Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study
RWTH Aachen University
15 participants
Aug 5, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria10
- 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
- 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
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04033614