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MonoMax for Abdominal Wall Closure

NCT01901068 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-12-13

No results posted yet for this study

Summary

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.

Conditions

  • Abdominal Wall Wound

Interventions

DEVICE

MonoMax

Abdominal wall will be closed with MonoMax after an elective primary laparotomy.

Sponsors & Collaborators

  • B.Braun Surgical SA

    collaborator INDUSTRY

  • Aesculap AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • Czechia
  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01901068 on ClinicalTrials.gov