Evaluation of Adhesion Properties in Wound Care Devices

NCT06392165 | Not Yet Recruiting

• 1 other identifier: DNR-2024-00715-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Adhesion Properties of Wound Care Devices

Outcome Measures

Primary Outcomes (1)

• Peel Off Force

  Internal machine shall measure the peel force expressed in Newton.

  up to 48 hours

Secondary Outcomes (3)

• Humidity

  up to 48 hours

• Redness

  up to 48 hours

• Pain assessment

  up to 48 hours

Other Outcomes (3)

• Adhesive residuals

  up to 48 hours

• Loosening

  up to 48 hours

• Comments

  up to 48 hours

Study Arms (1)

Self-adhesive wound care devices

OTHER

test devices with adhesive material to be attached to skin

Other: self-adhesive device

Interventions

self-adhesive device OTHER

Test device which is self-adhesive

Self-adhesive wound care devices

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed eligibility and signed consent form.

You may not qualify if:

• Known plaster allergy or other known contact hypersensitivity
• Pregnant or breastfeeding individual.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (1)

Mölnlycke Health Care AB

Gothenburg, 415 02, Sweden

Location

Central Study Contacts

Matthew Malone, PhD

CONTACT

+44 7977815953; matthew.malone@molnlycke.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: all participants will receive the same up to 12 test samples, which are randomized intra-individual.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: intra-individual test with up 12 test samples per study run; this treatment is announced here as single group study.

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: April 24, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)