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Change in Fascial Tension in Open Abdomens

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05579652
Enrollment
45
Registered
2022-10-14
Start date
2022-10-17
Completion date
2024-03-29
Last updated
2024-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Wall Defect, Incisional Hernia

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTAbdominal tension measurement

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

Sponsors

Benjamin T. Miller
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in tension over time1.5 yearsThe progressive change in abdominal wall tension will be analyzed

Secondary

MeasureTime frameDescription
Subject factors affecting abdominal wall tension over time1.5 yearsInvestigators will evaluate the relationship of BMI and age to the change in tension over time
Operative factors affecting abdominal wall tension over time1.5 yearsInvestigators 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.
Medical care factors affecting abdominal wall tension over time1.5 yearsInvestigators 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026