge of the hole in the baseplate to the stoma. The baseplates will be unique to each subject.

Comparator; Investigational device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has given written informed consent
• Is at least 18 years old
• Has full legal capacity
• Has an ileostomy with consistent liquid faecal output (6-7 Bristol scale).
• Has had the stoma for at least 90 days
• Has a stoma size less than 45mm in diameter
• Has experienced symptoms of peristomal skin complications such as itching, burning, or pain in the peristomal area within the last 14 days
• Has suitable peristomal skin area (assessed by investigator) to participate in investigation
• Is willing to refrain from analgesics within 24 hours before the test days
• Is willing to refrain from antihistamine within 96 hours before the test days
• Is willing to refrain from steroid treatment within 24 hours before the test days

You may not qualify if:

• Is currently receiving or have within the past 60 days received radio-and/or chemotherapy.
• low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for other indications than cancer.
• Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray.
• Is breastfeeding
• Is pregnant based on urine pregnancy test.
• Has known hypersensitivity towards any of the devices used in the investigation.

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Thomas Krarup Simonsen

Humlebæk, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 5, 2026
• Study Start: November 3, 2025
• Primary Completion: January 9, 2026
• Study Completion: January 9, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-10

Locations

DK (1)