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

Launched by MOLNLYCKE HEALTH CARE AB · Oct 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how well an absorbent dressing called Mepilex Up works for people with chronic wounds, specifically venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). The aim is to monitor the healing progress of these wounds over time, starting from the first visit and continuing through regular follow-ups for up to 6 weeks or until the wounds heal. Participants will have the dressing changed once a week during this period.

To be eligible for the trial, participants must be adults aged 18 or older with a moderate to large amount of wound drainage and specific wound sizes. They should also be willing to follow recommended treatments, like wearing compression bandages for VLUs. However, individuals with infected wounds or specific allergies to the dressing materials cannot participate. If you join the trial, you can expect regular check-ins to assess your wound healing and receive support throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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