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临床试验/NCT04532840
NCT04532840Unknown2 期

Effect of Cryotherpy on Hypertrophic Scar

Zakria Mowafy1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年4月15日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
60
试验地点
1
主要终点
scar height

研究概览

简要总结

Purpose of the study:

The purpose of the study is to evaluate the therapeutic effect of cryotherpy in treating hypertrophic scar.

It will be hypothesized that:

Cryotherapy may not have an effect on hypertrophic scar.

详细描述

The potential of cryotherapy application in vitro data indicated that using freezing treatment on VFFs + TGF-β1 (myofibroblast) modulated ECM turnover toward antifibrosis and normalization, attenuated myofibroblast differentiation, reduced cell migration, and weakened the contractile activity. On both VFFs ± TGF-β1, freezing treatment raised LP regeneration (HAS1, decorin).

The findings indicate that cryotherapy may play a protective role in scar formation and contribute to lamina regeneration.

Furthermore the need of this study was developed from the lack in the quantitative knowledge and information in the published studies about the effect of cryotherapy on hypertrophic scar.

This study will be designed to provide a guideline about the effect of effect of cryotherapy on hypertrophic scar height, thickness and discoloration, and to assist in planning an ideal treatment regimen for reducing hypertrophic scar.

Delimitations:

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
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age range between 20- 40 years.
  • Both sexes will participate in the study.
  • All patients participated will begin treatment program one month after injury depending on injury characteristics.
  • All patients enrolled to the study will have their informed consent.

排除标准

  • Diabetes mellitus.
  • Individuals with cardiopulmonary conditions.
  • Individuals undergoing radiation therapy or chemotherapy.
  • Hepatic or pancreatic diseases.
  • Sensory impairment

结局指标

主要结局

scar height

时间窗: 3 months

The potential of cryotherapy application in vitro data indicated that using freezing treatment on scar decrease its height

次要结局

未报告次要终点

研究者

发起方
Zakria Mowafy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zakria Mowafy

Professor of Physical Therapy for Surgery Faculty of Physical Therapy

Cairo University

研究点 (1)

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