<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03777774</url>
  </required_header>
  <id_info>
    <org_study_id>VADER 1.0</org_study_id>
    <nct_id>NCT03777774</nct_id>
  </id_info>
  <brief_title>Subgaleal Drains in Decompressive Craniectomies</brief_title>
  <acronym>VADER</acronym>
  <official_title>Vacuum Drains vs Passive Drains vs no Drains in Decompressive Craniectomies - A Randomized Controlled Trial on Subgaleal Drain Complication Rates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Sains Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiti Sains Malaysia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is about the use of subgaleal drains to prevent accumulation of blood under the&#xD;
      skin in patients undergoing surgery to remove part of the skull(craniectomy) and its&#xD;
      associated complications. There have been early research that shows usage of subgaleal drains&#xD;
      maybe related to increase in complication rates after craniectomy. These complications&#xD;
      include hydrocephalus (accumulation of fluid in the brain), new hemorrhages, infection and&#xD;
      low blood pressure. The investigators are performing this research to determine which type of&#xD;
      subgaleal drains would produce the least complications. With this knowledge, the&#xD;
      investigators would be able to reduce the amount of complications for future patients that&#xD;
      undergo surgery to remove part of the skull.&#xD;
&#xD;
      The purpose of this study is to determine the rate of complications in the 3 different groups&#xD;
      of patients using the different types of drains under the skin in surgeries that involve&#xD;
      removal of part of the skull.&#xD;
&#xD;
      All participants will undergo the required surgery to remove part of the skull (craniectomy).&#xD;
      Participants will then be randomly assigned to either one of 3 groups which are the vacuum&#xD;
      drain group, passive drain group or no drain group.Participants in the vacuum drain group&#xD;
      will have vacuum drains inserted during the closing stage of the surgery. Participants in the&#xD;
      passive drain group will have passive drains inserted during the closing stage of the&#xD;
      surgery. Participants in the no drain group will have a drain inserted during the closing&#xD;
      stage of the procedure but the drain will remained closed.&#xD;
&#xD;
      Data will then be collected and analysed to determine if the type of drains influence the&#xD;
      rate of complications in craniectomy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prophylactic subcutaneous drains in surgery have generally been used for detection and&#xD;
      drainage of hematomas or excessive secretions. In the past three decades, multiple surgical&#xD;
      disciplines have conducted studies to determine the necessity of vacuum drains or even the&#xD;
      need of drains altogether and a meta-analysis found that many operations can be carried out&#xD;
      safely without prophylactic drainage.&#xD;
&#xD;
      In addition to that, drains have been associated with complications. A few of them include&#xD;
      wound infections, injury to tissues, source of discomfort and pain during removal, limiting&#xD;
      mobility and additional scarring.&#xD;
&#xD;
      Of all the cranial surgeries, the most commonly performed surgery is decompressive&#xD;
      craniectomy. This surgery has been an increasingly common surgical procedure for the&#xD;
      neurosurgical community as there is clear evidence from numerous studies that support&#xD;
      decompressive craniectomy as a life-saving surgical procedure in traumatic brain injury,&#xD;
      malignant middle cerebral artery infarction and spontaneous intracerebral haemorrhage.&#xD;
&#xD;
      Decompressive craniectomies have been associated with many complications including subdural&#xD;
      effusions (49%), post-craniectomy hydrocephalus (14%), subgaleal hematomas and new remote&#xD;
      hematomas (10.2%). These complications may just be due to the surgery itself. But it may&#xD;
      still be possible that these complications are worsened or arise solely due to the routine&#xD;
      use of the vacuum drain.&#xD;
&#xD;
      As the utility of decompressive craniectomy increases, efforts should be made to reduce the&#xD;
      complications related to it. Studies have been done to optimize and standardize the technique&#xD;
      of decompressive craniectomy but the necessity to use the vacuum drains and the possible&#xD;
      contribution that these drains may have to the complications of decompressive craniectomies&#xD;
      have been overlooked so far. There have been no randomized studies to compare usage of&#xD;
      subgaleal vacuum drains, subgaleal passive drains and the omission of subgaleal drains in&#xD;
      neurosurgical practice to date.&#xD;
&#xD;
      Usage of subgaleal vacuum drains for decompressive craniectomies have been the usual practice&#xD;
      so far to prevent subgaleal hematoma collection. However, this practice is not backed by any&#xD;
      strong evidence that these vacuum drains actually deter subgaleal hematoma collection. On top&#xD;
      of that, these vacuum drains may itself be causing complications that have not been&#xD;
      discovered before. The usual complications associated with prophylactic vacuum drains are&#xD;
      surgical site infections and wound breakdown. There are other complications that could be&#xD;
      attributed to the routine usage of prophylactic vacuum drains. These include new remote&#xD;
      intracranial hematomas, post craniectomy hydrocephalus and bradycardia or hypotension during&#xD;
      the skin closure stage of craniectomy.&#xD;
&#xD;
      The investigators plan to compare the complication rates of vacuum drains, passive drains and&#xD;
      no drains in decompressive craniectomy. These 3 groups include a group with active vacuum&#xD;
      drains, another group with passive non-vacuum drains and a group without any drains. The&#xD;
      current practice is to use active or passive vacuum drains as prophylactic drains in patients&#xD;
      undergoing decompressive craniectomy.&#xD;
&#xD;
      The complication rates to be studied are:&#xD;
&#xD;
        1. subgaleal hematoma thickness&#xD;
&#xD;
        2. new remote hematomas,&#xD;
&#xD;
        3. post craniectomy hydrocephalus,&#xD;
&#xD;
        4. surgical site infection,&#xD;
&#xD;
        5. wound breakdown,&#xD;
&#xD;
        6. bradycardia/hypotension during closing stage of craniectomy&#xD;
&#xD;
        7. and functional outcomes of patients at 6 months&#xD;
&#xD;
      If the rates of complications in the groups without a drain or a passive drain are lower or&#xD;
      equal to that of the group with active drains, this study may change the paradigm of&#xD;
      prophylactic drain usage in decompressive craniectomies&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Patients will be randomized only after the closing stage of decompressive craniectomy to avoid surgeon bias</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Subgaleal hematomas</measure>
    <time_frame>24 hours +/- 12 hours post craniectomy</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>New remote hematomas</measure>
    <time_frame>1 week post craniectomy</time_frame>
    <description>Rate of new remote hematomas. Defined as hematomas not previously seen on earlier CT brains but seen on post operative CT brain that cannot be explained by direct connection or complication from the original hematomas</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical site infection</measure>
    <time_frame>1 month post craniectomy</time_frame>
    <description>Rate of surgical site infection. Defined as purulent or serous discharge from the surgical site with clinical signs of inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound breakdown</measure>
    <time_frame>1 month post craniectomy</time_frame>
    <description>Rate of wound breakdown. Defined as spontaneous separation of sutured edges</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bradycardia or hypotension during skin closure stage.</measure>
    <time_frame>end of surgery till 30 minutes after surgery has ended</time_frame>
    <description>Rate of bradycardia or hypotension during skin closure stage. Bradycardia defined as &lt;60 beat per minute, hypotension defined as BP &lt;90/60 mmHg, that cannot be clearly explained by other possible causes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post craniectomy hydrocephalus</measure>
    <time_frame>6 months post craniectomy</time_frame>
    <description>Rate of post craniectomy hydrocephalus. Defined as radiographic and clinical evidence of hydrocephalus post craniectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>6 months post craniectomy</time_frame>
    <description>Modified Rankin Scale(MRS) score on 6 months post craniectomy&#xD;
MRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities&#xD;
The scale runs from 0-6, running from perfect health without symptoms to death.&#xD;
0 - No symptoms.&#xD;
- No significant disability. Able to carry out all usual activities, despite some symptoms.&#xD;
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.&#xD;
- Moderate disability. Requires some help, but able to walk unassisted.&#xD;
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.&#xD;
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.&#xD;
- Dead.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Hematoma Intracranial</condition>
  <condition>Hydrocephalus</condition>
  <condition>Surgical Site Infection</condition>
  <condition>Wound Breakdown</condition>
  <condition>Bradycardia</condition>
  <condition>Hypotension Postprocedural</condition>
  <arm_group>
    <arm_group_label>No subgaleal drains</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Drains will be placed during closing stage of craniectomy but will be clamped so that no drainage takes place. Drains can be opened if needed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Passive subgaleal drains</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Passive non-vacuum drains will be placed during closing stage of craniectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vacuum subgaleal drains</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active vacuum drains will be placed during closing stage of craniectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Passive Redon subgaleal drains</intervention_name>
    <description>Passive non-vacuum subgaleal drains will be placed during closing stage of craniectomy. Drain used is closed suction drain system (3.2 mm in outer diameter, 10 French, round and transparent polyvinyl chloride tube with a 400 mL Redon bottle spring evacuator chamber; Privac, Primed, Germany)</description>
    <arm_group_label>Passive subgaleal drains</arm_group_label>
    <other_name>Non-vacuum drain</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vacuum Redon subgaleal drains</intervention_name>
    <description>Active vacuum subgaleal drains will be placed during the closing stage of craniectomy. Drain used is closed suction drain system (3.2 mm in outer diameter, 10 French, round and transparent polyvinyl chloride tube with a 400 mL Redon bottle spring evacuator chamber; Privac, Primed, Germany)</description>
    <arm_group_label>Vacuum subgaleal drains</arm_group_label>
    <other_name>Active drains</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No Redon subgaleal drains</intervention_name>
    <description>A subgaleal drain will be placed during the closing stage of craniectomy but it will be clamped. The drain will be unclamped if necessary. Drain used is closed suction drain system (3.2 mm in outer diameter, 10 French, round and transparent polyvinyl chloride tube with a 400 mL Redon bottle spring evacuator chamber; Privac, Primed, Germany)</description>
    <arm_group_label>No subgaleal drains</arm_group_label>
    <other_name>no drains</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with indication for decompressive craniectomy as decided by the neurosurgeon&#xD;
             in-charge. Indications maybe for traumatic intracranial bleed, spontaneous&#xD;
             intracranial bleed and malignant middle cerebral artery territory infarction&#xD;
&#xD;
          -  Written informed consent by legal representative of patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of recent antiplatelet or anticoagulant use&#xD;
&#xD;
          -  patients with evidence of coagulopathy or thrombocytopenia from lab results&#xD;
&#xD;
          -  possible disseminated intravascular coagulation preoperatively&#xD;
&#xD;
          -  Presence of hydrocephalus preoperatively&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jo Ee Sam</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital University Sains Malaysia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital University Sains Malaysia</name>
      <address>
        <city>Kubang Kerian</city>
        <state>Kelantan</state>
        <zip>16150</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarawak General Hospital</name>
      <address>
        <city>Kuching</city>
        <state>Sarawak</state>
        <zip>93586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
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  </reference>
  <reference>
    <citation>Anile C, De Bonis P, Di Chirico A, Ficola A, Mangiola A, Petrella G. Cerebral blood flow autoregulation during intracranial hypertension: a simple, purely hydraulic mechanism? Childs Nerv Syst. 2009 Mar;25(3):325-35; discussion 337-40. doi: 10.1007/s00381-008-0749-7. Epub 2009 Jan 17.</citation>
    <PMID>19152096</PMID>
  </reference>
  <reference>
    <citation>Takeuchi S, Nawashiro H, Wada K, Takasato Y, Masaoka H, Hayakawa T, Nagatani K, Otani N, Osada H, Shima K. Ventriculomegaly after decompressive craniectomy with hematoma evacuation for large hemispheric hypertensive intracerebral hemorrhage. Clin Neurol Neurosurg. 2013 Mar;115(3):317-22. doi: 10.1016/j.clineuro.2012.05.026. Epub 2012 Jun 21.</citation>
    <PMID>22727212</PMID>
  </reference>
  <reference>
    <citation>Jiao QF, Liu Z, Li S, Zhou LX, Li SZ, Tian W, You C. Influencing factors for posttraumatic hydrocephalus in patients suffering from severe traumatic brain injuries. Chin J Traumatol. 2007 Jun;10(3):159-62.</citation>
    <PMID>17535639</PMID>
  </reference>
  <reference>
    <citation>Honeybul S, Ho KM. Incidence and risk factors for post-traumatic hydrocephalus following decompressive craniectomy for intractable intracranial hypertension and evacuation of mass lesions. J Neurotrauma. 2012 Jul 1;29(10):1872-8. doi: 10.1089/neu.2012.2356.</citation>
    <PMID>22583391</PMID>
  </reference>
  <reference>
    <citation>Pandey S, Jin Y, Gao L, Zhou CC, Cui DM. Negative-Pressure Hydrocephalus: A Case Report on Successful Treatment Under Intracranial Pressure Monitoring with Bilateral Ventriculoperitoneal Shunts. World Neurosurg. 2017 Mar;99:812.e7-812.e12. doi: 10.1016/j.wneu.2016.12.049. Epub 2016 Dec 23.</citation>
    <PMID>28017745</PMID>
  </reference>
  <reference>
    <citation>Yadav M, Nikhar SA, Kulkarni DK, Gopinath R. Cardiac Arrest after Connecting Negative Pressure to the Subgaleal Drain during Craniotomy Closure. Case Rep Anesthesiol. 2014;2014:146870. doi: 10.1155/2014/146870. Epub 2014 May 22.</citation>
    <PMID>24963414</PMID>
  </reference>
  <reference>
    <citation>Quinn TM, Taylor JJ, Magarik JA, Vought E, Kindy MS, Ellegala DB. Decompressive craniectomy: technical note. Acta Neurol Scand. 2011 Apr;123(4):239-44. doi: 10.1111/j.1600-0404.2010.01397.x.</citation>
    <PMID>20637010</PMID>
  </reference>
  <reference>
    <citation>Huang X, Wen L. Technical considerations in decompressive craniectomy in the treatment of traumatic brain injury. Int J Med Sci. 2010 Nov 8;7(6):385-90. doi: 10.7150/ijms.7.385.</citation>
    <PMID>21103073</PMID>
  </reference>
  <reference>
    <citation>Roth J, Galeano E, Milla S, Hartmannsgruber MW, Weiner HL. Multiple epidural hematomas and hemodynamic collapse caused by a subgaleal drain and suction-induced intracranial hypotension: case report. Neurosurgery. 2011 Jan;68(1):E271-5; discussion E276. doi: 10.1227/NEU.0b013e3181fe6165.</citation>
    <PMID>21099705</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>May 28, 2021</last_update_submitted>
  <last_update_submitted_qc>May 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiti Sains Malaysia</investigator_affiliation>
    <investigator_full_name>Sam Jo Ee</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Decompressive craniectomy</keyword>
  <keyword>subgaleal drain</keyword>
  <keyword>subgaleal hematoma</keyword>
  <keyword>Post craniectomy hydrocephalus</keyword>
  <keyword>surgical site infection</keyword>
  <keyword>Bradycardia</keyword>
  <keyword>Hypotension</keyword>
  <keyword>Wound breakdown</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Hydrocephalus</mesh_term>
    <mesh_term>Hypotension</mesh_term>
    <mesh_term>Bradycardia</mesh_term>
    <mesh_term>Hematoma</mesh_term>
    <mesh_term>Surgical Wound Dehiscence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03777774
org study id: VADER 1.0
nct id: NCT03777774
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
masking description: Patients will be randomized only after the closing stage of decompressive craniectomy to avoid surgeon bias
measure: Subgaleal hematomas
time frame: 24 hours +/- 12 hours post craniectomy
description: 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.
measure: New remote hematomas
time frame: 1 week post craniectomy
description: Rate of new remote hematomas. Defined as hematomas not previously seen on earlier CT brains but seen on post operative CT brain that cannot be explained by direct connection or complication from the original hematomas
measure: Surgical site infection
time frame: 1 month post craniectomy
description: Rate of surgical site infection. Defined as purulent or serous discharge from the surgical site with clinical signs of inflammation
measure: Wound breakdown
time frame: 1 month post craniectomy
description: Rate of wound breakdown. Defined as spontaneous separation of sutured edges
measure: Bradycardia or hypotension during skin closure stage.
time frame: end of surgery till 30 minutes after surgery has ended
description: Rate of bradycardia or hypotension during skin closure stage. Bradycardia defined as <60 beat per minute, hypotension defined as BP <90/60 mmHg, that cannot be clearly explained by other possible causes
measure: Post craniectomy hydrocephalus
time frame: 6 months post craniectomy
description: Rate of post craniectomy hydrocephalus. Defined as radiographic and clinical evidence of hydrocephalus post craniectomy
measure: Functional outcome
time frame: 6 months post craniectomy
description: Modified Rankin Scale(MRS) score on 6 months post craniectomy
MRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities
The scale runs from 0-6, running from perfect health without symptoms to death.
0 - No symptoms.
- No significant disability. Able to carry out all usual activities, despite some symptoms.
- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- Moderate disability. Requires some help, but able to walk unassisted.
- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- Dead.
arm group label: No subgaleal drains
arm group type: Active Comparator
description: Drains will be placed during closing stage of craniectomy but will be clamped so that no drainage takes place. Drains can be opened if needed
arm group label: Passive subgaleal drains
arm group type: Active Comparator
description: Passive non-vacuum drains will be placed during closing stage of craniectomy
arm group label: Vacuum subgaleal drains
arm group type: Active Comparator
description: Active vacuum drains will be placed during closing stage of craniectomy
intervention type: Procedure
intervention name: Passive Redon subgaleal drains
description: Passive non-vacuum subgaleal drains will be placed during closing stage of craniectomy. Drain used is closed suction drain system (3.2 mm in outer diameter, 10 French, round and transparent polyvinyl chloride tube with a 400 mL Redon bottle spring evacuator chamber; Privac, Primed, Germany)
arm group label: Passive subgaleal drains
other name: Non-vacuum drain
intervention type: Procedure
intervention name: Vacuum Redon subgaleal drains
description: Active vacuum subgaleal drains will be placed during the closing stage of craniectomy. Drain used is closed suction drain system (3.2 mm in outer diameter, 10 French, round and transparent polyvinyl chloride tube with a 400 mL Redon bottle spring evacuator chamber; Privac, Primed, Germany)
arm group label: Vacuum subgaleal drains
other name: Active drains
intervention type: Procedure
intervention name: No Redon subgaleal drains
description: A subgaleal drain will be placed during the closing stage of craniectomy but it will be clamped. The drain will be unclamped if necessary. Drain used is closed suction drain system (3.2 mm in outer diameter, 10 French, round and transparent polyvinyl chloride tube with a 400 mL Redon bottle spring evacuator chamber; Privac, Primed, Germany)
arm group label: No subgaleal drains
other name: no drains
criteria: 
gender: All
minimum age: 0 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jo Ee Sam
role: Principal Investigator
affiliation: Hospital University Sains Malaysia
facility: 
facility: 
country: Malaysia
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PMID: 23584625
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PMID: 20812777
citation: Anile C, De Bonis P, Di Chirico A, Ficola A, Mangiola A, Petrella G. Cerebral blood flow autoregulation during intracranial hypertension: a simple, purely hydraulic mechanism? Childs Nerv Syst. 2009 Mar;25(3):325-35; discussion 337-40. doi: 10.1007/s00381-008-0749-7. Epub 2009 Jan 17.
PMID: 19152096
citation: Takeuchi S, Nawashiro H, Wada K, Takasato Y, Masaoka H, Hayakawa T, Nagatani K, Otani N, Osada H, Shima K. Ventriculomegaly after decompressive craniectomy with hematoma evacuation for large hemispheric hypertensive intracerebral hemorrhage. Clin Neurol Neurosurg. 2013 Mar;115(3):317-22. doi: 10.1016/j.clineuro.2012.05.026. Epub 2012 Jun 21.
PMID: 22727212
citation: Jiao QF, Liu Z, Li S, Zhou LX, Li SZ, Tian W, You C. Influencing factors for posttraumatic hydrocephalus in patients suffering from severe traumatic brain injuries. Chin J Traumatol. 2007 Jun;10(3):159-62.
PMID: 17535639
citation: Honeybul S, Ho KM. Incidence and risk factors for post-traumatic hydrocephalus following decompressive craniectomy for intractable intracranial hypertension and evacuation of mass lesions. J Neurotrauma. 2012 Jul 1;29(10):1872-8. doi: 10.1089/neu.2012.2356.
PMID: 22583391
citation: Pandey S, Jin Y, Gao L, Zhou CC, Cui DM. Negative-Pressure Hydrocephalus: A Case Report on Successful Treatment Under Intracranial Pressure Monitoring with Bilateral Ventriculoperitoneal Shunts. World Neurosurg. 2017 Mar;99:812.e7-812.e12. doi: 10.1016/j.wneu.2016.12.049. Epub 2016 Dec 23.
PMID: 28017745
citation: Yadav M, Nikhar SA, Kulkarni DK, Gopinath R. Cardiac Arrest after Connecting Negative Pressure to the Subgaleal Drain during Craniotomy Closure. Case Rep Anesthesiol. 2014;2014:146870. doi: 10.1155/2014/146870. Epub 2014 May 22.
PMID: 24963414
citation: Quinn TM, Taylor JJ, Magarik JA, Vought E, Kindy MS, Ellegala DB. Decompressive craniectomy: technical note. Acta Neurol Scand. 2011 Apr;123(4):239-44. doi: 10.1111/j.1600-0404.2010.01397.x.
PMID: 20637010
citation: Huang X, Wen L. Technical considerations in decompressive craniectomy in the treatment of traumatic brain injury. Int J Med Sci. 2010 Nov 8;7(6):385-90. doi: 10.7150/ijms.7.385.
PMID: 21103073
citation: Roth J, Galeano E, Milla S, Hartmannsgruber MW, Weiner HL. Multiple epidural hematomas and hemodynamic collapse caused by a subgaleal drain and suction-induced intracranial hypotension: case report. Neurosurgery. 2011 Jan;68(1):E271-5; discussion E276. doi: 10.1227/NEU.0b013e3181fe6165.
PMID: 21099705
responsible party type: Principal Investigator
investigator affiliation: Universiti Sains Malaysia
investigator full name: Sam Jo Ee
investigator title: Principal investigator
mesh term: Surgical Wound Infection
mesh term: Hydrocephalus
mesh term: Hypotension
mesh term: Bradycardia
mesh term: Hematoma
mesh term: Surgical Wound Dehiscence
sharing ipd: No