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

Study Overview
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Brief Summary
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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]

Official Title
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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

Conditions
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Primary Median Laparotomy

Intervention / Treatment
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* Device: MonoMax®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MonoMax<br>MonoMax is used for abdominal wall closure | Device: MonoMax®<br>* Abdominal wall closure with ultra-longterm absorbable monofilament suture after primary median laparotomy<br>* Other names: ultra-longterm-absorbable monofilament suture Aesculap MonoMax®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of wound infection, frequency of reoperation due to burst-abdomen after primary median laparotomy |  | till day of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Absorbable Monofilament Suture Material, Safety and Efficacy, Abdominal Wall/ Fascia, Laparotomy