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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KCI USA, Inc
- 入组人数
- 283
- 试验地点
- 11
- 主要终点
- Number of Participants With Primary Fascial Closure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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):
排除标准
- •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
结局指标
主要结局
Number of Participants With Primary Fascial Closure
时间窗: Up to 30 days
次要结局
未报告次要终点