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

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ClinicalTrials.gov Identifier: NCT00572507
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Aesculap AG

Brief 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]

Condition or disease Intervention/treatment Phase
Primary Median Laparotomy Device: MonoMax® Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : July 2009

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 Name: ultra-longterm-absorbable monofilament suture Aesculap MonoMax®



Primary Outcome Measures :
  1. frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy [ Time Frame: till day of discharge ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Other Publications:
Schumpelick V, Kingsanorth AN. Incisional Hernia. Questionnaire Survetta Meeting, March 1998: 496
Schumpelick V, Arlt G, Klinge U. Versorgung von Nabelhernien und Narbenhernien. Dt. Aerzteblatt 94, 51-52. Dez. 1997 (35)
Odermatt EK, Funk L, Bargon R, Martin DP, Rizk S, Williams SF. MonoMax Suture: A New Long-Term Absorbable Monofilament Suture Made from Poly-4-Hydroxybutyrate. International Journal of Polymer Science Volume 2012, Article ID 216137, 12 pages. doi:10.1155/2012/216137

Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT00572507     History of Changes
Other Study ID Numbers: AAG-G-H-0701
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

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