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

Aesculap

Status: Completed

Conditions: Primary Median Laparotomy

Treatments: Device: MonoMax®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00572507

AAG-G-H-0701

Details and patient eligibility

About

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]

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

MonoMax

Experimental group

Description:

MonoMax is used for abdominal wall closure

Treatment:

Device: MonoMax®