At a glance
ClinicalIndex Comparison RecordN/ACompleted· 30 enrolled
Drug / intervention
Mepilex XT +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Mepilex XT and standard care for Venous Leg Ulcer (VLU). Completed, enrolled 30 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Leg Ulcer (VLU)
CountriesCzechia
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedJun 2014
Primary CompletionJul 2015
TodayJul 2026
First PostedJun 19, 2014
Enrollment StartMay 1, 2014
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.0 years ago
Interventions
Mepilex XTdevice
Experimental arm
standard careother