NCT04033614 Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study
| NCT ID | NCT04033614 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RWTH Aachen University |
| Condition | Abdominal Compartment Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2019-08-05 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2019-08-05 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04033614 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Abdominal Compartment Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04033614 currently recruiting?
Yes, NCT04033614 is actively recruiting participants. Contact the research team at reickhoff@ukaachen.de for enrollment information.
Where is the NCT04033614 trial being conducted?
This trial is being conducted at Aachen, Germany.
Who is sponsoring the NCT04033614 clinical trial?
NCT04033614 is sponsored by RWTH Aachen University. The trial plans to enroll 15 participants.