跳至主要内容
临床试验/CTRI/2023/05/052350
CTRI/2023/05/052350尚未招募不适用

Effect of burns on the functional impairments and quality of life in adult patients

Zoya Mohammed1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Primary outcome measure-

研究概览

简要总结

Burns commonly known asan injury to the skin caused by numerous agents such as heat, chemicals,electricity, and radiation is a debilitating concern. According to World Health Organization’s fact sheetof 2018 the global estimation of deaths due to burn injury is 1,80,000 peryear. In India, 7 million people are the victim of burn injuries with over10,00,000 people are casualty of moderate or severe burn injury every year1and 2.4 lakh people suffering from a disability2 and burns is one ofthe leading cause of disability-adjusted life years (DALYs).1, 3 Theincidence of burns in India hikes in Diwali festival with more than 23,000fire-related deaths were estimated in India in the year 2019, which accountsfor 20% of the global mortality burden. Also, 1.5 million DALYs were attributedto burns3. Burn patients do not exhibit homogeneity, the functionaloutcome is dependent on various factors such as age, mechanism of injury, totalbody surface area, depth as well as the site of the burn. Burns not onlyinfluences a person’s physical, psychological, and social functioning but alsoit often results in significant morbidity, impairment in emotional well-being,and negative effects on the appearance in turn affecting their ability toreturn to work.

 Brief summary- It is importantto understand the repercussions of burns beyond their quantification in termsof total body surface area and its depth because there are many confoundingfactors such as age, gender and personal factors could be varied and may affectthe patient’s condition.  Hence, there isa need to see an association between the quantification of burns withfunctional impairments and quality of life.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)

入选标准

  • •Age- 18 and above
  • •Gender- male and female
  • •Participants who are conscious and oriented.
  • •At least 3 weeks post partial thickness burns.
  • •At least 6 weeks post full thickness/surgically managed burn injury.
  • •Give written informed consent to the study.

排除标准

  • •Unstable vitals.
  • •Participants who sustained fracture during burns.
  • •Participants with neurological involvement.
  • •Participants with cognitive impairment.
  • •Participants with a clinically diagnosed psychiatric condition.

结局指标

主要结局

Primary outcome measure-

时间窗: Baseline

1.Pain (NRS)

时间窗: Baseline

2.Total body surface area and depth of burn (Lund and Browder chart.)

时间窗: Baseline

3.Upper limb functional impairment (QuickDASH)

时间窗: Baseline

4.Lower limb functional impairment [Lower Limb Functional Index-10 (LLFI-10)]

时间窗: Baseline

5.Quality of life [Burn-Specific Health Scale- revised brief and adapted (BSHS-RBA)]

时间窗: Baseline

次要结局

  • statistically significant determinants of disability in burns cases(Same day)

研究者

发起方
Zoya Mohammed
申办方类型
Other [individual]

研究点 (1)

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