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View Clinical Trial (Medical Research Study)
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ABRA Abdominal Closure System in Open Abdomen Management - NCT00754156-40536 (Clinical Trial 242283)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy242283.aspx
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| City: |
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Lexington |
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State:
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KY |
| Zip Code: |
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40536 |
| Conditions: |
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Open Abdomen |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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University of Kentucky Medical Center
Lexington, KY 40536
United States
Primary Contact:
Phillip Chang, M.D.
Email: pchang@uky.edu
Phone: 859-323-6346 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 4, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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