Efficay of Autologous Platelet Rich Plasma Obtained With RgenKit-BCT in the Prevention and the Treatment of Keloid Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Regen Lab SA
- 入组人数
- 15
- 主要终点
- Percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment.
研究概览
简要总结
The aim of this prospective study is to assess the efficacy of autologous Platelet Rich Plasma prepared with RegenKit-BCT in the prevention and the treatment of keloid scars refractory to conventional treatments. Fifteen patients were included and received three PRP injection sessions with a one-month interval. The outcomes were assessed at baseline (before treatment), 3, 6, 12 and 24 months after the last injection session. Safety was assessed by reported adverse event analysis.
详细描述
To evaluate the efficacy and the safety of platelet rich plasma in the treatment of keloid scars. This prospective, comparative study (before-after treatment) included 15 patients with keloid scars refractory to conventional treatment (corticoids, surgery, cryotherapy). The primary outcome was the percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment. Secondary outcomes were the Vancouver scar scale and pruritus severity scored at 3, 6, 12 and 24 months post treatment vs baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with keloid scars refractory to conventional treatments. The indication of PRP injection was based on the absence of response to corticosteroids alone or in combination with surgery after 4 sessions of infiltration and/or absence of response to other therapies.
排除标准
- •Patients younger than 18 years
- •Pregnancy or breastfeeding
- •Patients suffering from anemia
- •patients with active skin disorder infection including active hepatitis or human infection virus infection
- •Auto-immune disease such as Hashimoto, rheumatoid arthritis.
- •Malignancy with or without metastatic disease
- •Chemotherapy
- •Anticoagulant therapy
结局指标
主要结局
Percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment.
时间窗: 24 months
The efficacy of autologous platelet concentrate obtained with RegenKit®-BCT was assessed based on the percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment.
次要结局
- Adverse events(24 months)
- prirutis severity(24 months)
- Pain assessment(3 months)
- Evaluation of the scar using Vancouver scale.(24 months)
- patient satisfaction(24 months)