A Randomized Controlled Clinical Investigation Evaluating a Flat Ostomy Barrier With A Novel Skin Protection Technology

NCT04868617 | Completed Results

• 1 other identifier: CP338
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation is a randomized, controlled, open-label, comparative, cross-over, multicenter investigation, with two test periods. In total, 82 subjects will be included and randomized, and each subject will have three test visits overseen by the Principal Investigator, or designee. Each subject will be enrolled for 2 × 35 -1/+3 days in total for the entire investigation, thus approximately 70 days. The subjects will test the non-CE marked test product and the comparator product in randomized order.

Conditions

Peristomal Skin Complication

Outcome Measures

Primary Outcomes (1)

• The Peristomal Skin Condition Measured by the Decision Tree Score (Scale From 0-3)

  The peristomal skin condition measured by the Decision Tree Score on baseplate level at steady state (scale from 0-3). Higher score means worse outcome

  after 5 weeks

Secondary Outcomes (1)

• Health-related Quality of Life (Scale 0-30)

  5 weeks

Study Arms (2)

Test Product

EXPERIMENTAL

The non-CE marked test product is a stoma product based on the flat SenSura® Mio 1-piece (1-pc) and the flat 2-piece with mechanical coupling (2-pc MC) product that includes a novel skin protective layer in the baseplate.

Device: ATTRACT-I

SenSura® Mio Comparator - Standard of Care

ACTIVE COMPARATOR

The following comparator products will be used in this investigation: * SenSura® Mio 1-piece (1-pc) flat, Midi bag with normal outlet and * SenSura® Mio 2-piece with mechanical coupling (2-pc MC) flat, Maxi or Midi bag with normal outlet

Device: ATTRACT-I

Interventions

ATTRACT-I DEVICE

The aim of this investigation is to evaluate the performance and safety of an ostomy baseplate with a novel skin protection technology and its ability to reduce peristomal skin complications compared to SenSura® Mio. The subject will be randomized to either test product or comparator at enrollment. The subject will wear the test product for approximately 35 days and then cross-over to the comparator (or vice-versa) for approximately 35 days. At each baseplate change, the subject will answer questions about their skin, and take pictures of their stoma and used baseplate. They will also answer quality of life questionnaires at each study visit.

SenSura® Mio Comparator - Standard of Care; Test 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 written consent to participate by signing the Informed Consent Signature Form
• Is at least 18 years of age and have full legal capacity
• Has an ileostomy or colostomy with consistent liquid fecal output (6-7 Bristol scale.
• Is currently using a SenSura® Mio flat product with open bag.
• Has had the ostomy for at least 90 days.
• Can use an ostomy product with a max cut size of 45 mm (1-piece) or 38 mm (2-piece).
• Has experienced leakage\*\* under the baseplate at least three times within the last fourteen days.
• \*\*Leakage defined as output/seeping under the baseplate (see appendix 7)
• Has experienced symptoms of peristomal skin complications such as itching, burning, or pain in the peristomal area within the last fourteen days. \*\*
• \*\* Proper training of the PI and nurses in how to ask the subject about these symptoms is essential.
• Is able to handle the electronic diary (questionnaire/photo) themselves. If needed, a trained spouse or caretaker is allowed to assist.
• Is able to handle (apply, remove, cut, etc.) the product themselves.
• Understands that any barrier products (film, cream, spray, wipes etc.) are not permissible during the investigation, and is willing to not use these accessories during the investigation.
• Is willing and suitable (determined by the Principal Investigator or designee) to use a flat custom cut one-piece open or two-piece open product during the investigation.
• Is willing to change the product (1-piece) or baseplate (2-piece) at least every fourth 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.
• Low dose systemic steroid treatment (e.g., inhalation) assessed by the investigator are allowed.
• Other systemic steroid treatment (e.g., injection or tablet) are not allowed.
• Is breastfeeding.
• Is pregnant based on urine pregnancy test.
• Has known hypersensitivity towards any of the products used in the investigation.

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Results Point of Contact

• Title: Pernille Nonboe
• Organization: Coloplast A/S

dkpen@coloplast.com

+4549113143

Study Officials

• Tonny Karlsmark, MD

  Coloplast A/S

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: April 22, 2021
• First Posted: May 3, 2021
• Study Start: September 1, 2021
• Primary Completion: February 13, 2022
• Study Completion: February 13, 2022
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)