Effect of Standard Normothermia Protocol On Surgical Site Infections
2017年11月13日 更新者：Ali Kadir Değirmenci、Dokuz Eylul University
Effect of Standard Normothermia Protocol On Surgical Site Infections: Randomized Controlled Trial
Aim of this study is to investigate the efficiency of a standard normothermia protocol and effects on postoperative Surgical Site Infection (SSI) rate.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
118
阶段
- 不适用
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 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
Inclusion Criteria:
- Elective
- Preoperatively not infected/dirty Surgical Site
- Open major abdominal operations (hepatobiliary, upper gastrointestinal or colorectal); under general anesthesia, longer than 30 minutes)
Exclusion Criteria:
- Emergent surgery
- Local/locoregional procedures
- Laparoscopic operation
- Minor abdominal operations (e.g. hernia repair, colostomy closure)
- Malign hyperthermia
- Signs of active infection or fever
- Immunosuppression
- Severe malnutrition
- Kidney/liver failure and antibiotic use within the previous 1 week or immunosuppressive use (chemotherapy, steroids.) within the previous 1 month and reversal of patients opinion while randomization period
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 |
|---|---|
|
无干预：Control Group
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
|
|
|
有源比较器：Intervention Group
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
|
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 |
|---|---|---|
|
Surgical Site Infection Rate
大体时间：Postoperative 30 days
|
Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed. All patients were made enough incision wide to explore their entire abdomen defined as "Major Abdominal Surgery" . With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n<30), (p=0.044 chi-square ) |
Postoperative 30 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maintaining Normothermia Rate
大体时间：Surgery day
|
Within the surgery day, from patient bed through the operating room to PACU or ICU or back to patient bed. With these results our intervention group's maintaining normothermia rates were higher respectively. ( p=0.001) For each patients around 11 temperature measurement had been made according to the operation time . If any measurement of any patients was <36 ºC , that patient accepted as hypothermic. (Failure to maintain normothermia) |
Surgery day
|
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。
调查人员
- 研究主任：Mustafa Cem Terzi, Proffessor Doctor、Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department
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
2013年6月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2016年6月1日
研究注册日期
首次提交
2016年11月1日
首先提交符合 QC 标准的
2016年11月9日
首次发布 (估计)
2016年11月10日
研究记录更新
最后更新发布 (实际的)
2017年12月12日
上次提交的符合 QC 标准的更新
2017年11月13日
最后验证
2017年11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.