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临床试验/NCT05887232
NCT05887232已完成1 期

Comparative Study on the Efficacy of Fractional CO2 and Fractional CO2 Laser With Autologous Platelet Rich Plasma in Scars

Combined Military Hospital Abbottabad2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Quartile grading scale for assessment of scars

研究概览

简要总结

Objective: To compare the effect of Fractional Carbon dioxide Laser (FCL) Vs Fractional Carbon dioxide Laser with platelet rich plasma (PRP) in management of Scars.

Study design: Randomized-controlled trial (RCT). Study setting and duration: Dermatology Department, CMH-Abbottabad, November 2022/April 2023.

Methodology: The sample size of 60 patients, age 18 to 50 years, was calculated by using Openepi app and the non-probability consecutive sampling technique was used. Patient in group A received FCL treatment's four sessions with four weeks apart, whereas Group B received four PRP and FCL sessions. The Quartile grading scale (score 0 is <25%, score 1 is 25-50%, score 2 is 51-75% and score 3 is >75% improvement) was used to assess the patient's clinical improvement at 4 weeks after each session. To determine statistical significance χ2-square test, taking p-value <0.05 as significant, was used.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-50 years
  • Fitzpatrick skin type III-V
  • Presented with post-acne, post traumatic or post burn scars
  • all those patients emotionally balanced with realistic expectations were included in the study.

排除标准

  • scar that was less than 6 months old
  • if they had an active infection or inflammatory skin condition
  • having a history of malignancy
  • a known connective tissue illness
  • history of excessive bleeding or keloids
  • unrealistic expectations
  • pregnant or breastfeeding.

结局指标

主要结局

Quartile grading scale for assessment of scars

时间窗: 16 weeks

Quartile grading scale was used to assess effectiveness of CO2 laser and CO2 laser with Platelet rich plasma in scars.Minimum score=0,Maximum Score=3 .Maximum score means better outcome.The Quartile grading scale (score 0 is \<25%, score 1 is 25-50%, score 2 is 51-75% and score 3 is \>75% improvement) was used to assess the patient's clinical improvement at 4 weeks after each session.

次要结局

未报告次要终点

研究者

发起方
Combined Military Hospital Abbottabad
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zahra Nigar

Principle Investigator

Combined Military Hospital Abbottabad

研究点 (2)

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