NCT06221761尚未招募不适用
A Prospective Randomized Controlled Study on the Prophylactic Use of Antibiotics Within 72 Hours After Acute Burn Injury in Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Negative rate of bacterial culture
研究概览
简要总结
The goal of this clinical trial is to compare in acute burn patients.
The main question it aims to answer are:
• what is the impact of early prophylactic use of antibiotics on prognosis Participants will be randomly divided into an antibiotic group and a non antibiotic group.
Researchers will compare the two groups to see the 72 hour wound bacterial culture negative rate.
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
- Single (Participant)
盲法说明
Participants do not know which group they will be assigned to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form
- •Promise to comply with research procedures and cooperate with the implementation of full process research
- •Age 18 and above
- •Emergency hospitalization of patients in the burn department, within 24 hours after injury
- •No immunodeficiency disease, no history of using immunosuppressive drugs, no antibiotics being used or infectious diseases at the time of admission
- •If a woman is in the reproductive period, she should not be pregnant
排除标准
- •Unable to obtain informed consent from subjects, family members, or authorized agents
- •At the time of admission, antibiotics were being administered
- •During pregnancy
- •Presence of infectious diseases before admission
- •Existence of immunodeficiency diseases or use of immunosuppressive drugs
- •The subjects are currently undergoing other clinical studies
研究组 & 干预措施
Non antibiotic group
Experimental
Not using antibiotics within 72 hours after burns
干预措施: not using antibiotic (Drug)
antibiotic group
Active Comparator
Using antibiotics within 72 hours after burns
干预措施: using antibiotic (Drug)
结局指标
主要结局
Negative rate of bacterial culture
时间窗: hour 72
Number of cases with negative wound culture bacteria/total number of cases
次要结局
- 28 day mortality rate(28 day after burn)
研究者
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