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周双白医师:请尽快在ResMan IPD平台上传原始数据以完成补注册。 自体SVF对皮片移植效果的改善作用研究
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注册号:

Registration number:

ChiCTR2000039317 

最近更新日期:

Date of Last Refreshed on:

2021-01-25 

注册时间:

Date of Registration:

2020-10-23 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

周双白医师:请尽快在ResMan IPD平台上传原始数据以完成补注册。 自体SVF对皮片移植效果的改善作用研究 

Public title:

Treatment of Skin Expansion with adipose-derived stromal vascular fraction Cells transplantation: a randomized controlled trial  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

自体SVF对皮片移植效果的改善作用研究 

Scientific title:

Treatment of Skin Expansion with SVF transplantation: a randomized controlled trial  

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:

周双白 

研究负责人:

李青峰 

Applicant:

Shuangbai Zhou 

Study leader:

Qingfeng Li 

申请注册联系人电话:

Applicant telephone:

+86 21-23271699-5120 

研究负责人电话:

Study leader's telephone:

+86 21-23271699-5120 

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:

shuangbaizhou@yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

qf_li@yahoo.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:

上海市黄浦区制造局路639号第九人民医院1号楼19楼1906室 

研究负责人通讯地址:

上海市黄浦区制造局路639号第九人民医院1号楼19楼1906室 

Applicant address:

Room 1906, 19th Floor, Building 1, The Ninth People's Hospital, 639 Zhizaoju Road, Huangpu District, Shanghai, China 

Study leader's address:

Room 1906, 19th Floor, Building 1, The Ninth People's Hospital, 639 Zhizaoju Road, Huangpu District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200011 

研究负责人邮政编码:

Study leader's postcode:

200011 

申请人所在单位:

上海交通大学医学院附属第九人民医院 

Applicant's institution:

The Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong 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:

沪九院伦审[2013]45号 

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:

上海交通大学医学院附属第九人民医院医学伦理委员会 

Name of the ethic committee:

Ethnics Committee of the Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-12-30 

伦理委员会联系人:

甄红 

Contact Name of the ethic committee:

Zhen Hong 

伦理委员会联系地址:

上海市黄浦区制造局路639号 

Contact Address of the ethic committee:

639 Zhizaoju Road, Huangpu District, Shanghai, China 

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:

上海交通大学医学院附属第九人民医院 

Primary sponsor:

The Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University 

研究实施负责(组长)单位地址:

上海市黄浦区制造局路639号 

Primary sponsor's address:

639 Zhizaoju Road, Huangpu District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属第九人民医院

具体地址:

黄浦区制造局路639号

Institution
hospital:

The Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University

Address:

639 Zhizaoju Road, Huangpu District

经费或物资来源:

自筹 

Source(s) of funding:

Funds raised independently 

研究疾病:

扩张皮肤再生能力不足 

Target disease:

Insufficient regeneration of expanded skin 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

促进皮片生长 

Objectives of Study:

To promote skin regeneration  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1) 年龄:18-65岁; 2) 性别:男女不限; 3) 出现皮肤生长困难,如皮肤菲薄、真皮层断裂等,且仍需进一步扩张者; 

Inclusion criteria

1. Age: 18-65 years old; 2. Gender: not limited to men and women; 3. Subjects with skin growth difficulties, such as thin skin, broken dermis, etc., and still need further expansion. 

排除标准:

1) 扩张区域存在感染风险的患者; 2) 毛发区或肌肉下放置扩张器; 3) 合并严重内科疾病(如糖尿病、肝炎、冠心病、动脉硬化、肾小球肾炎、血液系统疾病、自身免疫性疾病等); 4) 有长期吸烟史并且6个月内曾吸烟者。 

Exclusion criteria:

1. Patients with infection risk in the expansion area; 2. Patients with expander placed in hair area or under muscle; 3. Patients with severe medical diseases (such as diabetes, hepatitis, coronary heart disease, arteriosclerosis, glomerulonephritis, hematological diseases, autoimmune diseases, etc.); 4. Subjects with long-term smoking history and smoking within 6 months. 

研究实施时间:

Study execute time:

From2013-12-30To 2015-12-30 

征募观察对象时间:

Recruiting time:

From2014-01-01To 2015-01-01 

干预措施:

Interventions:

组别:

试验组

样本量:

10

Group:

experimental group

Sample size:

干预措施:

SVF移植

干预措施代码:

Intervention:

SVF transplantation

Intervention code:

组别:

对照组

样本量:

10

Group:

control group

Sample size:

干预措施:

注射生理盐水

干预措施代码:

Intervention:

injection of saline

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属第九人民医院 

单位级别:

三级甲等 

Institution
hospital:

The Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

皮肤厚度

指标类型:

主要指标 

Outcome:

skin thickness

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

扩张指数

指标类型:

次要指标 

Outcome:

Expansion index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

扩张皮肤表面积

指标类型:

次要指标 

Outcome:

Expanded skin surface area

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:

脂肪组织

组织:

Sample Name:

Adipose tissue

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 18 years
最大 Max age 65 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

使用计算机生成的随机分组表对每位符合条件的患者,以1:1的比例,随机分配到SVF或对照组。

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

Each eligible patient was randomly assigned to the SVF or control group in a 1:1 ratio using a computer-generated randomization schedule.

盲法:

未说明

Blinding:

Not stated

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

是Yes

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):

本研究中受试者的试验数据及结果会在发表的文章中共享。

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

Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)

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:

eCRF

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

eCRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-10-23
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