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

NCT00572507 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-05-28

No results posted yet for this study

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

DEVICE

MonoMax®

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

Sponsors & Collaborators

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Markus W Buechler, Prof. Dr. · Universitaetsklinikum Heidelberg; Chirugische Klinik

  • Karl-Walter Jauch, Prof. Dr. · Klinikum der Universitaet Muenchen, Grosshadern; Chirurgische Klinik und Poliklinik

  • Annette Franck, Dr. · Universitaets-Klinikum Giessen-Marburg; Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie

  • Christoph Seidlmayer, Dr. · St. Bonifatius Hospital, Lingen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-08-31
Completion
2009-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00572507 on ClinicalTrials.gov