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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aesculap AG
ClinicalTrials.gov Identifier:
NCT00572507
First received: December 11, 2007
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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]


Condition Intervention
Primary Median Laparotomy
Device: MonoMax®

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy [ Time Frame: till day of discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: December 2007
Study Completion Date: July 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ultra-longterm-absorbable monofilament suture Aesculap MonoMax®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572507

Locations
Germany
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
St. Bonifatius-Hospital; Chirurgische Klinik
Lingen, Germany, 49808
Universitaetsklinikum Giessen-Marburg, Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie
Marburg, Germany, 35043
Universitaetsklinikum Muenchen Grosshadern
Muenchen, Germany, 81377
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT00572507     History of Changes
Other Study ID Numbers: AAG-G-H-0701
Study First Received: December 11, 2007
Last Updated: September 20, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Aesculap AG:
Absorbable Monofilament Suture Material
Safety and Efficacy
Abdominal Wall/ Fascia
Laparotomy

ClinicalTrials.gov processed this record on October 29, 2014