Evaluation of Adhesion Properties in Wound Care Devices

Not Applicable

Not yet recruiting

• Conditions: Adhesion Properties of Wound Care Devices

• Registration Number: NCT06392165
• Lead Sponsor: Molnlycke Health Care AB

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study Start: 2024-04-24
• Study First Submitted QC: 2024-04-26
• Last Update Submitted: 2024-04-26
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Confirmed eligibility and signed consent form.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Peel Off Force	up to 48 hours	Internal machine shall measure the peel force expressed in Newton.

Secondary Outcome Measures

Name	Time	Method
Pain assessment	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.
Humidity	up to 48 hours	Humidity shall be evaluated using tactile and visual assessment
Redness	up to 48 hours	Visual assessment of redness of the skin

Trial Locations

Locations (1)

Mölnlycke Health Care AB; 🇸🇪 Gothenburg, Sweden