Subgaleal Drains in Decompressive Craniectomies

NCT03777774 | Completed DMC

• 1 other identifier: VADER 1.0
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours +/- 12 hours post craniectomy

Secondary Outcomes (6)

• New remote hematomas

  1 week post craniectomy

• Surgical site infection

  1 month post craniectomy

• Wound breakdown

  1 month post craniectomy

• Bradycardia or hypotension during skin closure stage.

  end of surgery till 30 minutes after surgery has ended

• Post craniectomy hydrocephalus

  6 months post craniectomy

Study Arms (3)

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

Procedure: No Redon subgaleal drains

Passive subgaleal drains

ACTIVE COMPARATOR

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

Procedure: Passive Redon subgaleal drains

Vacuum subgaleal drains

ACTIVE COMPARATOR

Active vacuum drains will be placed during closing stage of craniectomy

Procedure: Vacuum Redon subgaleal drains

Interventions

Passive Redon subgaleal drains PROCEDURE

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)

Also known as: Non-vacuum drain

Passive subgaleal drains

Vacuum Redon subgaleal drains PROCEDURE

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)

Also known as: Active drains

Vacuum subgaleal drains

No Redon subgaleal drains PROCEDURE

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)

Also known as: no drains

No subgaleal drains

Eligibility Criteria

• Age: 0 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (2)

Hospital University Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

Related Publications (38)

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MeSH Terms

Conditions

Hydrocephalus; Surgical Wound Infection; Surgical Wound Dehiscence; Bradycardia; Hypotension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jo Ee Sam

  Hospital University Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients will be randomized only after the closing stage of decompressive craniectomy to avoid surgeon bias
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 17, 2018
• Study Start: January 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)