Sponsor study identifier
interventional
89
1 country
1
Study Start
September 1, 2021
Actual (reported)Primary Completion
February 13, 2022
Actual (reported)Study Completion
February 13, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 13, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 22, 2021
Actual (reported)May 3, 2021
Actual (reported)September 1, 2021
Actual (reported)February 13, 2022
Actual (reported)February 13, 2022
Actual (reported)April 30, 2025
Actual (reported)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
Health-related Quality of Life (Scale 0-30)
5 weeks
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.
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Bispebjerg Hospital
Copenhagen, 2400, Denmark
Tonny Karlsmark, MD
Coloplast A/S
89 participants (actual enrollment reported by the registry).
First Submitted
April 22, 2021
First Posted
May 3, 2021
Study Start
September 1, 2021
Actual (reported)Efficacy of Gel With Ecological Extra Virgin Olive Oil in Peristomal Skin Hygiene
Contact the study team to confirm eligibility.
Primary Completion
February 13, 2022
Actual (reported)Study Completion
February 13, 2022
Actual (reported)Last Updated
April 30, 2025
Results First Posted
April 30, 2025
Record last verified: 2025-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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