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.
This prospective, open-label, multicenter, post-market clinical follow-up investigation will evaluate Mepilex® Up used as the primary absorbent dressing in the treatment of exuding ulcers and skin tears located on the leg and foot. Approximately 70 adult participants will be enrolled and followed for up to 6 weeks or until wound healing, whichever occurs first. Assessments include wound progression, wound healing, wound area reduction, peri-wound skin condition, dressing performance, participant-reported pain, and safety outcomes. Treatment and wound care procedures will follow local standard clinical practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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.
Forsåker Vårdcentral
Mölndal, Västra Götaland County, Sweden
Wound progress towards healing
Assessment of wound progress compared with the previous visit and classified as Deteriorated, no change, improved, or healed.
Time frame: Up to 6 weeks
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