An Investigation to Evaluate Wearing Properties of Three Different Investigational Devices

Официальное название

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

Обзор

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

Вмешательства

• Устройство 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.

Первичные конечные точки

• Evaluate stay-on-ability of the test specimens compared to the test specimen reference [Срок оценки: From enrollment to end of follow-up at day 14.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Германия · 1 центр

• SGS proderm GmbH — Schenefeld

Идентификаторы

NCT: NCT07034014 · PENGUIN study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗