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

Launched by KCI USA, INC · Nov 18, 2009

Keywords

ClinConnect Summary

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 differ...

Gender

ALL

Eligibility criteria

• 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