Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives
21 de maio de 2026 atualizado por: Medline Industries
surgical adhesive systems are used to close surgical cuts and simple skin wounds.
This system is a non-invasive option, meaning it can be used instead of stitches or staples.
Because these products do not require stitching deep into the skin, they can reduce the time it takes to close a wound and may reduce stress or damage to the skin edges.
Visão geral do estudo
Status
Concluído
Descrição detalhada
The OptiClose surgical adhesive system combines a liquid adhesive with a self-adhering mesh for the closure of surgical incisions and simple lacerations. It acts as a demonstrated noninvasive alternative to skin sutures and staples.
The OptiClose and Dermabond topical skin adhesives combine a self-adhering, pressure sensitive adhesive (PSA), polyester-based mesh (for incisions requiring a mesh), as well as a simple non mesh application system (for incisions that do not require a mesh) for temporarily adjoining the approximated skin edges of an incision, and a 2-octyl cyanoacrylate liquid adhesive formulation for final skin closure. By sparing long intracutaneous sutures, wound closure time is significantly reduced and wound edge ischemia potentially diminished. The purpose of this study is to conduct a two arm, prospective, randomized control trial by which participants will be randomly assigned to either receive the Dermabond wound closure adhesive or the OptiClose wound closure adhesive in participants undergoing the closure of any subcutaneous tissue following surgical site incisions.
Tipo de estudo
Intervencional
Inscrição (Real)
60
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Colorado
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Johnstown, Colorado, Estados Unidos, 80534
- Nadora Healthcare
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Are able to understand and willing to carry out instructions for this study.
- Full thickness surgical incision requiring subcutaneous closure.
Exclusion Criteria:
- Known sensitivities/allergies to the ingredients contained in the products. Individuals with a self-reported Type IV hypersensitivity reaction to cyanoacrylates (namely acrylates).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: larger incisions requiring mesh are randomized to two a Medline product and the other a comparator
In the first arm, larger incisions (greater than 20cm) requiring mesh are randomized to either OptiClose Secure or Dermabond Prineo.
Participants are assessed at three post procedure time points: immediately after skin closure and at two subsequent follow up visits.
Study endpoints include cosmetic outcome (cosmesis score), incidence of wound dehiscence or allergic reactions, dry time, and ease of application.
Participants complete the study following the final assessment visit, though withdrawal is permitted at any time, and investigators may discontinue participation if clinical concerns arise.
The study involved an overall duration of approximately 4-6 months[SR1] [NS2] , with participant follow up lasting about 4-6 weeks, including a 2 week post operative visit, placing all follow up activities within the referenced 8-12 week completion window.[
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Participants receive surgical incision closure using either OptiClose or Dermabond, selected through randomization based on incision characteristics.
Incisions requiring mesh support (>20 cm) are closed with adhesive plus mesh using one of the assigned products.
Outros nomes:
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Experimental: smaller incisions not requiring mesh are closed using adhesive only with participants randomized
In the second arm, smaller incisions (19 cm or smaller) not requiring mesh are closed using cyanoacrylate-based adhesive ("glue") only, with participants randomized to OptiClose Rapid or Dermabond Advanced.
Participants are assessed at three post procedure time points: immediately after skin closure and at two subsequent follow up visits.
Study endpoints include cosmetic outcome (cosmesis score), incidence of wound dehiscence or allergic reactions, dry time, and ease of application.
Participants complete the study following the final assessment visit, though withdrawal is permitted at any time, and investigators may discontinue participation if clinical concerns arise.
The study involved an overall duration of approximately 4-6 months.
, with participant follow up lasting about 4-6 weeks, including a 2 week post operative visit, placing all follow up activities within the referenced 8-12 week completion window
|
Participants receive surgical incision closure using either OptiClose or Dermabond, selected through randomization based on incision characteristics.
Incisions not requiring mesh (≤19 cm) are closed using cyanoacrylate-based adhesive alone.
Product assignment is randomized within each incision category.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Wound Adhesion Scoring
Prazo: 8-12 weeks post-operation
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Incidence of wound edge apposition without dehiscence or need of reapproximation following wound closure.
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8-12 weeks post-operation
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Dry Time
Prazo: During the procedure
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Timing in seconds to start once the applicator has contacted the skin and ends when the application of the liquid adhesive is complete and is no longer wet to the touch.
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During the procedure
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Modified Hollander Cosmesis Score (Total Score)
Prazo: 8-12 weeks post-operation
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Cosmetic appearance of the wound as identified by the Modified Hollander Wound Evaluation Scale.
The Modified Hollander Cosmesis Scale consists of multiple components assessed as binary outcomes (1 = absence, 0 = presence).
Individual item scores are summed to generate a total score per participant (overall cosmesis score) The total score ranges from 1 to 6, with higher scores indicating better cosmetic outcome.
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8-12 weeks post-operation
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Participant Satisfaction With Cosmetic Outcome
Prazo: 8-12 weeks post-operation
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Participant satisfaction with the cosmetic outcome was assessed using a numeric rating scale ranging from 1 to 10, where lower scores indicate greater satisfaction.
This assessment was collected alongside the Modified Hollander cosmesis evaluation.
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8-12 weeks post-operation
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Operator Satisfaction Score (1-10 Scale)
Prazo: 8-12 weeks post-operation
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Operator satisfaction with the cosmetic outcome was assessed using a numeric rating scale ranging from 1 to 10, where lower scores indicate greater satisfaction.
This assessment was collected alongside the Modified Hollander cosmesis evaluation.
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8-12 weeks post-operation
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Counts of Surgical Site Infections
Prazo: 8-12 weeks post-operation
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The counts will be collected of participants experiencing surgical site infections (SSIs) and recorded for each subject (as occurring within 30 days of treatment) as per the CDC guidelines.
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8-12 weeks post-operation
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Counts of Inflammatory reactions
Prazo: 8-12 weeks post-operation
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The counts will be collected of participants experiencing Inflammatory reactions and recorded for each subject as per the ICDRG guidelines.
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8-12 weeks post-operation
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mesh application time
Prazo: During the procedure
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Time to apply Mesh in seconds
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During the procedure
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Glue Application Time
Prazo: During the procedure
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Time to apply glue
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During the procedure
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Scott Dupar, Physician - Doctor of Medicine, Nadora Healthcare
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
2 de abril de 2025
Conclusão Primária (Real)
18 de março de 2026
Conclusão do estudo (Real)
18 de março de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
7 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de maio de 2026
Primeira postagem (Real)
29 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- MED-2024-DIV71-003
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
produto fabricado e exportado dos EUA
Não
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