Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04033614

Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study

Led by RWTH Aachen University · Updated on 2023-04-19

15

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

R

RWTH Aachen University

Lead Sponsor

F

Fasciotens GmbH

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research evaluates the use of the Fasciotens Abdomen device for patients with an open abdomen, a serious condition that can result from infections, abdominal compartment syndromes, or trauma. The open abdomen condition can last from days to months, during which the fascia and abdominal wall structures retract, making direct abdominal closure difficult or impossible. The study aims to prove that the Fasciotens Abdomen device can prevent this fascial retraction, which is a key challenge in treating these critically ill patients. The Fasciotens Abdomen device applies a ventrally directed pulling force on the two fascial edges using an external support on the thorax and pelvis. A resorbable surgical mesh is sewn into the fascia margin, and sutures attached to this mesh are connected to a height-adjustable suspension linked to the external support, providing continuous traction. This traction counteracts the natural muscle pull and fascia retraction while keeping the abdomen open to avoid organ necrosis. The wound surface is then managed with conventional dressing materials. Participants who need a laparostoma will be treated with the Fasciotens Abdomen device. The distance between the fasciae is measured regularly using a ruler, and twelve months after treatment, an ultrasound will assess hernia formation. The primary outcome measured is the closure rate of the abdominal wall fascia up to 24 weeks. The study involves ongoing monitoring of fascia retraction prevention and user feasibility of the device throughout the treatment and follow-up periods.

CONDITIONS

Brief Title

Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Laparostoma with a resorbable net and a planned or necessary second look operation
  • Age of majority (18 years or older)
  • Signed informed consent form or consent from an authorized representative if the patient is unable to consent
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding at the time of inclusion
  • Moribund patient with life expectancy less than 24 hours despite laparostomy
  • Unstable thorax or severe skeletal instability preventing use of the Fasciotens Abdomen device
  • Open wounds or infections at potential contact points of the device
  • Known cardiac insufficiency with ejection fraction less than 35%
  • Lung failure (ARDS) requiring abdominal positioning within the next 24 hours
  • Persons in mental hospitals or institutions by official or judicial instruction
  • Persons dependent on or employed by the principal investigator
  • Other conditions judged by the investigator to prevent use of the investigational product
  • Minority (under legal adult age)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Implementation

Duration - Up to 24 weeks

Participants receive treatment with the Fasciotens Abdomen device, which applies continuous traction to the fascial edges to prevent abdominal wall retraction while the abdomen remains open.

Frequent measurements of the fascia distance and wound assessments during treatment

Follow-up

Duration - 12 months after treatment

Participants undergo ultrasound measurement 12 months after treatment to assess hernia formation.

1 ultrasound follow-up visit

Trial Site Locations

Total: 1 location

1

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Aachen, North Rhine-Westphalia, Germany, 52074

Actively Recruiting

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Research Team

R

Roman Marius Eickhoff, Dr. med.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Management of the open abdomen: a national study of clinical outcome and safety of negative pressure wound therapy.

Gordon L Carlson, Hannah Patrick, Amin I Amin...

https://pubmed.ncbi.nlm.nih.gov/23478532

Prospective study examining clinical outcomes associated with a negative pressure wound therapy system and Barker's vacuum packing technique.

Michael L Cheatham, Demetrios Demetriades, Timothy C Fabian...

https://pubmed.ncbi.nlm.nih.gov/23674252