A Prospective Study Examining Clinical Outcomes Associated With the Management of the Open Abdomen With the ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- KCI USA, Inc
- Enrollment
- 283
- Locations
- 11
- Primary Endpoint
- Number of Participants With Primary Fascial Closure
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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):
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
Outcomes
Primary Outcomes
Number of Participants With Primary Fascial Closure
Time Frame: Up to 30 days
Secondary Outcomes
No secondary outcomes reported