NCT02952976

Brief Summary

This study is being done to compare two different Temporary Abdominal Closure methods that could be used in cases like yours. The methods being compared are the Barker's vacuum packing technique (BVPT) and the Open Abdomen Negative Pressure Therapy System (ABThera).

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
94

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2017

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

October 28, 2016

Last Update Submit

April 24, 2017

Conditions

Abdominal TraumaAbdominal SepsisAbdominal Compartment Syndrome

Keywords

open abdomenDamage controlAbdominal Compartment Syndrome

Outcome Measures

Primary Outcomes (1)

  • 30 day fascial closure

    Percentage of facial closure in each arm

    30 day

Secondary Outcomes (2)

  • Mortality

    30 days

  • Drainage

    30 days

Study Arms (2)

Abthera

ACTIVE COMPARATOR

Patients with open abdomen submitted to treatment with the Abthera dressing

Device: Abthera

Barker

ACTIVE COMPARATOR

Patients with open abdomen submitted to treatment with the Baker dressing

Device: Barker

Interventions

AbtheraDEVICE

ABThera group technique the dressing will be done according to the description and the manufacturer's instructions (Acelity, San Antonio, TX).

Abthera
BarkerDEVICE

In Barker Group a fenestrated plastic will be used and that will be in contact with viscera followed by four pads with a suction drain and an adhesive finishing layer.

Barker

Eligibility Criteria

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

You may qualify if:

  • Patients with indication of an open abdomen According to the Attending physician
  • Damage control surgery in trauma patients,
  • Patients with abdominal compartment syndrome,
  • Septic shock patients requiring short surgery and inability to close the abdominal cavity.

You may not qualify if:

  • Pregnancy;
  • Chronic renal impairment,
  • Child-Pugh C,
  • Body index over 40 kg / m2,
  • Uncontrolled bleeding during laparotomy
  • Patients progressing to death within the first 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Abdominal InjuriesIntraabdominal InfectionsIntra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Wounds and InjuriesInfectionsCompartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Diogo Garcia, MD PhD FACS

CONTACT

+5511996131077diogogarcia@me.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD FACS

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 2, 2016

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share