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Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study (Fasciotens)

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ClinicalTrials.gov Identifier: NCT04033614
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : August 8, 2019
Sponsor:
Collaborator:
Fasciotens GmbH
Information provided by (Responsible Party):
Dr. Roman Marius Eickhoff, RWTH Aachen University

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 lasts from days to months. Within a very short time, the fascia and abdominal wall structures retract in such a way that direct abdominal closure is often impossible. In addition, there is a pronounced intraabdominal oedema, which additionally increases the space required by the abdominal organs. Therefore, it is clinically indispensable to increase the space of the intraabdominal organs in this life-threatening situation. After the laparotomy (opening of the abdomen) has been performed, it is therefore not closed. However, the natural traction on the abdominal wall, in particular on the fascia, the attached musculature as well as skin and subcutis, no longer exists in this situation. As a result, these structures retract over the period of the existing laparostoma.

In the present study, the CE-certified medical device Fasciotens Abdomen will be used to prove the functionality of this device and the user feasibility.

The basic principle of Fasciotens Abdomen is the ventrally directed pulling force on the two fascial edges via an external device with support on the thorax and pelvis. The possibility to apply a traction to the fascia from the moment of opening the abdomen without reducing the intraabdominal space is absolutely new and the rationale of this technique. The objective of this study is to prove the obvious prevention of fascial retraction through the Fasciotens Abdomen device.


Condition or disease Intervention/treatment Phase
Abdominal Compartment Syndrome Pancreatitis,Acute Necrotizing Intraabdominal Hypertension Peritonitis Device: Fasciotens-Abdomen Not Applicable

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 lasts from days to months. Within a very short time, the fasciae and abdominal wall structures retract in such a way that direct abdominal closure is often impossible. In addition, there is a pronounced intraabdominal oedema, which additionally increases the space required by the abdominal organs. Therefore, it is clinically indispensable to increase the space of the intraabdominal organs in this life-threatening situation. After the laparotomy (opening of the abdomen) has been performed, it is therefore not closed. However, the natural traction on the abdominal wall, in particular on the fascia, the attached musculature as well as skin and subcutis, no longer exists in this situation. As a result, these structures retract over the period of the existing laparostoma.

The current state of the art is the treatment of the open abdomen using low-pressure therapy or other temporary abdominal wall closure. The most common method is pure vacuum dressing on the abdominal wall wound and the abdominal organs (2, 3). However, traction to the edges of the fascia is only possible after the intraabominal increase in volume and pressure has decreased. All previously described methods for temporary abdominal wall closure cannot counteract abdominal wall retraction and can only begin with a pull on the already retracted fascia after normalization of the abdominal volume.

The later abdominal closure then often requires alloplastic materials or results in a defect healing as abdominal wall hernia (4, 5). The temporal extension of the open abdomen is also associated with intestinal adhesions, formation of intestinal fistula and loss of abdominal volume (6-12). Mortality of the open abdomen is 12-40%, with septic genesis associated with higher mortality (1). In addition, reocclusion should be sought at an early stage. Trauma patients with a re-closure within 48 hours show a more favourable course of disease, a lower complication rate and lower mortality (13-15). The retraction of the abdominal wall and the later often impossible abdominal closure are the main problems in the treatment of these seriously ill patients. This problem, which has not yet been solved, is the reason for the development of this new technique.

In the present study, the CE-certified medical device Fasciotens Abdomen will be used to prove the functionality of this device and the user feasibilty.

The basic principle of Fasciotens Abdomen is the ventrally directed pulling force on the two fascial edges via an external device with support on the thorax and pelvis. A commercially available resorbable surgical mesh is sewn into the fascia margin, which would also have been used without the Fasciotens system. Commercial surgical sutures attached to this net are then attached to a height-adjustable suspension, which is connected to an external support on the thorax and pelvis. This ensures continuous traction to the two fascial edges. This counteracts the natural muscle pull of the abdominal muscles and thus the retraction of the abdominal wall to both sides laterally. At the same time the abdomen is still open preventing necrosis of the abdominal organs. The remaining wound surface can then be treated with conventional dressing material.

The possibility to apply a traction to the fascia from the moment of opening the abdomen without reducing the intraabdominal space is absolutely new and the rationale of this technique. The objective of this study is to prove the obvious prevention of fascial retraction through the Fasciotens Abdomen device.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Experimental: Patients with Laparostoma

Patients needing a laparostoma will be treated with the fasciotens abdomen device. The distance between the fasciae will be measured frequently using a ruler.

12 months after the treatment an ultrasound measurement will be performed to assess hernia formation

Device: Fasciotens-Abdomen
The basic principle of Fasciotens Abdomen is the ventrally directed pulling force on the two fascial edges via an external device with support on the thorax and pelvis. A commercially available resorbable surgical mesh is sewn into the fascia margin. Commercial surgical sutures attached to this net are then attached to a height-adjustable suspension, which is connected to an external support on the thorax and pelvis. This ensures continuous traction to the two fascial edges. The remaining wound surface can then be treated with conventional dressing material.




Primary Outcome Measures :
  1. Closure rate of the abdominal wall fascia [ Time Frame: Up to 24 weeks ]
    The primary endpoint of the study is the closure rate of the fascia.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033614


Contacts
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Contact: Roman Marius Eickhoff, Dr. med. +49 241 80 89500 reickhoff@ukaachen.de

Locations
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Germany
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Recruiting
Aachen, North Rhine Westphalia, Germany, 52074
Contact: Roman Eickhoff, Dr. med.         
Sponsors and Collaborators
RWTH Aachen University
Fasciotens GmbH

Publications:

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Responsible Party: Dr. Roman Marius Eickhoff, Specialist in surgery, RWTH Aachen University
ClinicalTrials.gov Identifier: NCT04033614     History of Changes
Other Study ID Numbers: 18-019
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Roman Marius Eickhoff, RWTH Aachen University:
Laparotomy, open abdomen, fascia, retraction, intraabdominal oedema
Additional relevant MeSH terms:
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Peritonitis
Compartment Syndromes
Intra-Abdominal Hypertension
Pancreatitis
Pancreatitis, Acute Necrotizing
Vascular Diseases
Cardiovascular Diseases
Pancreatic Diseases
Digestive System Diseases
Intraabdominal Infections
Infection
Peritoneal Diseases
Muscular Diseases
Musculoskeletal Diseases