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临床试验/NCT03279549
NCT03279549Unknown不适用

A Randomized, Controlled, Prospective Clinical Trial on the Key Technology of Burn Wound Treatment

Xijing Hospital0 个研究点目标入组 200 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

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

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

Active Comparator

Routine dressing change group

干预措施: Routine dressing change (Procedure)

Dermal matrix dressing group

Experimental

Limited debridement & Acellular dermal matrix dressing group.

干预措施: Limited debridement & Acellular dermal matrix dressing (Procedure)

Epidermal cell spraying group

Experimental

Limited debridement & Epidermal cell spraying group

干预措施: Limited debridement & Epidermal cell spraying (Procedure)

BFGF group

Experimental

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

发起方
Xijing Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hu Dahai

Director of Burn Center

Xijing Hospital

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