Change in Fascial Tension in Open Abdomens

Completed

• Conditions: Abdominal Wall Defect; Incisional Hernia
• Interventions: Diagnostic Test: Abdominal tension measurement

• Registration Number: NCT05579652
• Lead Sponsor: Benjamin T. Miller

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.

Study Timeline

• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-14
• Study Start: 2022-10-17
• Primary Completion: 2024-03-29
• Study Completion: 2024-03-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with open abdomen	Abdominal tension measurement	All non-pregnant adults with an open abdomen who are consentable or who have a legally authorized representative will have the tension on each side of their abdominal wall measured using a tensiometer at each abdominal exploration

Primary Outcome Measures

Name	Time	Method
Change in tension over time	1.5 years	The progressive change in abdominal wall tension will be analyzed

Secondary Outcome Measures

Name	Time	Method
Medical care factors affecting abdominal wall tension over time	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.
Subject factors affecting abdominal wall tension over time	1.5 years	Investigators will evaluate the relationship of BMI and age to the change in tension over time
Operative factors affecting abdominal wall tension over time	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.

Trial Locations

Locations (1)

Cleveland Clinic Main Campus; 🇺🇸 Cleveland, Ohio, United States