MonoMax for Abdominal Wall Closure

Study Overview
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Brief Summary
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A great number of different suture techniques and suture materials are in use in order to reconstitute the abdominal wall integrity, but there is no surgical gold standard for abdominal wall closure until today. Various Meta-Analyses and randomized controlled trials have been performed, which compared non-absorbable or long-term absorbable versus rapid absorbable suture materials or monofilament versus multifilament suture materials, or continuous versus interrupted suture techniques respectively. This lack of evidence has the following outcome: burst abdomen is observed in 1-3% of patients within the first days after a laparotomy. The incidence of abdominal wall hernias 12 months postoperatively is estimated to be up to 20% (range 9 to 20%) . Wound infections develop in 3 to 21% of patients undergoing a median laparotomy within the first 30 days. At present most surgeons favour monofilament long-absorbable continuous sutures as the most suitable material for closing abdominal wounds after midline laparotomy.

Official Title
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A Multicentre, International, Prospective Post-market Clinical Follow-up to Evaluate MonoMax for Abdominal Wall Closure

Conditions
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Abdominal Wall Wound

Intervention / Treatment
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* Device: MonoMax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Elective primary laparotomy Written informed consent Exclusion Criteria: Peritonitis Emergency surgery Severe psychiatric and neurologic disease Drug- and / or alcohol abuse according to local standard Lack of informed consent Current immunosuppressive therapy Chemotherapy within the 2 weeks before operation Radiotherapy of the abdomen completed less than 8 before surgery Pregnant or breast-feeding women Coagulopathy

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MonoMax<br>Elective primary laparotomy | Device: MonoMax<br>* Abdominal wall will be closed with MonoMax after an elective primary laparotomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of reoperation due to burst abdomen |  | participants will be followed for the duration of hospital stay, an expected average of 10 days | 
| Frequency of wound infections |  | participants will be followed for the duration of hospital stay, an expected average of 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of wound healing until day of discharge |  | participants will be followed for the duration of hospital stay, an expected average of 10 days | 
| Length of hospital stay |  | participants will be followed for the duration of hospital stay, an expected average of 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparotomy, Surgical Procedures, Elective, Sutures, Abdominal Wound Closure Techniques