Change in Fascial Tension in Open Abdomens

Incisional Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05579652
• Other study ID #: 22-845
• Status: Completed
• Start date: October 17, 2022
• Est. completion date: March 29, 2024

Study information

• Verified date: May 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 29, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Wall Defect
• Incisional Hernia

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic Main Campus	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Benjamin T. Miller

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tension over time	The progressive change in abdominal wall tension will be analyzed	1.5 years
Secondary	Subject factors affecting abdominal wall tension over time	Investigators will evaluate the relationship of BMI and age to the change in tension over time	1.5 years
Secondary	Operative factors affecting abdominal wall tension over time	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.	1.5 years
Secondary	Medical care factors affecting abdominal wall tension over time	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.	1.5 years