Diabetic Foot Ulcer, Foot Ulcer, Leg Ulcer, Pressure Ulcer (PU), Skin Tears
Conditions
Keywords
MepilexUp, PMCF Clinical Investigation, Wound Healing, Exuding Wounds
Brief 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.
Detailed description
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.
Interventions
DEVICEMepilex® 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.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All enrolled participants receive treatment with Mepilex® Up. There is no comparator group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent. 2. Adults aged ≥18 years 3. Exudate levels moderate to high 4. Wound sizes: 1. Leg ulcers: between 3 cm² and 30 cm² 2. Foot ulcers: ≥0,75 cm² 3. Skin tears: between 3 cm² and 30 cm² 5. Pressure ulcers: Foot ulcer caused by pressure
Exclusion criteria
1. Circumferential ulcer 2. Known allergy/hypersensitivity to the materials of the dressings or products 3. Use of wound fillers 4. Infected ulcer/wound, defined as any wound condition requiring the prescription or continuation of systemic antibiotics (orally or parental) at enrolment 5. Participating in ongoing clinical investigations, or during the past 30 days, which may impact the outcome of this investigation based on the judgement of the investigator 6. Woman of childbearing potential, who is pregnant or breastfeeding or plans on becoming pregnant during the investigation period 7. Not willing or able to comply to clinical investigation procedures, or not suitable for participation according to the investigator (e.g., alcohol or substance abuse)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound progress towards healing | Up to 6 weeks | Assessment of wound progress compared with the previous visit and classified as Deteriorated, no change, improved, or healed. |
Countries
Sweden
Contacts
CONTACTDaniel Sundh, Ph.D.
Outcome results
None listed