Investigation of a New Stoma Product for People With a Stoma

NCT04101318 | Completed Results

• 1 other identifier: CP288
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The CP288 study is an investigation of a non-Conformité Européene marked stoma product which will be conducted in the UK, Italy, Netherlands, Germany, and Norway. The study will enroll up to 100 subjects. The study is a randomized, open-label, comparative study.

Conditions

Peristomal Skin Complication

Outcome Measures

Primary Outcomes (1)

• Max Itching Within a Week at Steady State

  Participant were asked to rate their itching around the ostomy on a scale of 0-10 with 0= no itch ad 10= worst possible peristomal skin itch. The primary outcome measure was done on the Intended to Treat population. Steady state period of the treatment period began after three weeks of product use.

  Within a week at steady state

Secondary Outcomes (17)

• Percentage of Participants With Varying Frequency of Itching Skin in the Past 14 Days by End of Treatment

  past 14 days by end of treatment

• Max Pain Within a Week at Steady State

  Within one week at steady state

• Percentage of Participants With Varying Frequency of Pain in the Past 14 Days by End of Treatment

  past 14 days by end of treatment

• Max Burning Within a Week at Steady State

  Within one week at steady state

• Percentage of Participants With Varying Frequency of Burning in the Past 14 Days by End of Treatment

  past 14 days by end of treatment

Study Arms (2)

The non-Conformité Européene marked product, a Conformité Européene marked product

EXPERIMENTAL

Participants first received the non-Conformité Européene marked investigational product for 42±3 days. Then there was a cross-over and the participants received one of the five Conformité Européene marked comparators products, which they used the following 42±3 days.

Device: Non-Conformité Européene marked product; Device: Conformité Européene marked competitor products

A Conformité Européene marked product, then the non-Conformité Européene marked product

EXPERIMENTAL

Participants first received one of the five Conformité Européene marked comparators products for 42±3 days. Then there was a cross-over and the participants received the non-Conformité Européene marked investigational products, which they used the following 42±3 days.

Device: Non-Conformité Européene marked product; Device: Conformité Européene marked competitor products

Interventions

Non-Conformité Européene marked product DEVICE

New Baseplate is not named at this point

A Conformité Européene marked product, then the non-Conformité Européene marked product; The non-Conformité Européene marked product, a Conformité Européene marked product

Conformité Européene marked competitor products DEVICE

The Conformité Européene marked competitor products are considered Standard of Care or products considered to be part of Standard of Care in coming years.

A Conformité Européene marked product, then the non-Conformité Européene marked product; The non-Conformité Européene marked product, a Conformité Européene marked product

Eligibility Criteria

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

You may qualify if:

• Has given informed consent to participate by signing the informed consent signature form.
• Has an ileostomy or colostomy with liquid output (defined by a 6-7 on the Bristol Scale)
• Currently using a flat product
• Be at least 18 years of age and have full legal capacity
• Have had their stoma for at least three months (90 days)
• Can use a product with a max cut size of 40 mm
• Has experienced leakage\* under the baseplate at least three times within the last 14 days. \*leakage defined as output seeping under the baseplate (Appendix 6 - Classification of leakage)
• Has symptoms of peristomal skin complications or has peristomal skin complications defined by at least one of the below
• Has experienced symptoms of skin complications (itching, burning, pain) within the last fourteen days
• Has experienced red skin in the inner circle (within three cm from stoma edge) within the last fourteen days
• Has skin complication (assessed by Principal Investigator, or delegate) in the inner circle (within three cm from stoma edge) of the peristomal area
• Is able to handle the electronic diary (questionnaire/ photo) themselves.
• Is able to handle (apply, remove, cut etc.) the product themselves
• Is willing to not use barrier film or barrier cream during the investigation
• Is willing and suitable (determined by Principal Investigator, or delegate) to use a flat custom cut one-piece open or a two-piece open product during the investigation.

You may not qualify if:

• Is currently receiving or have within the past 60 days received radio-and/or chemotherapy
• \- low doses chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer.
• Is currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray.
• Low dose systemic steroid treatment (e.g. inhalation) assessed by the Principal Investigator are allowed.
• Other systemic steroid treatment (e.g. injection, or tablet) are not allowed.
• Is breastfeeding
• Is pregnant (based on pregnancy test -urine)
• Has known hypersensitivity towards any of the products used in the investigation

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Ragene Saetre

Larvik, 3256, Norway

Location

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Coloplast

clinical-studies@coloplast.com

+45 4911 1111

Study Officials

• Nazarena Mazzarro, MD

  Coloplast A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 24, 2019
• Study Start: January 22, 2020
• Primary Completion: July 17, 2020
• Study Completion: July 17, 2020
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)