Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547138
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Pilot Study on the Effectiveness and Safety of OPTILENE SILVER MESH ELASTIC in Prevention of Surgical Site Infection SSI and Incisional Hernia IH
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Descriptive Multicentre Pilot Study On The Effectiveness and Safety Of Optilene Silver Mesh Elastic In Prevention Of Surgical Site Infection SSI And Incisional Hernia IH
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SSIHLVER
Brief Summary:
The aim of the study is to describe the effectiveness of Optilene Silver Mesh Elastic on prevention of surgical site infection SSI at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on the SSI rates IH rates and overall clinical performance of Optilene Silver Mesh Elastic used for the prevention of incisional hernia as prophylactic mesh in patients that require urgent median laparotomy in clinical routine
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None