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OpenTrials
Completed

NCT Number: NCT05579652

Change in Fascial 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients with an open abdomen and plan for abdominal re-exploration

Exclusion criteria

  • patients under the age of 18 years
  • pregnant patients
  • patients who have no available Legally Authorized Representative to provide consent.
  • patients with a current hernia
  • patients with a prior component separation

Treatment and study plan

Abdominal tension measurement

Diagnostic Test

A tensiometer scale will be used to measure the tension needed to pull each side of the abdominal wall to midline

Primary outcomes

  1. Change in tension over time

    Time frame: 1.5 years

    The progressive change in abdominal wall tension will be analyzed

Secondary outcomes

  1. Subject factors affecting abdominal wall tension over time

    Time frame: 1.5 years

    Investigators will evaluate the relationship of BMI and age to the change in tension over time

  2. Operative factors affecting abdominal wall 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.

  3. Medical care factors affecting abdominal wall tension 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.

Sponsors and collaborators

Lead sponsor

Benjamin T. Miller

Other

Registry information

Official study title

The Change in Tension of the Abdominal Wall Tension in Open Abdomens

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 14, 2022
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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