NCT00572507

Multi-center Study to Evaluate the Safety and Efficacy of Aesculap MonoMax® for Abdominal Wall Closure

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. \[Knaebel HP et al., 2005\]

Conditions

• Primary Median Laparotomy

Interventions

Type	Name	Description
DEVICE	MonoMax®	Abdominal wall closure with ultra-longterm absorbable monofilament suture after primary median laparotomy

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-08-01
• Completion: 2009-07-01
• First posted: 2007-12-13
• Last updated: 2015-05-28

Locations

4 sites across 1 country: Germany