ChiCTR2500115786 版本V1.0 版本创建时间2025/12/31 09:33:41 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：

ChiCTR2500115786 

最近更新日期：

Date of Last Refreshed on：

2025-12-31 09:33:18 

注册时间：

Date of Registration：

2025-12-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

手性材料与创面再生的作用和机制研究

Public title：

The Roles and Mechanisms of Chiral Materials in Wound Regeneration

注册题目简写：

English Acronym：

研究课题的正式科学名称：

手性材料与创面再生的作用和机制研究

Scientific title：

The Roles and Mechanisms of Chiral Materials in Wound Regeneration

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：

王旭 

研究负责人：

范存义 

Applicant：

Xu Wang 

Study leader：

Cunyi Fan 

申请注册联系人电话：

Applicant telephone：

+86 180 1910 8986

研究负责人电话：

Study leader's telephone：

+86 189 3017 7799

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：

wangxuany@foxmail.com

研究负责人电子邮件：

Study leader's E-mail：

cyfan@sjtu.edu.cn

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：

上海市徐汇区宜山路600号

研究负责人通讯地址：

上海市徐汇区宜山路600号

Applicant address：

600 Yishan Road, Xuhui District, Shanghai

Study leader's address：

600 Yishan Road, Xuhui District, Shanghai

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：

上海市第六人民医院

Applicant's institution：

Shanghai Sixth People’s Hospital

研究负责人所在单位：

上海市第六人民医院

Affiliation of the Leader：

Shanghai Sixth People’s Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025-KY-448(K)

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：

上海市第六人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Sixth People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-11-19 00:00:00

伦理委员会联系人：

贾伟平

Contact Name of the ethic committee：

Weiping Jia

伦理委员会联系地址：

宜山路600号11号楼（教学楼）

Contact Address of the ethic committee：

Building 11 (Teaching Building), No. 600 Yishan Road

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 6436 9181

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：

上海市第六人民医院

Primary sponsor：

Shanghai Sixth People’s Hospital

研究实施负责（组长）单位地址：

上海市徐汇区宜山路600号

Primary sponsor's address：

600 Yishan Road, Xuhui District, Shanghai

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

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市第六人民医院

具体地址：

上海市徐汇区宜山路600号

Institution
hospital：

Shanghai Sixth People’s Hospital

Address：

600 Yishan Road, Xuhui District, Shanghai

经费或物资来源：

纵向课题

Source(s) of funding：

Vertical research project

Target disease：

wound healing

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

本研究主要收集健康人群清创时多余的皮肤组织以及瘢痕增生患者清创时多余的皮肤组织进行多组学测序探索其根本机制，不直接使用手性凝胶接触患者创面，因此不会对人体造成可能的不良反应，却有利于我们进一步探索瘢痕形成的分子生物学机制以及改进我们设计的手性凝胶材料，期待为创面治疗从“单纯止血”跃升为“程序性无瘢痕再生”提供一定参考。  

Objectives of Study：

In the present study, surplus skin tissues obtained from debridement procedures of healthy individuals and patients with hypertrophic scarring were collected for multi-omics sequencing, aiming to elucidate the fundamental mechanisms underlying scar formation. Notably, chiral hydrogels were not directly applied to patients' wound surfaces, thereby eliminating the potential for adverse effects on the human body. This research not only facilitates in-depth exploration of the molecular biological mechanisms of scar formation and optimization of the custom-designed chiral hydrogels, but also is anticipated to provide valuable insights for advancing wound therapy from a "simple hemostasis" paradigm to a "programmed scar-free regeneration" strategy.

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.健康人群： （1）年龄在18-65岁之间（含18岁和65岁）； （2）同意参与研究并签署知情同意书； （3）清创操作时有多余皮肤组织可提供； （4）无重大传染病（如乙肝、艾滋病等）； （5）无瘢痕体质（Vancouver瘢痕评分=0）。 2.瘢痕增生患者： （1）年龄在18-65岁之间（含18岁和65岁）； （2）经病理诊断确认为增生性瘢痕（Vancouver瘢痕评分＞5）； （3）近1年内未接受过瘢痕相关治疗（如激光、手术等）； （4）同意参与研究并签署知情同意书； （5）清创操作时有多余瘢痕组织可提供。

Inclusion criteria

1. Healthy Participants (1) Aged between 18 and 65 years (inclusive). (2) Voluntarily agreed to participate in the study and signed the informed consent form. (3) Availability of surplus skin tissue during debridement procedures. (4) No history of major infectious diseases (e.g., hepatitis B, human immunodeficiency virus [HIV] infection). (5) Non-scar-forming constitution, defined as a Vancouver Scar Scale (VSS) score of 0 . 2. Patients with Hypertrophic Scarring (1) Aged between 18 and 65 years (inclusive). (2) Pathologically confirmed diagnosis of hypertrophic scarring, with a VSS score > 5 . (3) No prior scar-related treatments (e.g., laser therapy, surgical excision) within 1 year before enrollment. (4) Voluntarily agreed to participate in the study and signed the informed consent form. (5) Availability of surplus scar tissue during debridement procedures.

排除标准：

共同排除标准： 1.妊娠期或哺乳期女性； 2.存在凝血功能障碍（如INR＞1.5或APTT＞正常值1.5倍）； 3.近6个月内使用过免疫抑制剂或糖皮质激素； 4.合并严重心肺疾病（如NYHA心功能Ⅲ级及以上）或肝肾功能衰竭； 5.感染性创面或存在活动性感染病灶（如WBC＞12×10?/L或CRP＞10 mg/L）。

Exclusion criteria：

Common Exclusion Criteria 1. Females who were pregnant or lactating. 2. Presence of coagulation dysfunction (e.g., international normalized ratio [INR] > 1.5 or activated partial thromboplastin time [APTT] > 1.5 times the upper limit of the normal reference range). 3. Administration of immunosuppressants or glucocorticoids within the preceding 6 months. 4. Comorbidities of severe cardiopulmonary diseases (e.g., New York Heart Association [NYHA] functional class Ⅲ or higher) or acute hepatic/renal failure. 5. Infected wounds or active infectious foci (evidenced by white blood cell [WBC] count > 12 × 10?/L or C-reactive protein [CRP] level > 10 mg/L).

研究实施时间：

Study execute time：

从 From 2025-11-19 00:00:00至 To 2026-11-19 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-01 00:00:00 至 To 2026-11-19 00:00:00  

干预措施：

Interventions：

组别：

正常对照组

样本量：

20

Group：

Control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

组别：

瘢痕创面组

样本量：

20

Group：

Scar wound group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

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)：

上海市第六人民医院 

单位级别：

三甲 

Institution
hospital：

Shanghai Sixth People’s Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

基因表达差异、信号通路活性差异及组织学特征差异

指标类型：

主要指标

Outcome：

Differences in gene expression, signaling pathway activity, and histological features

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

创面愈合率

指标类型：

次要指标

Outcome：

Wound healing rate

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：

皮肤组织

组织：

Sample Name：

Skin tissue

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

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）：

无

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:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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）：

投稿后根据读者需要提供相关数据

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

Relevant datasets generated and/or analyzed during the current study will be made freely available upon reasonable request to the corresponding author, to meet the data access requirements of readers and peer researchers.

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：

1. CRF设计依据：参照《医疗器械临床试验质量管理规范》《临床研究数据管理工作技术指南》等相关规范，结合创面诊疗临床特点，设计标准化CRF。内容涵盖：①患者基本信息（姓名、性别、年龄、身份证号、联系方式等）；②创面基本信息（病因、发生时间、部位、面积、深度、类型等）；③临床诊疗信息（检查结果、诊断结论、治疗方案、用药情况、手术记录等）；④预后随访信息（创面愈合时间、愈合情况、并发症、复发情况等）；⑤其他相关信息（既往病史、过敏史、生活习惯等）。 2. CRF使用规范：由经过培训的研究人员或医护人员，在获得患者知情同意后，根据患者临床实际情况准确、完整、及时地填写CRF。填写过程严格遵循“真实、准确、完整、规范”原则，避免遗漏或错误记录。填写完成后，由专人进行一级审核，确保数据逻辑一致性和准确性，审核无误后录入EDC系统。 电子数据采集与管理系统（EDC）选择与应用 1. EDC系统选择：本项目选用ResMan系统作为电子数据采集与管理平台。ResMan是一款基于互联网的专业化EDC系统，具备数据录入、审核、质疑、查询、存储、导出等功能，已通过相关安全认证，能够满足临床研究数据管理的规范化要求，保障数据采集与管理过程的安全性、可靠性和可追溯性。 2. EDC系统应用流程：①用户权限管理：为不同研究人员分配分级权限（如数据录入员、审核员、管理员等），明确各角色职责，确保数据操作的可控性；②数据录入：研究人员将审核通过的CRF数据准确录入EDC系统，系统具备数据类型校验、逻辑核查等功能，可实时提示录入错误；③数据审核：审核员通过EDC系统对录入数据进行二级审核，对存在疑问的数据发起质疑，由录入员核实后进行修正并反馈；④数据存储与备份：EDC系统采用加密存储技术，对数据进行定期自动备份和异地备份，防止数据丢失或损坏；⑤数据导出与使用：如需导出数据用于科研分析，需经项目负责人审批，导出数据需进行脱敏处理，确保患者隐私安全。

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

Design Basis of the Case Report Form (CRF) In accordance with relevant regulatory guidelines including the Quality Management Standards for Clinical Trials of Medical Devices and the Technical Guidelines for Data Management in Clinical Research, a standardized CRF was developed by integrating the clinical characteristics of wound diagnosis and treatment. The CRF comprehensively covers the following domains:① Basic patient demographics: Name, gender, age, national identification number, and contact information;② Fundamental wound characteristics: Etiology, onset time, anatomical location, surface area, depth, and classification;③ Clinical diagnosis and treatment details: Laboratory and imaging test results, definitive diagnosis, treatment regimen, medication administration records, and surgical operation notes;④ Prognostic follow-up data: Wound healing time, healing status, occurrence of complications, and recurrence rate;⑤ Other relevant clinical information: Past medical history, allergy history, and lifestyle habits. Standard Operating Procedures for CRF Completion The CRF was completed accurately, comprehensively, and in a timely manner by trained researchers or medical staff, following the acquisition of written informed consent from patients. The entire data collection process strictly adhered to the principles of truthfulness, accuracy, completeness, and standardization, to minimize data omissions or erroneous recordings. After completion, the CRF underwent a primary review by designated personnel to verify the logical consistency and accuracy of the recorded data. Only after confirmation of data validity were the CRF data entered into the Electronic Data Capture (EDC) system. Selection and Application of the Electronic Data Capture (EDC) System 1 EDC System Selection For the present study, the ResMan system was selected as the dedicated EDC platform for electronic data collection and management. ResMan is a web-based, professional EDC system equipped with comprehensive functionalities including data entry, verification, query management, data retrieval, secure storage, and data export. Having passed relevant security certification, this system fulfills the standardized requirements for clinical research data management, and ensures the security, reliability, and traceability throughout the entire data collection and management process. 2 EDC System Application Workflow ① User permission management: Hierarchical user permissions (e.g., data entry clerk, data verifier, system administrator) were assigned to different research personnel, with clearly defined responsibilities for each role, to ensure controllability of all data operations.② Data entry: Researchers accurately input the verified CRF data into the EDC system. The system is embedded with built-in functions for data type validation and logical consistency checks, enabling real-time alerts for entry errors.③ Data verification: A secondary data review was performed by designated verifiers via the EDC system. Queries were initiated for data points with discrepancies, which were then verified, corrected, and responded to by the original data entry personnel.④ Data storage and backup: The EDC system employs encrypted storage technology, with automated scheduled local backups and off-site backups implemented regularly, to prevent data loss or corruption.⑤ Data export and utilization: For data export intended for scientific research and statistical analysis, formal approval from the principal investigator was mandatory. All exported data were subjected to de-identification processing to ensure the protection of patient privacy.

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：

  2025-12-31 09:33:18