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A comparison of the efficacy of fibrin glue versus suction drainage in preventing hematoma and seroma in rhytidectomy: a randomized, double-blind, controlled trial
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注册号:

Registration number:

ChiCTR1800015746 

最近更新日期:

Date of Last Refreshed on:

2018-04-18 

注册时间:

Date of Registration:

2018-04-18 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

A comparison of the efficacy of fibrin glue versus suction drainage in preventing hematoma and seroma in rhytidectomy: a randomized, double-blind, controlled trial 

Public title:

A comparison of the efficacy of fibrin glue versus suction drainage in preventing hematoma and seroma in rhytidectomy: a randomized, double-blind, controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

A comparison of the efficacy of fibrin glue versus suction drainage in preventing hematoma and seroma in rhytidectomy: a randomized, double-blind, controlled trial 

Scientific title:

A comparison of the efficacy of fibrin glue versus suction drainage in preventing hematoma and seroma in rhytidectomy: a randomized, double-blind, 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:

Antonio Roberto da Rosa Rezende 

研究负责人:

Marcus Vinicius Martins Collares 

Applicant:

Antonio Roberto da Rosa Rezende 

Study leader:

Marcus Vinicius Martins Collares 

申请注册联系人电话:

Applicant telephone:

+55 5 1 985810248 

研究负责人电话:

Study leader's telephone:

+55 51 99862023 

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:

2rezende@terra.com.br 

研究负责人电子邮件:

Study leader's E-mail:

collares.cmf@gmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

Clinica Rezende Ltda 

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:

rua mariante 284, conj 507/508 

研究负责人通讯地址:

rua mariante 284, conj 507 

Applicant address:

rua mariante 284, conj 507/508 

Study leader's address:

RUA MARIANTE 284 CONJ. 507 

申请注册联系人邮政编码:

Applicant postcode:

90430180 

研究负责人邮政编码:

Study leader's postcode:

90430180 

申请人所在单位:

International Society of Aesthetic Plastic Surgery - ISAPS 

Applicant's institution:

International Society of Aesthetic Plastic Surgery - ISAPS 

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:

86232418.9.0000.5327 

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:

Comiss o Nacional de ética em Pesquisa 

Name of the ethic committee:

Comiss o Nacional de ética em Pesquisa 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-04-17 

伦理委员会联系人:

Comissao Nacional de ética em Pesquisa 

Contact Name of the ethic committee:

Comissao Nacional de ética em Pesquisa 

伦理委员会联系地址:

COMISS O NACIONAL DE éTICA EM PESQUISA – CONEP SRTV 702, Via W 5 Norte - Edifício PO 700, 3o andar – Asa Norte CEP: 70719-000, Brasília-D 

Contact Address of the ethic committee:

COMISS O NACIONAL DE éTICA EM PESQUISA – CONEP SRTV 702, Via W 5 Norte - Edifício PO 700, 3o andar – Asa Norte CEP: 70719-000, Brasília-D 

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:

NO SPONSOR 

Primary sponsor:

NO SPONSOR 

研究实施负责(组长)单位地址:

NO SPONSOR 

Primary sponsor's address:

NO SPONSOR 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

NO SPONSOR 

Source(s) of funding:

No sponsor 

研究疾病:

Hematoma 

Target disease:

Hematoma 

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:

I期临床试验 

Study phase:

研究目的:

A comparison of the efficacy of fibrin glue versus suction drainage in preventing hematoma and seroma in rhytidectomy 

Objectives of Study:

A comparison of the efficacy of fibrin glue versus suction drainage in preventing hematoma and seroma in rhytidectomy 

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. female patients; 2. facial aging; 3. indication of face lift. 

Inclusion criteria

1. female patients; 2. facial aging; 3. indication of face lift. 

排除标准:

1. less than 43 years old; 2. comorbidities without any treatment. 

Exclusion criteria:

1. less than 43 years old; 2. comorbidities without any treatment. 

研究实施时间:

Study execute time:

From2017-08-18To 2018-01-18 

干预措施:

Interventions:

组别:

Two groups

样本量:

72

Group:

Two groups

Sample size:

干预措施:

fibrin glue versus suction drainage

干预措施代码:

Intervention:

fibrin glue versus suction drainage

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

巴西 

省(直辖市):

南里奥格兰德州 

市(区县):

阿雷格里港 

Country:

Brazil 

Province:

rio grande do sul 

City:

porto alegre 

单位(医院):

Hospital Moinhos de Vento 

单位级别:

Private 

Institution
hospital:

Hospital Moinhos de Vento  

Level of the institution:

Private 

测量指标:

Outcomes:

指标中文名:

volume of edema

指标类型:

主要指标 

Outcome:

volume of edema

Type:

Primary indicator 

测量时间点:

测量方法:

ultrassonography

Measure time point of outcome:

Measure method:

ultrassonography

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

plasma

组织:

skin

Sample Name:

plasma

Tissue:

skin

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 43 years
最大 Max age 79 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):

windows randomization system software

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

windows randomization system software

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

即时公开/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):

http://conselho.saude.gov.br/Web_comissoes/conep/index.html

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

http://conselho.saude.gov.br/Web_comissoes/conep/index.html

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:

http://conselho.saude.gov.br/Web_comissoes/conep/index.html

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

http://conselho.saude.gov.br/Web_comissoes/conep/index.html

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-04-18
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