Adhesion Properties of Wound Care DevicesNCT06392165
Evaluation of Adhesion Properties in Wound Care Devices
A study testing self-adhesive device in people with Adhesion Properties of Wound Care Devices, run by Molnlycke Health Care AB at 1 site in Sweden.
Trial summary
Molnlycke manufactures and markets self-adhesive wound care devices intended to protect various types of wounds during treatment. This study aims to measure and evaluate the adhesion properties of self-adhesive wound care devices. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Adhesion Properties of Wound Care Devices
- What is being tested?
- self-adhesive device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 24 Apr 2024to Jun 2025
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed eligibility and signed consent form.
Who cannot join
- Known plaster allergy or other known contact hypersensitivity
- Pregnant or breastfeeding individual.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Mölnlycke Health Care AB
Gothenburg, 415 02
Jessica Fredriksson, Master, +46737733909, jessica.fredriksson@molnlycke.com
Matthew Malone, PhD
About this study
Molnlycke manufactures and markets self-adhesive wound care devices intended to protect various types of wounds during treatment. This study aims to measure and evaluate the adhesion properties of self-adhesive wound care devices. To measure the adhesion properties test strips will be applied to the participant's skin for a predetermined time and will be removed while measuring the adhesion properties afterwards. This method has been chosen since there is no in vitro method available that can simulate adhesion to human skin
- Being tested
- self-adhesive device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-adhesive deviceOther
Test device which is self-adhesive
| Study group | Role | What they receive |
|---|---|---|
| Self-adhesive wound care devices | Other | test devices with adhesive material to be attached to skin Receives: Other: self-adhesive device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peel Off Force
Internal machine shall measure the peel force expressed in Newton.
Measured: up to 48 hours
Secondary outcomes (3)
Humidity
Humidity shall be evaluated using tactile and visual assessment
Measured: up to 48 hours
Redness
Visual assessment of redness of the skin
Measured: up to 48 hours
Pain assessment
Visual analog scale (VAS) assessment of pain after removal. The scale is 100mm long whether 0mm means no pain and 100mm means the maximum pain a participant could imagine.
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start24 Apr 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesion Properties of Wound Care DevicesStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- intra-individual test with up 12 test samples per study run; this treatment is announced here as single group study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392165
- Sponsor's protocol ID
- DNR-2024-00715-02
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adhesion Properties in Wound Care Devices
- ClinicalTrials.gov ID
- NCT06392165
- Acronym / sponsor ID
- DNR-2024-00715-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
Molnlycke manufactures and markets self-adhesive wound care devices intended to protect various types of wounds during treatment. This study aims to measure and evaluate the adhesion properties of self-adhesive wound care devices. To measure the adhesion properties test strips will be applied to the participant's skin for a predetermined time and will be removed while measuring the adhesion properties afterwards. This method has been chosen since there is no in vitro method available that can simulate adhesion to human skin
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- intra-individual test with up 12 test samples per study run; this treatment is announced here as single group study.
| Arm | Type | Receives |
|---|---|---|
| Self-adhesive wound care devices | Other | Other: self-adhesive devicetest devices with adhesive material to be attached to skin |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed eligibility and signed consent form.
Key exclusion criteria (2 listed)
- Known plaster allergy or other known contact hypersensitivity
- Pregnant or breastfeeding individual.
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 |
|---|---|---|
| self-adhesive deviceTest device which is self-adhesive | Other | Self-adhesive wound care devices |
Primary outcome
Peel Off Force
Time frame: up to 48 hours
Internal machine shall measure the peel force expressed in Newton.
3 secondary outcomes
Humidity
Time frame: up to 48 hours
Redness
Time frame: up to 48 hours
Pain assessment
Time frame: up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-adhesive device in people with Adhesion Properties of Wound Care Devices, run by Molnlycke Health Care 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Malone, PhD (+44 7977815953, matthew.malone@molnlycke.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peel Off Force (time frame: up to 48 hours). 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 30 Apr 2024.