Direct Resuscitation of the Open Peritoneum: A Randomized Controlled Trial in Non-Traumatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Major Complications
研究概览
简要总结
The DROP trial evaluates two ways of treating patients whose abdomens are left open after their abdominal surgery. The current standard of care at Sanford is for patients to have their wound covered with a sterile dressing connected to a vacuum with suction, which removes fluid from the abdomen. In this trial, we are evaluating the benefits of adding dialysis fluid to the abdomen periodically, prior to suctioning it out with the vacuum system. This trial will show if the addition of this fluid lowers the risk of complications and death, and allows the surgeon to close the abdomen sooner
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
- •≥18 years of age
- •Have index operation performed by one of the Trauma and Acute Care surgeons at Sanford Medical Center Fargo
- •Require an open abdomen due to a non-traumatic cause and placement of an Abthera™ wound vacuum
- •Cognitively impaired adults will be included if a Legally Authorized Representative is available to provide informed consent.
排除标准
- •Patients under the age of 18
- •Vulnerable populations such as pregnant women and prisoners
- •Patients with open abdomens as the result of trauma
- •Non-English speaking (Due to time constraints pre-operatively and the length of time necessary to secure translation services, non-English speaking patients will not be enrolled).
研究组 & 干预措施
Negative Wound Pressure Therapy
Negative Pressure Would Therapy
干预措施: Abthera™ Open Abdomen Negative Pressure Therapy Device System (Device)
Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation
Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation
干预措施: Abthera™ Open Abdomen Negative Pressure Therapy Device System (Device)
Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation
Negative Wound Pressure Therapy with Direct Peritoneal Resuscitation
干预措施: Dianeal PD-2 with 2.5% Dextrose (Drug)
结局指标
主要结局
Major Complications
时间窗: Through study completion, an average of 6 months
Major complications (yes/no). Major complications include intra-abdominal abscess, wound dehiscence, anastomotic leak, intra-abdominal bleed, biloma, enterocutaneous fistula, evisceration, acute respiratory distress syndrome (ARDS)
Number of operations and time to closure
时间窗: up to 4 weeks
how many procedures/how long did it take to close the abdomen
次要结局
- Length of ICU Stay(up to 4 weeks)
- Time on Vasopressors(up to 4 weeks)