MANAGEMENT OF NON-HEALING WOUNDS IN ASIAN PATIENTS WITH ADJUVANT TOPICAL HAEMOGLOBIN SPRAY. A CASE SERIES.

注册号:

Registration number:

ChiCTR2100051571 

最近更新日期:

Date of Last Refreshed on:

2021-09-27 04:57:13 

注册时间:

Date of Registration:

2021-09-27 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

MANAGEMENT OF NON-HEALING WOUNDS IN ASIAN PATIENTS WITH ADJUVANT TOPICAL HAEMOGLOBIN SPRAY. A CASE SERIES.

Public title:

MANAGEMENT OF NON-HEALING WOUNDS IN ASIAN PATIENTS WITH ADJUVANT TOPICAL HAEMOGLOBIN SPRAY. A CASE SERIES.

注册题目简写:

English Acronym:

研究课题的正式科学名称:

MANAGEMENT OF NON-HEALING WOUNDS IN ASIAN PATIENTS WITH ADJUVANT TOPICAL HAEMOGLOBIN SPRAY. A CASE SERIES.

Scientific title:

MANAGEMENT OF NON-HEALING WOUNDS IN ASIAN PATIENTS WITH ADJUVANT TOPICAL HAEMOGLOBIN SPRAY. A CASE SERIES.

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:

LOO GUO HOU 

研究负责人:

LOO GUO HOU 

Applicant:

LOO GUO HOU 

Study leader:

Loo Guo Hou 

申请注册联系人电话:

Applicant telephone:

+60 1 02393995

研究负责人电话:

Study leader's
telephone:

+60 2 0393 9995

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:

looguohou@gmail.com

研究负责人电子邮件:

Study leader's E-mail:

Looguohou@gmail.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:

Department of Surgery, Universiti Kebangsaan Malaysia Medical Centre, Jln Yaacob Latiff, 56000, WP Kuala Lumpur, Malaysia

研究负责人通讯地址:

Universiti Kebangsaan Malaysia Medical Centre, Jalan yaacob latif

Applicant address:

Department of Surgery, Universiti Kebangsaan Malaysia Medical Centre, Jln Yaacob Latiff, 56000, WP Kuala Lumpur, Malaysia

Study leader's address:

University Kebangsaan Malaysia Medical Centre, Jalan yaacob latif

申请注册联系人邮政编码:

Applicant postcode:

56000

研究负责人邮政编码:

Study leader's postcode:

56000

申请人所在单位:

马来西亚Universiti Kebangsaan Malaysia Medical Centre

Applicant's institution:

Universiti Kebangsaan Malaysia Medical Centre

研究负责人所在单位:

马来西亚Universiti Kebangsaan Malaysia Medical Centre

Affiliation of the Leader:

Universiti Kebangsaan Malaysia Medical Centre

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

FF-2017-103

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:

Universiti Kebangsaan Malaysia Research Ethics Committee

Name of the ethic committee:

Universiti Kebangsaan Malaysia Research Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2017-09-26 00:00:00

伦理委员会联系人:

Fatimah Binti Mat Zin

Contact Name of the ethic committee:

Fatimah Binti Mat Zin

伦理委员会联系地址:

Sekretariat Etika Penyelidikan UKM Tingkat 1, Blok Klinikal, Pusat Perubatan UKM Jalan Yaakob Latiff, Bandar Tun Razak 56000 Cheras, Kuala Lumpur.

Contact Address of the ethic committee:

Sekretariat Etika Penyelidikan UKM Tingkat 1, Blok Klinikal, Pusat Perubatan UKM Jalan Yaakob Latiff, Bandar Tun Razak 56000 Cheras, Kuala Lumpur.

伦理委员会联系人电话:

Contact phone of the ethic committee:

+60 3-9145 504

伦理委员会联系人邮箱:

Contact email of the ethic committee:

fatimahz@ppukm.ukm.edu.my

研究实施负责(组长)单位:

LOO GUO HOU

Primary sponsor:

LOO GUO HOU

研究实施负责(组长)单位地址:

DEPARTMENT OF SURGERY, UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTRE

Primary sponsor's address:

DEPARTMENT OF SURGERY, UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTRE

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

马来西亚

省(直辖市):

WP KUALA LUMPUR

市(区县):

BANDAR TUN RAZAK

Country:

MALAYSIA

Province:

WP KUALA LUMPUR

City:

BANDAR TUN RAZAK

单位(医院):

UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTRE

具体地址:

JLN YAACOB LATIFF, 56000, WP KUALA LUMPUR, MALAYSIA

Institution
hospital:

UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTRE

Address:

JLN YAACOB LATIFF, 56000, WP KUALA LUMPUR, MALAYSIA

经费或物资来源:

None

Source(s) of funding:

NONE

研究疾病:

NON-HEALING WOUND  

Target disease:

NON-HEALING WOUND

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

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

TO ASSESS THE EFFECTIVENESS OF TOPICAL HAEMOGLOBIN SPRAY ON NON-HEALING WOUNDS IN ASIAN POPULATION  

Objectives of Study:

TO ASSESS THE EFFECTIVENESS OF TOPICAL HAEMOGLOBIN SPRAY ON NON-HEALING WOUNDS IN ASIAN POPULATION

药物成份或治疗方案详述:

GRANULOX (TOPICAL HAEMOGLOBIN SPRAY) 

Description for medicine or protocol of treatment in detail:

GRANULOX (TOPICAL HAEMOGLOBIN SPRAY) 

纳入标准:

Inclusion criteria

排除标准:

PREGNANT PATIENTS;
PATIENTS WITH A HISTORY OF ALLERGIC REACTION TO PORCINE PRODUCTS.

Exclusion criteria:

PREGNANT PATIENTS;
PATIENTS WITH A HISTORY OF ALLERGIC REACTION TO PORCINE PRODUCTS.

研究实施时间:

Study execute time:

From 2017-12-01 00:00:00 To 2018-06-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2017-12-01 00:00:00 To 2018-06-30 00:00:00

干预措施:

Interventions:

组别:

Case series

样本量:

7

Group:

SINGLE GROUP

Sample size:

干预措施:

TOPICAL HAEMOGLOBIN SPRAY

干预措施代码:

Intervention:

TOPICAL HAEMOGLOBIN SPRAY

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

马来西亚

省(直辖市):

WP KUALA LUMPUR 

市(区县):

BANDAR TUN RAZAK 

Country:

Malaysia

Province:

WP KUALA LUMPUR

City:

BANDAR TUN RAZAK

单位(医院):

UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTRE 

单位级别:

三级医院 

Institution
hospital:

UNIVERSITI KEBANGSAAN MALAYSIA MEDICAL CENTRE

Level of the institution:

Tertiary A Hospital

测量指标:

Outcomes:

指标中文名:

WOUND HEALING

指标类型:

主要指标

Outcome:

WOUND HEALING

Type:

Primary indicator

测量时间点:

3 months

测量方法:

SIZE OF WOUND

Measure time point of outcome:

3 months

Measure method:

SIZE OF WOUND

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

NOT APPLICABLE

Tissue:

NOT APPLICABLE

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

NO SAMPLES COLLECTED

征募研究对象情况:

Recruiting status:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 9 years
最大 Max age 78 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):

No

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

NOT APPLICABLE. CASE SERIES

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

N/A

Blinding:

NOT APPLICABLE

是否共享原始数据:

IPD sharing

否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):

No

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

NOT APPLICABLE

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:

THIS IS A CASE SERIES, NOT APPLICABLE

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

THIS IS A CASE SERIES, NOT APPLICABLE

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-09-27 04:57:13