Ignite Creation Date:
2024-05-05 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00572507
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2007-12-11
Brief Title:
Multi-center Study to Evaluate the Safety and Efficacy of Aesculap MonoMax for Abdominal Wall Closure
Sponsor:
Aesculap AG
Organization:
Aesculap AG
Study Overview
Official Title:
A Historically-controlled Single-arm Multi-center Prospective Trial to Evaluate the Safety and Efficacy of Aesculap MonoMax Suture Material for Abdominal Wall Closure After Primary Median Laparotomy
Status:
COMPLETED
Status Verified Date:
2015-05
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:
ISSAAC
Brief Summary:
MonoMax will be used for a continuous all-layer except skin suture to close abdominal wall after midline incision The primary objective of this trial is to demonstrate that the frequency of wound infection and the frequency of reoperation due to burst-abdomen after primary median laparotomy for elective surgical intervention are equal or lower than in the INSECT trial The secondary objectives are to demonstrate that the length of postoperative hospital stay and the frequency of abdominal hernias 12 months after the surgery are equal or lower than in the INSECT trial Knaebel HP et al 2005
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