Last reviewed · How we verify

NCT03777774: VADER

Subgaleal Drains in Decompressive Craniectomies

Completed NA Last updated 2 June 2021
What this trial tests

NA trial testing Passive Redon subgaleal drains in Hematoma Intracranial in 78 participants. Completed in 30 June 2020.

Timeline
1 January 2019
Primary endpoint
30 June 2020
30 June 2020

Quick facts

Lead sponsorUniversiti Sains Malaysia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment78
Start date1 January 2019
Primary completion30 June 2020
Estimated completion30 June 2020
Sites2 locations across Malaysia

Drugs / interventions tested

Conditions studied

Sponsor

Universiti Sains Malaysia — full company profile →

Who can join

Adults 0 to 80, any sex, with Hematoma Intracranial or Hydrocephalus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Current State of Clinical Trials Studying Hydrocephalus: An Analysis of ClinicalTrials.gov.
    Abraham ME, Povolotskiy R, Gold J, Ward M, et al · · 2020 · cited 3× · PMID 32983722 · DOI 10.7759/cureus.10029

Verify or expand the search:

Other Universiti Sains Malaysia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03777774.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing