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The Change in Tension of the Abdominal Wall Tension in Open Abdomens
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
Start Date
October 17, 2022
Primary Completion Date
March 29, 2024
Completion Date
March 29, 2024
Last Updated
May 23, 2024
45
ACTUAL participants
Abdominal tension measurement
DIAGNOSTIC_TEST
Lead Sponsor
Benjamin T. Miller
NCT04718168
NCT05599750
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07192978