在具有不可改变的危险因素的患者中用硫酸钙珠预防假体周围关节感染。 (Stimulan)
2020年8月18日 更新者：Julio Carlos Velez de Lachica、Hospital Regional Tlalnepantla
应用载有抗生素的硫酸钙预防具有不可改变的危险因素的假体周围关节感染患者
与对照组相比，要证明载有抗生素的硫酸钙珠对具有不可改变的危险因素且将接受髋关节或膝关节置换术的患者的预防作用。
了解在接受髋关节或膝关节置换术且具有不可改变的风险因素的患者中使用硫酸钙珠进行抗生素预防所产生的经济成本。
研究概览
详细说明
由于近几十年来关节置换手术取得了成功，每年植入假体的数量都在增加，但与此同时，整形外科医生也发现该手术固有的并发症，其中假体周围感染是最具破坏性的。
为了找到解决这一可怕并发症的方法，已经实施了预防和治疗措施，在手术部位应用局部抗生素的新兴技术已被证明是一个有前途的概念。
已经表明，接受关节置换手术的患者的不可改变的危险因素增加了感染率的风险。
因此，识别危险因素、去定植和预防性使用抗生素可以有效减少假体周围感染。
为了减少并尽可能避免参与者在接受膝关节或髋关节置换术且具有不可改变的风险因素时发生假体周围感染，建议在局部应用时预防性使用载有抗生素的硫酸钙。
研究类型
介入性
注册 (实际的)
87
阶段
- 第四阶段
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。
学习地点
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Tlalnepantla、墨西哥、54090
- HOSPITAL REGIONAL TLALNEPANTLA ISSEMyM
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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
60年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
- 需要关节置换治疗的髋关节或膝关节骨折或骨关节病患者。
- 在手术前或手术期间有任何不可改变的风险因素的患者。
- 有权获得 ISSEMyM（Instituto de Seguridad Social del Estado de Mexico y Municipios）的患者
排除标准：
- 失去机构权利有效性且未随访的患者
- 由于与骨科手术无关的其他原因而在研究期间死亡的患者。
- 没有任何假体周围感染危险因素的患者
- 对万古霉素或头孢曲松过敏的患者。
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：硫酸钙组
将接受药物硫酸钙珠预防髋关节或膝关节置换术的成员组
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具有不可改变的假体周围关节感染危险因素的患者的抗生素预防
其他名称：
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有源比较器：控制组
将接受髋关节或膝关节置换术经典预防的一组成员
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具有不可改变的假体周围关节感染危险因素的患者的抗生素预防
其他名称：
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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 |
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在为期 12 周的观察期内，通过血清和滑膜液白细胞中的 CRP、ERS 测量，与传统静脉内抗生素预防相比，参与者的髋关节或膝关节假体关节感染率较低。
大体时间：第 5 天，第 4、8 和 12 周
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使用 CRP 和 ESR 血清生物标志物确定急性膝关节或髋关节假体周围感染，这是假体周围关节感染文献中最常发表的血清生物标志物。
CRP 的截止点被认为是 93mg/L 和 ESR 的 44mm/hr。
在第 5 天和第 4、8 和 12 周采集并评估血清生物标志物样本。滑液中的白细胞是假体周围关节感染的定义标准之一，截止点高于 12,800 个细胞/µL，并且仅当血清生物标志物出现时才包括在内被升高。
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第 5 天，第 4、8 和 12 周
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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住院时间作为医院经济负担的指标
大体时间：手术日至出院。
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住院时间长短是衡量效率和医院经济负担的重要指标。
住院天数的减少导致感染风险降低、药物副作用减少以及对医院用品的需求减少。
两组之间平均住院天数的差异间接代表了医院花费的经济成本。
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手术日至出院。
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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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 (实际的)
2019年5月22日
初级完成 (实际的)
2020年4月22日
研究完成 (实际的)
2020年7月15日
研究注册日期
首次提交
2019年5月29日
首先提交符合 QC 标准的
2019年6月3日
首次发布 (实际的)
2019年6月6日
研究记录更新
最后更新发布 (实际的)
2020年8月20日
上次提交的符合 QC 标准的更新
2020年8月18日
最后验证
2020年8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.