Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma

NCT03770078 | Completed Results

• 1 other identifier: CP300
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 4

Brief Summary

The study investigates the performance of a new adhesive with regard to the skin condition

Conditions

Ileostomy - Stoma; Colostomy Stoma

Outcome Measures

Primary Outcomes (1)

• Trans Epidermal Water Loss

  Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage. Trans Epidermal Water Loss is reported in grams of water per square meter per hour (g/m\^2/h).

  Four weeks

Study Arms (1)

Study period

EXPERIMENTAL

First the subjects will use the comparator (SenSura Mio) and then the test products (Test Product A)

Device: Test Product A

Interventions

Test Product A DEVICE

The test product is a newly developed ostomy product

Study period

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
• Have an ileostomy or a colostomy with liquid\* output (as their usual output)
• Be at least 18 years of age and have full legal capacity
• Have had their stoma for at least three months
• Be able to use products with max cut size 45 mm
• Have self-reported problems with leakage\*\* (three times within 14 days)
• Handle the Clinical App, test product and comparator product themselves
• Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current product
• Minimum change of baseplate at least once every 3rd day
• Are willing and suitable (determined by investigator/study nurse) to use the test product and comparator without using a paste/mouldable ring during the investigation
• Are willing and suitable (determined by investigator/study nurse) to use a 1-piece product during the investigation

You may not qualify if:

• Are currently receiving or have within the past two 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) or systemic treatment\* (e.g. injection or tablets).
• Get a positive result of a pregnancy test for women of childbearing age/fertile (\*\*clarified in section 6.3.2)
• Are breast feeding
• Are participating in other interventional clinical investigations or have previously participated in this investigation
• Exception:
• \- Have known hypersensitivity towards any of the products used in the investigation

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (4)

CCBR Aalborg

Aalborg, 9000, Denmark

Location

Coloplast

Humlebæk, 3050, Denmark

Location

CCBR Vejle

Vejle, 7100, Denmark

Location

KTA Prim Stockholm

Stockholm, 11361, Sweden

Location

Results Point of Contact

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

dkpen@coloplast.com

49113143

Study Officials

• Birte P Jakobsen, MD

  Consultant

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 10, 2018
• Study Start: November 12, 2018
• Primary Completion: March 6, 2019
• Study Completion: March 6, 2019
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-03

Locations

SE (1); DK (3)