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Human Acellular Amniotic Membrane Implantation for Lower Third Nasal Reconstruction: A Preliminary Study
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注册号:

Registration number:

ChiCTR1800017618 

最近更新日期:

Date of Last Refreshed on:

2018-08-07 

注册时间:

Date of Registration:

2018-08-07 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

人脱细胞生物羊膜对鼻下1/3缺损修复作用初探 

Public title:

Human Acellular Amniotic Membrane Implantation for Lower Third Nasal Reconstruction: A Preliminary Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

人脱细胞生物羊膜对鼻下1/3缺损修复作用初探 

Scientific title:

Human Acellular Amniotic Membrane Implantation for Lower Third Nasal Reconstruction: A Preliminary Study 

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:

薛斯亮 

研究负责人:

薛斯亮 

Applicant:

Xue Siliang 

Study leader:

Xuesiliang 

申请注册联系人电话:

Applicant telephone:

+86 13982262622 

研究负责人电话:

Study leader's telephone:

+86 13982262622 

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:

xuesiliang@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xuesiliang@163.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:

中国四川成都市武侯区国学巷37号 

研究负责人通讯地址:

中国四川成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610000 

研究负责人邮政编码:

Study leader's postcode:

610000 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, SIchuan University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川大学华西医院 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

成都市外南国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

经费或物资来源:

自筹 

Source(s) of funding:

self 

研究疾病:

创伤愈合 

Target disease:

wound healing 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

鼻下1/3对面部美容非常重要,但修复此处创面是一个很大的挑战。本研究将脱细胞生物羊膜运用于此处,希望发现好的修复方法。 

Objectives of Study:

The lower third of the nose is one of the most important cosmetic units of the face and its reconstructive techniques remain a big challenge. As an alternative approach to repair or regenerate the nasal tissue, the biomaterial-based strategy has been extensively investigated.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

鼻头、鼻翼处创伤,需要二期愈合的病人。 

Inclusion criteria

Patients who had directly excisable lesions at the nasal tip or ala nasi regions and underwent secondary healing.  

排除标准:

1.年龄小于12岁患者; 2.患者创面不适于使用二期愈合; 3.术前检查异常; 4.手术区域感染; 5.有慢性全身性疾病,如糖尿病、肾衰或免疫抑制。 

Exclusion criteria:

1. patients aged younger than 12 years; 2. patients whose defects were unsuitable for secondary healing; 3. With abnormality during preoperative examination; 4. With infection at the surgical areas; 5. patients who had a long-term history of chronic diseases, such as diabetes, renal failure, or immunosuppression.  

研究实施时间:

Study execute time:

From2012-07-01To 2018-07-01 

征募观察对象时间:

Recruiting time:

From2012-07-01To 2016-08-31 

干预措施:

Interventions:

组别:

Case series

样本量:

92

Group:

Case series

Sample size:

干预措施:

人脱细胞生物羊膜

干预措施代码:

Intervention:

Human Acellular Amniotic Membrane Implantation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

haemostasis time

指标类型:

主要指标 

Outcome:

haemostasis time

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 15 years
最大 Max age 67 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

公布email,接受电子邮件询问

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

reply by email when asked

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:

数据采集使用门诊病历,数据办理采用office表格

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

Student’s t, Chi-square and Fisher’s exact tests were performed to compare the characteristic data of patients and the data of clinical assessments between the two groups. Significance was accepted when P-value <.05.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-08-07
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