MonoMax for Abdominal Wall Closure (MULTIMAC)
Status
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Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
200 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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