Clinical trial NCT00572507: Multi-center Study to Evaluate the Safety and Efficacy of Aesculap MonoMax® for Abdominal Wall Closure
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Median Laparotomy
Keywords: Absorbable Monofilament Suture Material
Safety and Efficacy
Abdominal Wall/ Fascia
Laparotomy
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2007-12-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. \[Knaebel HP et al., 2005\]


Eligibility 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

Primary outcomes:
measure: frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy
timeFrame: till day of discharge
Secondary outcomes:
measure: 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
timeFrame: different
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Lingen
country: Germany
facility: St. Bonifatius-Hospital; Chirurgische Klinik
city: Marburg
country: Germany
facility: Universitaetsklinikum Giessen-Marburg, Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie
city: Muenchen
country: Germany
facility: Universitaetsklinikum Muenchen Grosshadern
Study officials:
affiliation: Universitaetsklinikum Heidelberg; Chirugische Klinik
name: Markus W Buechler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum der Universitaet Muenchen, Grosshadern; Chirurgische Klinik und Poliklinik
name: Karl-Walter Jauch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaets-Klinikum Giessen-Marburg; Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie
name: Annette Franck, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Bonifatius Hospital, Lingen
name: Christoph Seidlmayer, Dr.
role: PRINCIPAL_INVESTIGATOR
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