NCT05990842尚未招募不适用
"Antibiotic Prophylaxis in Clean Soft Tissue Hand Surgery Among a Population in a Developing Country: A Randomized, Parallel, Triple-Blind, Placebo-Controlled Clinical Trial"
Marcos Felipe Marcatto de Abreu0 个研究点目标入组 51 人开始时间: 2023年8月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 主要终点
- Surgical wound infection
研究概览
简要总结
The goal of this clinical trial is to compare the use of antibiotics with no use in people undergoing soft tissue hand surgery in developing countries.
The main question it aims to answer is:
• Is an antibiotic necessary for this type of surgery in this population? Researchers will compare a group of patients who receives antibiotics during the surgical procedure with a group who receives no antibiotics to see if infection rates are the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •individuals with clean soft tissue conditions of the upper limb requiring surgery
排除标准
- •abandonment of treatment
研究组 & 干预措施
antibiotic prophylaxis
Experimental
干预措施: Antibiotic (Drug)
placebo
Placebo Comparator
干预措施: placebo (Other)
结局指标
主要结局
Surgical wound infection
时间窗: 30 days
CDC protocol for surgical wound infection surveillance
次要结局
未报告次要终点
研究者
Marcos Felipe Marcatto de Abreu
Medical Doctor
University of Campinas, Brazil
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