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临床试验/NCT06135480
NCT06135480已完成不适用

Subcision With Platelet-Rich Plasma and Microneedling Versus Subcision With Saline and Micro-needling in Treatment of Posttraumatic Scars: Randomized Clinical Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Scar severity grading

研究概览

简要总结

Compare different minimally invasive approaches to reach optimum improvement by comparing the efficacy and safety of both combined subcision with platelet-rich plasma and microneedling versus combined subcision with saline and microneedling in the treatment of post-traumatic scars.

详细描述

The scars at the level of the skin represent a normal and inevitable process of healing traumatic or surgical lesions, but except for the appearance of the skin, they also have a profound psychological impact . Thus, people with scars try to integrate them into their sense of self to gain psychological acceptance .

Many treatment options have been developed for the management of traumatic scars .Surgical intervention is an invasive technique, surgery has a high risk of inducing new scar formation .

Non-surgical approaches for the treatment of traumatic scars include topical treatments and minimally invasive approached as subcision,microneedling and laser.

Autologous platelet-rich plasma is plasma with a higher concentration of platelets than normally found, it can enhance wound healing which has been demonstrated in controlled studies for soft and hard tissues . The application of autologous platelet-rich plasma to surgical wounds has been shown to accelerate tissue repair and reduce postoperative pain .

Subcision is a procedure in which a needle is inserted under the skin and passed in multiple directions . Although subcision is adequate as a stand-alone treatment, improved results are achieved when it is combined with other modalities.

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 (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with posttraumatic scars
  • •Age more than 12 years

排除标准

  • •Patients with platelet or blood clotting disorders, and chronic liver or autoimmune diseases.
  • •Patients with chronic debilitating diseases, uncontrolled systemic infection, or keloid tendency or with unrealistic expectations.
  • •Pregnant females.
  • •Patients who did not complete the treatment sessions or the follow-up period.

研究组 & 干预措施

combined subcision with platelet-rich plasma and microneedling group

Active Comparator

干预措施: subcision ,PRP or saline and microneedling (Other)

combined subcision with saline and microneedling group

Active Comparator

干预措施: subcision ,PRP or saline and microneedling (Other)

结局指标

主要结局

Scar severity grading

时间窗: after 1 month of treatment completion.

Scar severity grading will be evaluated by blinded dermatologist

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Howida Omar Twisy

principal investigator

Assiut University

研究点 (1)

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