ChiCTR-OON-17013246 版本V1.2 版本创建时间2017/11/05 11:26:03 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR-OON-17013246 

最近更新日期：

Date of Last Refreshed on：

2017-11-05 11:24:56 

注册时间：

Date of Registration：

2017-11-05 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Impact of Pharmacist Educational Intervention on Antibiotic Post-surgical Prophylaxis

Public title：

Impact of Pharmacist Educational Intervention on Antibiotic Post-surgical Prophylaxis

注册题目简写：

English Acronym：

PEAPP

研究课题的正式科学名称：

Post-surgical Antibiotic Prophylaxis: Impact of Pharmacist’s Intervention on Appropriate Use of Antibiotics

Scientific title：

Post-surgical Antibiotic Prophylaxis: Impact of Pharmacist’s Intervention on Appropriate Use of Antibiotics

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

HAMID SAEED 

研究负责人：

HAMID SAEED 

Applicant：

HAMID SAEED 

Study leader：

HAMID SAEED 

申请注册联系人电话：

Applicant telephone：

+92 30 4880 1243

研究负责人电话：

Study leader's telephone：

+92 30 4880 1243

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

hamid.pharmacy@pu.edu.pk

研究负责人电子邮件：

Study leader's E-mail：

hamid.pharmacy@pu.edu.pk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

University College of Pharmacy, Punjab University Lahore, Pakistan

研究负责人通讯地址：

University College of Pharmacy, Punjab University Lahore, Pakistan

Applicant address：

University College of Pharmacy, Punjab University Lahore, Pakistan

Study leader's address：

University College of Pharmacy, Punjab University Lahore, Pakistan

申请注册联系人邮政编码：

Applicant postcode：

54000

研究负责人邮政编码：

Study leader's postcode：

54000

申请人所在单位：

University College of Pharmacy, Punjab University Lahore, Pakistan

Applicant's institution：

University College of Pharmacy, Punjab University

研究负责人所在单位：

University College of Pharmacy, Punjab University Lahore, Pakistan

Affiliation of the Leader：

University College of Pharmacy, Punjab University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

HEC/PUCP/1931

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Human Ethical Committee, University College of Pharmacy

Name of the ethic committee：

Human Ethical Committee, University College of Pharmacy

伦理委员会批准日期：

Date of approved by ethic committee：

2016-07-26 00:00:00

伦理委员会联系人：

Prof. Dr. Nadeem Irfan Bukhari

Contact Name of the ethic committee：

Prof. Dr. Nadeem Irfan Bukhari

伦理委员会联系地址：

University College of Pharmacy, University of the Punajb, Lahore, Pakistan

Contact Address of the ethic committee：

University College of Pharmacy, University of the Punajb, Lahore, Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

+92 300 4259738

伦理委员会联系人邮箱：

Contact email of the ethic committee：

principal.pharmacy@pu.edu.pk

研究实施负责（组长）单位：

University College of Pharmacy

Primary sponsor：

University College of Pharmacy

研究实施负责（组长）单位地址：

University College of Pharmacy, University of the Punjab, Allama Iqbal Campus, 54000, Lahore, Pakistan

Primary sponsor's address：

University College of Pharmacy, University of the Punjab, Allama Iqbal Campus, 54000, Lahore, Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Pakistan

省(直辖市)：

Punjab

市(区县)：

Lahore

Country：

Pakistan

Province：

Punjab

City：

Lahore

单位(医院)：

University of the Punjab

具体地址：

University College of Pharmacy, University of the Punjab, Allama Iqbal Campus, 54000, Lahore, Pakistan

Institution
hospital：

University of the Punjab

Address：

University College of Pharmacy, University of the Punjab, Allama Iqbal Campus, 54000, Lahore, Pakistan

经费或物资来源：

College Funds

Source(s) of funding：

College Funds

Target disease：

Orthopedic, General & Gynecological Surgery

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

To evaluate the impact of Pharmacists Educational intervention on appropriate and cost-effective use of post-surgical antibiotic prophylaxis  

Objectives of Study：

To evaluate the impact of Pharmacists Educational intervention on appropriate and cost-effective use of post-surgical antibiotic prophylaxis

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

Intervention: The standard criteria for post-surgery prophylactic antibiotic usage was established according to clinical practice guidelines for antimicrobial prophylaxis in surgery published in 2013 (Bratzler et al., 2013), (Table 1 S1 Text). Results obtained in the pre-intervention arm were shared and discussed with surgeons, surgery residents, postgraduate fellows and nurses in ward meetings. After general ward meetings, in each ward, the general and specific problems related to appropriate use of antibiotic prophylaxis were discussed regarding post-surgical antibiotic prophylaxis with concerned personals & committees. The principle of post-surgery prophylaxis & precautionary measures need to be taken were discussed and reviewed with the concerned surgeons to reduce the probability of SSIs. The educational training continued for 10 - 15 days. In the second phase, i-e., post-intervention, data was arbitrated identically as was done in the first phase. Data obtained from both the phases were compared to ascertain the effectiveness of pharmacist educational interventions. 

纳入标准：

Inclusion criteria: Inpatients with clean and clean contaminated procedures, on post-surgery antibiotic prophylaxis, without systemic disease and willing to participate in the study were included in the study.

Inclusion criteria

Inclusion criteria: Inpatients with clean and clean contaminated procedures, on post-surgery antibiotic prophylaxis, without systemic disease and willing to participate in the study were included in the study.

排除标准：

Exclusion criteria: All inpatients, who have been through invasive procedure at least thirty days prior to the surgery, known allergies to antibiotics, have been using any antibiotic within fourteen days before the procedure and were not willing to participate were excluded from the study.

Exclusion criteria：

Exclusion criteria: All inpatients, who have been through invasive procedure at least thirty days prior to the surgery, known allergies to antibiotics, have been using any antibiotic within fourteen days before the procedure and were not willing to participate were excluded from the study.

研究实施时间：

Study execute time：

从 From 2016-08-22 00:00:00至 To 2017-03-05 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2016-08-22 00:00:00 至 To 2016-10-21 00:00:00  

干预措施：

Interventions：

组别：

1

样本量：

225

Group：

1

Sample size：

干预措施：

Educational

干预措施代码：

Intervention：

Educational

Intervention code：

组别：

2

样本量：

225

Group：

2

Sample size：

干预措施：

Data collected from same wards of equal no. of patients from each ward (Nov 06, 2016 to Mar 05, 2017)

干预措施代码：

Intervention：

Data collected from same wards of equal no. of patients from each ward (Nov 06, 2016 to Mar 05, 2017)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Pakistan

省(直辖市)：

 Punjab 

市(区县)：

  

Country：

Pakistan 

Province：

Punjab 

City：

Lahore 

单位(医院)：

Tertiary Care Hospital 

单位级别：

Tertiary hospital 

Institution
hospital：

Tertiary Care Hospital

Level of the institution：

Tertiary hospital

测量指标：

Outcomes：

指标中文名：

Rationale/appropriate use of antibiotics (choice, dose, frequency and Duration)

指标类型：

主要指标

Outcome：

Rationale/appropriate use of antibiotics (choice, dose, frequency and Duration)

Type：

Primary indicator

测量时间点：

1

测量方法：

as per Evaluation Criteria

Measure time point of outcome：

1

Measure method：

as per Evaluation Criteria

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

No Sample collection

Tissue：

No tissue collection

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

Just data from patient profile

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 15 岁 years
最大 Max age 75 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

Non-randomized Sampling

Randomization Procedure (please state who generates the random number sequence and by what method)：

Non-randomized Sampling

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

No Blinding

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

Not stated

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

N/A

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Not stated

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

N/A

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2017-11-05 11:19:35