Subgaleal Drains in Decompressive Craniectomies

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

Interventions

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)

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)

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)

Sponsors & Collaborators

• Universiti Sains Malaysia

  lead OTHER

Principal Investigators

• Jo Ee Sam · Hospital University Sains Malaysia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

0 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2020-06-30

Completion

2020-06-30

Countries

• Malaysia

Study Locations