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

KCI USA, Inc

Status: Completed

Conditions: Open Abdomen

Treatments: Device: NPWT; Device: BVPT

Study type: Observational

Funder types: Industry

Identifiers

NCT01016353

ABT2009-50

Details and patient eligibility

About

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.

Full 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.

Enrollment: 283 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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