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Status:

RECRUITING

Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study

Lead Sponsor:

RWTH Aachen University

Collaborating Sponsors:

Fasciotens GmbH

Conditions:

Abdominal Compartment Syndrome

Pancreatitis,Acute Necrotizing

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The open abdomen can occur as a result of various diseases. After infections of the abdomen, compartment syndromes or traumata, it is essential for survival (1). This condition of the open abdomen las...

Detailed Description

The open abdomen can occur as a result of various diseases. After infections of the abdomen, compartment syndromes or traumata, it is essential for survival (1). This condition of the open abdomen las...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Laparostoma with a resorbable net and planned or necessary "second look" operation.
  • Age of majority
  • Signed informed consent form or in the case of patients unable to give consent, signature from the authorised representative/legal carevier or consultant.
  • Exclusion Criteria for the period of use of the Fasciotens Abdomen device:
  • Pregnancy or breast-feeding at the time of inclusion into the study
  • A Moribund patient with a life expectancy of less than 24 hours despite laparostomy
  • Unstable thorax or known severe skeletal instability which impaires the use of the fasciotens abdomen device.
  • Open wounds or infections at the potential contact points of the Fasciotens abdomen device
  • Known cardiac insufficiency with ejection fraction less than 35%
  • Patients with lung failure (ARDS) and the need for abdominal positioning within the next 24h
  • Exclusion criteria for the entire duration of the study:
  • Persons who are accommodated in a mental hospital or an insititution on official or judicial instruction
  • Persons who are dependent on or have an employment relationship with the principal investigator
  • Other conditions which, at the judgement of the investigator, militate against the use of the investigational product
  • Minority

Exclusion

    Key Trial Info

    Start Date :

    August 5 2019

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 1 2026

    Estimated Enrollment :

    15 Patients enrolled

    Trial Details

    Trial ID

    NCT04033614

    Start Date

    August 5 2019

    End Date

    August 1 2026

    Last Update

    April 19 2023

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

    Aachen, North Rhine-Westphalia, Germany, 52074