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| Sponsored by: |
Aesculap AG & Co. KG |
| Information provided by: | Aesculap AG & Co. KG |
| ClinicalTrials.gov Identifier: | NCT00572507 |
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: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | June 2009 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Baerbel Kaestner, Dr. | +49-6221-56-0 ext 38218 | baerbel.kaestner@med.uni-heidelberg.de |
| Contact: Petra Baumann, Dr. | +49-7461-95-0 ext 1646 | petra.baumann@aesculap.de |
| Germany | |||||
| Universitaetsklinikum Heidelberg | Recruiting | ||||
| Heidelberg, Germany, 69120 | |||||
| Principal Investigator: Markus W Buechler, Prof. Dr. | |||||
| Universitaetsklinikum Muenchen Grosshadern | Recruiting | ||||
| Muenchen, Germany, 81377 | |||||
| Principal Investigator: Karl-Walter Jauch, Prof. Dr. | |||||
| Universitaetsklinikum Giessen-Marburg, Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie | Recruiting | ||||
| Marburg, Germany, 35043 | |||||
| Principal Investigator: Annette Franck, Dr. | |||||
| St. Bonifatius-Hospital; Chirurgische Klinik | Recruiting | ||||
| Lingen, Germany, 49808 | |||||
| Principal Investigator: Christoph Seidlmayer, Dr. | |||||
| Aesculap AG & Co. KG |
| 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
| Responsible Party: | Aesculap AG & Co. KG ( Dr. Hanns-Peter Knaebel ) |
| Study ID Numbers: | AAG-G-H-0701 |
| First Received: | December 11, 2007 |
| Last Updated: | March 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00572507 |
| Health Authority: | Germany: German Institute of Medical Documentation and Information |
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