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人胎盘间充质干细胞治疗烧伤患者中厚供皮区创面的随机对照临床研究
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注册号:

Registration number:

ChiCTR2000038275 

最近更新日期:

Date of Last Refreshed on:

2020-12-13 

注册时间:

Date of Registration:

2020-09-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

人胎盘间充质干细胞治疗烧伤患者中厚供皮区创面的随机对照临床研究 

Public title:

Human placental mesenchymal stem cell in the treatment of wounds in partial-thickness skin donor site in burn patients: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

人胎盘间充质干细胞治疗烧伤患者中厚供皮区创面的随机对照临床研究 

Scientific title:

Human placental mesenchymal stem cell in the treatment of wounds in partial-thickness skin donor site in burn patients: a randomized 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:

刘磊 

研究负责人:

夏成德 

Applicant:

Liu Lei 

Study leader:

Xia Chengde 

申请注册联系人电话:

Applicant telephone:

+86 18801202625 

研究负责人电话:

Study leader's telephone:

+86 13837171639 

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:

1162245569@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

2273451508@qq.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:

河南省郑州市管城区东大街56号 

研究负责人通讯地址:

河南省郑州市管城区东大街56号 

Applicant address:

56 East Street, Guancheng District, Zhengzhou, He'nan, China 

Study leader's address:

56 East Street, Guancheng District, Zhengzhou, He'nan, China 

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:

郑州市第一人民医院 

Applicant's institution:

Zhengzhou First People's 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:

【2019】第04-001-1 

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:

郑州市第一人民医院干细胞临床研究伦理委员会 

Name of the ethic committee:

Ethics Committee of Clinical Research on Stem Cells of Zhengzhou First People's Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-06 

伦理委员会联系人:

母心灵 

Contact Name of the ethic committee:

Mu Xinling 

伦理委员会联系地址:

河南省郑州市管城区东大街56号 

Contact Address of the ethic committee:

56 East Street, Guancheng District, Zhengzhou, He'nan, China 

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:

郑州市第一人民医院 

Primary sponsor:

Zhengzhou First People's Hospital 

研究实施负责(组长)单位地址:

河南省郑州市管城区东大街56号 

Primary sponsor's address:

56 East Street, Guancheng District, Zhengzhou, He'nan, 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):

河南

市(区县):

郑州

Country:

China

Province:

He'nan

City:

Zhengzhou

单位(医院):

郑州市第一人民医院

具体地址:

管城区东大街56号

Institution
hospital:

Zhengzhou First People's Hospital

Address:

56 East Street, Guancheng District

经费或物资来源:

郑州市第一人民医院 

Source(s) of funding:

The First People's Hospital of Zhengzhou City 

研究疾病:

烧伤患者中厚供皮区创面 

Target disease:

Wound of medium thickness donor site in burn patients 

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:

探索性研究/预试验 

Study phase:

研究目的:

1 评价人胎盘间充质干细胞凝胶治疗供皮区创面的安全性; 2 观察人胎盘间充质干细胞凝胶物是否能够有效缩短供皮区创面愈合时间; 3 观察人胎盘间充质干细胞凝胶物是否能够有效减轻供皮区创面愈合后瘢痕形成; 4 探讨人胎盘间充质干细胞凝胶物治疗供皮区创面量效关系。 

Objectives of Study:

1. Evaluate the safety of human placenta derived mesenchymal stem cells in the treatment of donor site wounds. 2. Observe whether the gel of human placenta mesenchymal stem cells can effectively shorten the healing time of donor site. 3. Observe whether human placenta derived mesenchymal stem cells gel can effectively reduce scar formation after donor site wound healing. 4. Investigate the dose effect relationship of human placenta derived mesenchymal stem cells gel in donor site wounds. 

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)自愿参加并签署知情同意书; (2)烧伤患者,需要自体皮移植的受试者; (3)年龄18~65周岁,性别不限; (4)本次临床研究期间,供皮区选取大腿外侧或躯干部治疗; (5)皮肤烧伤面积<30%体表总面积(TBSA); (6)供皮区为首次供皮,供皮区为中厚皮(厚度约0.4mm); (7)切取皮片面积90cm2 (8)能配合本研究方案,接受术后定期访视。 

Inclusion criteria

1. Patients who voluntarily participate and sign informed consent form; 2. Burn patients, subjects who need autologous skin graft; 3. Patients aged from 18 to 65 years old, regardless of gender; 4. During this clinical study, the donor site was selected from the lateral thigh or trunk for treatment; 5. Patients with skin burn area less than 30% of total body surface area (TBSA); 6. The donor site was the first time, and the donor site was medium thickness (about 0.4mm thick); 7. The area of skin graft is 90cm2; 8. Patients who can cooperate with this study plan should receive regular postoperative visits. 

排除标准:

(1)对海藻酸钠(凝胶成分)过敏者; (2)电击伤、化学烧伤、放射伤或合并其他创伤; (3)有严重系统疾病的受试者(研究者判定); (4)有不能稳定控制的高血压、糖尿病受试者(研究者判定); (5)妊娠或哺乳期妇女; (6)受试者病情可能影响研究评估或需要合并采用可能影响疗效评估的医学治疗; (7)有急性或慢性肾脏疾病、肾功能衰竭或血清肌酐水平=正常值上限1.5倍; (8)有急性或慢性肝脏疾病,肝功能中总胆红素、丙氨酸氨基转移酶、门冬氨酸氨基转移酶=正常值上限2.0倍; (9)有恶性肿瘤病史的受试者; (10)参加其他临床研究未满 3个月者; (11)有精神疾病及无自知力、不能确切表达者; (12)使用免疫抑制剂及长期(超过 1个月)应用皮质激素者(不包含局部应用); (13)感染性疾病受试者(传染病四项任一项阳性); (14)合并其他严重系统疾病者; (15)其他研究者认为不能入选的受试者。 

Exclusion criteria:

1. Allergic to alginate (gel); 2. Patients with electrical injury, chemical burn, radiation injury or combined with other trauma; 3. Subjects with severe systemic diseases (determined by the researcher); 4. Patients with unstable hypertension and diabetes mellitus (determined by the researcher); 5. Pregnant or lactating women; 6. The patient's condition may affect the study evaluation or need to combine medical treatment that may affect the evaluation of efficacy; 7. Patients with acute or chronic kidney disease, renal failure or serum creatinine level = 1.5 times the upper limit of normal value; 8. In patients with acute or chronic liver disease, the total bilirubin, alanine aminotransferase and aspartate aminotransferase in liver function = 2.0 times of the upper limit of normal value; 9. Subjects with a history of malignant tumor; 10. Patients who have participated in other clinical studies for less than 3 months; 11. Patients with mental illness, lack of insight and unable to express exactly; 12. Patients with immunosuppressants and long-term (more than 1 month) use of corticosteroids (excluding local application); 13. Subjects with infectious diseases (positive for any of the four infectious diseases); 14. Patients with other severe systemic diseases; 15. Subjects that other researchers thought could not be selected. 

研究实施时间:

Study execute time:

From2020-09-01To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2020-09-01To 2022-12-31 

干预措施:

Interventions:

组别:

高剂量干细胞凝胶组

样本量:

30

Group:

High dose stem cell gel group

Sample size:

干预措施:

高剂量干细胞凝胶(60000 cells/cm2)作为内层敷料,均匀涂抹于创面

干预措施代码:

Intervention:

High dose stem cell gel (60000 cells/cm2) was applied to the wound as an inner dressing.

Intervention code:

组别:

低剂量干细胞凝胶组

样本量:

30

Group:

Low dose stem cell gel group

Sample size:

干预措施:

低剂量干细胞凝胶(30000 cells/cm2)作为内层敷料,均匀涂抹于创面

干预措施代码:

Intervention:

Low dose stem cell gel (30000 cells/cm2) was applied to the wound as an inner dressing.

Intervention code:

组别:

单独凝胶组

样本量:

30

Group:

Individual gel group

Sample size:

干预措施:

不含干细胞凝胶作为内层敷料均匀涂抹创面

干预措施代码:

Intervention:

Gel without stem cell was applied to the wound as an inner dressing.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

He'nan 

City:

Zhengzhou 

单位(医院):

郑州市第一人民医院 

单位级别:

市级 

Institution
hospital:

The First People's Hospital of Zhengzhou City  

Level of the institution:

Municipal level 

测量指标:

Outcomes:

指标中文名:

创面愈合时间

指标类型:

主要指标 

Outcome:

Wound healing time

Type:

Primary indicator 

测量时间点:

1d、3d、7d、14d、21d、创面愈合当天

测量方法:

由两位副高级别医师进行独立评价

Measure time point of outcome:

Measure method:

指标中文名:

创面愈合率

指标类型:

主要指标 

Outcome:

Wound healing rate

Type:

Primary indicator 

测量时间点:

1d、3d、7d、14d、21d、创面愈合当天

测量方法:

拍照记录每个时间点创面愈合情况,使用image-pro-plus软件进行创面面积估算,计算创面愈合率。

Measure time point of outcome:

Measure method:

指标中文名:

术后创面感染情况

指标类型:

次要指标 

Outcome:

Postoperative wound infection

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

创面边缘炎症反应的程度

指标类型:

次要指标 

Outcome:

The degree of inflammation at the edge of wound

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

受试者自觉疼痛程度

指标类型:

次要指标 

Outcome:

Subjective pain level

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

创面瘢痕增生情况

指标类型:

次要指标 

Outcome:

Degree of scar hyperplasia of wound

Type:

Secondary 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:

血液

组织:

Sample Name:

blood

Tissue:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

随机分配表由SPSS程序产生。对受试者进行随机化,干细胞凝胶组与安慰剂组人数的比例为2:1。研究者在核实入选、排除标准后按受试者入组的时间先后顺序依次将受试者分配到相应编号(顺序号)的受试组。

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

The random distribution table is generated by SPSS program. Randomization of subjects, the proportion of stem cell gel group and placebo group was 2:1.

盲法:

双盲

Blinding:

Double blind

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):

发表论文

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

Open in the form of published papers

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:

Not stated

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

Not stated

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-09-15
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