A Clinical Investigation Evaluating Three New 1-piece Ostomy Products

NCT03154944 | Completed Results

• 1 other identifier: CP275
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.

Conditions

Ileostomy - Stoma

Outcome Measures

Primary Outcomes (1)

• Trans Epidermal Water Loss

  The trans epidermal water loss is measured on the peristomal skin using a probe. The Tran epirdermal water loss is a maesure for the skins barrier function. There is always a loss of water from the skin due to natural evaporation. However, when the skin barrier is damaged the evaporation of water increases leading to a higher trans epidermal water loss. Thus, trans epidermal water loss is used to assess the damage to the skin. Measurements are in grams of water per square meter per hour (g/m\^2/h).

  7 days

Study Arms (3)

Ostomy device 1

EXPERIMENTAL

In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film

Device: Ostomy device 1

Ostomy device 2

EXPERIMENTAL

In this arm the subjects test a new ostomy device consisting of a new adhesive and a known top film

Device: Ostomy device 2

Ostomy device 3

EXPERIMENTAL

In this arm the subjects test a new ostomy device consisting of a known adhesive and a new top film

Device: Ostomy device 3

Interventions

Ostomy device 1 DEVICE

This device consists of a known adhesive and a new top film

Ostomy device 1

Ostomy device 2 DEVICE

This device consists of a new adhesive and a known top film

Ostomy device 2

Ostomy device 3 DEVICE

This device consists of a known adhesive and a new top film

Ostomy device 3

Eligibility Criteria

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

You may qualify if:

• Have given written informed consent and in DK: signed a letter of authority
• Be at least 18 years of age and have full legal capacity
• Have had their ileostomy for at least 3 months
• Have an ileostomy with a diameter between 10 and 55 mm
• Be able to handle the Clinical App. and product themselves
• Must be able to use custom cut product
• Minimum change of product every second day
• If current product is SenSura Mio - Be willing to use Maxi bag during investigation
• Negative result of a pregnancy test for women of childbearing age (only DK)

You may not qualify if:

• Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
• Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
• Are pregnant or breastfeeding\*\*
• Are participating in other interventional clinical investigations or have previously participated in this investigation
• Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
• Have known hypersensitivity towards any of the products used in the investigation

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Coloplast A/S

Humlebæk, 3050, Denmark

Location

Results Point of Contact

• Title: Head of Medical Writing and Biostatistics
• Organization: Coloplast

dkpen@coloplast.com

49113143

Study Officials

• Birte P Jakosen, MD

  Medial director

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 16, 2017
• Study Start: May 15, 2017
• Primary Completion: February 2, 2018
• Study Completion: February 2, 2018
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)