An Investigation to Evaluate Wearing Properties of Three Different Investigational Devices

NCT ID: NCT07034014

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-05
• Study Completion Date: 2025-08-31

Brief Summary

This clinical investigation will assess the self-adhesive properties of two investigational devices compared to a test specimen reference.

Conditions

Healthy Volunteer Study

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

12 dressings applied to designated sites on healthy volunteer participants

The investigation will evaluate the dressing and the application regimen.

Group Type: OTHER

Dressing

Intervention Type: DEVICE

The dressing will be applied to intact skin on healthy volunteers participants to assess the self-adhesive properties of two investigational devices compared to a test specimen reference. The dressing will be worn for up to 14 days on a designated area on the health volunteers participants back.

Interventions

Dressing

The dressing will be applied to intact skin on healthy volunteers participants to assess the self-adhesive properties of two investigational devices compared to a test specimen reference. The dressing will be worn for up to 14 days on a designated area on the health volunteers participants back.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Uta Solecke

Role: PRINCIPAL_INVESTIGATOR

SGS proderm GmbH

Locations

SGS proderm GmbH

Schenefeld, City state of Hamburg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Kristina Welinder

Role: CONTACT

kristina.welinder@molnlycke.com

+46 (0)31- 722 31 96

Facility Contacts

Uta Solecke, Dr.

Role: primary

USolecke@proderm.de

+49 40 839 358 160

Other Identifiers

PENGUIN study

Identifier Type: -

Identifier Source: org_study_id