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: |
1 |
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: |
从From2017-08-18至To 2018-01-18 |
干预措施: Interventions: |
|
研究实施地点: Countries of recruitment and research settings: |
|
测量指标: Outcomes: |
|
采集人体标本:
Collecting sample(s)
|
|
征募研究对象情况: Recruiting status: |
结束 Completed |
年龄范围: Participant age: |
|
||||||
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): |
|
Calculated Results after
|
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 |