How to Prevent Post-surgery Infections (Bundle)
Evaluation of a Bundle of Actions to Prevent Skin Infections
Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden opatients through the use of two different cleaning and washing systems (swash bathing gloves vs pre-soaped sponges). The evaluation will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days
研究概览
地位
详细说明
Since bed is recognized as a critical time for the onset of skin superinfections, the study aims to evaluate, by comparison, two different methods of managing bedridden patients using time spent for hygiene, daily skin pH measurement and samples for cilture tests
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Giorgio Oriani, Physician - Anesthetist
- 电话号码：+39335225452
- 邮箱：giorgio.oriani@grupposandonato.it
研究联系人备份
- 姓名：Elena Cittera
学习地点
-
-
-
Milan、意大利
- 招聘中
- Istituto Clinico San Siro
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age over 18 -
- Both sexes
- ASA III with need of monitoring
- Major surgery (Hip, Knee- Shoulder-first or revision)
Exclusion Criteria:
- Lack of consent
- Poor cooperation
- Post-operative delirium
- Pregnant women
学习计划
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Swab washing group, that means we want to use a specific swab for cleaning
Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients . The evaluations will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days. Evaluation is comprehensive of pH value before and after cleaning and cultural exam before and after |
The method will be the same of the swab arm. The goal is to compare the two groups looking at any differences
其他名称：
|
|
假比较器：Pre-soaped sponges, using an usual methods for skin cleaning
Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients . The evaluations will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days. Evaluation is comprehensive of pH value before and after cleaning and cultural exam before and after |
Procedure/Surgery: Sponge group: Use of this device for skin detersion, measuring also pH test and coltural examination before and after cleaning Description: we want to compare sponge detersion in bedridden patient, looking at pH test and coltural examination before and after surgery |
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 |
|---|---|---|
|
Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients through the use of two different cleaning and washing systems . Two different devices (swab vs sponge) will be compared.
大体时间：18 months
|
Evaluation of pH before and after cleaning activity looking at the pH skin (using a dedicated device) and coltural charge befdore and after cleaning. These tests will be done three days after surgery, and the results will be collected in an Excel file to prepare a future analysis |
18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluation of time spent for cleaning and patient satisfaction using one device for three days. The device choice is depending on randomization file and the evaluator is blind of the device used
大体时间：three days for each patient of the two groups, plus a follow up 30 days afetr surgery
|
This evaluation will be carried out on a daily frequence and will begin on the first day after surgery and for three days |
three days for each patient of the two groups, plus a follow up 30 days afetr surgery
|
合作者和调查者
调查人员
- 首席研究员：Giorgio Oriani、IRCCS OGSA - Site Istituto San Siro
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Bundle to prevent infection
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
If someone will be interested in reproduce this study or proceed in this direction we surely would like to give our data
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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