Cleveland Clinic Main Campus
Cleveland, Ohio, 44195, United States
NCT Number: NCT05579652
The goal of this observational study is to quantitatively measure the change in tension of the abdominal wall over time in subjects with open abdomens using a tensiometer.
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Notify Me18 year and older
All sexes
Observational
Cleveland, Ohio, 44195, United States
For subjects undergoing damage control and decompressive laparotomy, surgeons frequently elect to keep the abdomen open in anticipation of multiple re-explorations or to prevent and/or treat abdominal compartment syndrome. The eventual goal is to definitively close the abdomen, including the fascia, when medically and surgically safe. The natural tendency with prolonged open abdomen is lateralization of the fascia, making closure of the fascia progressively more difficult as time passes. Though this is subjectively observed in the operating room as increased tension during fascial closure, there is no quantitative data describing how duration of open abdomen affects tension on the abdominal wall. This information has potential implications on the likelihood of successful primary closure, risk of dehiscence, and long term hernia development. This study aims to quantitatively measure the changes in tension of the abdominal wall over time in subjects with an open abdomen. A tensiometer will be used to measure the tension needed to approximate each side of the abdominal fascia to midline with each re-exploration until definitive abdominal wall closure.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A tensiometer scale will be used to measure the tension needed to pull each side of the abdominal wall to midline
Time frame: 1.5 years
The progressive change in abdominal wall tension will be analyzed
Time frame: 1.5 years
Investigators will evaluate the relationship of BMI and age to the change in tension over time
Time frame: 1.5 years
Investigators will evaluate the relationship of incision width and length, time in days that the abdomen was open, number of reoperations, and abdominal wall tension change over time.
Time frame: 1.5 years
Investigators will evaluate the relationship of volume and type of intravenous fluid administered, blood transfusion, diuresis, and vasopressor use and the change in abdominal wall tension over time.
Benjamin T. Miller
Other
The Change in Tension of the Abdominal Wall Tension in Open Abdomens
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