Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study

Launched by RWTH AACHEN UNIVERSITY · Jul 23, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a device called Fasciotens Abdomen, which is designed to help treat patients with an "open abdomen." This condition can happen after serious abdominal issues like infections or trauma, and it often requires a surgical procedure called a laparotomy, where the abdomen is opened but not closed immediately. The Fasciotens device works by gently pulling the edges of the abdominal wall to prevent them from retracting while keeping enough space for the organs inside. The goal of the study is to see if this device can effectively prevent the muscles and tissues from pulling back too much, which can complicate recovery.

To be eligible for this trial, participants need to have an open abdomen that is treated with a specific type of mesh and must be planning for a follow-up surgery. They should be adults and able to give informed consent, or have someone who can provide consent for them. However, there are some important exclusions: for instance, pregnant or breastfeeding women, patients with certain severe health conditions, or those with open wounds where the device would be placed cannot participate. If someone joins the study, they can expect to have the Fasciotens device applied and monitored during their treatment, helping to support their recovery in a critical time.

Gender

ALL

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