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Evaluation of Adhesion Properties in Wound Care Devices

NCT ID: NCT06392165

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-24

Study Completion Date

2025-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Adhesion Properties of Wound Care Devices

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

intra-individual test with up 12 test samples per study run; this treatment is announced here as single group study.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

all participants will receive the same up to 12 test samples, which are randomized intra-individual.

Study Groups

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Self-adhesive wound care devices

test devices with adhesive material to be attached to skin

Group Type OTHER

self-adhesive device

Intervention Type OTHER

Test device which is self-adhesive

Interventions

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self-adhesive device

Test device which is self-adhesive

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed eligibility and signed consent form.

Exclusion Criteria

* Known plaster allergy or other known contact hypersensitivity
* Pregnant or breastfeeding individual.
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Molnlycke Health Care AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mölnlycke Health Care AB

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Central Contacts

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Matthew Malone, PhD

Role: CONTACT

Phone: +44 7977815953

Email: [email protected]

Facility Contacts

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Jessica Fredriksson, Master

Role: primary

Other Identifiers

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DNR-2024-00715-02

Identifier Type: -

Identifier Source: org_study_id