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Study identifier: NCT04033614 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study

Condition: Abdominal Compartment Syndrome · Pancreatitis,Acute Necrotizing · Intraabdominal Hypertension  ·  Sponsor: RWTH Aachen University

PhaseNA
Planned participants15
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this 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 o…

This description comes directly from the study's public registry record.

Talk to the study team

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

Always discuss trial participation with your own doctor first.

Locations (1)

Klinik für Allgemein-, Viszeral- und TransplantationschirurgieAachen, North Rhine-Westphalia, GermanyRecruiting

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Source record: clinicaltrials.gov/study/NCT04033614