NCT05588583

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This investigation is designed as a prospective, open, multi-center, interventional, non-comparative investigation with the aim to follow exuding chronic wound progression for 6 weeks according to local standard of care. Wound progress is a summary endpoint of the total effect of treatment using Mepilex Up as the absorbent dressing and includes the changes in an objectively measured wound area and subjectively evaluated wound condition. Two indications will be included: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcers (DFU). A total of n=68 participants, approximately 34 per indication, will be recruited at up to 8 centers in the US. There will be a total of seven (7) visits to the investigation site for participants during the treatment period: baseline, followed by weekly visits up to six (6) weeks post baseline. During visits, evaluations will be performed to assess wound progression and status, wound dressing properties, as well as Subject pain, comfort, and quality of life. Safety will be assessed at all visits. One target wound per participant will be included in this investigation.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Mepilex 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

Timeline

• Start date: 2022-10-31
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-10-20
• Last updated: 2023-04-20

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study