CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
MonoMax®device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00572507
NCT00572507N/ACompleted
CompareCT.gov

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

Aesculap AG·interventional·Posted Dec 13, 2007·Updated May 28, 2015

In Brief

A clinical study evaluating MonoMax® for Primary Median Laparotomy. Completed, enrolled 150 participants across 4 sites.

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Median Laparotomy
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 13, 2007
Enrollment StartDec 1, 2007
Primary CompletionAug 1, 2008
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.6 years ago

Interventions

MonoMax®device

Abdominal wall closure with ultra-longterm absorbable monofilament suture after primary median laparotomy