CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 248 enrolled
Drug / intervention
Exufiber Gelling Fibre Dressing +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.

Search/NCT02921750
NCT02921750N/ACompleted
CompareCT.gov

A Randomised Multi-centre Non-inferiority Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin

Molnlycke Health Care AB·interventional·Posted Oct 3, 2016·Updated Nov 2, 2020

In Brief

A clinical study evaluating Exufiber Gelling Fibre Dressing and Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre for Venous Leg Ulcer. Completed, enrolled 248 participants across 33 sites in 6 countries.

Detailed Summary

The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation. 212 evaluable subjects will be randomised. Subjects to be included will suffer from an exuding venous or mixed ulcer of predominantly venous origin. Subjects will either be randomized to Exufiber®Gelling Fibre Dressing or Aquacel®Extra Hydrofiber® Dressing with Strengthening Fibre using, centralized randomization

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Leg Ulcer
CountriesCzechia, Denmark, France, Germany, Poland, Sweden
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 3, 2016
Enrollment StartOct 1, 2016
Primary CompletionNov 27, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.7 years ago

Interventions

Exufiber Gelling Fibre Dressingdevice

Gelling fibre dressing

Aquacel Extra Hydrofiber® Dressing with Strengthening Fibredevice

Hydrofiber® Dressing with Strengthening Fibre