Subgaleal Drains in Decompressive Craniectomies (VADER)

May 28, 2021 updated by: Sam Jo Ee, Universiti Sains Malaysia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Hospital University Sains Malaysia
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Sarawak General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: No subgaleal drains
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
Procedure: No Redon subgaleal drains
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)
Other Names:
  • no drains
Active Comparator: Passive subgaleal drains
Passive non-vacuum drains will be placed during closing stage of craniectomy
Procedure: Passive Redon subgaleal drains
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)
Other Names:
  • Non-vacuum drain
Active Comparator: Vacuum subgaleal drains
Active vacuum drains will be placed during closing stage of craniectomy
Procedure: Vacuum Redon subgaleal drains
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)
Other Names:
  • Active drains

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgaleal hematomas
Time Frame: 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.
24 hours +/- 12 hours post craniectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New remote hematomas
Time Frame: 1 week post craniectomy
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
1 week post craniectomy
Surgical site infection
Time Frame: 1 month post craniectomy
Rate of surgical site infection. Defined as purulent or serous discharge from the surgical site with clinical signs of inflammation
1 month post craniectomy
Wound breakdown
Time Frame: 1 month post craniectomy
Rate of wound breakdown. Defined as spontaneous separation of sutured edges
1 month post craniectomy
Bradycardia or hypotension during skin closure stage.
Time Frame: end of surgery till 30 minutes after surgery has ended
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
end of surgery till 30 minutes after surgery has ended
Post craniectomy hydrocephalus
Time Frame: 6 months post craniectomy
Rate of post craniectomy hydrocephalus. Defined as radiographic and clinical evidence of hydrocephalus post craniectomy
6 months post craniectomy
Functional outcome
Time Frame: 6 months post craniectomy

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.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
6 months post craniectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Investigators

  • Principal Investigator: Jo Ee Sam, Hospital University Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 14, 2018

First Posted (Actual)

December 17, 2018

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VADER 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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