Actively Recruiting
A Healthy Volunteer, Single Center, Exploratory Investigation to Evaluate Wearing Properties of Three Different Non-sterile Silicone Self-adhesive Investigational Devices
Led by Molnlycke Health Care AB · Updated on 2025-06-24
35
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the self-adhesive properties of three different investigational silicone devices designed as dressings. The study is conducted with healthy volunteers to compare two investigational devices against a reference device, focusing on their ability to stay adhered over time. The investigation is exploratory and single-center, involving non-sterile silicone self-adhesive devices. Participants will have 12 dressings applied to designated areas on their backs to test and compare the dressings' staying power. The dressings will be worn for up to 14 days, and the study will assess the dressing and application regimen during this period. The investigation includes the application and monitoring of these devices on intact skin with minimal hairiness. During the study, volunteers will undergo multiple visits and assessments to monitor the dressings and application sites. Researchers will measure the primary outcome of how well the devices stay on from enrollment until 14 days later. Participants must follow specific instructions to avoid contact with water, detergents, and cosmetics on the application sites during the study. The total participation duration lasts approximately two weeks, and adherence to the protocol is closely observed.
CONDITIONS
Brief 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.
- Minimal hairiness at the back where dressings will be applied.
- Signed written informed consent.
You will not qualify if you...
- Known allergy or hypersensitivity to the dressing or its components.
- Any features at the application sites that may affect the adhesive.
- Unwillingness to avoid water contact on application sites during the study.
- Unwillingness to avoid detergents on application sites during the study.
- Unwillingness to avoid leave-on cosmetics like creams, lotions, or sunscreens on application sites 3 days before and during the study.
- Unwillingness to refrain from activities affecting dressings or application sites during the study.
- Back not large enough to accommodate all 12 application sites.
- Severe systemic disease interfering with study performance or evaluation.
- Recent cancer treatment within last 2 years.
- Active skin disease at application sites.
- Use of topical medication at application sites within last 24 hours or during study.
- Use of pain relief medication on assessment days without reporting.
- Pregnancy or lactation.
- Drug addiction or alcoholism.
- AIDS, HIV-positive, or infectious hepatitis.
- Inmates or vulnerable individuals as defined.
- Participation in another drug or device study within last 30 days.
- Current participation in a cosmetic study.
- Employees involved in this investigation or of sponsor or competing companies.
- Investigator's judgment deeming participant unsuitable for any reason.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to assess eligibility and obtain consent
Duration - Up to 14 days
Participants will have 12 dressings applied to designated sites on their back to evaluate the self-adhesive properties of three investigational devices.
1 baseline visit for dressing application and follow-up visits as needed during the 14-day wearing period
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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