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Table 3 Eligibility Criteria

From: A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]

Inclusion criteria

Exclusion criteria

Age equal or greater than 18 years

Peritonitis

Expected survival time more than 12 months

Emergency surgery

Patients undergoing primary and elective midline laparotomy (patients with prior laparoscopy or abdominal operation via paramedian incision (e.g. appendectomy) may be included in the trial

Coagulopathy (= A group of disorders of the blood clotting (coagulation) system in which bleeding is prolonged and excessive with abnormal values in the blood laboratory

• Lack of compliance

BMI < 35

Severe psychiatric or neurologic disease

Expected length of skin incision > 15 cm

Lack of informed consent

 

Participation in another intervention with interference of intervention and outcome of this trial

 

Drug- and/or alcohol-abuse according to local standard

 

Current immunosuppressive therapy (more than 40 mg of a corticoid per days or azathioprin

 

Chemotherapy within two 2 before operation

 

Radiotherapy of the abdomen completed less than 8 weeks before operation

 

Inability to understand and to follow the instructions given by the investigator (e.g. insufficient command of language, dementia, lack of time)

 

Pregnant or breast-feeding woman (according to information given by the patient)

 

Patients who have been committed to an institution by virtue of an order issued either by the courts or by an authority