RecruitingNot ApplicableNCT04033614

Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study


Sponsor

RWTH Aachen University

Enrollment

15 participants

Start Date

Aug 5, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks patients who have had their abdomen left open after emergency surgery (called an open abdomen), and tests a device called Fasciotens — a system that helps close the belly gradually — to see how well it works and whether patients recover without complications. **You may be eligible if...** - You had emergency abdominal surgery and your abdomen was intentionally left open (open abdomen technique) - You are being treated in a participating hospital **You may NOT be eligible if...** - Your abdomen was closed during the initial surgery - You are not eligible for the Fasciotens device based on your surgeon's judgment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFasciotens-Abdomen

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. 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. The remaining wound surface can then be treated with conventional dressing material.


Locations(1)

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Aachen, North Rhine-Westphalia, Germany

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NCT04033614


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