Vacuum Drains vs Passive Drains vs no Drains in Decompressive Craniectomies - A Randomized Controlled Trial on Subgaleal Drain Complication Rates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 4
- 主要终点
- Subgaleal hematomas
研究概览
简要总结
This research is about the use of subgaleal drains to prevent accumulation of blood under the skin in patients undergoing surgery to remove part of the skull(craniectomy) and its associated complications. There have been early research that shows usage of subgaleal drains maybe related to increase in complication rates after craniectomy. These complications include hydrocephalus (accumulation of fluid in the brain), new hemorrhages, infection and low blood pressure. The investigators are performing this research to determine which type of subgaleal drains would produce the least complications. With this knowledge, the investigators would be able to reduce the amount of complications for future patients that undergo surgery to remove part of the skull.
The purpose of this study is to determine the rate of complications in the 3 different groups of patients using the different types of drains under the skin in surgeries that involve removal of part of the skull.
All participants will undergo the required surgery to remove part of the skull (craniectomy). Participants will then be randomly assigned to either one of 3 groups which are the vacuum drain group, passive drain group or no drain group.Participants in the vacuum drain group will have vacuum drains inserted during the closing stage of the surgery. Participants in the passive drain group will have passive drains inserted during the closing stage of the surgery. Participants in the no drain group will have a drain inserted during the closing stage of the procedure but the drain will remained closed.
Data will then be collected and analysed to determine if the type of drains influence the rate of complications in craniectomy
详细描述
Prophylactic subcutaneous drains in surgery have generally been used for detection and drainage of hematomas or excessive secretions. In the past three decades, multiple surgical disciplines have conducted studies to determine the necessity of vacuum drains or even the need of drains altogether and a meta-analysis found that many operations can be carried out safely without prophylactic drainage.
In addition to that, drains have been associated with complications. A few of them include wound infections, injury to tissues, source of discomfort and pain during removal, limiting mobility and additional scarring.
Of all the cranial surgeries, the most commonly performed surgery is decompressive craniectomy. This surgery has been an increasingly common surgical procedure for the neurosurgical community as there is clear evidence from numerous studies that support decompressive craniectomy as a life-saving surgical procedure in traumatic brain injury, malignant middle cerebral artery infarction and spontaneous intracerebral haemorrhage.
Decompressive craniectomies have been associated with many complications including subdural effusions (49%), post-craniectomy hydrocephalus (14%), subgaleal hematomas and new remote hematomas (10.2%). These complications may just be due to the surgery itself. But it may still be possible that these complications are worsened or arise solely due to the routine use of the vacuum drain.
As the utility of decompressive craniectomy increases, efforts should be made to reduce the complications related to it. Studies have been done to optimize and standardize the technique of decompressive craniectomy but the necessity to use the vacuum drains and the possible contribution that these drains may have to the complications of decompressive craniectomies have been overlooked so far. There have been no randomized studies to compare usage of subgaleal vacuum drains, subgaleal passive drains and the omission of subgaleal drains in neurosurgical practice to date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
Patients will be randomized only after the closing stage of decompressive craniectomy to avoid surgeon bias
入排标准
- 年龄范围
- 0 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with indication for decompressive craniectomy as decided by the neurosurgeon in-charge. Indications maybe for traumatic intracranial bleed, spontaneous intracranial bleed and malignant middle cerebral artery territory infarction
- •Written informed consent by legal representative of patient
排除标准
- •history of recent antiplatelet or anticoagulant use
- •patients with evidence of coagulopathy or thrombocytopenia from lab results
- •possible disseminated intravascular coagulation preoperatively
- •Presence of hydrocephalus preoperatively
结局指标
主要结局
Subgaleal hematomas
时间窗: 24 hours +/- 12 hours post craniectomy
Mean maximum thickness and volume of subgaleal hematomas as post craniectomy complication. Defined as maximum thickness and volume (using XYZ/2 formula) of subgaleal hematoma on CT brain post craniectomy.
次要结局
- Surgical site infection(1 month post craniectomy)
- Wound breakdown(1 month post craniectomy)
- New remote hematomas(1 week post craniectomy)
- Bradycardia or hypotension during skin closure stage.(end of surgery till 30 minutes after surgery has ended)
- Post craniectomy hydrocephalus(6 months post craniectomy)
- Functional outcome(6 months post craniectomy)
研究者
Sam Jo Ee
Principal investigator
Universiti Sains Malaysia