An interventional study of Fasciotens-Abdomen in Abdominal Compartment Syndrome, Pancreatitis,Acute Necrotizing and Intraabdominal Hypertension, sponsored by RWTH Aachen University. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by RWTH Aachen University · Not applicable, Interventional, and Treatment
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.
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.
71 studies on the registry are indexed under Intra-Abdominal Hypertension; 16 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 32 interventional studies indexed under Intra-Abdominal Hypertension.
Browse Intra-Abdominal Hypertension studies →RWTH Aachen University is the lead sponsor of 230 studies on the registry; 19 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria for the period of use of the Fasciotens Abdomen device:
Exclusion criteria for the entire duration of the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Closure rate of the abdominal wall fascia
The primary endpoint of the study is the closure rate of the fascia.
Time frame: Up to 24 weeks
Plan to share: No
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Intra-Abdominal Hypertension →