Change in Fascial Tension in Open Abdomens

NCT05579652 | Completed

• 1 other identifier: 22-845
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Wall Defect; Incisional Hernia

Outcome Measures

Primary Outcomes (1)

• Change in tension over time

  The progressive change in abdominal wall tension will be analyzed

  1.5 years

Secondary Outcomes (3)

• Subject factors affecting abdominal wall tension over time

  1.5 years

• Operative factors affecting abdominal wall tension over time

  1.5 years

• Medical care factors affecting abdominal wall tension over time

  1.5 years

Study Arms (1)

Patients with open abdomen

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

Diagnostic Test: Abdominal tension measurement

Interventions

Abdominal tension measurement DIAGNOSTIC_TEST

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

Patients with open abdomen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will identify patients with an open abdomen following laparotomy with plans to return to the operating room for re-exploration. Previous laparotomy, presence of a stoma, and presence of a previous hernia repair without component separation will not exclude patients from this study.

You may qualify if:

• Adult patients with an open abdomen and plan for abdominal re-exploration

You may not qualify if:

• 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

Sponsors & Collaborators

• Benjamin T. Miller: lead

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Benjamin Miller, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: October 17, 2022
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)