CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 490 enrolled
Drug / intervention
No dural tenting techniques +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03658941
NCT03658941N/ACompleted

Prophylactic Use of Dural Tenting Sutures in Elective Craniotomies - is it Necessary? A Multicentre Randomised Study.

Medical University of Warsaw·interventional·Posted Sep 6, 2018·Updated Jul 30, 2024

In Brief

A clinical study evaluating No dural tenting techniques and Dural tenting techniques for Epidural Hematoma. Completed, enrolled 490 participants across 5 sites.

Detailed Summary

This study evaluates the necessity of dural tenting sutures in craniotomies. The sutures elevate the dura, a layer between the brain and skull. Supposedly, by doing so, they prevent blood collecting between dura mater and the skull. These blood collections, called epidural hematomas, contributed greatly to postoperative mortality in the early days of neurosurgery. There have been several reports questioning the ongoing need for them in neurosurgery, thanks to modern hemostatic techniques. Moreover, it has been published in the literature, and is a common knowledge as well, that some neurosurgeons do not use these sutures at all, and do not have worse outcomes than their colleagues. In this study, half of the randomly assigned participants will undergo craniotomy without dural tenting sutures and will be considered an intervention group. The other half will undergo craniotomy with these sutures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPoland
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 6, 2018
Enrollment StartSep 7, 2018
Primary CompletionSep 1, 2021
Study CompletionSep 1, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.8 years ago

Interventions

No dural tenting techniquesprocedure

Not applying dural tenting sutures during closure of a craniotomy

Dural tenting techniquesprocedure

Applying at least 3 dural tenting sutures during closure of a craniotomy