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临床试验/NCT05404191
NCT05404191招募中不适用

DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF LOW LEVEL LASER ON BURN WOUND HEALING

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
reduced wound surface area

研究概览

简要总结

The purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to low level laser therapy in burn patients

详细描述

It will be hypothesized that

  1. Age may significantly affect burn wound healing's response to low level laser therapy.
  2. TBSA may significantly affect burn wound healing's response to low level laser therapy.
  3. Depth of wound may significantly affect burn wound healing's response to low level laser therapy.
  4. Wound healing stage may significantly affect burn wound healing's response to low level laser therapy. There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units.

Low level laser therapy will be performed for 30 min 3 times per week for 8 weeks on the wound area.

Wound area was irradiated by a red 655 nm light, 150 mW, 2 J/cm2 at the bed of the wound.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Partial thickness Burn wound depth.
  • Age ranges from 20-50 years.
  • TBSA more than 15%
  • Sufficient understanding to perform the test

排除标准

  • Diabetic patients.
  • Burn wound with skin graft
  • Infected wounds
  • Patients receiving immunosuppressive drugs.
  • Patients receiving irradiation or chemotherapy.
  • Chronic circulatory diseases
  • Severe associated injury with burn.
  • Associated co-morbidities, such as neurological diseases, malnutrition, and other inflammatory and/or infectious diseases.

结局指标

主要结局

reduced wound surface area

时间窗: maximum of 6 weeks

measure of wound surface area using manual tracing method before and after application of treatment

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

ahmed mohamed nagy

lecturer of physical therapy for surgery- Cairo university

Cairo University

研究点 (1)

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