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临床试验/NCT04781348
NCT04781348已完成4 期

Efficacy of Platelet Rich Plasma Injection Plus Fat Grafting as Compared to Fat Grafting Alone on Burn Scar by Using Vancouver Scar Scale

Dow University of Health Sciences2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
64
试验地点
2
主要终点
Assessment of change in scar

研究概览

简要总结

Background: - Burn injuries always leave behind some permanent marks on the body of a victim. For the treatment of these scars, digital photography along with scar scales instrument are an important instrument for the patient's evaluation and finally for the follow-up of scars. Clinical evaluation of the patient after the use of Platelet concentration that it is a beneficial treatment which affects both on hard and soft tissues healing because of having growth factors deposited in PRP. Therefore, it can be used as an alternative to surgery which promotes safe and natural healing in such patients.

Objectives: -

  1. To determine the efficacy of Platelet Rich Plasma plus fat grafting as compared to fat grafting alone on the Vancouver scar scale.

Methodology: - An experimental controlled comparison trial study will be done on burn patients, admitted for recovery at the Plastic surgery department, Civil Hospital Karachi after the approval of the scientific committee and Institutional review board of Dow University of Health Sciences, Karachi. The study participants fulfilling the inclusion criteria giving consent will be randomly divided into two groups, one group will receive only fat grafting whereas another group will receive Platelet Rich Plasma plus fat grafting. The sample size of the study will be 52(26 in each group). Both the groups will be followed initially for 15 days of two visits then monthly two visits and finally after 6 months. Assessment of scar with Vancouver Scars Scale (VSS) will be done. The association of the PRP plus fat cells group and control group will be done by applying Chi-square statistical test. P-Value will be set for statistical significance level at <0.05.

详细描述

OBJECTIVE:

  1. To determine the Efficacy of platelet rich plasma injection (PRP) plus fat grafting as compared to fat grafting alone on burn scar by using Vancouver Scar Scale.

HYPOTHESIS:

Null hypothesis:

There is no difference between the effect of Platelet-rich plasma (PRP) plus fat grafting and only fat grafting on the burn scar.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All the buns patients of either age or sex coming with burn scar for plastic surgery.
  • Give consent for this study
  • Aesthetically not pleasant
  • Exposed body parts
  • Mature scar

排除标准

  • Immature scar
  • Systematic illness.
  • Psychiatric illness.
  • Pregnant women

结局指标

主要结局

Assessment of change in scar

时间窗: Both the groups will be followed initially for 15 days of two visits then monthly two visits and finally after 6 months.

Assessment of scar with Vancouver Scars Scale

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

Nasreen Bano

Dr.

Dow University of Health Sciences

研究点 (2)

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