Using Fasciotens to treat open abdomen conditions
Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study
This study is testing whether the Fasciotens device can help people with an open abdomen feel better and avoid complications during their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RWTH Aachen University Academic / other |
| Locations | 1 site (Aachen, North Rhine-Westphalia) |
| Trial ID | NCT04033614 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of the Fasciotens device to manage patients with an open abdomen, a condition that can arise from various abdominal diseases. The open abdomen can lead to complications such as abdominal compartment syndrome and intraabdominal hypertension, making it crucial to maintain abdominal wall integrity. The study aims to evaluate the effectiveness of the Fasciotens device in preventing retraction of the abdominal wall structures and improving patient outcomes. Participants will be monitored for their response to this intervention during their treatment.
Who should consider this trial
Good fit: Ideal candidates include adults with laparostoma requiring a second look operation and who can provide informed consent.
Not a fit: Patients who are moribund, pregnant, or have severe cardiac or respiratory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery and outcomes for patients with open abdomen conditions.
How similar studies have performed: While the use of low-pressure therapy is common, the specific application of the Fasciotens device in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aachen, North Rhine-Westphalia
- Klinik für Allgemein-, Viszeral- und Transplantationschirurgie — Aachen, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Study coordinator: Roman Marius Eickhoff, Dr. med.
- Email: reickhoff@ukaachen.de
- Phone: +49 241 80 89500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.