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MonoMax for Abdominal Wall Closure (MULTIMAC)

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Aesculap

Status

Completed

Conditions

Abdominal Wall Wound

Treatments

Device: MonoMax

Study type

Observational

Funder types

Industry

Identifiers

NCT01901068
AAG-O-H-1010

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

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy 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

MonoMax
Description:
Elective primary laparotomy
Treatment:
Device: MonoMax

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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