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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Gharbia Governorate
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Tanta、Gharbia Governorate、エジプト、31527
- Tanta University Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.-
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
他の名前：
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アクティブコンパレータ：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.
他の名前：
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アクティブコンパレータ：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.
|
Fractional ablative carbon dioxide laser (10,600 nm) administered in three sessions at one-month intervals for treatment of post-traumatic atrophic scars.
他の名前：
A single session of intradermal injection of autologous nanofat prepared from centrifuged and mechanically emulsified adipose tissue for treatment of post-traumatic atrophic scars.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Vancouver Scar Scale Score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physician Global Assessment of Clinical Improvement
時間枠：3 months after completion of treatment
|
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).
|
3 months after completion of treatment
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TANTA-33465-11-19
- TU-DERM-PTAS-2020-01 (レジストリ識別子：Internal Protocol Number)
- 33465/11/19 (その他の識別子：Ethics Approval Number)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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