An Investigation to Evaluate Wearing Properties of Three Different Investigational Devices

NCT07034014 | Recruiting

• 1 other identifier: PENGUIN study
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Evaluate stay-on-ability of the test specimens compared to the test specimen reference

  The percentage detachment of each test specimen and the test specimen reference will be assessed using a counting grid method. A standardized grid-patterned template will be applied to the application area to objectively quantify the area of detachment. The result will be expressed as a percentage of the total surface area in terms of the mean % detachment at Day 14. Unit of Measure: Percentage (%)

  From enrollment to end of follow-up at day 14.

Study Arms (1)

12 dressings applied to designated sites on healthy volunteer participants

OTHER

The investigation will evaluate the dressing and the application regimen.

Device: Dressing

Interventions

Dressing 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.

12 dressings applied to designated sites on healthy volunteer participants

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (1)

SGS proderm GmbH

Schenefeld, Hamburg, 22869, Germany

RECRUITING

MeSH Terms

Interventions

Bandages

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Dr. Uta Solecke

  SGS proderm GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Welinder

CONTACT

+46 (0)31- 722 31 96; kristina.welinder@molnlycke.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 24, 2025
• Study Start: June 5, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

DE (1)