Nanofat Injection and Fractional CO2 Laser for Post-Traumatic Atrophic Scars (NANOCO2-PTS)
Safety and Efficacy of Nanofat Injection and Fractional CO2 Laser: Monotherapy Versus Combined Therapy in Post-Traumatic Atrophic Scars
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Post-traumatic atrophic scars are characterized by dermal collagen loss, epidermal thinning, and alterations in skin texture and pigmentation. These scars may result in significant cosmetic disfigurement and negatively affect patients' quality of life. Despite the availability of multiple treatment modalities, no single intervention has consistently demonstrated optimal efficacy.
Fractional carbon dioxide (CO2) laser induces controlled microthermal injury that stimulates collagen remodeling and skin regeneration. Autologous nanofat grafting, which is rich in adipose-derived regenerative cells and growth factors, has emerged as a promising regenerative treatment for improving skin quality and scar remodeling. Combining these two modalities may provide synergistic effects by enhancing tissue regeneration and improving both structural and aesthetic outcomes.
This prospective comparative study was conducted to evaluate and compare the safety and efficacy of fractional CO2 laser monotherapy, autologous nanofat injection monotherapy, and combination therapy in the treatment of post-traumatic atrophic scars. Clinical efficacy was assessed using physician evaluation, Vancouver Scar Scale scores, and patient satisfaction, while dermoscopic and histopathological examinations were performed to investigate treatment-induced structural changes and the mechanisms underlying scar improvement.
The study aimed to determine whether combined therapy offers superior clinical and regenerative outcomes compared with either treatment alone while maintaining an acceptable safety profile.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Gharbia Governorate
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Tanta, Gharbia Governorate, Egito, 31527
- Tanta University Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Male or female participants aged 12 years or older.
- Presence of post-traumatic atrophic scar(s) of at least 6 months' duration.
- No scar treatment received during the previous 6 months.
- Willingness and ability to provide written informed consent (or assent with -parental/guardian consent for minors, according to local regulations).
- Willingness to comply with study procedures and follow-up assessments.
Exclusion Criteria:
- Hemoglobin <10 g/dL.
- Active infection or viral skin disease.
- Coagulopathy or hemophilia.
- Current anticoagulant therapy.
- Diabetes mellitus.
- History of keloid formation.
- History of malignancy or prior radiation therapy.
- Immunosuppression.
- Long-term systemic corticosteroid therapy.
- Photosensitivity disorders.
- Pregnancy or breastfeeding.
- Renal or hepatic disease.
- Systemic diseases affecting wound healing.
- Thin patients with insufficient adipose tissue for adipose tissue harvesting.
- Previous scar treatment within the preceding 6 months.
- Use of systemic retinoids within the preceding 6 months. -Use of topical retinoids within the preceding 2 weeks.-
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Fractional CO2 Laser
Participants will receive three sessions of fractional carbon dioxide laser treatment at one-month intervals.
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Fractional ablative carbon dioxide laser (10,600 nm) administered in three sessions at one-month intervals for treatment of post-traumatic atrophic scars.
Outros nomes:
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Comparador Ativo: Autologous Nanofat Injection
Participants will receive one session of autologous nanofat injection for treatment of post-traumatic atrophic scars.
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A single session of intradermal injection of autologous nanofat prepared from centrifuged and mechanically emulsified adipose tissue for treatment of post-traumatic atrophic scars.
Outros nomes:
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Comparador Ativo: Fractional CO2 Laser + Autologous Nanofat Injection
Participants will receive three sessions of fractional carbon dioxide laser at one-month intervals followed by one session of autologous nanofat injection.
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Fractional ablative carbon dioxide laser (10,600 nm) administered in three sessions at one-month intervals for treatment of post-traumatic atrophic scars.
Outros nomes:
A single session of intradermal injection of autologous nanofat prepared from centrifuged and mechanically emulsified adipose tissue for treatment of post-traumatic atrophic scars.
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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Change in Vancouver Scar Scale Score
Prazo: Baseline and 3 months after completion of treatment
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The change in scar severity assessed using the Vancouver Scar Scale (VSS), including vascularity, pigmentation, and pliability, from baseline to the post-treatment assessment.
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Baseline and 3 months after completion of treatment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Physician Global Assessment of Clinical Improvement
Prazo: 3 months after completion of treatment
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Clinical improvement evaluated by three blinded dermatologists using a quartile grading scale (poor: 0-25%, fair: 25-50%, good: 50-75%, excellent: 75-100% improvement).
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3 months after completion of treatment
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TANTA-33465-11-19
- TU-DERM-PTAS-2020-01 (Identificador de registro: Internal Protocol Number)
- 33465/11/19 (Outro identificador: Ethics Approval Number)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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