NCT02229695

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

1.2 years

First QC Date

August 28, 2014

Last Update Submit

August 28, 2014

Conditions

Intra Abdominal HypertensionAbdominal Compartment Syndrome

Keywords

TraumaSepsisTemporary abdominal closureBogota bagVacuum 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

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intra-Abdominal HypertensionWounds and InjuriesSepsis

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological 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