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]

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