Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
RECRUITING
Aachen
Contact Information
Primary
Roman Marius Eickhoff, Dr. med.
reickhoff@ukaachen.de
+49 241 80 89500
Time Frame
Start Date: 2019-08-05
Estimated Completion Date: 2026-08
Participants
Target number of participants: 15
Treatments
Experimental: Patients with Laparostoma
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
Sponsors
Leads: RWTH Aachen University
Collaborators: Fasciotens GmbH

This content was sourced from clinicaltrials.gov