MonoMax for Abdominal Wall Closure (MULTIMAC)

February 9, 2016 updated by: Aesculap AG

A Multicentre, International, Prospective Post-market Clinical Follow-up to Evaluate 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 05
        • Chirurgicka klinika, Fakultni nemocnine
      • Olomouc, Czech Republic, 77520
        • Chirurgicka klinika, Fakultni nemocnine
  • Romania
      • Bucharest, Romania
        • Central Emergency Military Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MonoMax
Elective primary laparotomy
Device: MonoMax
Abdominal wall will be closed with MonoMax after an elective primary laparotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
participants will be followed for the duration of hospital stay, an expected average of 10 days
Frequency of wound infections
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
participants will be followed for the duration of hospital stay, an expected average of 10 days
Length of hospital stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
participants will be followed for the duration of hospital stay, an expected average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Collaborators

B.Braun Surgical SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 5, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAG-O-H-1010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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