Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study (NCT04033614) | Clinical Trial Compass
RecruitingNot Applicable
Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study
Germany15 participantsStarted 2019-08-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria for the period of use of the Fasciotens Abdomen device:
* Pregnancy or breast-feeding at the time of inclusion into the study
* A Moribund patient with a life expectancy of less than 24 hours despite laparostomy
* Unstable thorax or known severe skeletal instability which impaires the use of the fasciotens abdomen device.
* Open wounds or infections at the potential contact points of the Fasciotens abdomen device
* Known cardiac insufficiency with ejection fraction less than 35%
* Patients with lung failure (ARDS) and the need for abdominal positioning within the next 24h
Exclusion criteria for the entire duration of the study:
* Persons who are accommodated in a mental hospital or an insititution on official or judicial instruction
* Persons who are dependent on or have an employment relationship with the principal investigator
* Other conditions which, at the judgement of the investigator, militate against the use of the investigational product
* Minority
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.