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Subgaleal Drains in Decompressive Craniectomies (VADER)

Primary Purpose

Hematoma Intracranial, Hydrocephalus, Surgical Site Infection

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Passive Redon subgaleal drains
Vacuum Redon subgaleal drains
No Redon subgaleal drains
Sponsored by
Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hematoma Intracranial focused on measuring Decompressive craniectomy, subgaleal drain, subgaleal hematoma, Post craniectomy hydrocephalus, surgical site infection, Bradycardia, Hypotension, Wound breakdown

Eligibility Criteria

0 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital University Sains Malaysia
  • Sarawak General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

No subgaleal drains

Passive subgaleal drains

Vacuum subgaleal drains

Arm 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

Passive non-vacuum drains will be placed during closing stage of craniectomy

Active vacuum drains will be placed during closing stage of craniectomy

Outcomes

Primary Outcome Measures

Subgaleal hematomas
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.

Secondary Outcome Measures

New remote hematomas
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
Surgical site infection
Rate of surgical site infection. Defined as purulent or serous discharge from the surgical site with clinical signs of inflammation
Wound breakdown
Rate of wound breakdown. Defined as spontaneous separation of sutured edges
Bradycardia or hypotension during skin closure stage.
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
Post craniectomy hydrocephalus
Rate of post craniectomy hydrocephalus. Defined as radiographic and clinical evidence of hydrocephalus post craniectomy
Functional outcome
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.

Full Information

First Posted
December 11, 2018
Last Updated
May 28, 2021
Sponsor
Universiti Sains Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT03777774
Brief Title
Subgaleal Drains in Decompressive Craniectomies
Acronym
VADER
Official Title
Vacuum Drains vs Passive Drains vs no Drains in Decompressive Craniectomies - A Randomized Controlled Trial on Subgaleal Drain Complication Rates
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: subgaleal hematoma thickness new remote hematomas, post craniectomy hydrocephalus, surgical site infection, wound breakdown, bradycardia/hypotension during closing stage of craniectomy 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematoma Intracranial, Hydrocephalus, Surgical Site Infection, Wound Breakdown, Bradycardia, Hypotension Postprocedural
Keywords
Decompressive craniectomy, subgaleal drain, subgaleal hematoma, Post craniectomy hydrocephalus, surgical site infection, Bradycardia, Hypotension, Wound breakdown

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Patients will be randomized only after the closing stage of decompressive craniectomy to avoid surgeon bias
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No subgaleal drains
Arm Type
Active Comparator
Arm 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 Title
Passive subgaleal drains
Arm Type
Active Comparator
Arm Description
Passive non-vacuum drains will be placed during closing stage of craniectomy
Arm Title
Vacuum subgaleal drains
Arm Type
Active Comparator
Arm Description
Active vacuum drains will be placed during closing stage of craniectomy
Intervention Type
Procedure
Intervention Name(s)
Passive Redon subgaleal drains
Other Intervention Name(s)
Non-vacuum drain
Intervention 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)
Intervention Type
Procedure
Intervention Name(s)
Vacuum Redon subgaleal drains
Other Intervention Name(s)
Active drains
Intervention 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)
Intervention Type
Procedure
Intervention Name(s)
No Redon subgaleal drains
Other Intervention Name(s)
no drains
Intervention 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)
Primary Outcome Measure Information:
Title
Subgaleal hematomas
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.
Time Frame
24 hours +/- 12 hours post craniectomy
Secondary Outcome Measure Information:
Title
New remote hematomas
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
Time Frame
1 week post craniectomy
Title
Surgical site infection
Description
Rate of surgical site infection. Defined as purulent or serous discharge from the surgical site with clinical signs of inflammation
Time Frame
1 month post craniectomy
Title
Wound breakdown
Description
Rate of wound breakdown. Defined as spontaneous separation of sutured edges
Time Frame
1 month post craniectomy
Title
Bradycardia or hypotension during skin closure stage.
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
Time Frame
end of surgery till 30 minutes after surgery has ended
Title
Post craniectomy hydrocephalus
Description
Rate of post craniectomy hydrocephalus. Defined as radiographic and clinical evidence of hydrocephalus post craniectomy
Time Frame
6 months post craniectomy
Title
Functional outcome
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.
Time Frame
6 months post craniectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Ee Sam
Organizational Affiliation
Hospital University Sains Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital University Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Sarawak General Hospital
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
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Subgaleal Drains in Decompressive Craniectomies

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