RBR-2fcsnhq Quality of post-surgical healing in patients with Dupuytren's Disease

Date of registration: 02/14/2022 ^(mm/dd/yyyy)
Last approval date : 02/14/2022 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1273-2903

• Public title:

  en

  Quality of post-surgical healing in patients with Dupuytren's Disease

  pt-br

  Qualidade da cicatrização pós cirúrgica de pacientes com Doença de Dupuytren

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 61495516.1.0000.5505
    Issuing authority: Plataforma Brasil
  • 1.814.239
    Issuing authority: Comitê de ética em pesquisa da Universidade Federal de São Paulo

Sponsors

• Primary sponsor: Luiz Guilherme de Saboya Lenzi
• Secondary sponsor:
  • Institution: Universidade Federal de São Paulo
• Supporting source:
  • Institution: Fundação Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Health conditions

• Health conditions:

  en

  Dupuytren

  pt-br

  Dupuytren

• General descriptors for health conditions:

  en

  M72.0 Palmar fascia fibromatosis

  pt-br

  M72.0 Fibromatose da fascia palmar

• Specific descriptors:

  en

  M72.0 Dupuytren

  pt-br

  M72.0 Dupuytren

Interventions

• Interventions:

  en

  Experimental group: 2 technical patients diagnosed with Dupuytren's disease, divided into two groups, randomly selected, will be included in an open partial fasciectomy surgery by Bruner and by the McCash technique, and followed up for a period of 6 months, and how much satisfaction with healing.

  pt-br

  Grupo experimental: 60 pacientes com diagnóstico de Doença de Dupuytren, divididos em dois grupos, selecionados de forma randomizada, serão submetidos a cirurgia de fasciectomia parcial aberta pela técnica de Bruner e pela técnica de McCash, e acompanhados por um período de 6 meses, e avaliados quanto a satisfação com a cicatriz.

• Descriptors:

  en

  M72.0 Partial fasciectomy

  pt-br

  M72.0 Fasciectomia parcial

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 06/15/2016 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  60	-	0	0

• Inclusion criteria:

  en

  Patients with a previous diagnosis of Dupuytren's disease, indication for surgical treatment, both sexes, older than 40 years, who agree to participate in the research, prior signature of the free and informed consent form

  pt-br

  Pacientes com diagnóstico prévio de doença de Dupuytren, indicação de tratamento cirúrgico, ambos os sexos, maiores do que 40 anos, que concordem em participar da pesquisa, assinatura previa do termo de consentimento livre e esclarecido

• Exclusion criteria:

  en

  Patients under 40 years of age, without clinical conditions to undergo surgical treatment, presence of previous trauma to the hand and wrist that will undergo surgical treatment, previous hand and wrist surgery that will undergo surgical treatment

  pt-br

  Paciente menores do que 40 anos, sem condições clinicas para ser submetido a tratamento cirúrgico, presença de trauma prévio em mão e punho que será submetida ao tratamento cirúrgico, cirurgia prévia em mão e punho que será submetida ao tratamento cirúrgico

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Prognostic	Other	2	Triple-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Comparison of the degree of satisfaction with the post-surgical scar, in both techniques, evaluated by the Patient And Observe Scar Assessment Scale translated into Portuguese

  pt-br

  Comparação do grau de satisfação com a cicatriz pós cirúrgica, em ambas as técnicas, avaliada pelo Patient And Observe Scar Assessment Scale traduzido para o portuguesa.

• Secondary outcomes:

  en

  Secondary outcomes are not expected

  pt-br

  Não são esperados desfechos secundários

Contacts

• Public contact
  • Full name: Flavio Faloppa
  • • Address: Rua Borges Lagoa, 786 - Vila Clementino
    • City: São Paulo / Brazil
    • Zip code: 04038-001
  • Phone: +55(47)5579-7049
  • Email: faloppa.dot@gmail.com
  • Affiliation: Universidade Federal de São Paulo
   
• Scientific contact
  • Full name: Luiz Guilherme de Saboya Lenzi
  • • Address: Rua Borges Lagoa, 786 - Vila Clementino
    • City: São Paulo / Brazil
    • Zip code: 04038-001
  • Phone: +55(11)5579-7049
  • Email: lenzimedicina@yahoo.com.br
  • Affiliation: Fundação Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
   
• Site contact
  • Full name: João Baptista Gomes dos Santos
  • • Address: Rua Borges Lagos, 786
    • City: São Paulo / Brazil
    • Zip code: 04038-001
  • Phone: +55(11)55797049
  • Email: joaobgs@ig.com.br
  • Affiliation: Universidade Federal de São Paulo
   

Additional links:

• Download in ICTRP format