ABRA Abdominal Closure System in Open Abdomen Management
Condition: Open Abdomen
Intervention: ABRA Abdominal Closure System; V.A.C. Therapy; KCI ABThera
Intervention description: ABRA Abdominal Closure System; V.A.C. Therapy Alone; KCI ABThera
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Closure, Wounds

Summary:

      For the last 20 to 30 years, damage control laparotomy and decompressive laparotomy have
      emerged as part of the armamentariums for treatment of complex abdominal trauma, abdominal
      compartment syndrome, and critically ill surgical patients with profound acidosis. While
      these advances have saved lives, they have also led to a dramatic increase in patients with
      open abdominal cavities. Various methods have been employed to offer protection to the
      viscera and at the same time, encourage gradual closure of the abdominal fascia. Some of the
      techniques have included the Bogota bag, vacuum pack described by Barker , Wittman patch ,
      and the use of vacuum assisted fascia-closure, including the commercially available system
      offered by KCI. Overall, the abdominal closure rate is approximately 50% to 90% over an
      average of 10 days. Unfortunately, there has been no well-designed comparison study
      available. Some of the best results also require returning to the operating room every 3 to 5
      days.

      At the University of Kentucky Medical Center, a combination of the vacuum pack dressing
      described by Barker, the commercially available VAC system (V.A.C.; KCI International, San
      Antonio, TX) and vicryl mesh closure systems are used. The primary fascial closure rate is
      approximately 50%. It is not standard practice to take patients to the OR every 3-5 days
      routinely.

      Recently, a new FDA listed system (ABRA by Canica) has been introduced using a progressive
      tension system as a novel approach to the management of open abdomen. ABRA provides a dynamic
      reduction of full thickness, severely retracted midline abdominal defects with the goal of
      maintaining or restoring the primary closure option. This subdermal method uses button
      anchors and elastomer to gradually pull the wound margins together. Tension can be set and
      adjusted according to the desired outcome; to stabilize a retracted wound, reduce the wound,
      close the wound or prevent wound dehiscence (Attachment 1: Company brochure). Currently there
      is only one published case report of the success of this device. We hope to be the first
      center to prospectively report a series of patients with open abdomen managed with the new
      ABRA system. In this study, this system will be used in combination with a standard therapy
      used in abdominal wound closure at the University of Kentucky Medical Center. This system is
      called the V.A.C system (V.A.C.; KCI International, San Antonio, Tx). This therapy provides
      active exudate management and containment, assists in reducing abdominal volume and adds
      structural stabilization to adipose tissue.

      Although no highly powered study has been done to establish data on performance, individual
      experiences at several institutions have reached fascial closure rates of higher than 70%
      using the ABRA device. One institution in Las Vegas, Nevada is using the ABRA device in
      combination with the VAC system and has experienced 100% closure rate to date with 12
      patients. The purpose of this study is to collect information about the ABRA system in
      combination with the VAC technique at the University of Kentucky Medical Center. It is our
      belief that using this system will improve the fascial closure rate and thereby produce less
      chance of hernia and reduce long periods of open abdominal wounds. The objective of the study
      is to evaluate a novel approach for closure of open abdomen utilizing the Canica ABRA system
      combined with the K.C.I. VAC System to KCI VAC System alone.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ages of 18 and 70

          2. patients deemed not a candidate for primary fascial closure at the second laparotomy.

        Exclusion Criteria:

          1. High risk for imminent death, as determined by the attending surgeon and PI

          2. Pre-existing large ventral hernia

          3. Significant loss of abdominal wall fascia as a result of trauma or infection

          4. Known Crohn's disease

          5. Pregnancy