Single-arm, open-label, multicentre first in human study to evaluate the safety and performance of dural sealant patch in reducing CSF leakage following elective cranial surgery: the ENCASE trial

Article Clinical Neurology

Treatment of CSF leakage and infections of dural substitute in decompressive craniectomy using fascia lata implants and related anatomopathological findings

Giorgio M. Callovini et al.

Summary: This study evaluated the surgical treatment of infections related to the use of a dural substitute with concurrent CSF leakage in decompressive craniectomy patients, showing successful resolution of infection and CSF leaks after removing the substitute and implanting fascia lata. Autologous fascia lata is a cost-effective option for reconstruction and integration with the native dura, providing lasting vitality and successful infection suppression.

BRITISH JOURNAL OF NEUROSURGERY (2021)

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Review Surgery

The IDEAL Reporting Guidelines A Delphi Consensus Statement Stage Specific Recommendations for Reporting the Evaluation of Surgical Innovation

Nicole A. Bilbro et al.

Summary: This study aimed to define reporting standards for IDEAL format studies, and developed draft checklists for stages 1, 2a, 2b, and 4 through surveys and consensus processes. Participants familiar with IDEAL called for new reporting guidelines for most IDEAL stages except stage 3.

ANNALS OF SURGERY (2021)

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Article Clinical Neurology

Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing Cerebrospinal Fluid Leakage Following Elective Cranial Surgery: The ENCASE Trial Study Protocol

Tristan P. C. van Doormaal et al.

NEUROSURGERY (2020)

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Review Clinical Neurology

Effectiveness of Dural Sealants in Prevention of Cerebrospinal Fluid Leakage After Craniotomy: A Systematic Review

Ahmet Kinaci et al.

WORLD NEUROSURGERY (2018)

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Article Clinical Neurology

Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial

Gregor Hutter et al.

JOURNAL OF NEUROSURGERY (2014)

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Article Clinical Neurology

A Multicenter, Single-Blind, Prospective Randomized Trial to Evaluate the Safety of a Polyethylene Glycol Hydrogel (Duraseal Dural Sealant System) as a Dural Sealant in Cranial Surgery

Joshua W. Osbun et al.

WORLD NEUROSURGERY (2012)

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Article Clinical Neurology

Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases

JA Grotenhuis

SURGICAL NEUROLOGY (2005)

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Single-arm, open-label, multicentre first in human study to evaluate the safety and performance of dural sealant patch in reducing CSF leakage following elective cranial surgery: the ENCASE trial

Related references

Treatment of CSF leakage and infections of dural substitute in decompressive craniectomy using fascia lata implants and related anatomopathological findings

The IDEAL Reporting Guidelines A Delphi Consensus Statement Stage Specific Recommendations for Reporting the Evaluation of Surgical Innovation

Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing Cerebrospinal Fluid Leakage Following Elective Cranial Surgery: The ENCASE Trial Study Protocol

Effectiveness of Dural Sealants in Prevention of Cerebrospinal Fluid Leakage After Craniotomy: A Systematic Review

Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial

A Multicenter, Single-Blind, Prospective Randomized Trial to Evaluate the Safety of a Polyethylene Glycol Hydrogel (Duraseal Dural Sealant System) as a Dural Sealant in Cranial Surgery

Costs of postoperative cerebrospinal fluid leakage: 1-year, retrospective analysis of 412 consecutive nontrauma cases

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