- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02768467
Buccal Mucosa Healing Trial With Tissue Matrix Placement
A Prospective Randomized Controlled Trial of Buccal Mucosa Donor Site Healing With Tissue Matrix Placement
Prior studies have been performed to understand the optimal way to minimize the morbidity rate of buccal mucosa. While some studies have reported primary closure to be inferior to healing by secondary intention, this appears to be true for large defects greater than 2 cm in width. For small defects for which the wound can be closed without tension, the most recent study has shown improved pain outcomes in the immediate post-operative setting, although no difference is seen long term whether or not the wound was primarily closed. However, for larger defects, standard practice is to allow delayed healing by secondary intention.
The use of Alloderm graft placement for donor site coverage was first described in Armenakas' group. Alloderm is an acellular dermal lattice from human allograft skin. The only study to report the use of Alloderm failed to find a significant improvement in patient outcomes; however, very small defects were included in this study and the control group underwent primary closure, which has been shown to be inferior for large defects. Importantly, no increase in post-operative pain was noted, although there was some increased swelling reported. From experience, patients with moderate and large (>2 cm width) defects following buccal mucosa harvest benefit from Alloderm placement with decreased post-operative pain, more rapid resumption of normal diet and mouth function with no associated increase in morbidity of the procedure. This study aims to determine whether this is a reliable improvement in technique.
This study will clarify how the cheek heals after the buccal mucosa is removed during reconstructive surgery. Subjects will be randomized to either receive tissue collagen matrix or no stitches after the surgery. Subjects will be evaluated up to six months to determine if the outcomes of the tissue matrix graft are better for the subject.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10016
- New York University Langone Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- >18 years of age
- Male
- Patients with clinically necessary buccal mucosal graft >2 cm
- Patients who are able to present for pre-operative and post-operative evaluations
- Patients who are able to comprehend and read English
Exclusion Criteria:
- History of oral cancer
- Severe cognitive impairments
- Unwilling or unable to follow procedures in protocol
- Contraindicated to participate for any reason
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Tissue Matrix Graft Placement
After the buccal mucosa is removed during reconstructive surgery, the wound is covered with an acellular tissue collagen matrix
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Subject will receive a covering for the wound post buccal mucosa removal.
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Comparador Ativo: Without stitches
After the buccal mucosa is removed during reconstructive surgery, no stitches will be used for the wound to heal.
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Subject will not receive stitches post buccal mucosa removal.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Level
Prazo: Six months
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Measured by the Visual Analog Scale
|
Six months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to Normal Eating
Prazo: Six Months
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This is measured by time.
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Six Months
|
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Presence of Swelling
Prazo: Six Months
|
This is measured by time
|
Six Months
|
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Mouth mobility
Prazo: Six Months
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This is measured by time
|
Six Months
|
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Presence of Paresthesia
Prazo: Six Months
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This is measured by time
|
Six Months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lee Zhao, MD, NYU Langone Health
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 16-00669
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