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Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
Sponsor: Molnlycke Health Care AB
Summary
This post-market clinical follow-up investigation is designed to evaluate the performance and safety of Mepilex® Up when used for the management of exuding ulcers and skin tears on the leg and foot. Approximately 70 adult participants will be treated with Mepilex® Up and followed for up to 6 weeks to assess wound progression and safety.
Official title: An Open, Non-Comparative, Multi-Center Clinical Investigation to Confirm Performance and Safety of Mepilex® Up When Used on Ulcers and Skin Tears on Leg and Foot
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-08-31
Completion Date
2027-09-30
Last Updated
2026-08-26
Healthy Volunteers
No
Interventions
Mepilex® Up
Mepilex® Up is a soft silicone foam dressing intended for the management of exuding wounds. The dressing is used as the primary absorbent dressing throughout the investigation according to its instructions for use and local standard clinical practice.
Locations (1)
Forsåker Vårdcentral
Mölndal, Västra Götaland County, Sweden