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

Completed

Brief Summary: This study is being done to gather data that will be used to compare two different TAC (Temporary Abdominal Closure) methods that your doctor may use. 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Subjects 18-75 years of age
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

Pregnant females
Active, uncontrolled hemorrhage at the time of TAC placement
Diagnosis of pre-existing bleeding disorder
Known allergy or hypersensitivity to polyvinyl, polyurethane, acrylic, or acrylic adhesive
Subjects with fistulas
Subjects who have been enrolled in this study previously
Documented history of Child-Pugh Turcot Liver Dysfunction - Class C (10-15 points) at the time of enrollment
Subjects with body mass index (BMI) > 40 as estimated at the time of Emergency Department (ED) or OR admission
Known New York Heart Association Functional Classification - Class IV at the time of enrollment

Primary Outcome Measures

Name	Time	Method
Number of Participants With Primary Fascial Closure	Up to 30 days

Secondary Outcome Measures

Name	Time	Method

Locations (11): LAC/USC Medical Center
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Los Angeles, California, United States
University of Maryand
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Baltimore, Maryland, United States
University of Pennsylvania
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Philadelphia, Pennsylvania, United States
University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, United States
Oregon Health & Science University
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Portland, Oregon, United States
Albert Einstein Medical Center
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Philadelphia, Pennsylvania, United States
University of South Alabama Medical Center
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Mobile, Alabama, United States
Cook County Medical Center
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Chicago, Illinois, United States
Tulane Medical Center
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New Orleans, Louisiana, United States
Regional Medical Center
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Memphis, Tennessee, United States
Orlando Regional Medical Center
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Orlando, Florida, United States