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

Aesculap AG150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Primary Median Laparotomy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Universitaetsklinikum Heidelberg

Heidelberg, Germany

St. Bonifatius-Hospital; Chirurgische Klinik

Lingen, Germany

Universitaetsklinikum Giessen-Marburg, Klinik fuer Viszeral-, Thorax- und Gefaesschirurgie

Marburg, Germany

Universitaetsklinikum Muenchen Grosshadern

München, Germany

Outcomes

Primary Outcomes

frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy

Time frame: till day of discharge

Secondary Outcomes

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