Assessment of Wound Care Product Skin Adhesion

NCT07136870 | Not Yet Recruiting

• 1 other identifier: C3247 SWAP
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin (FLACC Scores of Test Subjects) After Tape Removal

Keywords

Tape adhesion; Adhesion residues on skin; Tape removal sensation degree; medical tapes; wide area fixation; Post-Operative dressings

Outcome Measures

Primary Outcomes (2)

• Adhesion

  Medical tape sample's adhesion force to skin measured in Newton-centimeter

  After 24 hours of tape use

• Adhesive forces measured in N/cm

  1-2 months

Study Arms (1)

Experimental Group Tape wearing

EXPERIMENTAL

Sixteen samples of different test materials (medical tape) will be placed on the participant's upper and lower back. This ingle group acts as it's own control.

Device: Medical tape

Interventions

Medical tape DEVICE

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

Also known as: Leukosilk tape, Fixomull stretch, wide area fixation tape, Fixomull skin sensitive, wide area fixation tape, Leukoplast tape, Fixomull transparent, wide area fixation tape, Leukopor tape, Leukomed, post-operative tape, Leukomed T skin sensitive, post-operative tape

Experimental Group Tape wearing

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead

Study Sites (1)

Essity Study Site

Mölndal, VGR, 43131, Sweden

Location

Central Study Contacts

Shabira Abbas Senior Scientist

CONTACT

+46 0766486586; Sabira.Abbas@essity.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

Model Details: * Exploratory * Intra-individual comparison * Coded test samples

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: February 11, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)