Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique

This study is being done to gather data that will be used to compare two different TAC
(Temporary Abdominal Closure) methods. The two TAC methods being compared are the Barker's
vacuum packing technique or BVPT and the Open Abdomen Negative Pressure Therapy System
(ABThera) developed by the sponsor of this research (KCI, San Antonio, TX). The BVPT is made
up of supplies that are stocked in most surgery rooms. The ABThera dressing is available
commercially. Neither method will be supplied to the doctor (Principal Investigator), so that
in no way would the subject's standard of care be different from what they would get if the
study was not being done.

This study is observational and only collects data about how the subject progresses after
surgery TAC is used. When a study is observational it means that the subject's standard
medical care will not be altered in any way, simply watched. The doctor will not change
treatment of your open abdomen.

Inclusion Criteria:

1. Subjects 18-75 years of age

2. OA Subjects treated with only one of the following TACs at initial placement (defined
as the time of the first application of a TAC method):

1. ABThera

2. BVPT

Exclusion Criteria:

1. Pregnant females

2. Active, uncontrolled hemorrhage at the time of TAC placement

3. Diagnosis of pre-existing bleeding disorder

4. Known allergy or hypersensitivity to polyvinyl, polyurethane, acrylic, or acrylic
adhesive

5. Subjects with fistulas

6. Subjects who have been enrolled in this study previously

7. Documented history of Child-Pugh Turcot Liver Dysfunction - Class C (10-15 points) at
the time of enrollment

8. Subjects with body mass index (BMI) > 40 as estimated at the time of Emergency
Department (ED) or OR admission

9. Known New York Heart Association Functional Classification - Class IV at the time of
enrollment