Comparing how three adhesive dressings stay on the skin

A Healthy Volunteer, Single Center, Exploratory Investigation to Evaluate Wearing Properties of Three Different Non-sterile Silicone Self-adhesive Investigational Devices

We will test how well three different self-adhesive dressings stick to and stay on the back of healthy adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Molnlycke Health Care AB (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Schenefeld, Free and Hanseatic City of Hamburg)
• Trial ID: NCT07034014 on ClinicalTrials.gov

What this trial studies

Healthy adult volunteers will have three different adhesive dressings applied to defined sites on the back and monitored over the course of the visit schedule. The study compares two investigational devices to a reference test specimen for their wearing and self-adhesive properties. Investigators will confirm intact skin and minimal hair at application sites before enrollment and will monitor the sites for adhesion and any skin reactions. Participants must avoid wetting or applying detergents to the application sites for the study duration and return for protocol-specified assessments.

Who should consider this trial

Good fit: Ideal candidates are healthy adults with intact, minimally hairy skin on the back who can follow visit schedules and avoid wetting or using detergents on the application sites.

Not a fit: People with known allergies to dressing components, existing skin problems at the application sites, or who cannot avoid washing or using detergents on the sites are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could identify dressing designs that stay attached longer and reduce the need for frequent replacements.

How similar studies have performed: Adhesion and wearability tests like this are commonly used to improve dressing design, though these specific investigational devices are being tested individually.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Known allergy/hypersensitivity to the dressing or its components.
* Participants with any features at the application sites will be in contact with the adhesive surface of the dressing, and 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 . If it is essential for the participant to take pain relief medication on the days mentioned above for any unforeseen reasons, the participant is allowed to use pain relief medication but has to report this to the study center in order to be documented as 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 any individuals otherwise regarded as vulnerable (as per ISO 14155 Section 3.55).
* 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. The participant should not work for any company which produces dressings.
* The participant is considered by the Investigator to be unsuitable to participate in the investigation for any other reason

Where this trial is running

Schenefeld, Free and Hanseatic City of Hamburg

• SGS proderm GmbH — Schenefeld, Free and Hanseatic City of Hamburg, Germany (Recruiting)

Study contacts

• Principal investigator: Dr. Uta Solecke — SGS proderm GmbH
• Study coordinator: Kristina Welinder

Conditions Healthy Volunteer Study