Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-27 @ 2:58 PM
Study NCT ID:
NCT01901068
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2013-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MonoMax for Abdominal Wall Closure
Sponsor:
Aesculap AG
Organization:
Study Overview
Official Title:
A Multicentre, International, Prospective Post-market Clinical Follow-up to Evaluate MonoMax for Abdominal Wall Closure
Status:
COMPLETED
Status Verified Date:
2024-12
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:
MULTIMAC
Brief Summary:
A great number of different suture techniques and suture materials are in use in order to reconstitute the abdominal wall integrity, but there is no surgical gold standard for abdominal wall closure until today. Various Meta-Analyses and randomized controlled trials have been performed, which compared non-absorbable or long-term absorbable versus rapid absorbable suture materials or monofilament versus multifilament suture materials, or continuous versus interrupted suture techniques respectively. This lack of evidence has the following outcome: burst abdomen is observed in 1-3% of patients within the first days after a laparotomy. The incidence of abdominal wall hernias 12 months postoperatively is estimated to be up to 20% (range 9 to 20%) . Wound infections develop in 3 to 21% of patients undergoing a median laparotomy within the first 30 days. At present most surgeons favour monofilament long-absorbable continuous sutures as the most suitable material for closing abdominal wounds after midline laparotomy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: