A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers

Venous Leg Ulcer (VLU) Clinical Trial

Official title: A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers

Status Completed

Clinical Trial Summary

This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory and granulating stages of the wound healing process.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer (VLU)

• NCT number: NCT02167815
• Study type: Interventional
• Source: Molnlycke Health Care AB
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Completion date: July 2015