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

NCT04868617 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-04-30

Study results available
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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

Interventions

DEVICE

ATTRACT-I

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.

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Tonny Karlsmark, MD · Coloplast A/S

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-02-13
Completion
2022-02-13

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04868617 on ClinicalTrials.gov