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 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.

NCT Number	NCT04033614
Lead Sponsor	RWTH Aachen University Collaborators: Fasciotens GmbH
Conditions	Abdominal Compartment Syndrome, Pancreatitis,Acute Necrotizing, Intraabdominal Hypertension, Peritonitis
Enrollment	15 participants
Start Date	2019-08-05
Primary Completion	2026-05 (estimated)
Study Completion	2026-08 (estimated)
Updated on ClinicalTrials.gov	2023-04-19