ChiCTR2500105804 版本V1.0 版本创建时间2025/07/11 08:58:53 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500105804 

最近更新日期：

Date of Last Refreshed on：

 2025-07-11 08:58:41 

注册时间：

Date of Registration：

 2025-07-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Role of Hair Follicle Transplantation in Reconstructive and Aesthetic Surgery

Public title：

Role of Hair Follicle Transplantation in Reconstructive and Aesthetic Surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Role of Hair Follicle Transplantation in Reconstructive and Aesthetic Surgery

Scientific title：

Role of Hair Follicle Transplantation in Reconstructive and Aesthetic Surgery

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：

Mohamed Hazem Elshahidi 

研究负责人：

Ahmed Hassam Elsabbagh 

Applicant：

Mohamed Hazem Elshahidi 

Study leader：

Ahmed Hassam Elsabbagh 

申请注册联系人电话：

Applicant telephone：

 +20 10 63106500

研究负责人电话：

Study leader's
telephone：

+20 10 63106500

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：

 mohamedissamelshahidi@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 mohamedissamelshahidi@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：

Mansoura University Hospitals, Mansoura, Dakahlia, Egypt

研究负责人通讯地址：

Mansoura University Hospitals, Mansoura, Dakahlia, Egypt

Applicant address：

Mansoura University Hospitals, Mansoura, Dakahlia, Egypt

Study leader's address：

Mansoura University Hospitals, Mansoura, Dakahlia, Egypt

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Mansoura University Hospital

Applicant's institution：

Mansoura University Hospital

研究负责人所在单位：

Mansoura University Hospital

Affiliation of the Leader：

Mansoura University Hospital

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：

 MS.24.12.3020

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：

Medical Research Ethics Committee IRB Mansoura Faculty of Medicine University

Name of the ethic committee：

Medical Research Ethics Committee IRB Mansoura Faculty of Medicine University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-01-02 00:00:00

伦理委员会联系人：

Mansoura IRB

Contact Name of the ethic committee：

Mansoura IRB

伦理委员会联系地址：

Mansoura Facutly of Medicine, Mansoura, Dakahlia, Egypt

Contact Address of the ethic committee：

Mansoura Facutly of Medicine, Mansoura, Dakahlia, Egypt

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +20 10 92127930

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：

Mansoura University Hospital

Primary sponsor：

Mansoura University Hospital

研究实施负责（组长）单位地址：

Mansoura University Hospitals, Mansoura, Dakahlia, Egypt

Primary sponsor's address：

Mansoura University Hospitals, Mansoura, Dakahlia, Egypt

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Egypt

省(直辖市)：

Dakahlia

市(区县)：

Country：

Egypt

Province：

Dakahlia

City：

单位(医院)：

Mansoura University Hospital

具体地址：

Mansoura University Hospitals, Mansoura, Dakahlia, Egypt

Institution
hospital：

Mansoura University Hospital

Address：

Mansoura University Hospitals, Mansoura, Dakahlia, Egypt

经费或物资来源：

Self-funded

Source(s) of funding：

Self-funded

研究疾病：

Chronic ulcer, chronic scars  

Target disease：

Chronic ulcer, chronic scars

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：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

To study the clinical efficacy of HFU transplantation into chronic wounds comparing it with phase-appropriate wound care such as skin grafting. Also, the aesthetic outcome of HFU transplantation into scars will be investigated and the role of prior nano-fat injection will be studied.  

Objectives of Study：

To study the clinical efficacy of HFU transplantation into chronic wounds comparing it with phase-appropriate wound care such as skin grafting. Also, the aesthetic outcome of HFU transplantation into scars will be investigated and the role of prior nano-fat injection will be studied.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Chronic ulcers for more than 3 months not responding to the usual phase-appropriate wound care 2. Ulcers of vascular or diabetic origin 3. Ulcers in the lower limbs 4. Ulcer size > 1 cm^2

Inclusion criteria

1. Chronic ulcers for more than 3 months not responding to the usual phase-appropriate wound care 2. Ulcers of vascular or diabetic origin 3. Ulcers in the lower limbs 4. Ulcer size > 1 cm^2

排除标准：

1. Ulcers due to vasculitis, radiation, pressure or other inflammatory pathologies. 2. Patients with poor control of the underlying aetiology of the lesion 3. Poor patient compliance 5. Patient on immunosuppressive drugs or on steroids 6. Patient with coagulopathy 7. Patient deemed unfit for surgery by anaesthesia consultation 8. Patients with peripheral arterial diseases 9. Pregnancy

Exclusion criteria：

1. Ulcers due to vasculitis, radiation, pressure or other inflammatory pathologies. 2. Patients with poor control of the underlying aetiology of the lesion 3. Poor patient compliance 5. Patient on immunosuppressive drugs or on steroids 6. Patient with coagulopathy 7. Patient deemed unfit for surgery by anaesthesia consultation 8. Patients with peripheral arterial diseases 9. Pregnancy

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2026-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-08-01 00:00:00 至 To 2026-01-01 00:00:00

干预措施：

Interventions：

组别：

Chronic ulcer patients and patients with chronic scars

样本量：

 30

Group：

Chronic ulcer patients and patients with chronic scars

Sample size：

干预措施：

Hair follicular unit transplantation

干预措施代码：

Intervention：

Hair follicular unit transplantation

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Egypt

省(直辖市)：

 Dakahlia 

市(区县)：

  

Country：

Egypt

Province：

Dakahlia

City：

单位(医院)：

 Mansoura University Hospital 

单位级别：

 Tertiary 

Institution
hospital：

Mansoura University Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Ulcer reduction size

指标类型：

主要指标

Outcome：

Ulcer reduction size

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：

标本中文名：

None

组织：

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

None

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 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）：

None

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

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）：

IPD can be shard by contacting the principal investigator.

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

IPD can be shard by contacting the principal investigator.

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：

Case Record Form

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

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-07-11 08:58:41