Safety and Efficacy of Nanofat Injection and Fractional CO2 Laser: Monotherapy Versus Combined Therapy in Post-Traumatic Atrophic Scars
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Vancouver Scar Scale Score
研究概览
简要总结
Post-traumatic atrophic scars are characterized by skin depressions caused by loss of collagen and can lead to cosmetic and psychological concerns. Several treatment options have been proposed, including fractional carbon dioxide (CO2) laser resurfacing and autologous nanofat grafting, both of which may improve scar appearance through skin remodeling and regeneration. This prospective comparative study evaluates the safety and efficacy of fractional CO2 laser alone, autologous nanofat injection alone, and combination therapy in patients with post-traumatic atrophic scars. Sixty participants were assigned to one of three treatment groups and were assessed using the Vancouver Scar Scale, physician global assessment, patient satisfaction, dermoscopic examination, and histopathological evaluation. The study aims to determine whether combining fractional CO2 laser and nanofat injection provides superior clinical and regenerative outcomes compared with either treatment alone while maintaining an acceptable safety profile.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.-
研究组 & 干预措施
Autologous Nanofat Injection
Participants will receive one session of autologous nanofat injection for treatment of post-traumatic atrophic scars.
干预措施: Autologous Nanofat Injection (Biological)
Fractional CO2 Laser
Participants will receive three sessions of fractional carbon dioxide laser treatment at one-month intervals.
干预措施: Fractional CO2 Laser (Device)
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.
干预措施: Autologous Nanofat Injection (Biological)
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.
干预措施: Fractional CO2 Laser (Device)
结局指标
主要结局
Change in Vancouver Scar Scale Score
时间窗: Baseline and 3 months after completion of treatment
The change in scar severity assessed using the Vancouver Scar Scale (VSS), including vascularity, pigmentation, and pliability, from baseline to the post-treatment assessment.
次要结局
- Physician Global Assessment of Clinical Improvement(3 months after completion of treatment)