Personalizar preferências de consentimento

Utilizamos cookies para ajudar você a navegar com eficiência e executar certas funções. Você encontrará informações detalhadas sobre todos os cookies sob cada categoria de consentimento abaixo.

Os cookies que são classificados com a marcação “Necessário” são armazenados em seu navegador, pois são essenciais para possibilitar o uso de funcionalidades básicas do site.... 

Sempre ativo

Os cookies necessários são cruciais para as funções básicas do site e o site não funcionará como pretendido sem eles. Esses cookies não armazenam nenhum dado pessoalmente identificável.

Bem, cookies para exibir.

Cookies funcionais ajudam a executar certas funcionalidades, como compartilhar o conteúdo do site em plataformas de mídia social, coletar feedbacks e outros recursos de terceiros.

Bem, cookies para exibir.

Cookies analíticos são usados para entender como os visitantes interagem com o site. Esses cookies ajudam a fornecer informações sobre métricas o número de visitantes, taxa de rejeição, fonte de tráfego, etc.

Bem, cookies para exibir.

Os cookies de desempenho são usados para entender e analisar os principais índices de desempenho do site, o que ajuda a oferecer uma melhor experiência do usuário para os visitantes.

Bem, cookies para exibir.

Os cookies de anúncios são usados para entregar aos visitantes anúncios personalizados com base nas páginas que visitaram antes e analisar a eficácia da campanha publicitária.

Bem, cookies para exibir.

Results of the Prospective, Randomized, Multicenter Clinical Trial Evaluating a Biosynthesized Cellulose Graft for Repair of Dural Defects

Compartilhe ►

Ahead of Print: Results of the Prospective, Randomized, Multicenter Clinical Trial Evaluating a Biosynthesized Cellulose Graft for Repair of Dural Defects

Full article access for Neurosurgery subscribers at Neurosurgery-Online.com.

BACKGROUND: Following intradural cranial surgery, a dural substitute is often required for dural closure. Although preferred, limitations of autograft include local availability and additional surgical site morbidity. Thus, allografts, xenografts, and synthetics are frequently used.

OBJECTIVE: To report 6-month results of a randomized, controlled trial (RCT) of a biosynthesized cellulose (BSC) composed duraplasty device compared to commercially available dural replacements.

METHODS: A total of 99 patients (62 BSC; 37 control) were treated on protocol, utilizing a 2:1 (BSC:control) blocked randomization schedule. Physical examinations were performed pre- and post-operatively within 10 days, and 1, 3, and 6 months. An MRI was performed pre-operatively and at 6 months. The primary study endpoint was absence of pseudomeningocele and extracerebral fluid collection confirmed radiographically and absence of cerebrospinal fluid (CSF) fistula at 6 months.

RESULTS: At 6 months, the primary hypothesis, non-inferiority of the BSC implant to the control group, was confirmed (P = 0.0206). Overall success was achieved by 96.6% of BSC and 97.1% of control patients. No significant difference was revealed between treatment groups for surgical site infection (P = 1.0000) or wound healing assessment (P >= 0.3685) outcomes, or radiologic endpoints (P >= 0.4061). Device strength and seal quality favored BSC.

CONCLUSION: This RCT establishes BSC as non-inferior to commercially available dural replacement devices. BSC offers a hypothetical advantage concerning prion and other infectious agent exposure; superior handling qualities are evident. Longer-term data are necessary to identify limitations of BSC and its potential equivalence to the gold standard of pericranium.

Full article access for Neurosurgery subscribers at Neurosurgery-Online.com.