The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension.

NCT02229695 | Unknown

• 1 other identifier: SOR-0167-14
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective comparison trial. Patients that will be included in the trial are those that will have operations in which their abdominal closure is temporary, i.e. patients sustaining trauma or septic abdomen. Patients will be grouped according to the method of temporarily abdominal closure (TAC) procedure:

1. 1.Vacuum-assisted closure (VAC)
2. 2."Bogota bag" (BB), a sterile intravenous bag silo closure. The two methods are currently accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center the decision to choose either of the methods is at the surgeon's discretion.

Conditions

Intra Abdominal Hypertension; Abdominal Compartment Syndrome

Keywords

Trauma; Sepsis; Temporary abdominal closure; Bogota bag; Vacuum assisted closure

Outcome Measures

Primary Outcomes (1)

• Intra abdominal hypertension

  measured via a Foley catheter

  48 hours

Secondary Outcomes (1)

• Abdominal compartment syndrome

  48 hours

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that undergo emergent laparotomy for trauma or non-traumatic surgical emergency condition, and that according to the surgeon decision get their abdominal wall closed by a temporary closure technique.

You may qualify if:

• Adults male or female over 18 year old undergoing emergency laparotomy. Patients that have their abdominal wall closed at the end of surgery by a temporary closure technique.

You may not qualify if:

• Patients that according to the surgeon estimates will not survive 24 hours.

Sponsors & Collaborators

• Soroka University Medical Center: lead

MeSH Terms

Conditions

Intra-Abdominal Hypertension; Wounds and Injuries; Sepsis

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gad Shaked, Prof.

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gad Shaked

CONTACT

shakedg@bgu.ac.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 1, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: September 1, 2014

Record last verified: 2014-08