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

This study has been completed.
Sponsor:
Information provided by:
KCI USA, Inc.
ClinicalTrials.gov Identifier:
NCT01016353
First received: November 18, 2009
Last updated: May 17, 2011
Last verified: November 2009
  Purpose

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.


Condition
Open Abdomen

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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

Further study details as provided by KCI USA, Inc.:

Estimated Enrollment: 250
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Emergent Care

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016353

Locations
United States, Alabama
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
United States, California
LAC/USC Medical Center
Los Angeles, California, United States, 90033
United States, Florida
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
United States, Illinois
Cook County Medical Center
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Medical Center
New Orleans, Louisiana, United States, 70117
United States, Maryland
University of Maryand
Baltimore, Maryland, United States, 21201
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19006
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Regional Medical Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
KCI USA, Inc.
  More Information

No publications provided

Responsible Party: Kelle Simpson / Sr. Director, Global Clinical Operations, KCI
ClinicalTrials.gov Identifier: NCT01016353     History of Changes
Other Study ID Numbers: ABT2009-50
Study First Received: November 18, 2009
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by KCI USA, Inc.:
ABThera
Barker's Vacuum Packing Technique

ClinicalTrials.gov processed this record on November 27, 2014