Open Abdomen
Conditions
Keywords
ABThera, Barker's Vacuum Packing Technique
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.
Interventions
DEVICENPWT
ABThera Open Abdomen Negative Pressure Therapy System
DEVICEBVPT
Barker's Vacuum Packing Technique
Sponsors
KCI USA, Inc
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Primary Fascial Closure | Up to 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NPWT ABThera Open Abdomen Negative Pressure Therapy System | 178 |
| BVPT Barker's vacuum-packing technique (BVPT) | 102 |
| Total | 280 |
Baseline characteristics
| Characteristic | NPWT | BVPT | Total |
|---|---|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 17 | 39 years STANDARD_DEVIATION 16 | 40 years STANDARD_DEVIATION 16 |
| Race/Ethnicity, Customized Race/Ethnicity American Indian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 54 Participants | 40 Participants | 94 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino | 37 Participants | 10 Participants | 47 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 81 Participants | 47 Participants | 128 Participants |
| Region of Enrollment United States | 178 Participants | 102 Participants | 280 Participants |
| Sex: Female, Male Female | 36 Participants | 28 Participants | 64 Participants |
| Sex: Female, Male Male | 142 Participants | 74 Participants | 216 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 21 / 178 | 20 / 102 |
| other Total, other adverse events | 65 / 180 | 36 / 103 |
| serious Total, serious adverse events | 3 / 180 | 0 / 103 |
Outcome results
Primary
Number of Participants With Primary Fascial Closure
Time frame: Up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NPWT | Number of Participants With Primary Fascial Closure | 139 Participants |
| BVPT | Number of Participants With Primary Fascial Closure | 69 Participants |
p-value: 0.06Log Rank