Research on the Key Technology of Burn Wound Treatment
2018年6月25日 更新者:Hu Dahai、Xijing Hospital
A Randomized, Controlled, Prospective Clinical Trial on the Key Technology of Burn Wound Treatment
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.
研究概览
地位
未知
条件
研究类型
介入性
注册 (预期的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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 60.
- No serious breathing, circulation and other systemic diseases, no surgical contraindications.
- Agrees to participate in this trial and has signed an informed consent form.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:dressing change group
Routine dressing change group
|
Through regular dressing changes to clean the wound, reduce bacterial growth in the wound and protect the wound.
In recent years, nano-silver ion gel and dressings are widely used in burns, which effectively reduced the risk of wound infection and beneficial for wound healing.
This technique is widely used in clinic.
|
|
实验性的:Dermal matrix dressing group
Limited debridement & Acellular dermal matrix dressing group.
|
In the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories.
This could improve circulation of wounds and improve wound healing.
The xenogeneic acellular dermal matrix dressing has a better protective effect on burn wound after debridement.
After covering, the wound will remain alive for about two weeks, providing a good microenvironment for wound repair.
|
|
实验性的:Epidermal cell spraying group
Limited debridement & Epidermal cell spraying group
|
In the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories.
This could improve circulation of wounds and improve wound healing.
Epidermal cell spraying technology is a brand new method to rapidly collect epidermal cells from patients themselves and then used on their wounds.
The recipient site is 40-80 times than the donor site.
|
|
实验性的:BFGF group
Limited debridement & Basic fibroblast growth factor group
|
In the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories.
This could improve circulation of wounds and improve wound healing.
BFGF is a kind of polypeptide capable of promoting the growth of fibroblasts, and it also promotes the proliferation, differentiation and migration of epidermal cells.
Studies have shown that bFGF could significantly improve the healing of burn wounds.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Wound healing time
大体时间:21 days after treatment
|
Healing time is the number of days when the wound healed completely after management.
|
21 days after treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Wound healing rate
大体时间:21 days after treatment
|
Wound healing rate =(area before management - area after management)/ area before management×100%.
|
21 days after treatment
|
|
Scar formation
大体时间:6 months after treatment
|
Vancouver scar score
|
6 months after treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Xie Songtao, Doctor、Xijing Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2018年7月1日
初级完成 (预期的)
2018年12月31日
研究完成 (预期的)
2019年9月30日
研究注册日期
首次提交
2017年9月5日
首先提交符合 QC 标准的
2017年9月8日
首次发布 (实际的)
2017年9月12日
研究记录更新
最后更新发布 (实际的)
2018年6月27日
上次提交的符合 QC 标准的更新
2018年6月25日
最后验证
2018年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Routine dressing change的临床试验
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National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); PENTA...完全的
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University of Witwatersrand, South AfricaDepartment for International Development, United Kingdom; Medical Research Council, South Africa 和其他合作者未知
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Johns Hopkins Bloomberg School of Public HealthInnovations for Poverty Action; Investors Club/Enterprise Uganda完全的
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University of Toronto Practice Based Research Network完全的
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VA Office of Research and Development完全的