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

December 11, 2007
September 20, 2012
December 2007
August 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00572507 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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

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]

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Median Laparotomy
Device: MonoMax®
Abdominal wall closure with ultra-longterm absorbable monofilament suture after primary median laparotomy
Other Name: ultra-longterm-absorbable monofilament suture Aesculap MonoMax®
Experimental: MonoMax
MonoMax is used for abdominal wall closure
Intervention: Device: MonoMax®

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2009
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00572507
AAG-G-H-0701
No
Aesculap AG
Aesculap AG
Not Provided
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
Aesculap AG
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP