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临床试验/CTRI/2024/05/068198
CTRI/2024/05/068198尚未招募不适用

A Comparative Study On Efficacy Of Injectable Platelet Rich Fibrin (i-PRF) And Platelet Rich Plasma (PRP) In Facial Scars - A Triple Blinded Randomized Clinical Trail.

Anil Neerukonda Institute of Dental Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
surface area of the scar

研究概览

简要总结

  1. Aim of this study is to compare the efficacy between Injectable Platelet-Rich Fibrin (i-PRF) and Platelet-Rich Plasma (PRP) in the treatment of Facial Scars. Patients who report with chief complaint of facial scar to the Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Visakhapatnam. Careful evaluation & selection of participants. Written Informed Consent will be taken from selected participants & Preoperative Patient and Observer Scar Assessment Scale (POSAS) will be takenrespectively. The co- investigator will be helping in blinding and allocation concealment. The participants will be randomly assigned to Group A & Group B. Both the Principal Investigator and Participant will be blinded. The Co-investigator will be helping with randomization, blinding and Allocation concealment. The Evaluator, who is blinded, will assess Postoperative outcomes one month after the last session in all the participants from both the groups by Patient and Observer Scar Assessment Scale (POSAS). The collected data will be consolidated and statistically analyzed.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Scars secondary to surgical incision and trauma.
  • Scars involving head and neck region.
  • Patients willing to participate in the study.

排除标准

  • Scars secondary to burns, acne.
  • Scars that received any previous revision/treatment.
  • Patients with history keloid tendency, any active skin/systemic conditions, immunosuppression, bleeding and clotting disorders, pregnancy.

结局指标

主要结局

surface area of the scar

时间窗: 1 month

次要结局

  • pigmentation and texture(1 month)

研究者

发起方
Anil Neerukonda Institute of Dental Sciences
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Narasimhadevara Santha Lakshmi Pratyusha

Anil Neerukonda Institute Of Dental Sciences

研究点 (1)

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