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Study of Primary Fascial Closure Rate in Patients With Open Abdomen Treated With Abthera Versus Barker Technique

NCT02952976 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2017-04-25

No results posted yet for this study

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).

Conditions

  • Abdominal Trauma
  • Abdominal Sepsis
  • Abdominal Compartment Syndrome

Interventions

DEVICE

Abthera

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

DEVICE

Barker

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.

Sponsors & Collaborators

  • Sociedade Brasileira de Atendimento Integrado ao Trauma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2019-07-31
Completion
2019-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02952976 on ClinicalTrials.gov