Evidence map›Paper›PMID 38727726›Full record

Trial reportChild's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery2024

Safety and effectiveness of Evicel

Gnanamurthy Sivakumar, Shailendra Magdum, Kristian Aquilina, Jothy Kandasamy, Vivek Josan, Bogdan Ilie, Ellie Barnett, Richard Kocharian, Benedetta Pettorini

Erratum issuedAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Gnanamurthy SivakumarLeeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK. gsivakumar1@nhs.net.
Shailendra MagdumJohn Radcliffe Hospital, Headley Way, Headington, Oxford, OX3 9DU, UK.ORCID 0000-0002-6830-3695
Kristian AquilinaGreat Ormond Street Hospital, London, WC1N 3JH, UK.ORCID 0000-0001-7015-5196
Jothy KandasamyRoyal Hospital for Sick Children, Sciennes Road, Edinburgh, EH9 1LF, UK.
Vivek JosanRoyal Manchester Children's Hospital, Oxford Road, Manchester, M13 9WL, UK.
Bogdan IlieEthicon, Inc., 1000 US-202 South, Raritan, NJ, 08869, USA.ORCID 0000-0001-6493-9103
Ellie BarnettEthicon, Inc., 8 Deer Park, Livingston, EH54 8AF, United Kingdom.
Richard KocharianEthicon, Inc., 1000 US-202 South, Raritan, NJ, 08869, USA.ORCID 0000-0002-4142-4489
Benedetta PettoriniAlder Hey Children's Hospital, Eaton Road, Liverpool, L12 2AP, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCerebrospinal fluid (CSF) leakage is a challenging complication of intradural cranial surgery, and children are particularly at risk. The use of dural sealants confers protection in adults, but pediatric studies are scarce. We evaluated the safety and efficacy of Evicel

methodsA multicenter trial prospectively enrolled pediatric subjects (< 18 years) undergoing cranial neurosurgery who, upon completion of primary sutured dural repair, experienced CSF leakage. As agreed by the EMA Evicel

resultsForty subjects (0.6-17 years) were randomized to Evicel

conclusionThis small-scale prospective study shows Evicel

Indexed as

Cerebrospinal Fluid LeakDura MaterFibrin Tissue AdhesiveNeurosurgical ProceduresAdolescentChildChild, PreschoolFemaleHumansInfantMalePostoperative ComplicationsProspective StudiesSuture TechniquesTissue AdhesivesTreatment OutcomeFibrin Tissue AdhesiveTissue AdhesivesCerebrospinal fluid leakDural sealingFibrin sealantPediatric neurosurgery

Identifiers

PMID38727726
PMCPMC11322203

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.