NCT05494450

An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds

Detailed description

The overall objective of this post market clinical follow-up (PMCF) investigation is to confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds, with Mepilex Border Flex as the secondary dressing, when used in accordance with the Instructions for Use.

Conditions

• Pressure Ulcer
• Diabetic Foot Ulcer
• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	ExufiberAG+	confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-11-29
• Completion: 2022-11-29
• First posted: 2022-08-10
• Last updated: 2023-04-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study