Change in Fascial Tension in Open Abdomens

Benjamin T. Miller

Status: Completed

Conditions: Incisional Hernia; Abdominal Wall Defect

Treatments: Diagnostic Test: Abdominal tension measurement

Study type: Observational

Funder types: Other

Identifiers

NCT05579652

22-845

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

45 participants in 1 patient group

Patients with open abdomen

Description:

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

Treatment:

Diagnostic Test: Abdominal tension measurement