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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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).

Detailed Summary:

This study is being done to compare two different Temporary Abdominal Closure methods that could be used in cases of open abdomen. The methods being compared are the Barker's vacuum packing technique (BVPT) and the Open Abdomen Negative Pressure Therapy System (ABThera). The BVPT will be made up by an internal plastic layer to cover abdominal viscera, a second layer with surgical sponges and a suction drain and will be covered by an adhesive plastic layer. Then the dressing will be connected to the hospital's vacuum system. The ABThera dressing is available commercially.

Study Participants Enrollment will happen at the operating room

Investigator will include in this study patients who have the following indications to laparostomy:

  • Damage control surgery in trauma patients,
  • Patients with abdominal compartment syndrome,
  • Septic shock patients requiring short surgery and inability to close the abdominal cavity.

Signing the consent form will be held in order of preference by:

  1. Patient
  2. Legal representative

  3. Doctor appointed by the hospital that does not participate in the study(only in cases where the urgency of the surgery do not allow contact with the representatives).

    In the latter case the signature of the term should be applied to the legal representative as soon as possible.

    Criteria for inclusion and exclusion:

    Sponsor: Sociedade Brasileira de Atendimento Integrado ao Trauma

    Current Primary Outcome: 30 day fascial closure [ Time Frame: 30 day ]

    Percentage of facial closure in each arm


    Original Primary Outcome: 30 day fascial closure [ Time Frame: 30 day ]

    Current Secondary Outcome:

    • Mortality [ Time Frame: 30 days ]
      Percentage of mortality closure in each arm
    • Drainage [ Time Frame: 30 days ]
      Amount of fluid in ml drained by the dressing


    Original Secondary Outcome:

    • Mortality [ Time Frame: 30 days ]
    • Drainage [ Time Frame: 30 days ]
      Amount of fluid drained by the dressing


    Information By: Sociedade Brasileira de Atendimento Integrado ao Trauma

    Dates:
    Date Received: October 28, 2016
    Date Started: July 1, 2017
    Date Completion: December 2019
    Last Updated: April 24, 2017
    Last Verified: April 2017