Evaluation of Adhesion Properties in Wound Care Devices

April 26, 2024 updated by: Molnlycke Health Care AB
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Gothenburg, Sweden, 415 02
        • Mölnlycke Health Care AB
        • Contact:
        • Principal Investigator:
          • Matthew Malone, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Confirmed eligibility and signed consent form.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Self-adhesive wound care devices
test devices with adhesive material to be attached to skin
Other: self-adhesive device
Test device which is self-adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peel Off Force
Time Frame: up to 48 hours
Internal machine shall measure the peel force expressed in Newton.
up to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humidity
Time Frame: up to 48 hours
Humidity shall be evaluated using tactile and visual assessment
up to 48 hours
Redness
Time Frame: up to 48 hours
Visual assessment of redness of the skin
up to 48 hours
Pain assessment
Time Frame: up to 48 hours
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.
up to 48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adhesive residuals
Time Frame: up to 48 hours
Adhesive residuals on the skin
up to 48 hours
Loosening
Time Frame: up to 48 hours
Assessment if the device is still in place or has been fallen of.
up to 48 hours
Comments
Time Frame: up to 48 hours
Further comments (not related to the other outcomes) by the participant or the investigator
up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molnlycke Health Care AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 24, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

April 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNR-2024-00715-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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