Subgaleal Drains in Decompressive Craniectomies
Subgaleal Drains in Decompressive Craniectomies
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
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.

 Usage of subgaleal vacuum drains for decompressive craniectomies have been the usual practice
 so far to prevent subgaleal hematoma collection. However, this practice is not backed by any
 strong evidence that these vacuum drains actually deter subgaleal hematoma collection. On top
 of that, these vacuum drains may itself be causing complications that have not been
 discovered before. The usual complications associated with prophylactic vacuum drains are
 surgical site infections and wound breakdown. There are other complications that could be
 attributed to the routine usage of prophylactic vacuum drains. These include new remote
 intracranial hematomas, post craniectomy hydrocephalus and bradycardia or hypotension during
 the skin closure stage of craniectomy.

 The investigators plan to compare the complication rates of vacuum drains, passive drains and
 no drains in decompressive craniectomy. These 3 groups include a group with active vacuum
 drains, another group with passive non-vacuum drains and a group without any drains. The
 current practice is to use active or passive vacuum drains as prophylactic drains in patients
 undergoing decompressive craniectomy.

 The complication rates to be studied are:

 1. subgaleal hematoma thickness

 2. new remote hematomas,

 3. post craniectomy hydrocephalus,

 4. surgical site infection,

 5. wound breakdown,

 6. bradycardia/hypotension during closing stage of craniectomy

 7. and functional outcomes of patients at 6 months

 If the rates of complications in the groups without a drain or a passive drain are lower or
 equal to that of the group with active drains, this study may change the paradigm of
 prophylactic drain usage in decompressive craniectomies
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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