Skin (FLACC Scores of Test Subjects) After Tape RemovalSWAPNCT07136870
Assessment of Wound Care Product Skin Adhesion
A study testing Medical tape in people with Skin (FLACC Scores of Test Subjects) After Tape Removal, run by Essity Hygiene and Health AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin (FLACC Scores of Test Subjects) After Tape Removal
- What is being tested?
- Medical tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSweden
- Study dates
- 2 Oct 2025to 19 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Medical tape
- Keywords
- Tape adhesion, Adhesion residues on skin, Tape removal sensation degree, medical tapes, wide area fixation, Post-Operative dressings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical tapeDevice
Also called Leukosilk tape, Fixomull stretch, wide area fixation tape, Fixomull skin sensitive, wide area fixation tape, Leukoplast 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
| Study group | Role | What they receive |
|---|---|---|
| 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 single group acts as it's own control. Receives: Device: Medical tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion
Medical tape sample's adhesion force to skin measured in Newton-centimeter
Measured: After 24 hours of tape use
Adhesive forces measured in N/cm
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start2 Oct 2025
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin (FLACC Scores of Test Subjects) After Tape RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- * Exploratory * Intra-individual comparison * Coded test samples
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136870
- Sponsor's protocol ID
- C3247 SWAP
- Acronym
- SWAP
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data will be only used internally by Essity and not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Wound Care Product Skin Adhesion
- ClinicalTrials.gov ID
- NCT07136870
- Acronym / sponsor ID
- SWAP / C3247 SWAP
- Keywords
- Tape adhesion, Adhesion residues on skin, Tape removal sensation degree, medical tapes, wide area fixation, Post-Operative dressings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * Exploratory * Intra-individual comparison * Coded test samples
| Arm | Type | Receives |
|---|---|---|
| Experimental Group Tape wearing | Experimental | Device: Medical tapeSixteen samples of different test materials (medical tape) will be placed on the participant's upper and lower back. This single group acts as it's own control. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The participants must meet all of the following criteria to be eligible to participate in the investigation:
Key exclusion criteria (15 listed)
- Participants meeting any of the following criteria will not be permitted to participate in the investigation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical tapeAlso: Leukosilk tape, Fixomull stretch, wide area fixation tape, Fixomull skin sensitive, wide area fixation tape, Leukoplast tapeThe 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 | Device | Experimental Group Tape wearing |
Primary outcome
Adhesion
Time frame: After 24 hours of tape use
Medical tape sample's adhesion force to skin measured in Newton-centimeter
Adhesive forces measured in N/cm
Time frame: 1-2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. IPD data will be only used internally by Essity and not be shared with other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical tape in people with Skin (FLACC Scores of Test Subjects) After Tape Removal, run by Essity Hygiene and Health AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion (time frame: After 24 hours of tape use). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.