Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study — Fasciotens  

Peritonitis Clinical Trial

Official title: Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Abdominal Compartment Syndrome
• Compartment Syndromes
• Intra-Abdominal Hypertension
• Intraabdominal Hypertension
• Pancreatitis
• Pancreatitis, Acute Necrotizing
• Pancreatitis,Acute Necrotizing
• Peritonitis

• NCT number: NCT04033614
• Study type: Interventional
• Source: RWTH Aachen University
• Contact: Roman Marius Eickhoff, Dr. med.
• Phone: +49 241 80 89500
• Email: reickhoff@ukaachen.de
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2019
• Completion date: August 2026