Subgaleal Drains in Decompressive Craniectomies

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Brief Title

Subgaleal Drains in Decompressive Craniectomies

Official Title

Vacuum Drains vs Passive Drains vs no Drains in Decompressive Craniectomies - A Randomized Controlled Trial on Subgaleal Drain Complication Rates

Brief Summary

      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
    

Detailed Description

      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
    


Study Type

Interventional


Primary Outcome

Subgaleal hematomas

Secondary Outcome

 New remote hematomas

Condition

Hematoma Intracranial

Intervention

Passive Redon subgaleal drains

Study Arms / Comparison Groups

 No subgaleal drains
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

78

Start Date

January 1, 2019

Completion Date

June 30, 2020

Primary Completion Date

June 30, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

0 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Jo Ee Sam, , 

Location Countries

Malaysia

Location Countries

Malaysia

Administrative Informations


NCT ID

NCT03777774

Organization ID

VADER 1.0


Responsible Party

Principal Investigator

Study Sponsor

Universiti Sains Malaysia


Study Sponsor

Jo Ee Sam, Principal Investigator, Hospital University Sains Malaysia


Verification Date

May 2021