A Randomized, Controlled, Prospective Clinical Trial on the Key Technology of Burn Wound Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Wound healing time
研究概览
简要总结
Burns are common injuries in the daily life and wars. With the development of medical techniques, the mortality has been significantly reduced. However, the deformity and disability caused by hypertrophic scar have not been improved effectively since the wound repair technology is limited and controversial, especially on the early treatment of deep second degree burns. The prognosis of burns is of great difference. In recent years, the promotion of wound repairing technologies provides a new opportunity for improving the quality of wound healing and solving the problem of scar formation. Although some new methods and techniques have shown significant efficacy in clinic, clinical researches with large samples conducted in multiple centers are still deficient, impeding the evaluation of their superiority. Therefore, the current protocol focuses on the repair of deep second degree burns based on previous researches. There are four types of treatment protocols for wounds. Patients were divided into four groups randomly, including regular dressing change group, controlled debridement + biological dressing covering group (xenogeneic acellular dermal matrix), controlled debridement + epidermal cell cultivation group, controlled debridement + bFGF treatment group. The wound healing rate, healing time and scar formation were observed. The availability and security were evaluated. Further more, treatment guidelines and expert consensuses on deep second degree burn wounds were concluded. Above studies are important to promote the treatment of deep second degree burns to be scientific, standardized and professional in China.
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 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Area of deep second burn wound >=10cm×10cm,total burn area ≤50% TBSA.
- •Within 96 hours after burns and could be managed within 24 hours after included.
- •Ages from 18 to
- •No serious breathing, circulation and other systemic diseases, no surgical contraindications.
- •Agrees to participate in this trial and has signed an informed consent form.
排除标准
- •Have severe inhalation injury or shock, or acute respiratory failure;
- •There are serious heart (especially the recent myocardial infarction, myocardial damage, etc.), brain, liver, kidney, lung and other organ disease;
- •Susceptible to allergies;
- •Islamic believers
- •Pregnant women
- •Other cases that are not suitable for study
研究组 & 干预措施
dressing change group
Routine dressing change group
干预措施: Routine dressing change (Procedure)
Dermal matrix dressing group
Limited debridement & Acellular dermal matrix dressing group.
干预措施: Limited debridement & Acellular dermal matrix dressing (Procedure)
Epidermal cell spraying group
Limited debridement & Epidermal cell spraying group
干预措施: Limited debridement & Epidermal cell spraying (Procedure)
BFGF group
Limited debridement & Basic fibroblast growth factor group
干预措施: Limited debridement & Basic fibroblast growth factor (Procedure)
结局指标
主要结局
Wound healing time
时间窗: 21 days after treatment
Healing time is the number of days when the wound healed completely after management.
次要结局
- Scar formation(6 months after treatment)
- Wound healing rate(21 days after treatment)
研究者
Hu Dahai
Director of Burn Center
Xijing Hospital
