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临床试验/NCT07716605
NCT07716605已完成不适用

Effectiveness of Alovera Gel vs 1% Silver Sulfadiazine in Superficial Partial Thickness Burn Patients in Pediatric Population.

University of Child Health Sciences and Children's Hospital, Lahore1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月20日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Degree of repithelization

研究概览

简要总结

This prospective randomized controlled study aims to compare the effectiveness of Aloe vera gel versus 1% silver sulfadiazine in the treatment of superficial and superficial partial-thickness burns in the pediatric population. Burn injuries are among the most common causes of morbidity in children, and optimal topical treatment is important for pain control, prevention of infection, and rapid wound healing.

Pediatric patients presenting with superficial and superficial partial-thickness burns will be enrolled and allocated into two treatment groups. One group will receive topical Aloe vera gel, while the other group will receive 1% silver sulfadiazine dressing according to standard burn care protocols. Patients will be followed regularly to assess wound healing progress, pain, infection rate, duration of healing, frequency of dressing changes, and any treatment-related complications. The primary outcome will be time to complete wound healing, while secondary outcomes will include pain score, infection rate, hospital stay, and scar formation.

详细描述

Burn injuries are a significant cause of morbidity among the pediatric population and require effective topical therapy to promote wound healing, prevent infection, reduce pain, and minimize treatment cost. Silver sulfadiazine 1% cream is commonly used as a standard topical antimicrobial agent for superficial burns; however, delayed wound healing and frequent dressing requirements have encouraged the search for alternative therapies. Aloe vera has demonstrated anti-inflammatory, antimicrobial, soothing, and wound-healing properties in previous studies and may serve as an effective and economical alternative in burn management.

This randomized controlled trial will be conducted at The Children's Hospital & Institute of Child Health Lahore over a duration of one year. A total of 60 pediatric patients aged 1 to 18 years presenting with superficial and superficial partial-thickness burns involving 1% to 25% total body surface area (TBSA) will be enrolled in the study. Patients will be randomly allocated into two groups by coin toss/lottery method. One group will receive topical Aloe vera gel dressing, while the second group will receive 1% silver sulfadiazine dressing. Dressings will be applied three times daily according to institutional burn care protocol.

Patients will be followed for a period of 14 days to assess treatment outcomes. The primary outcome measure will be the degree and rate of re-epithelialization of burn wounds. Secondary outcome measures will include pain relief, infection rate, and cost effectiveness of treatment. Patients with burns deeper than superficial partial-thickness burns, including deep second-degree and third-degree burns, as well as patients requiring surgical intervention or presenting with major associated comorbidities, will be excluded from the study.

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
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • - Patients aged 1 to 18 years
  • Both male and female patients
  • Superficial and superficial partial-thickness burns
  • Burn extent involving 1% to 25% total body surface area (TBSA)
  • Presentation within acute phase of burn injury

排除标准

  • - Deep partial-thickness (deep second-degree) or third-degree burns
  • Patients requiring surgical intervention (skin grafting)
  • Infected burns at presentation
  • Patients with major comorbidities affecting wound healing (e.g., immunodeficiency, diabetes mellitus)
  • Known hypersensitivity to Aloe vera or silver sulfadiazine

结局指标

主要结局

Degree of repithelization

时间窗: 14 days

The primary outcome is the degree and rate of re-epithelialization of superficial and superficial partial-thickness burn wounds in pediatric patients. Wound healing will be assessed clinically by measuring percentage of wound closure and epithelial regeneration over a follow-up period of 14 days or until complete healing, whichever occurs earlier

次要结局

  • Pain relief(14 days)
  • Wound Infection(14 days)
  • Cost effectiveness(14 days)

研究者

发起方
University of Child Health Sciences and Children's Hospital, Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad farrukh ahmad

Post Graduate Resident

University of Child Health Sciences and Children's Hospital, Lahore

研究点 (1)

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