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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Gharbia Governorate
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Tanta, Gharbia Governorate, Egipto, 31527
- Tanta University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.-
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
Otros nombres:
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Comparador activo: 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.
Otros nombres:
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Comparador activo: 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.
Otros nombres:
A single session of intradermal injection of autologous nanofat prepared from centrifuged and mechanically emulsified adipose tissue for treatment of post-traumatic atrophic scars.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Vancouver Scar Scale Score
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physician Global Assessment of Clinical Improvement
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TANTA-33465-11-19
- TU-DERM-PTAS-2020-01 (Identificador de registro: Internal Protocol Number)
- 33465/11/19 (Otro identificador: Ethics Approval Number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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