Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT05296902
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2022-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performance of Safety of SILKAM® Suture Material in Oral Surgery
Sponsor:
Aesculap AG
Organization:
Study Overview
Official Title:
Single Center Open-Label Post Market Clinical Follow-Up (PMCF) -Study on the Performance of Safety of SILKAM® Suture Material in Oral Surgery
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SILKOS
Brief Summary:
Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.
Detailed Description:
The aim of this Non Interventional Study is to collect systematically and proactively different clinical parameters regarding safety, effectiveness, and performance of SILKAM® suture material under the daily routine clinical practice when is intended to be used for oral surgery. All patients enrolled will be prospectively followed until suture removal, which takes place approximately one week post-operatively.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: