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OpenTrials
Completed

NCT Number: NCT01901068

MonoMax for Abdominal Wall Closure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chirurgicka klinika, Fakultni nemocnine, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MonoMax

Device

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

Primary outcomes

  1. Frequency of reoperation due to burst abdomen

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

  2. Frequency of wound infections

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary outcomes

  1. Incidence of wound healing until day of discharge

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

  2. Length of hospital stay

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

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

Acronym: MULTIMAC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2013
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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