今天是:2019-07-21 星期日

评价人工真皮支架作为自体微粒皮肤移植的覆盖物治疗大面积增生性瘢痕效果的单中心临床研究
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注册号:

Registration number:

ChiCTR1900024101 

最近更新日期:

Date of Last Refreshed on:

2019-07-01 

注册时间:

Date of Registration:

2019-06-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价人工真皮支架作为自体微粒皮肤移植的覆盖物治疗大面积增生性瘢痕效果的单中心临床研究 

Public title:

Evaluation of the effect of artificial dermal scaffolds as a covering for autologous micro-skin grafts in the treatment of large area hypertrophic scars 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价人工真皮支架作为自体微粒皮肤移植的覆盖物治疗大面积增生性瘢痕效果的单中心临床研究 

Scientific title:

Evaluation of the effect of artificial dermal scaffolds as a covering for autologous micro-skin grafts in the treatment of large area hypertrophic scars 

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:

李海航 

研究负责人:

朱世辉 

Applicant:

Li Haihang 

Study leader:

Zhu Shihui 

申请注册联系人电话:

Applicant telephone:

+86 13764246731 

研究负责人电话:

Study leader's telephone:

+86 13901971974 

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:

haihang88@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

Doctorzhushihui@163.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:

上海市杨浦区长海路168号 

研究负责人通讯地址:

上海市杨浦区长海路168号 

Applicant address:

168 Changhai Road, Yangpu District, Shanghai 

Study leader's address:

168 Changhai Road, Yangpu District, Shanghai 

申请注册联系人邮政编码:

Applicant postcode:

200433 

研究负责人邮政编码:

Study leader's postcode:

200433 

申请人所在单位:

上海长海医院烧伤科 

Applicant's institution:

Department of Burns, Shanghai Changhai 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:

CHEC2019-075 

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:

上海长海医院伦理委员会 

Name of the ethic committee:

Shanghai Changhai Hospital Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-19 

伦理委员会联系人:

计一平 

Contact Name of the ethic committee:

Ji Yiping 

伦理委员会联系地址:

中国上海市杨浦区长海路168号 

Contact Address of the ethic committee:

168 Changhai Road, Yangpu District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 21-31162338 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

changhaiec@126.com 

研究实施负责(组长)单位:

上海长海医院 

Primary sponsor:

Shanghai Changhai Hospital 

研究实施负责(组长)单位地址:

中国上海市杨浦区长海路168号 

Primary sponsor's address:

168 Changhai Road, Yangpu District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海长海医院

具体地址:

杨浦区长海路168号

Institution
hospital:

Shanghai Changhai Hospital

Address:

168 Changhai Road, Yangpu District

经费或物资来源:

中国国家卫生和计划生育委员会公益性行业科研专项《瘢痕诊断分类及危险评估的临床研究》 

Source(s) of funding:

National Health and Family Planning Commission of the People's Republic of China, Public Welfare Industry Research Project  

研究疾病:

瘢痕 

Target disease:

scar 

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)评价人工真皮支架作为微粒皮覆盖物对大面积增生性瘢痕切除后创面的封闭效果。 (2)评价人工真皮支架作为微粒皮覆盖物对大面积增生性瘢痕的远期效果。 

Objectives of Study:

(1) Evaluation of the sealing effect of artificial dermal scaffold as a microparticle cover for wounds after extensive hypertrophic scar resection; (2) Evaluate the long-term effect of artificial dermal scaffold as a microparticle cover for large-area hypertrophic scars. 

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)年龄在0~60岁,男女不限; (2)临床诊断为烧伤后增生性瘢痕,烧伤面积为:0-6岁≥5%,6-18岁≥10%,成人≥15%,且增生时间为6月~1年; (3)拟一次性切除单块瘢痕的总面积<2% (以手掌法估计),预计切除瘢痕后的目标创面在5cm×5cm~10cm×10cm之间,瘢痕位置为四肢或躯干; (4)经临床医师确认,采用其他方法治疗效果不佳或是严重影响四肢功能和日常生活; (5)同意参加本研究并签署书面知情同意书者。 

Inclusion criteria

(1) Aged 0 to 60 years, male or female; (2) The clinical diagnosis is hypertrophic scar after burn. The burn area is: 0-6 years old >=5%, 6-18 years old >=10%, adult >=15%, and the proliferative time is June~1 year; (3) The total area of a single scar to be removed at one time is <2% (estimated by the palm method), and the target wound after the scar is expected to be between 5 cm x5 cm and 10 cm x10 cm, and the position of the scar is the limbs or the trunk; (4) Confirmed by the clinician, using other methods to treat poor results or seriously affect the function of limbs and daily life; (5) Those who agree to participate in the study and sign written informed consent. 

排除标准:

(1)化学烧伤/电烧伤等特殊原因烧伤、慢性创面、手术切口不愈等引起的增生性瘢痕;明确诊断为瘢痕疙瘩或是萎缩性瘢痕; (2)严重营养不良,白蛋白<25g/L; (3)体温>38.5℃或白细胞>12×10^9/L或明显伴有局部炎症; (4)伴有全身严重感染需全身使用抗菌药物治疗者; (5)肿瘤、放疗或化疗患者; (6)合并有心血管、肝、肾和血液系统等严重原发性疾病、精神病患者; (7)已知对人工真皮支架所含成分或其它化学结构与之相似有过敏史或过敏体质者; (8)妊娠或哺乳期妇女及有生育计划者; (9)入选前1个月内参加过其他临床研究者; (10)有其他研究者认为不宜参加临床研究的情况者。 

Exclusion criteria:

(1) Proliferative scars caused by chemical burns/electric burns and other special causes such as burns, chronic wounds, and surgical incisions; keloids or atrophic scars are clearly diagnosed; (2) Severe malnutrition, albumin <25g/L; (3) Body temperature > 38.5 degree C or white blood cells > 12 x10^9/L or marked with local inflammation; (4) Patients with severe systemic infections who require systemic antibiotic treatment; (5) Patients with tumor, radiotherapy or chemotherapy; (6) Patients with serious primary diseases such as cardiovascular, liver, kidney and blood system, and mental patients; (7) It is known that the components or other chemical structures contained in the artificial dermal scaffold have a history of allergies or allergies; (8) Pregnant or lactating women and those with birth plans; (9) Those who have participated in other clinical research within one month prior to the election; (10) Some other investigators believe that it is not appropriate to participate in clinical research. 

研究实施时间:

Study execute time:

From2019-07-01To 2022-12-31 

干预措施:

Interventions:

组别:

1

样本量:

10

Group:

Group 1

Sample size:

干预措施:

微粒皮肤在下,人工真皮支架在上的方式,覆盖于瘢痕切除后的创面上

干预措施代码:

Intervention:

The surface of the microscopic skin is underneath, and the artificial dermal support is placed on the wound surface after the scar is removed.

Intervention code:

组别:

2

样本量:

10

Group:

Group 2

Sample size:

干预措施:

将人工真皮支架缝合在瘢痕切除后的创面上,21天后行自体超薄皮片移植

干预措施代码:

Intervention:

The artificial dermal stent was sutured on the wound surface after the scar resection, and the autologous ultrathin skin graft was performed 21 days later.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海长海医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shanghai Changhai Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

瘢痕切除后创面封闭的临床治疗时间

指标类型:

主要指标 

Outcome:

Clinical treatment time for wound closure after scar resection

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

瘢痕切除后的远期效果,瘢痕评估量表(POSAS)

指标类型:

主要指标 

Outcome:

Long-term outcome after scar removal, Scar Assessment Scale (POSAS)

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:

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 0 years
最大 Max age 60 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):

研究对象按未成年人和成年人分成2个层次,每个层次10人,按20%偏移发生率,即每层10+2人。每2人一个区组,每层分成5+1个区组。 根据上述设置,在ResMan内形成随机序列,并通过密封随机分组卡的方式,进行随机化分组

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

The subjects were divided into two levels according to minors and adults, with 10 people at each level, with a 20% offset rate, ie 10+2 people per layer. Each group of 2 people, each layer is divided into 5+1 groups. According to the above settings, a random sequence is formed in ResMan, and

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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://www.medresman.org/

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

http://www.medresman.org/

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:

一:病例记录表(Case Record Form, CRF),研究者根据受试者的原始观察记录,将数据及时、完整、正确、清晰地载入病例报告表。 临床监查员监查研究的进行是否遵循研究方案。确认所有病例报告表填写正确并与原始资料一致。如有错误和遗漏,及时要求研究者改正。修改时需保持原有记录清晰可见,改正处需经研究者签名并注明日期。 二:ResMan临床试验公共管理平台(http://www.medresman.org/)

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

A: Case Record Form (CRF), according to the original observation record of the subject, the data is loaded into the case report form in a timely, complete, correct and clear manner. The clinical monitor monitors whether the research is conducted in accordance with the research protocol. Confirm that all case report forms are correct and consistent with the original data. In case of errors or omissions, the researcher should be promptly corrected. The original records must be kept clearly visible when they are modified. The corrections must be signed and dated by the researcher. Two: ResMan Clinical Trial Public Management Platform (http://www.medresman.org/)

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-06-25
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