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Dural Tenting Sutures in Neurosurgery - is it Necessary?

NCT03658941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 490

Last updated 2024-07-30

No results posted yet for this study

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.

Conditions

  • Epidural Hematoma

Interventions

PROCEDURE

No dural tenting techniques

Not applying dural tenting sutures during closure of a craniotomy

PROCEDURE

Dural tenting techniques

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

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Łukasz Przepiórka · Department of Neurosurgery, Medical University of Warsaw

  • Przemysław Kunert, MD, PhD · Department of Neurosurgery, Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-07
Primary Completion
2021-09-01
Completion
2022-09-01

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03658941 on ClinicalTrials.gov