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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPWT | Device | ABThera Open Abdomen Negative Pressure Therapy System |
| |
| BVPT | Device | Barker's Vacuum Packing Technique |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Primary Fascial Closure | Up to 30 days |
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Inclusion Criteria:
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):
Exclusion Criteria:
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Emergent Care
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Medical Center | Mobile | Alabama | 36617 | United States | ||
| LAC/USC Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26929286 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NPWT | ABThera Open Abdomen Negative Pressure Therapy System |
| FG001 | BVPT | Barker's vacuum-packing technique (BVPT) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NPWT | ABThera Open Abdomen Negative Pressure Therapy System |
| BG001 | BVPT | Barker's vacuum-packing technique (BVPT) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Primary Fascial Closure | Posted | Count of Participants | Participants | Up to 30 days |
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30 day
All-cause mortality was an endpoint for the study, therefore it was reported based on the mITT population rather than the safety population. mITT population included subjects who received any study-related TAC, regardless of its duration, had a valid baseline, and at least 1 post baseline assessment for any of the study efficacy parameters.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NPWT | ABThera Open Abdomen Negative Pressure Therapy System | 21 | 178 | 3 | 180 | 65 | 180 |
| EG001 | BVPT | Barker's vacuum-packing technique (BVPT) | 20 | 102 | 0 | 103 | 36 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Compartment Syndrome | Gastrointestinal disorders | MedDRA |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Adhesions | Gastrointestinal disorders | MedDRA |
| ||
| Abdominal Infection | Infections and infestations | MedDRA |
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| Gastrointestinal Necrosis | Gastrointestinal disorders | MedDRA |
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| Intra-Abdominal Hypertension | Gastrointestinal disorders | MedDRA |
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| Intraloop Adhesions | Gastrointestinal disorders | MedDRA |
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| Loss of Fascial Domain | Musculoskeletal and connective tissue disorders | MedDRA |
| ||
| Mulitple Organ Dysfunction Syndrome | General disorders | MedDRA |
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| Sepsis | Infections and infestations | MedDRA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Global Clinical Development | KCI | (210) 255-5595 | jane.hart@kci1.com |
| Male |
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| Asian |
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| Black or African American |
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| Hispanic or Latino |
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| Native Hawaiian |
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| White |
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