RecruitingNot ApplicableNCT05588583

A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.

A Prospective, Open, Multi-Center, Interventional, Non-Comparative Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up

Sponsor

Molnlycke Health Care AB

Enrollment

68 participants

Start Date

Oct 31, 2022

Study Type

INTERVENTIONAL

Conditions

Wounds Diabetic Foot Ulcer Venous Leg Ulcer Wound of Skin Wound Leg Wound; Foot

Summary

The goal of this clinical trial is to follow the progress of wounds in those with venous leg ulcers and diabetic foot ulcers while using an absorbent dressing called Mepilex Up. The main objective is to follow the progress of these wounds over time from initial visit to each follow-up visit. Participants will be asked to wear Mepilex Up dressing for up to 6 weeks of treatment or until healed, changed at every one-week interval.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Signed consent to participate (including consent for digital imaging)
Adult aged ≥18 years
Diagnosed with a chronic, exuding VLU or DFU
Exudate amount moderate to large
Wound size from 3 cm2 to 30 cm2 for VLU and ≥1 cm2 for DFU, as determined by the clinician
For VLU: ABPI (within 3 months) \> 0.7. If ABPI \> 1.4, then big toe pressure \> 60 mmHg is required or an alternative measurement verifying normal distal arterial flow
For VLU: Willing to be compliant with compression therapy

Exclusion Criteria5

Infected ulcer according to the judgment of the investigator defined as any wound condition requiring the prescription or continuation of systemic antibiotic therapy at enrollment
Circumferential wound
Known allergy/hypersensitivity to the materials of the dressing
Patients participating in the DIPLO NBF study
Use of wound fillers

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Interventions

DEVICEMepilex Up

Mepilex Up is a highly conformable dressing that absorbs both low and high viscous exudates, maintains a moist wound environment and minimises the risk of maceration. The dressing has a Safetac® wound contact layer that is a unique adhesive technology. It minimises pain to patients and trauma to wounds and the surrounding skin at dressing removal. Mepilex Up consists of: * a soft silicone wound contact layer (Safetac) * a flexible absorbent pad of compressed polyurethane foam * an outer polyurethane film which is breathable but waterproof Dressing material content: Silicone, polyurethane