NCT07136870

Assessment of Wound Care Product Skin Adhesion

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Essity Hygiene and Health AB · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Skin (FLACC Scores of Test Subjects) After Tape Removal

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-10-01
• Completion: 2026-02-11
• First posted: 2025-08-22
• Last updated: 2025-09-02

Locations

1 site across 1 country: Sweden