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

KCI USA, Inc283 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

283

Conditions

Open Abdomen

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (11)

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

...and 1 more locations

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

Overview

Conditions

Interventions

Eligibility

Locations (11)

Outcomes

Primary Outcomes