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

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

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma; Colostomy Stoma
• Intervention / Treatment: Device: Test Product A

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • CCBR Aalborg
  • Humlebæk, Denmark, 3050
    • Coloplast
  • Vejle, Denmark, 7100
    • CCBR Vejle
• Sweden
  • Stockholm, Sweden, 11361
    • KTA Prim Stockholm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

Participation in other Coloplast in-house 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 (CP300) protocol.

- Have known hypersensitivity towards any of the products used in the investigation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study period; First the subjects will use the comparator (SenSura Mio) and then the test products (Test Product A)	Device: Test Product A; The test product is a newly developed ostomy product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 aloss 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	Four weeks

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Birte P Jakobsen, MD, Consultant

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): March 6, 2019

Study Registration Dates

• First Submitted: December 7, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CP300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No