NCT05579652

Change in Fascial Tension in Open Abdomens

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Benjamin T. Miller · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Abdominal Wall Defect
• Incisional Hernia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Abdominal tension measurement	A tensiometer scale will be used to measure the tension needed to pull each side of the abdominal wall to midline

Timeline

• Start date: 2022-10-17
• Primary completion: 2024-03-29
• Completion: 2024-03-29
• First posted: 2022-10-14
• Last updated: 2024-05-23

Locations

1 site across 1 country: United States