Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears

Sponsor
Molnlycke Health Care AB
Study ID
NCT07782008
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mepilex® Up — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mepilex® Up
    Participants receive treatment with Mepilex® Up as the primary absorbent dressing for up to 6 weeks or until wound healing. Wound care procedures follow local standard clinical practice.

Primary Outcome Measure

Wound progress towards healing [ Time Frame: Up to 6 weeks ]

Central Contacts

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