Today is 2020-07-05

A Medical Records Based study for Reducing Pain and Promoting Healing Following Negative Pressure Wound Therapy in Acute Suppurative Mastitis
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注册号:

Registration number:

ChiCTR2000031144 

最近更新日期:

Date of Last Refreshed on:

2020-03-23 

注册时间:

Date of Registration:

2020-03-23 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

负压吸引技术在急性化脓性乳腺炎患者中具有减轻疼痛和促进伤口愈合的作用:基于病历记录的研究 

Public title:

A Medical Records Based study for Reducing Pain and Promoting Healing Following Negative Pressure Wound Therapy in Acute Suppurative Mastitis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

负压吸引技术在急性化脓性乳腺炎患者中具有减轻疼痛和促进伤口愈合的作用 

Scientific title:

Reducing Pain and Promoting Healing Following Negative Pressure Wound Therapy in Acute Suppurative Mastitis 

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:

邱琳 

研究负责人:

吴巧艺 

Applicant:

Lin Qiu 

Study leader:

Qiaoyi Wu 

申请注册联系人电话:

Applicant telephone:

+86 13313754691 

研究负责人电话:

Study leader's telephone:

+86 13705067202 

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:

1050295769@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

qywu@fjmu.edu.cn 

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:

福州市茶中路20号 

研究负责人通讯地址:

福建省福州市茶中路20号 

Applicant address:

20 Chazhong Road, Fuzhou, Fujian, China 

Study leader's address:

20 Chazhong Road, Fuzhou, Fujian, China 

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:

福建医科大学附属第一医院 

Applicant's institution:

Department of Emergency Surgery, the First Affiliated Hospital of Fujian Medical University 

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:

[2020]045 

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:

福建医科大学附属第一医院伦理委员会 

Name of the ethic committee:

the Ethics Committee of the First Affiliated Hospital of Fujian Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-13 

伦理委员会联系人:

王老师 

Contact Name of the ethic committee:

Mr. Wang 

伦理委员会联系地址:

福建省福州市茶中路20号 

Contact Address of the ethic committee:

20 Chazhong Road, Fuzhou, Fujian, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0591-87981028 

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:

福建医科大学附属第一医院 

Primary sponsor:

the First Affiliated Hospital of Fujian Medical University 

研究实施负责(组长)单位地址:

福建省福州市茶中路20号 

Primary sponsor's address:

20 Chazhong Road, Fuzhou, Fujian, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

福建

市(区县):

福州

Country:

China

Province:

Fujian

City:

Fuzhou

单位(医院):

福建医科大学附属第一医院

具体地址:

福建省福州市茶中路20号

Institution
hospital:

the First Affiliated Hospital of Fujian Medical University

Address:

20 Chazhong Road, Fuzhou, Fujian

经费或物资来源:

无 

Source(s) of funding:

NO 

研究疾病:

急性化脓性乳腺炎 

Target disease:

Acute Suppurative Mastitis 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

探索负压吸引技术对急性化脓性乳腺炎患者是否具有减轻疼痛和促进伤口愈合的潜能 

Objectives of Study:

To investigate the potential for vacuum sealing drainage (VSD) to reduce pain and promote wound healing in patients with acute suppurative mastitis 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

1.年龄20-50岁妇女2.超声诊断急性化脓性乳腺炎3.通过普通的切开引流或者负压吸引技术治疗 

Inclusion criteria

Inclusion criteria included women aged 20-50 years ultrasound confirmation of a breast abscess and treatment with traditional incision and drainage or Vacuum sealing drainage. 

排除标准:

1.合并有其他基础疾病,像糖尿病等2.操作由其他医生实施 

Exclusion criteria:

Patients with co-morbid medical conditions such as diabetes, and those operated upon by other surgical teams were excluded 

研究实施时间:

Study execute time:

From2019-01-01To 2020-06-30 

干预措施:

Interventions:

组别:

样本量:

24

Group:

No

Sample size:

干预措施:

干预措施代码:

Intervention:

No

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

福建 

市(区县):

福州 

Country:

China 

Province:

Fujian 

City:

Fuzhou 

单位(医院):

福建医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

the First Affiliated Hospital of Fujian Medical University  

Level of the institution:

top three hospitals 

测量指标:

Outcomes:

指标中文名:

疼痛指数

指标类型:

主要指标 

Outcome:

Pain score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院天数

指标类型:

主要指标 

Outcome:

Hospital stay

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治愈时间

指标类型:

主要指标 

Outcome:

Healing time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

年龄

指标类型:

次要指标 

Outcome:

age

Type:

Secondary 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:

组织:

Sample Name:

no

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 49 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):

患者根据自身情况选择治疗方法

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

patients choose treatments according to condition

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

2020.03,向项目负责人索要

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

2020.03,it can be available from project leader

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:

数据采集通过病案室查阅资料和电话随访,数据统计则通过SPSS19软件进行数据分析

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

The data collected through reference and telephone follow-up and calculated by SPSS19

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-03-23
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