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New treatment option for Abdominal Compartment Syndrome
Official title Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study
ClinicalTrials.gov ID: NCT04033614
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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%
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aachen, North Rhine-Westphalia, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aachen, North Rhine-Westphalia, Germany. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.