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

May 27, 2015 updated by: Aesculap AG

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg
      • Lingen, Germany, 49808
        • St. Bonifatius-Hospital; Chirurgische Klinik
      • Marburg, Germany, 35043
        • Universitaetsklinikum Giessen-Marburg, Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie
      • Muenchen, Germany, 81377
        • Universitaetsklinikum Muenchen Grosshadern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age equal or greater than 18 years
  • Expected survival time > 12 months
  • Patient undergoing elective and primary median laparotomy
  • BMI < 35
  • Expected length of skin incision > 15 cm

Exclusion Criteria:

  • Peritonitis
  • Emergency surgery
  • Coagulopathy
  • Current immunosuppressive therapy (> 40 mg of a Corticoid per day or Azathioprin)
  • Chemotherapy within 2 weeks before operation
  • Radiotherapy of the abdomen completed less than 8 weeks before operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MonoMax
MonoMax is used for abdominal wall closure
Device: MonoMax®
Abdominal wall closure with ultra-longterm absorbable monofilament suture after primary median laparotomy
Other Names:
  • ultra-longterm-absorbable monofilament suture Aesculap MonoMax®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy
Time Frame: till day of discharge
till day of discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
length of postoperative hospital stay after surgery and frequency of incisional hernias 12 months after the surgery and frequency of wound infections 30 days postoperative
Time Frame: different
different

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Investigators

  • Principal Investigator: Markus W Buechler, Prof. Dr., Universitaetsklinikum Heidelberg; Chirugische Klinik
  • Principal Investigator: Karl-Walter Jauch, Prof. Dr., Klinikum der Universitaet Muenchen, Grosshadern; Chirurgische Klinik und Poliklinik
  • Principal Investigator: Annette Franck, Dr., Universitaets-Klinikum Giessen-Marburg; Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie
  • Principal Investigator: Christoph Seidlmayer, Dr., St. Bonifatius Hospital, Lingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 12, 2007

First Posted (Estimate)

December 13, 2007

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAG-G-H-0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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