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临床试验/NCT02958306
NCT02958306终止2 期

Evaluation of the Effect of Platelet Rich Plasma (PRP) on the Esthetic Outcome and Scar Formation of Unilateral Cleft Lip Repair by Modified Millard Cheiloplasty: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
终止
入组人数
24
试验地点
1
主要终点
scar width

研究概览

简要总结

The purpose of this study is to evaluate effect of platelet rich plasma on scar formation of unilateral cleft lip repair.

详细描述

PRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values. PRP is made by centrifugation of whole blood (drawn from a peripheral vein and stored in an acid citrate dextrose solution A (ACD-A) anticoagulant), which separates the various components of blood by their specific weight and increases the concentration of platelets.

Platelets are a rich source of the complex group of proteins called growth factors (GFs) involved in natural wound healing and in regeneration of injured tissues. GFs are active signals for attracting stem cells into the site of injury and triggering proliferation of these cells. PRP limit inflammation, interacting with macrophages to improve tissue healing and regeneration, promote new capillary growth, and accelerate epithelialization. Platelets in PRP also play a role in host defense mechanism at the wound site by producing signaling proteins that attract macrophages; PRP also may contain a small number of leukocytes that synthesize interleukins as part of a non-specific immune response. Previous studies of PRP have demonstrated antimicrobial activity against Escherichia coli, Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus, Candida albicans, and Cryptococcus neoforma. So, PRP is effective in soft tissue healing, having no side effect and showed excellent healing score in skin wound healing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
3 Months 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with nonsyndromic cleft lip
  • Primary, unilateral, complete or incomplete cleft lip
  • Patient's age younger than six months
  • Lip repair performed by one craniofacial surgeon
  • Completeness of medical records including preoperative and postoperative photographs at approximately 6 months after surgery

排除标准

  • Patients with syndromic cleft lip
  • Secondary lip treatment (previous operated cases)
  • Bilateral cleft lip
  • Patient older than six months
  • Associated Cardiac anomalies
  • Any systemic condition

研究组 & 干预措施

platelet rich plasma

Experimental

autologous blood product

干预措施: platelet rich plasma (Biological)

no platelet rich plasma

No Intervention

control

结局指标

主要结局

scar width

时间窗: 6months

scar width at skin surface via photograph

次要结局

  • vancouver scar scale(6 months)

研究者

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

Shaimaa Mohsen

assisstant lecturer

Cairo University

研究点 (1)

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