Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-28 @ 1:28 AM
Study NCT ID:
NCT05494450
Status:
TERMINATED
Last Update Posted:
2023-04-06
First Post:
2022-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Molnlycke Health Care AB
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision secondary to data collection
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: