NCT06920147尚未招募4 期
PRevention Of Trauma-related Infections Through an Embedded Clinical Trials (PROTECT) Network
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年5月1日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of participants that have post-laparotomy OS-SSIs
研究概览
简要总结
The purpose of this study is to compare the effectiveness of 2 prophylactic antibiotic regimens, ertapenem and cefazolin with metronidazole, in preventing organ space surgical site infections (OS-SSI) after emergency trauma laparotomy embedded into routine clinical care and to validate a Bayesian OS-SSI risk calculator using Trauma Quality Improvement Program (TQIP) standardized variables
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
- Triple (Participant, 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
- •Trauma laparotomy within 90 minutes of arrival
排除标准
- •Patients with a known allergy to cephalosporins or β-lactamase inhibitors
- •Prisoners
- •Pregnant and lactating women
研究组 & 干预措施
Combination of cefazolin and metronidazole.
Experimental
干预措施: Cefazolin and Metronidazole. (Drug)
Ertapenem only
Experimental
干预措施: Ertapenem (Drug)
结局指标
主要结局
Number of participants that have post-laparotomy OS-SSIs
时间窗: 30 days after surgery
次要结局
- Number of participants that have superficial incisional SSIs(30 days after surgery)
- Number of participants that have deep incisional SSIs(30 days after surgery)
- Number of patients that show highest Clavien-Dindo grade for OS-SSIs(30 days after surgery)
- Number of unplanned reoperations(30 days after surgery)
- Number of readmissions(30 days after surgery)
- Number of participants that have Clostridium difficile infections(30 days after surgery)
研究者
Lillian Kao
Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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