Clinical trial NCT01016353: Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Abdomen
Keywords: ABThera
Barker's Vacuum Packing Technique
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
First posted: 2009-11-19
Enrollment: 283
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergent Care

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Primary Fascial Closure
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
city: Los Angeles
country: United States
facility: LAC/USC Medical Center
state: California
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Chicago
country: United States
facility: Cook County Medical Center
state: Illinois
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryand
state: Maryland
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: Regional Medical Center
state: Tennessee
Study officials:
References:
citation: 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.