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

Open Abdomen Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016353
• Other study ID #: ABT2009-50
• Status: Completed
• Start date: December 2009
• Est. completion date: January 2011

Study information

• Verified date: July 2022
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Open Abdomen

Intervention

Device:
• NPWT
ABThera Open Abdomen Negative Pressure Therapy System
• BVPT
Barker's Vacuum Packing Technique

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Primary Fascial Closure		Up to 30 days