Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMolnlycke Health Care AB
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent.
Adults aged ≥18 years
Exudate levels moderate to high
Leg ulcers: between 3 cm² and 30 cm²
Disqualifiers
Circumferential ulcer
Known allergy/hypersensitivity to the materials of the dressings or products
Use of wound fillers
Infected ulcer/wound, defined as any wound condition requiring the prescription or continuation of systemic antibiotics (orally or parental) at enrolment
Trial design
Design model
Single group
Treatments tested in this trial
Mepilex® Up
DeviceMepilex® 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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Mepilex® UpExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: