Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study
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 di
| Condition(s) | Abdominal Compartment Syndrome, Pancreatitis,Acute Necrotizing, Intraabdominal Hypertension, Peritonitis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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, |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | RWTH Aachen University |
| Locations | Aachen, North Rhine-Westphalia, Germany |
| Start date | 2019-08-05 |
| NCT ID | NCT04033614 |
| Official listing | https://clinicaltrials.gov/study/NCT04033614 |