Poly-L-Lactic Acid Threads Versus Platelet-Rich Plasma for Post-Traumatic Atrophic Scars (PLLA-PRP PTAS)
A Comparative Study of Poly-L-Lactic Acid Threads Versus Platelet-Rich Plasma, Both Combined With Subcision, in the Treatment of Post-Traumatic Atrophic Scars
研究概览
详细说明
Post-traumatic atrophic scars result from abnormal healing following skin injury and may cause significant cosmetic and functional impairment. Subcision releases the fibrous bands tethering the scar to deeper tissues and may improve the response to additional treatments. PLLA threads are biodegradable materials that can stimulate collagen production, while PRP contains concentrated platelets and growth factors that may enhance tissue repair and remodeling.
This comparative study was conducted at the Dermatology and Venereology Department, Tanta University Hospital. Patients diagnosed with post-traumatic atrophic scars for at least one year and who had not received treatment during the preceding six months were enrolled. Patients with keloids, immunosuppression, coagulative or thrombophilic disorders, or chronic diseases were excluded.
Participants were divided into two equal treatment groups. Group A received a single session of subcision followed by insertion of poly-L-lactic acid threads. Group B received subcision combined with PRP injection for four sessions at one-month intervals. Clinical photographs were obtained before treatment and three months after treatment. Clinical improvement was assessed by two blinded dermatologists using the Global Aesthetic Improvement Scale, while patient satisfaction and treatment-related complaints or adverse effects were also recorded.
Skin biopsies were obtained from six patients before treatment and three months after treatment and evaluated using hematoxylin and eosin and trichrome staining to assess histopathological changes. All patients were followed for three months.
The study was approved by the Research Ethics Committee of the Faculty of Medicine, Tanta University, with approval number 32889/01/19, and informed consent was obtained from all participants.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Tanta、埃及
- Tanta University Hospitals
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-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Patients with post-traumatic atrophic scars. Scar duration of at least 1 year. No treatment received during the previous 6 months.
Exclusion Criteria:
- Keloids Immunosuppression Coagulative disorders Thrombophilic disorders Any chronic diseases
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:subcision and PLLA threads
subcision and PLLA threads' insertion at the same session
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subcision and PLLA threads' insertion at the same session
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有源比较器:PRP and subcision (PRP-S) injection
PRP and subcision (PRP-S) injection monthly for four sessions
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PRP and subcision (PRP-S) injection monthly for four sessions
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Global Aesthetic Improvement Scale (GAIS) score
大体时间:3 months after treatment
|
Clinical improvement of post-traumatic atrophic scars was assessed using the Global Aesthetic Improvement Scale by two dermatologists blinded to the treatment group.
The scale was graded from 1 to 4: Grade 1 = mild/no improvement (0-25%), Grade 2 = moderate improvement (26-50%), Grade 3 = marked improvement (51-75%), and Grade 4 = excellent improvement (>75%).
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3 months after treatment
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 32889/01/19
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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