NCT02167815

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Leg Ulcer (VLU)

Interventions

Type	Name	Description
DEVICE	Mepilex XT	Experimental arm
OTHER	standard care

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-06-19
• Last updated: 2016-10-26
• Results posted: 2016-10-26

Locations

3 sites across 1 country: Czechia