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

Completed

Conditions studied: Open Abdomen

In brief

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.

Key facts

Study ID

NCT01016353

Run by

KCI USA, Inc

People needed

283

Starts

2009-12-01

Expected to finish

2011-01-01

Last updated by the study team

2024-12-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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):
• ABThera
• BVPT

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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