Actively Recruiting
An Investigation to Evaluate Wearing Properties of Three Different Investigational Devices
Led by Molnlycke Health Care AB · Updated on 2025-06-24
35
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical investigation will assess the self-adhesive properties of two investigational devices compared to a test specimen reference.
CONDITIONS
Official Title
An Investigation to Evaluate Wearing Properties of Three Different Investigational Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who are capable and willing to comply with protocol visits, assessments, and instructions.
- Participants must be in general good health with healthy and intact skin in the test area (as determined by the investigator based on medical history and examination of the application sites).
- Minimal hairiness at the back (location of the application sites).
- Signed written informed consent.
You will not qualify if you...
- Known allergy/hypersensitivity to the dressing or its components.
- Participants with any features at the application sites that could influence the investigation.
- Participants not willing to avoid contact of the application sites with water in the morning prior to dressing application and throughout the entire course of the study.
- Participants not willing to avoid applying any detergents to the application sites in the morning prior to dressing application and throughout the entire course of the study.
- Participants not willing to avoid the use of leave on cosmetics such as creams/lotions and sunscreens at the application sites 3 days leading up to dressing application and throughout the entire course of the study.
- Participants not willing to refrain from activities which may directly affect the dressings, application sites or assessments in the morning prior to dressing application and throughout the entire course of the study.
- Participants whose back is not large enough to accommodate all 12 application sites.
- Any severe systemic disease that may interfere with the performance, evaluation, and outcome of the investigation as judged by the investigator.
- Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
- Active skin disease at the application sites.
- Any topical medication at the application sites within the last 24 hours prior to the start of the test and/or throughout the entire course of the investigation.
- Pain relief medication on assessment visits unless reported as a protocol deviation.
- Pregnancy or lactation.
- Drug addicts, alcoholics.
- AIDS, HIV-positive or infectious hepatitis.
- Individuals who are inmates in psychiatric wards, prison or state institutions, or otherwise regarded as vulnerable.
- Participation in another investigative drug or device study currently or within the last 30 days.
- Current participation in a cosmetic study.
- Employees of the investigation sites directly involved in this clinical investigation.
- Employees of the sponsor's company.
- Employees of a competitor company producing dressings.
- Participants deemed unsuitable by the investigator for any other reason.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
SGS proderm GmbH
Schenefeld, Free and Hanseatic City of Hamburg, Germany, 22869
Actively Recruiting
Research Team
K
Kristina Welinder
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here