Assessment of a Non-invasive Device in the Management of Open Abdomen (AbCLO)- Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Primary Fascial Closure
研究概览
简要总结
The goal of this multicenter, prospective Cohort Interventional study is to perform a pilot study of the AbCLO (Abdominal Wall Closure) device in patients with Open Abdomen. The main question it aims to answer is:
• Does the Abdominal Wall Closure Device (AbCLO) increase the likelihood of primary facial closure in cases of open abdomen when compared to historical controls?
Participants will be cases of open abdomen who underwent emergency surgery for Trauma or Acute Care Surgery, will have the AbCLO device. These will be compared to historical controls managed at the same center.
详细描述
This is a multi-center matched prospective cohort study. It will be performed in collaboration between 2 centers in the USA: Tufts Medical Center (TMC) and Los Angeles County + University of Southern California (LAC + USC) Medical Center.
The cohort (interventional) patients will receive the standard of care (Lahey bag, Ioban and closed suction drains) in addition to the study intervention (AbCLO Device).
The control group is retrospective patients that were previously managed at the same center, regardless of the technique or the device used to close the OA.
The total sample size is 80 patients, 20 in the treatment arm (15 from TMC and 5 from LAC+USC) and 60 in the control arm (45 from TMC and 15 from LAC+USC). The treatment arm will be matched to historical control based on the following pre-specified variables:
- Age
- Diagnosis: trauma case vs acute general surgery cases,
- Assessment of severity: Injury severity scores (ISS) for Trauma cases and APACHEII score for acute general surgery cases
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults more than 18 years of age, and less than 100 years of age
- •Admitted to the trauma and acute care surgery service, underwent damage control laparotomy and left with an open abdomen (OA). Trauma or Emergency General Surgery, such as perforated viscus, Bowel obstruction or abdominal compartment syndrome.
排除标准
- •Pregnant patients
- •Patients who lost any portion of the abdominal wall that preclude primary abdominal wall closure
- •Patient who previously had a ventral hernia before having an open abdomen
- •Patient who already had a previous mesh repair
- •Burn patients
结局指标
主要结局
Primary Fascial Closure
时间窗: 14 days
Proportion of patients achieved primary facial closure within 14 days. (This is defined as approximation of the fascia on either side of the midline to perform suture closure without using any mesh or additional procedures.
次要结局
- Duration of open abdomen(14 days)
- ICU length of stay and Hospital length of stay(14 days)
- The need for additional device(14 days)
- Device complications(14 days)
- Duration of mechanical ventilation(14 days)
- The need for additional procedure to perform fascial closure(14 days)
- cost(14 days)