Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique
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
1 other identifier
observational
283
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2009
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2009
CompletedFirst Posted
Study publicly available on registry
November 19, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
January 3, 2018
CompletedDecember 2, 2024
November 1, 2024
1.1 years
November 18, 2009
July 5, 2017
November 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Primary Fascial Closure
Up to 30 days
Interventions
Eligibility Criteria
Emergent Care
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KCI USA, Inclead
Study Sites (11)
University of South Alabama Medical Center
Mobile, Alabama, 36617, United States
LAC/USC Medical Center
Los Angeles, California, 90033, United States
Orlando Regional Medical Center
Orlando, Florida, 32806, United States
Cook County Medical Center
Chicago, Illinois, 60612, United States
Tulane Medical Center
New Orleans, Louisiana, 70117, United States
University of Maryand
Baltimore, Maryland, 21201, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19006, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Regional Medical Center
Memphis, Tennessee, 38163, United States
Related Publications (1)
Bjorck M, Kirkpatrick AW, Cheatham M, Kaplan M, Leppaniemi A, De Waele JJ. Amended Classification of the Open Abdomen. Scand J Surg. 2016 Mar;105(1):5-10. doi: 10.1177/1457496916631853. Epub 2016 Feb 29.
PMID: 26929286DERIVED
Results Point of Contact
- Title
- Senior Director, Global Clinical Development
- Organization
- KCI
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2009
First Posted
November 19, 2009
Study Start
December 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
December 2, 2024
Results First Posted
January 3, 2018
Record last verified: 2024-11