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临床试验/NCT03815370
NCT03815370Unknown不适用

A Non-Traumatic Binder for Temporary Abdominal Wall Closure (ABRO) Multicentre Trial

Unity Health Toronto8 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
试验地点
8
主要终点
Total number of patients who experience complete abdominal closure with sutures without the use of mesh and/or component separation.

研究概览

简要总结

At the end of most abdominal operations, the fascial layer is closed by stitching edges of the wound together. However, because of logistic and/or technical reasons or the patient's critical condition, the surgeon is forced to leave the abdomen open.

The current approach for temporary coverage of abdomen is vacuum assisted techniques (VAT). This technique requires the use of vacuum-assisted drainage to remove blood or watery fluid from a wound or operative site. Although this is the most successful and commonly used procedure, there are some limitations to this method. For example, VAT have little effect on preventing lateral movement of the wound edges. Therefore, VAT it is not the ideal procedure in aiding surgeons to closed the abdomen.

The purpose of this study is to compare usual care (vacuum or non-vacuum methods for temporary coverage of the OA) versus usual care plus a novel new abdominal binder device called ABRO™ that may aid in the closure of patients who undergo open abdomen closure procedures.

详细描述

At the end of most abdominal operations the fascial layer is closed primarily. However, because of logistic, physiological and or anatomical reasons, the surgeon needs to leave the abdomen open. In those circumstances, attempts to close the abdomen could potentially lead to unnecessary damage to the abdominal wall fascia, intra-abdominal hypertension, abdominal compartment syndrome and abdominal wall dehiscence post-operatively.

The use of the "open abdomen" (OA) in the post-operative period is not uncommon. Currently, three important trends provide grounds for increased use of this surgical strategy:

  • Lifesaving surgical procedures in severely injured trauma patients.
  • Surgical procedures performed in patients with non-traumatic surgical emergencies
  • Abdominal catastrophes in elderly patients with pre-existing medical conditions. The OA is not a new strategy in the surgeon's armamentarium. A recent publication retrieved more than 1300 articles over the last 25 years relative to the management of the OA, published in the English language.5 However, the precise incidence of the OA is unknown. Nonetheless, hospitals around the world, particularly those that receive trauma victims, have an OA rate of 1-5% among their most critically ill surgical patients.

This lifesaving surgical strategy does not come without a price. The mortality rate of an OA is approximately 30%. There is also a wide range of complications linked to this procedure. The OA exposes large surface area of the body to the environment increasing fluid losses. Maintenance of adequate fluid and nutritional status of the patient are challenging in this setting.

Furthermore, the exposed abdominal cavity also poses greater risk for local contamination from external sources that could ultimately result in sepsis. Impaired abdominal wall function interferes with ventilatory mechanics. Consequently, patients with OA are prone to respiratory complications. However, the most dreaded complication of an OA is the formation of an enteroatmospheric fistula (EF). The incidence of EF is approximately 11-15%, and increases with time. Patients who have an OA for more than 8 days have an incidence of ECF as high as 25%, caused mainly by damage to the exposed bowel. Management this complication is extremely challenging, very costly, and carries a mortality rate of 36-64%.

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

盲法说明

It is impossible for the participant or anyone within the patients circle of care to be blinded in this study, as it is clear if the abdominal binder is on the participant or not. There is no way to blind in this interventional study.

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mechanically ventilated patients, managed with the OA strategy.
  • 16 years of age or older

排除标准

  • Patients who are pregnant
  • Loss of any portion of the abdominal wall that could preclude primary closure
  • Burn patients
  • BMI greater than 40 kg/m2

结局指标

主要结局

Total number of patients who experience complete abdominal closure with sutures without the use of mesh and/or component separation.

时间窗: Outcome measures will record when closure of the abdomen takes place up to 11 days after randomization.

The primary outcome will measure the total number of patients who experience complete abdominal closure with sutures without the use of mesh and/or component separation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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