Study of Primary Fascial Closure Rate in Patients With Open Abdomen Treated With Abthera Versus Barker Technique
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 94
- 主要终点
- 30 day fascial closure
研究概览
简要总结
This study is being done to compare two different Temporary Abdominal Closure methods that could be used in cases like yours. The methods being compared are the Barker's vacuum packing technique (BVPT) and the Open Abdomen Negative Pressure Therapy System (ABThera).
详细描述
This study is being done to compare two different Temporary Abdominal Closure methods that could be used in cases of open abdomen. The methods being compared are the Barker's vacuum packing technique (BVPT) and the Open Abdomen Negative Pressure Therapy System (ABThera). The BVPT will be made up by an internal plastic layer to cover abdominal viscera, a second layer with surgical sponges and a suction drain and will be covered by an adhesive plastic layer. Then the dressing will be connected to the hospital's vacuum system. The ABThera dressing is available commercially.
Study Participants Enrollment will happen at the operating room
Investigator will include in this study patients who have the following indications to laparostomy:
- Damage control surgery in trauma patients,
- Patients with abdominal compartment syndrome,
- Septic shock patients requiring short surgery and inability to close the abdominal cavity.
Signing the consent form will be held in order of preference by:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with indication of an open abdomen According to the Attending physician
- •Damage control surgery in trauma patients,
- •Patients with abdominal compartment syndrome,
- •Septic shock patients requiring short surgery and inability to close the abdominal cavity.
排除标准
- •Pregnancy;
- •Chronic renal impairment,
- •Child-Pugh C,
- •Body index over 40 kg / m2,
- •Uncontrolled bleeding during laparotomy
- •Patients progressing to death within the first 48 hours
结局指标
主要结局
30 day fascial closure
时间窗: 30 day
Percentage of facial closure in each arm
次要结局
- Mortality(30 days)
- Drainage(30 days)
研究者
Diogo De Freitas Valeiro Garcia
MD PhD FACS
Sociedade Brasileira de Atendimento Integrado ao Trauma