ChiCTR2600126151 版本V1.0 版本创建时间2026/06/04 15:01:45 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：

 ChiCTR2600126151 

最近更新日期：

Date of Last Refreshed on：

 2026-06-04 14:56:25 

注册时间：

Date of Registration：

 2026-06-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

喷雾成膜敷料治疗浅Ⅱ度烧伤的随机对照临床试验

Public title：

A randomized controlled clinical trial of a spray film-forming dressing for superficial partial-thickness burns

注册题目简写：

English Acronym：

研究课题的正式科学名称：

喷雾成膜敷料临床应用的安全性和有效性的前瞻性随机对照临床试验

Scientific title：

A prospective randomized controlled clinical trial on the safety and effectiveness of a spray film-forming dressing in clinical application

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：

蔺立诚 

研究负责人：

申传安 

Applicant：

Licheng Lin 

Study leader：

Chuanan Shen 

申请注册联系人电话：

Applicant telephone：

 +86 183 6303 9159

研究负责人电话：

Study leader's
telephone：

+86 139 1059 5595

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：

 linbiomaterials@foxmail.com

研究负责人电子邮件：

Study leader's E-mail：

 shenchuanan@301hospital.com.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：

北京市海淀区阜成路51号中国人民解放军总医院第四医学中心

研究负责人通讯地址：

北京市海淀区阜成路51号中国人民解放军总医院第四医学中心

Applicant address：

The Fourth Medical Center, Chinese PLA General Hospital, 51 Fucheng Road, Haidian District, Beijing, China

Study leader's address：

The Fourth Medical Center, Chinese PLA General Hospital, 51 Fucheng Road, Haidian District, Beijing, 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：

中国人民解放军总医院第四医学中心

Applicant's institution：

The Fourth Medical Center, Chinese PLA General Hospital

研究负责人所在单位：

北京市海淀区阜成路51号中国人民解放军总医院第四医学中心

Affiliation of the Leader：

The Fourth Medical Center, Chinese PLA General 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：

 2026KY076-HS001

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：

中国人民解放军总医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Chinese PLA General Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-05-13 00:00:00

伦理委员会联系人：

张卓辉

Contact Name of the ethic committee：

Zhuohui Zhang

伦理委员会联系地址：

北京市海淀区阜成路51号中国人民解放军总医院第四医学中心

Contact Address of the ethic committee：

The Fourth Medical Center, Chinese PLA General Hospital, 51 Fucheng Road, Haidian District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 150 0138 1638

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：

中国人民解放军总医院第四医学中心

Primary sponsor：

The Fourth Medical Center, Chinese PLA General Hospital

研究实施负责（组长）单位地址：

北京市海淀区阜成路51号中国人民解放军总医院第四医学中心

Primary sponsor's address：

The Fourth Medical Center, Chinese PLA General Hospital, 51 Fucheng Road, Haidian District, Beijing, Chin

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国人民解放军总医院第四医学中心

具体地址：

北京市海淀区阜成路51号中国人民解放军总医院第四医学中心

Institution
hospital：

The Fourth Medical Center, Chinese PLA General Hospital

Address：

The Fourth Medical Center, Chinese PLA General Hospital, 51 Fucheng Road, Haidian District, Beijing, China

经费或物资来源：

军队课题

Source(s) of funding：

Supported by a military-funded research project

研究疾病：

浅Ⅱ度烧伤（浅层部分皮层损伤）  

Target disease：

Superficial partial-thickness burn wounds

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：

随机平行对照 

Study design：

Parallel 

研究目的：

总体目的：评价喷雾成膜敷料（EDA-HA/OHA双组分原位交联成膜）在伤后Day0–Day2随机干预期内相较常规治疗（Day0–Day2为凡士林油纱+磺胺嘧啶银，伤后Day3评估后改为凡士林油纱+外用生长因子）在换药效率、早期创面稳定性与后续创面修复方面的临床价值，并为后续扩大样本的验证性研究提供效应量与可行性依据。 主要目的：比较两组目标创面在伤后Day0–Day2期间单次换药床旁总耗时均值的差异。 关键次要目的：比较两组目标创面在伤后Day0–Day2期间单次换药直接操作时间均值的差异；比较两组目标创面临床愈合时间的差异，并评估Day3时创面是否加深及是否感染。 次要目的：评估Day3不良反应发生情况，并记录全随访期换药相关疼痛（VAS）及其他不良事件，用于验证产品在早期使用阶段的临床可接受性与风险边界。  

Objectives of Study：

Overall objective: To evaluate the clinical value of a spray film-forming dressing (an EDA-HA/OHA dual-component in situ cross-linking film-forming system), compared with conventional treatment (petrolatum gauze plus silver sulfadiazine during Day0–Day2, followed by petrolatum gauze plus topical growth factor after Day3 assessment), during the randomized intervention period from Day0 to Day2 after injury, with respect to dressing-change efficiency, early wound stability, and subsequent wound repair, and to provide effect-size and feasibility data for future confirmatory studies. Primary objective: To compare the mean bedside elapsed time for a single dressing change during Day0–Day2 between the two groups. Key secondary objectives: To compare the mean hands-on time for a single dressing change during Day0–Day2 between the two groups; to compare time to clinical wound healing between the two groups; and to assess wound deepening and wound infection on Day3. Secondary objectives: To evaluate adverse reactions on Day3 and to record dressing-change-related pain (VAS) and other adverse events throughout follow-up, in order to assess the early clinical acceptability and risk boundary of the product.

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.年龄18–65岁，性别不限； 2.入组时临床诊断为烧伤/烫伤浅Ⅱ度创面，且受伤至入组≤12小时； 3.每位受试者仅纳入1处目标创面； 3.目标创面面积25–50 cm2； 4.目标创面为浅Ⅱ度且可独立换药、独立计时； 5.目标创面入组前未接受局部药物或敷料处理；允许入组前进行单纯清水或生理盐水冲洗，但不得使用局部药物、消毒剂或敷料覆盖； 6.目标创面允许污染但无明确感染； 7.受试者自愿参加并签署知情同意书。

Inclusion criteria

1.Male or female, aged 18–65 years. 2.Clinically diagnosed burn/scald patients with a superficial partial-thickness burn wound, enrolled within 12 hours after injury. 3.Each participant contributes only one target wound. 4.The target wound is superficial partial-thickness, with an area of 25–50 cm2, and can be dressed and timed independently. 5.Before enrollment, the target wound must not have received any topical medication, disinfectant, or dressing; simple rinsing with clean water or normal saline is allowed. 6.Wound contamination is allowed, but there must be no definite infection. 7.The participant is compliant and willing to sign the informed consent form.

排除标准：

1.已知对透明质酸或本产品任何成分过敏； 2.妊娠或哺乳期； 3.严重肝肾功能异常或重要脏器功能不全； 4.糖尿病、血管性疾病、凝血功能异常、免疫性疾病等可能影响创面愈合的疾病； 5.目标创面明确感染或高度疑似感染； 6.目标创面为深Ⅱ度/Ⅲ度或研究者判断可能需要植皮/手术处理； 7.位置特殊导致无法标准化处理与计时； 8.研究者认为不适合入组的其他情况。

Exclusion criteria：

1.Known allergy to hyaluronic acid or any component of the investigational product. 2.Pregnancy or lactation. 3.Severe hepatic or renal dysfunction or or insufficiency of vital organs 4.major conditions that may affect wound healing, including diabetes mellitus, vascular disease, coagulation disorders, or immune disorders. 5.The target wound has definite infection or is highly suspected of infection. 6.The target wound is deep partial-thickness or full-thickness, or is considered likely to require skin grafting or other surgical treatment. 7.The wound is located at a special site that precludes standardized treatment and timing. 8.The investigator considers the participant unsuitable for enrollment.

研究实施时间：

Study execute time：

从 From 2026-06-05 00:00:00至 To 2026-06-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-05 00:00:00 至 To 2026-06-14 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 30

Group：

Experimental arm

Sample size：

干预措施：

喷雾成膜敷料： 伤后 Day0–Day2 随机干预期内，在常规处理后，于距创面约 5–10 cm 使用 A/B 双组分喷雾原位成膜敷料覆盖目标创面。A 组分为胺化透明质酸 EDA-HA，B 组分为氧化透明质酸 OHA。喷涂后约 60 s 定形、约 180 s 完成成膜，成膜后不额外外覆敷料。Day1、Day2 每日换药时以生理盐水充分冲洗；膜完整则整体揭除，不完整则机械擦除残留后再重新喷涂。Day3 换药前完成预设评估后，停止喷雾成膜干预，并改为凡士林油纱+外用生长因子常规治疗。伤后 Day0–Day2 期间，试验创面范围内不联合外用抗菌药膏、生长因子或银离子敷料。

干预措施代码：

Intervention：

Spray film-forming dressing: During the randomized intervention period from Day0 to Day2 after injury, after routine wound care, the target wound will be covered with an A/B dual-component spray in situ film-forming dressing applied from a distance of approximately 5–10 cm. Component A is ethylenediamine-modified hyaluronic acid (EDA-HA), and component B is oxidized hyaluronic acid (OHA). The dressing sets in about 60 seconds and forms a film in about 180 seconds, with no additional outer dressing required. On Day1 and Day2, during daily dressing changes, the wound will be thoroughly rinsed with normal saline; if the film is intact, it will be removed en bloc, and if incomplete, residual material will be mechanically removed before re-spraying. After the planned assessment before dressing change on Day3, the spray film-forming intervention will be discontinued and conventional treatment with petrolatum gauze plus topical growth factor will be used. During Day0–Day2, no topical antimicrobial ointments, growth factors, or silver-containing dressings will be allowed on the target wound.

Intervention code：

组别：

对照组

样本量：

 30

Group：

Control arm

Sample size：

干预措施：

常规治疗： 伤后 Day0–Day2 随机干预期内，采用凡士林油纱+磺胺嘧啶银常规治疗。Day3 换药前完成与试验组相同的预设评估后，自 Day3 起改为凡士林油纱+外用生长因子常规治疗。

干预措施代码：

Intervention：

Conventional treatment: During the randomized intervention period from Day0 to Day2 after injury, conventional treatment with petrolatum gauze plus silver sulfadiazine will be used. After the same planned assessment before dressing change on Day3, treatment will be switched to petrolatum gauze plus topical growth factor from Day3 onward.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 中国人民解放军总医院第四医学中心 

单位级别：

 三甲 

Institution
hospital：

The Fourth Medical Center, Chinese PLA General Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

伤后Day0–Day2单次换药床旁总耗时均值

指标类型：

主要指标

Outcome：

Mean bedside elapsed time for a single dressing change during Day0–Day2 after injury

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

伤后Day0–Day2单次直接操作时间均值

指标类型：

次要指标

Outcome：

Mean hands-on time for a single dressing change during Day0–Day2 after injury

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

创面临床愈合时间

指标类型：

次要指标

Outcome：

Time to clinical wound healing

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Day3创面是否加深

指标类型：

次要指标

Outcome：

Wound deepening on Day3

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Day3创面是否感染

指标类型：

次要指标

Outcome：

Wound infection on Day3

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Day3不良反应

指标类型：

副作用指标

Outcome：

Adverse reactions on Day3

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

换药相关疼痛VAS评分

指标类型：

次要指标

Outcome：

Dressing-change-related pain assessed by VAS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Day14愈合率

指标类型：

次要指标

Outcome：

Healing rate on Day14

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

全随访期其他不良事件

指标类型：

副作用指标

Outcome：

Other adverse events during the follow-up period

Type：

Adverse events

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：

无

组织：

无

Sample Name：

none

Tissue：

none

人体标本去向

 其它  

说明

本研究不采集血液、组织、分泌物或其他人体生物样本，仅采集病历资料、换药计时记录、疼痛评分、标准化创面照片及不良事件等临床研究数据。

Fate of sample：

0thers  

Note：

No blood, tissue, secretion, or other human biological samples will be collected in this study. Only clinical research data, including medical record information, dressing-change timing records, pain scores, standardized wound photographs, and adverse event records, will be collected.

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）：

采用计算机生成随机序列，以1:1比例在受试者层面将符合条件的受试者随机分配至试验组或对照组。随机序列由非实施研究干预的研究人员生成并保管，在确认受试者符合入组条件并确定目标创面后实施随机分组。

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

A computer-generated random sequence will be used to randomly allocate eligible participants at the participant level to the experimental group or the control group in a 1:1 ratio. The random sequence will be generated and kept by study personnel who are not involved in implementing the study intervention. Randomization will be performed after eligibility is confirmed and the target wound is determined.

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：

本研究为开放性试验。由于试验组采用喷雾成膜敷料，对照组采用凡士林油纱+磺胺嘧啶银，干预方式和外观差异明显，实施者和受试者无法实施盲法。为降低偏倚，换药时间由独立观察者/第三方计时人员按统一起止点记录；创面照片去标识化后，由与分组信息隔离的研究者进行评估。

Blinding：

This is an open-label trial. Because the experimental group receives a spray film-forming dressing and the control group receives petrolatum gauze plus silver sulfadiazine, the interventions and their appearances are clearly different, making blinding of participants and operators infeasible. To reduce bias, dressing-change time will be recorded by an independent observer or third-party timing personnel using predefined start and end points. Wound photographs will be de-identified and evaluated by investigators blinded to group allocation information as far as possible.

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

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）：

不公开共享去标识化个体受试者原始数据。研究结果将以汇总统计形式用于注册平台结果更新、学术交流或论文发表，不包含可识别受试者个人身份的信息。

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

De-identified individual participant data will not be publicly shared. Study results will be reported in aggregate form for registry update, academic communication, or publication, without personally identifiable information.

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：

本研究采用纸质病例报告表（CRF）进行数据采集。数据来源包括原始病历、目标创面床旁评估记录、换药计时记录、疼痛VAS评分、标准化创面照片、不良事件记录及合并用药/治疗记录。每位受试者使用唯一研究编号进行去标识化管理，姓名、住院号、联系方式等直接身份信息与CRF及创面照片资料分开保存。CRF由授权研究人员填写，研究者负责核查数据的完整性、准确性和一致性。研究数据录入去标识化电子数据表后保存于受控设备或受控文件夹中，仅授权研究成员可访问。统计分析使用去标识化数据集完成。

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

Data will be collected using paper Case Report Forms (CRFs). Data sources include source medical records, bedside wound assessments, dressing-change timing records, VAS pain scores, standardized wound photographs, adverse event records, and concomitant medication/treatment records. Each participant will be identified by a unique study ID. Direct identifiers such as name, hospital number, and contact information will be stored separately from CRFs and wound photographs. CRFs will be completed by authorized study personnel, and investigators will check data completeness, accuracy, and consistency. De-identified data will be entered into an electronic dataset and stored in a controlled device or folder accessible only to authorized study members. Statistical analysis will be performed using the de-identified dataset.

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：

  2026-06-04 14:56:25