Health TrialsbyHealthPanel

An Investigation to Evaluate Wearing Properties of Three Different Investigational Devices

ConditionHealthy Volunteer Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMolnlycke Health Care AB

About this trial

This clinical investigation will assess the self-adhesive properties of two investigational devices compared to a test specimen reference.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants who are capable and willing to comply with protocol visits, assessments, and instructions.

Participants must be in general good health with healthy and intact skin in the test area (as determined by the investigator based on medical history and examination of the application sites).

Minimal hairiness at the back (location of the application sites).

Signed written informed consent.

Disqualifiers

Known allergy/hypersensitivity to the dressing or its components.

Participants with any features at the application sites will be in contact with the adhesive surface of the dressing, and could influence the investigation.

Participants not willing to avoid contact of the application sites with water in the morning prior to dressing application and throughout the entire course of the study.

Participants not willing to avoid applying any detergents to the application sites in the morning prior to dressing application and throughout the entire course of the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Dressing

    Device

    The dressing will be applied to intact skin on healthy volunteers participants to assess the self-adhesive properties of two investigational devices compared to a test specimen reference. The dressing will be worn for up to 14 days on a designated area on the health volunteers participants back.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: 12 dressings applied to designated sites on healthy volunteer participantsOther 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate stay-on-ability of the test specimens compared to the test specimen reference

The percentage detachment of each test specimen and the test specimen reference will be assessed using a counting grid method. A standardized grid-patterned template will be applied to the application area to objectively quantify the area of detachment. The result will be expressed as a percentage of the total surface area in terms of the mean % detachment at Day 14. Unit of Measure: Percentage (%)

Time frame
From enrollment to end of follow-up at day 14.

Secondary outcomes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

SGS proderm GmbHRecruiting22869, Schenefeld, Free and Hanseatic City of HamburgGermanyGermany

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Molnlycke Health Care AB

Lead sponsor

Source ClinicalTrials.gov
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