Hematoma IntracranialVADERNCT03777774
Subgaleal Drains in Decompressive Craniectomies
A study testing Passive Redon subgaleal drains, Vacuum Redon subgaleal drains and No Redon subgaleal drains in people with Hematoma Intracranial and Hydrocephalus, run by Universiti Sains Malaysia at 2 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 80 years
- Conditions the study is for
- Hematoma Intracranial, Hydrocephalus, Surgical Site Infection
- What is being tested?
- Passive Redon subgaleal drains, Vacuum Redon subgaleal drains and No Redon subgaleal drains
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Jan 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Hospital University Sains Malaysia
Kubang Kerian, Kelantan, 16150
Sarawak General Hospital
Kuching, Sarawak, 93586
About this study
Official title: 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.
Read more
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
Read the 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
- Conditions
- Hematoma Intracranial, Hydrocephalus, Surgical Site Infection, Wound Breakdown, Bradycardia, Hypotension Postprocedural
- Being tested
- Passive Redon subgaleal drains, Vacuum Redon subgaleal drains, No Redon subgaleal drains
- Keywords
- Decompressive craniectomy, subgaleal drain, subgaleal hematoma, Post craniectomy hydrocephalus, surgical site infection, Bradycardia, Hypotension, Wound breakdown
- Medical subject headings
- Hydrocephalus, Surgical Wound Infection, Surgical Wound Dehiscence, Bradycardia, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Redon subgaleal drainsProcedure or surgery
Also called Non-vacuum drain
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)
Vacuum Redon subgaleal drainsProcedure or surgery
Also called Active 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)
No Redon subgaleal drainsProcedure or surgery
Also called no 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)
| Study group | Role | What they receive |
|---|---|---|
| No subgaleal drains | Active comparator | 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 Receives: Procedure: No Redon subgaleal drains |
| Passive subgaleal drains | Active comparator | Passive non-vacuum drains will be placed during closing stage of craniectomy Receives: Procedure: Passive Redon subgaleal drains |
| Vacuum subgaleal drains | Active comparator | Active vacuum drains will be placed during closing stage of craniectomy Receives: Procedure: Vacuum Redon subgaleal drains |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours +/- 12 hours post craniectomy
Secondary outcomes (6)
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
Measured: 1 week post craniectomy
Surgical site infection
Rate of surgical site infection. Defined as purulent or serous discharge from the surgical site with clinical signs of inflammation
Measured: 1 month post craniectomy
Wound breakdown
Rate of wound breakdown. Defined as spontaneous separation of sutured edges
Measured: 1 month post craniectomy
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
Measured: end of surgery till 30 minutes after surgery has ended
Post craniectomy hydrocephalus
Rate of post craniectomy hydrocephalus. Defined as radiographic and clinical evidence of hydrocephalus post craniectomy
Measured: 6 months 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.
Measured: 6 months post craniectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Jan 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Hematoma IntracranialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Jo Ee, Universiti Sains Malaysia
- Investigators
- Jo Ee Sam, Principal investigator, Hospital University Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777774
- Sponsor's protocol ID
- VADER 1.0
- Acronym
- VADER
- Status last verified
- May 2021
- First submitted
- 11 Dec 2018
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kosins AM, Scholz T, Cetinkaya M, Evans GRD. Evidence-based value of subcutaneous surgical wound drainage: the largest systematic review and meta-analysis. Plast Reconstr Surg. 2013 Aug;132(2):443-450. doi: 10.1097/PRS.0b013e3182958945.
PubMed 23584625Cruse PJ, Foord R. A five-year prospective study of 23,649 surgical wounds. Arch Surg. 1973 Aug;107(2):206-10. doi: 10.1001/archsurg.1973.01350200078018. No abstract available.
PubMed 4719566Nalbach SV, Ropper AE, Dunn IF, Gormley WB. Craniectomy-associated Progressive Extra-Axial Collections with Treated Hydrocephalus (CAPECTH): redefining a common complication of decompressive craniectomy. J Clin Neurosci. 2012 Sep;19(9):1222-7. doi: 10.1016/j.jocn.2012.01.016. Epub 2012 Jun 20.
PubMed 22727206Vedantam A, Yamal JM, Hwang H, Robertson CS, Gopinath SP. Factors associated with shunt-dependent hydrocephalus after decompressive craniectomy for traumatic brain injury. J Neurosurg. 2018 May;128(5):1547-1552. doi: 10.3171/2017.1.JNS162721. Epub 2017 Jun 16.
PubMed 28621627Manfiotto M, Mottolese C, Szathmari A, Beuriat PA, Klein O, Vinchon M, Gimbert E, Roujeau T, Scavarda D, Zerah M, Di Rocco F. Decompressive craniectomy and CSF disorders in children. Childs Nerv Syst. 2017 Oct;33(10):1751-1757. doi: 10.1007/s00381-017-3542-7. Epub 2017 Sep 6.
PubMed 29149390Weintraub AH, Gerber DJ, Kowalski RG. Posttraumatic Hydrocephalus as a Confounding Influence on Brain Injury Rehabilitation: Incidence, Clinical Characteristics, and Outcomes. Arch Phys Med Rehabil. 2017 Feb;98(2):312-319. doi: 10.1016/j.apmr.2016.08.478. Epub 2016 Sep 23.
PubMed 27670926Powers AK, Neal MT, Argenta LC, Wilson JA, DeFranzo AJ, Tatter SB. Vacuum-assisted closure for complex cranial wounds involving the loss of dura mater. J Neurosurg. 2013 Feb;118(2):302-8. doi: 10.3171/2012.10.JNS112241. Epub 2012 Nov 16.
PubMed 23157181Wilkie KP, Nagra G, Johnston M. A MATHEMATICAL ANALYSIS OF PHYSIOLOGICAL AND MOLECULAR MECHANISMS THAT MODULATE PRESSURE GRADIENTS AND FACILITATE VENTRICULAR EXPANSION IN HYDROCEPHALUS. Int J Numer Anal Model B. 2012;316:65-81.
PubMed 25678938Waziri A, Fusco D, Mayer SA, McKhann GM 2nd, Connolly ES Jr. Postoperative hydrocephalus in patients undergoing decompressive hemicraniectomy for ischemic or hemorrhagic stroke. Neurosurgery. 2007 Sep;61(3):489-93; discussion 493-4. doi: 10.1227/01.NEU.0000290894.85072.37.
PubMed 17881960Yadav YR, Parihar V, Chourasia ID, Bajaj J, Namdev H. The role of subgaleal suction drain placement in chronic subdural hematoma evacuation. Asian J Neurosurg. 2016 Jul-Sep;11(3):214-8. doi: 10.4103/1793-5482.145096.
PubMed 27366247Van Roost D, Thees C, Brenke C, Oppel F, Winkler PA, Schramm J. Pseudohypoxic brain swelling: a newly defined complication after uneventful brain surgery, probably related to suction drainage. Neurosurgery. 2003 Dec;53(6):1315-26; discussion 1326-7. doi: 10.1227/01.neu.0000093498.08913.9e.
PubMed 14633298Huang YH, Lee TC, Lee TH, Yang KY, Liao CC. Remote epidural hemorrhage after unilateral decompressive hemicraniectomy in brain-injured patients. J Neurotrauma. 2013 Jan 15;30(2):96-101. doi: 10.1089/neu.2012.2563.
PubMed 23013227Meguro T, Terada K, Hirotsune N, Nishino S, Asano T. Postoperative extradural hematoma after removal of a subgaleal drainage catheter--case report. Neurol Med Chir (Tokyo). 2007 Jul;47(7):314-6. doi: 10.2176/nmc.47.314.
PubMed 17652918Kurland DB, Khaladj-Ghom A, Stokum JA, Carusillo B, Karimy JK, Gerzanich V, Sahuquillo J, Simard JM. Complications Associated with Decompressive Craniectomy: A Systematic Review. Neurocrit Care. 2015 Oct;23(2):292-304. doi: 10.1007/s12028-015-0144-7.
PubMed 26032808Chang V, Hartzfeld P, Langlois M, Mahmood A, Seyfried D. Outcomes of cranial repair after craniectomy. J Neurosurg. 2010 May;112(5):1120-4. doi: 10.3171/2009.6.JNS09133.
PubMed 19612971
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum Drains vs Passive Drains vs no Drains in Decompressive Craniectomies - A Randomized Controlled Trial on Subgaleal Drain Complication Rates
- ClinicalTrials.gov ID
- NCT03777774
- Acronym / sponsor ID
- VADER / VADER 1.0
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No subgaleal drains | Active comparator | Procedure: No Redon subgaleal drainsDrains 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 subgaleal drains | Active comparator | Procedure: Passive Redon subgaleal drainsPassive non-vacuum drains will be placed during closing stage of craniectomy |
| Vacuum subgaleal drains | Active comparator | Procedure: Vacuum Redon subgaleal drainsActive vacuum drains will be placed during closing stage of craniectomy |
Who may qualify
- Ages
- 0 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive Redon subgaleal drainsAlso: Non-vacuum drainPassive 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) | Procedure or surgery | Passive subgaleal drains |
| Vacuum Redon subgaleal drainsAlso: Active drainsActive 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) | Procedure or surgery | Vacuum subgaleal drains |
| No Redon subgaleal drainsAlso: no drainsA 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) | Procedure or surgery | No subgaleal drains |
Primary outcome
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.
6 secondary outcomes
New remote hematomas
Time frame: 1 week post craniectomy
Surgical site infection
Time frame: 1 month post craniectomy
Wound breakdown
Time frame: 1 month post craniectomy
Bradycardia or hypotension during skin closure stage.
Time frame: end of surgery till 30 minutes after surgery has ended
Post craniectomy hydrocephalus
Time frame: 6 months post craniectomy
Functional outcome
Time frame: 6 months post craniectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Background: PubMed 23584625Kosins AM, Scholz T, Cetinkaya M, Evans GRD. Evidence-based value of subcutaneous surgical wound drainage: the largest systematic review and meta-analysis. Plast Reconstr Surg. 2013 Aug;132(2):443-450. doi: 10.1097/PRS.0b013e3182958945.
- Background: PubMed 4719566Cruse PJ, Foord R. A five-year prospective study of 23,649 surgical wounds. Arch Surg. 1973 Aug;107(2):206-10. doi: 10.1001/archsurg.1973.01350200078018. No abstract available.
- Background: PubMed 22727206Nalbach SV, Ropper AE, Dunn IF, Gormley WB. Craniectomy-associated Progressive Extra-Axial Collections with Treated Hydrocephalus (CAPECTH): redefining a common complication of decompressive craniectomy. J Clin Neurosci. 2012 Sep;19(9):1222-7. doi: 10.1016/j.jocn.2012.01.016. Epub 2012 Jun 20.
- Background: PubMed 28621627Vedantam A, Yamal JM, Hwang H, Robertson CS, Gopinath SP. Factors associated with shunt-dependent hydrocephalus after decompressive craniectomy for traumatic brain injury. J Neurosurg. 2018 May;128(5):1547-1552. doi: 10.3171/2017.1.JNS162721. Epub 2017 Jun 16.
- Background: PubMed 29149390Manfiotto M, Mottolese C, Szathmari A, Beuriat PA, Klein O, Vinchon M, Gimbert E, Roujeau T, Scavarda D, Zerah M, Di Rocco F. Decompressive craniectomy and CSF disorders in children. Childs Nerv Syst. 2017 Oct;33(10):1751-1757. doi: 10.1007/s00381-017-3542-7. Epub 2017 Sep 6.
- Background: PubMed 27670926Weintraub AH, Gerber DJ, Kowalski RG. Posttraumatic Hydrocephalus as a Confounding Influence on Brain Injury Rehabilitation: Incidence, Clinical Characteristics, and Outcomes. Arch Phys Med Rehabil. 2017 Feb;98(2):312-319. doi: 10.1016/j.apmr.2016.08.478. Epub 2016 Sep 23.
- Background: PubMed 23157181Powers AK, Neal MT, Argenta LC, Wilson JA, DeFranzo AJ, Tatter SB. Vacuum-assisted closure for complex cranial wounds involving the loss of dura mater. J Neurosurg. 2013 Feb;118(2):302-8. doi: 10.3171/2012.10.JNS112241. Epub 2012 Nov 16.
- Background: PubMed 25678938Wilkie KP, Nagra G, Johnston M. A MATHEMATICAL ANALYSIS OF PHYSIOLOGICAL AND MOLECULAR MECHANISMS THAT MODULATE PRESSURE GRADIENTS AND FACILITATE VENTRICULAR EXPANSION IN HYDROCEPHALUS. Int J Numer Anal Model B. 2012;316:65-81.
- Background: PubMed 17881960Waziri A, Fusco D, Mayer SA, McKhann GM 2nd, Connolly ES Jr. Postoperative hydrocephalus in patients undergoing decompressive hemicraniectomy for ischemic or hemorrhagic stroke. Neurosurgery. 2007 Sep;61(3):489-93; discussion 493-4. doi: 10.1227/01.NEU.0000290894.85072.37.
- Background: PubMed 27366247Yadav YR, Parihar V, Chourasia ID, Bajaj J, Namdev H. The role of subgaleal suction drain placement in chronic subdural hematoma evacuation. Asian J Neurosurg. 2016 Jul-Sep;11(3):214-8. doi: 10.4103/1793-5482.145096.
- Background: PubMed 14633298Van Roost D, Thees C, Brenke C, Oppel F, Winkler PA, Schramm J. Pseudohypoxic brain swelling: a newly defined complication after uneventful brain surgery, probably related to suction drainage. Neurosurgery. 2003 Dec;53(6):1315-26; discussion 1326-7. doi: 10.1227/01.neu.0000093498.08913.9e.
- Background: PubMed 23013227Huang YH, Lee TC, Lee TH, Yang KY, Liao CC. Remote epidural hemorrhage after unilateral decompressive hemicraniectomy in brain-injured patients. J Neurotrauma. 2013 Jan 15;30(2):96-101. doi: 10.1089/neu.2012.2563.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jo Ee Sam principal investigator
Hospital University Sains Malaysia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Redon subgaleal drains, Vacuum Redon subgaleal drains and No Redon subgaleal drains in people with Hematoma Intracranial and Hydrocephalus, run by Universiti Sains Malaysia at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subgaleal hematomas (time frame: 24 hours +/- 12 hours post craniectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03777774, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.