NCT02921750

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Visits are planned for baseline followed by 1, 2, 3, 4 and 6 weeks post treatment. The sub-group of at least 50 subjects will also be followed at week 8, 12, 16, 20, and 24 post treatment or until wound is healed if earlier.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	Exufiber Gelling Fibre Dressing	Gelling fibre dressing
DEVICE	Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre	Hydrofiber® Dressing with Strengthening Fibre

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-11-27
• Completion: 2019-11-27
• First posted: 2016-10-03
• Last updated: 2020-11-02
• Results posted: 2020-11-02

Locations

33 sites across 6 countries: Czechia, Denmark, France, Germany, Poland, Sweden