ChiCTR1900022954 版本V1.0 版本创建时间2019/05/05 08:53:43 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：

 ChiCTR1900022954 

最近更新日期：

Date of Last Refreshed on：

 2019-05-05 08:52:54 

注册时间：

Date of Registration：

 2019-05-05 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Effect of Topical Application of Tranxamic Acid on reduction of wound drainage and seroma formation after Mastectomy

Public title：

Effect of Topical Application of Tranxamic Acid on reduction of wound drainage and seroma formation after Mastectomy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effect of Topical Application of Tranxamic Acid on reduction of wound drainage and seroma formation after Mastectomy

Scientific title：

Effect of Topical Application of Tranxamic Acid on reduction of wound drainage and seroma formation after Mastectomy

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：

mahmoud shahin 

研究负责人：

mahmoud shahin 

Applicant：

mahmoud shahin 

Study leader：

mahmoud shahin 

申请注册联系人电话：

Applicant telephone：

 +201 0 06573800

研究负责人电话：

Study leader's
telephone：

+201 0 06573800

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：

 dr.mshaheen@ymail.com

研究负责人电子邮件：

Study leader's E-mail：

 dr.mshaheen@ymail.com

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：

Menoufia , Egypt

研究负责人通讯地址：

Menoufia , Egypt

Applicant address：

Menoufia , Egypt

Study leader's address：

Menoufia , Egypt

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

埃及姆努菲亚大学医学院

Applicant's institution：

Faculty of medicine, Menoufia University, Egypt

研究负责人所在单位：

埃及姆努菲亚大学医学院

Affiliation of the Leader：

Faculty of medicine, Menoufia University, Egypt

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 054374

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：

埃及姆努菲亚大学医学院伦理委员会

Name of the ethic committee：

Institutional review board of the Faculty of medicine Menoufia University

伦理委员会批准日期：

Date of approved by ethic committee：

 2016-01-02 00:00:00

伦理委员会联系人：

Institutional review board of the Faculty of medicine Menoufia University

Contact Name of the ethic committee：

Institutional review board of the Faculty of medicine Menoufia University

伦理委员会联系地址：

1st Yassen Abdelghafar st, Shibin Elkom, menoufia, egypt

Contact Address of the ethic committee：

1st Yassen Abdelghafar st, Shibin Elkom, menoufia, egypt

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

埃及姆努菲亚大学医院

Primary sponsor：

menoufia university hospital

研究实施负责（组长）单位地址：

埃及姆努菲亚

Primary sponsor's address：

menoufia, Egypt

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

埃及

省(直辖市)：

姆努菲亚

市(区县)：

Country：

Egypt

Province：

menoufia

City：

单位(医院)：

医学院

具体地址：

埃及姆努菲亚

Institution
hospital：

faculty of Medicine

Address：

menoufia, Egypt

经费或物资来源：

funding of scientific research

Source(s) of funding：

funding of scientific research

研究疾病：

breast cancer  

Target disease：

breast cancer

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

investigate whether moistening a wound surface with tranexamic acid reduces bleeding and fibrinolysis and so, reduces the total wound drainage after mastectomy and also the incidence of hematoma or seroma formation.  

Objectives of Study：

investigate whether moistening a wound surface with tranexamic acid reduces bleeding and fibrinolysis and so, reduces the total wound drainage after mastectomy and also the incidence of hematoma or seroma formation.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. women aged 18 years or older;
2. patients with breast carcinoma (ductal or lobular) of any stage;
3. patients for whom MRM had been recommended.

Inclusion criteria

1. women aged 18 years or older;
2. patients with breast carcinoma (ductal or lobular) of any stage;
3. patients for whom MRM had been recommended.

排除标准：

1. had any history of thromboembolic events;
2. had severe varicose veins, coagulation disorders or receiving anticoagulant drugs;
3. Patients with no measurable drain volume were also excluded.

Exclusion criteria：

1. had any history of thromboembolic events;
2. had severe varicose veins, coagulation disorders or receiving anticoagulant drugs;
3. Patients with no measurable drain volume were also excluded.

研究实施时间：

Study execute time：

从 From 2016-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-03-11 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 65

Group：

Group I

Sample size：

干预措施：

Topical Tranxamic acid application

干预措施代码：

Intervention：

Topical Tranxamic acid application

Intervention code：

组别：

Group 2

样本量：

 50

Group：

Group II

Sample size：

干预措施：

No tranxamic acid used

干预措施代码：

Intervention：

No tranxamic acid used

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 埃及

省(直辖市)：

 Menoufia 

市(区县)：

  

Country：

Egypt

Province：

Menoufia

City：

单位(医院)：

 Menoufia University Hospital 

单位级别：

 三级医院 

Institution
hospital：

Menoufia University Hospital

Level of the institution：

Tertiary Care Hospital

测量指标：

Outcomes：

指标中文名：

amount of drained fluid

指标类型：

主要指标

Outcome：

amount of drained fluid

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

drained fluid

组织：

Sample Name：

drained fluid

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 68 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

non randamized method

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

non randamized method

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

N/A

Blinding：

N/A

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否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）：

corresponding author contacting at Dr.mshaheen@ymail.com

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

corresponding author contacting at Dr.mshaheen@ymail.com

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：

Demographic, clinical, and treatment-related variables were recorded on a standardized form. SPSS_ software version 15 (SPSS Inc., Chicago, IL, USA) was used for statistical analysis. The study population was characterised using descriptive statistics. As most of the quantitative variables did not adhere to the normal distribution curve according to the Kolmogorove Smirnov test, nonparametric tests were chosen for analysis of the differences among these variables. Comparisons between unpaired groups were carried out by means of ManneWhitney when the variables were numerical. The chi-square test or Fisher’s exact test were used to compare qualitative variables and risks. The risk was investigated using the odds ratio (OR). We used a non-exploratory multivariate analysis model.

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

Demographic, clinical, and treatment-related variables were recorded on a standardized form. SPSS_ software version 15 (SPSS Inc., Chicago, IL, USA) was used for statistical analysis. The study population was characterised using descriptive statistics. As most of the quantitative variables did not adhere to the normal distribution curve according to the Kolmogorove Smirnov test, nonparametric tests were chosen for analysis of the differences among these variables. Comparisons between unpaired groups were carried out by means of ManneWhitney when the variables were numerical. The chi-square test or Fisher’s exact test were used to compare qualitative variables and risks. The risk was investigated using the odds ratio (OR). We used a non-exploratory multivariate analysis model.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-05-05 08:52:54