Status:
NOT_YET_RECRUITING
Assessment of Wound Care Product Skin Adhesion
Lead Sponsor:
Essity Hygiene and Health AB
Conditions:
Skin (FLACC Scores of Test Subjects) After Tape Removal
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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.
Detailed Description
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 charact...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 11 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07136870
Start Date
September 1 2025
End Date
February 11 2026
Last Update
September 2 2025
Active Locations (1)
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1
Essity Study Site
Mölndal, VGR, Sweden, 43131