Assessment of Wound Care Product Skin Adhesion

Обзор

The purpose of this exploratory study is to assess the adhesive forces to skin of samples over the period of 24 hours to establish the peel-off measurement method at the Essity study site.

Подробное описание

The main international standard for testing wound care products is EN 13726, which includes laboratory test methods for absorbency, fluid handling, breathability, adherence, and other physical characteristics of wound dressings. Different types of medical-grade adhesives are used, including rubber, acrylate, and silicone adhesives, each chosen based on the specific needs of the wound and the patient's skin. Proper application techniques are crucial for ensuring effective adhesion, such as ensuring the skin is clean and dry before applying the dressing, using side tabs to handle the dressing without touching the adhesive, and smoothing down the adhesive film to remove air bubbles.

Performance of all three product categories is reflected by general adhesion, e.g. to steel during quality control measurements and finally to skin when also considering the intended purpose of the product. Peel-off force measurement from tapes, WAFs and post-OPs applied to healthy skin are an established routine to compare different products and to test new adhesives or backings during new product development. Such measurements are conducted based on standardized peel-off methods which need to be established before running reliable quantitative measurements.

As the performance and safety of the tapes, WAFs and post-OPs in its intended use are not tested in the current study it is not considered a medical device study according to EU medical device regulation (MDR) 2017/745.

The samples will be investigated on female and male participants with healthy skin on the back (the application area). This assessment implies the determination of adhering properties to the skin, adhesive residues after removal of the samples as well as sensations during removal. Additionally, images of samples will be taken for documentation purposes.

Вмешательства

• Устройство Medical tape
  The purpose of this exploratory study is to assess the adhesion to skin properties of test material samples over 24 hours to establish the peel-off measurement method at the new Essity study site. As the performance and safety of the tapes, WAFs and post-OPs in its intended use are not tested in the current study it is not considered a medical device study according to EU medical device regulation (MDR) 2017/745

Первичные конечные точки

• Adhesion [Срок оценки: After 24 hours of tape use]
• Adhesive forces measured in N/cm [Срок оценки: 1-2 months]

Критерии участия

Критерии включения

• The participants must meet all of the following criteria to be eligible to participate in the investigation:

• Written informed consent to participate in the study.
• Willingness to actively participate in the study and to come to the scheduled visits.
• Female and/or male.
• From 18 to 70 years of age.
• Minimal hairiness on the back (the test area)

Критерии исключения

• Participants meeting any of the following criteria will not be permitted to participate in the investigation:

• Female participants: Pregnancy or lactation.
• Drug or alcohol addiction.
• AIDS, HIV-positive or infectious hepatitis.
• Conditions which exclude a participation or might influence the test reaction/evaluation.
• Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area.
• Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
• Diabetes mellitus (type 1 and 2).
• One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases.
• Active skin disease at the test area.
• Documented allergies to dressings in particular with acrylates and natural rubber (latex).
• Wounds, moles, tattoos, scars, irritated skin at the test area that could influence the investigation.
• Any topical medication at the test area within the last 24 hours prior to the start of the study and/or throughout the entire course of the study.
• Application of cosmetics (e.g. creams, lotions, sunscreens) to the test area within the last 3 days prior to start of the study.
• Showering at the day of study start.

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

Швеция · 1 центр

• Essity Study Site — Mölndal

Идентификаторы

NCT: NCT07136870 · C3247 SWAP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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