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

Not Applicable

Completed

• Conditions: Primary Median Laparotomy
• Interventions: Device: MonoMax®

• Registration Number: NCT00572507
• Lead Sponsor: Aesculap AG

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Primary Completion: 2008-08
• Study Completion: 2009-07
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MonoMax	MonoMax®	MonoMax is used for abdominal wall closure

Primary Outcome Measures

Name	Time	Method
frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy	till day of discharge

Secondary Outcome Measures

Name	Time	Method
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	different

Trial Locations

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; 🇩🇪 Muenchen, Germany