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评价CareSYS Ⅰ水动力治疗工作站配套一次性使用清创水刀刀头用于深Ⅱ度烧伤创面清创的有效性及安全性的一项前瞻性、多中心、随机、平行对照、非劣效临床试验
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注册号:

Registration number:

ChiCTR1900024446 

最近更新日期:

Date of Last Refreshed on:

2019-07-12 

注册时间:

Date of Registration:

2019-07-12 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

评价CareSYS Ⅰ水动力治疗工作站配套一次性使用清创水刀刀头用于深Ⅱ度烧伤创面清创的有效性及安全性的一项前瞻性、多中心、随机、平行对照、非劣效临床试验 

Public title:

A prospective, multicenter, randomized, parallel-controlled, non-inferior clinical trial for evaluating the effectiveness and safety of a one-time debridement waterjet cutter for the treatment of deep second - degree burns in CareSYS I hydrodynamic workstation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评价CareSYS Ⅰ水动力治疗工作站配套一次性使用清创水刀刀头用于深Ⅱ度烧伤创面清创的有效性及安全性的一项前瞻性、多中心、随机、平行对照、非劣效临床试验 

Scientific title:

A prospective, multicenter, randomized, parallel-controlled, non-inferior clinical trial for evaluating the effectiveness and safety of a one-time debridement waterjet cutter for the treatment of deep second - degree burns in CareSYS I hydrodynamic workstation 

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:

徐小艳 

研究负责人:

吴军 

Applicant:

Xiaoyan Xu 

Study leader:

Jun Wu 

申请注册联系人电话:

Applicant telephone:

+86 18129586460 

研究负责人电话:

Study leader's telephone:

+86 13983130289 

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:

xxy@caresys.cc 

研究负责人电子邮件:

Study leader's E-mail:

junwupro@126.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:

广东省惠州市大亚湾响水河龙山七路域鑫科技园 

研究负责人通讯地址:

广东省广州市越秀区中山二路58号 

Applicant address:

Yuxin Industrial Park, Seventh Longshan Road, Xiang-Shui-He, Daya Bay, Huizhou, Guangdong, China 

Study leader's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, 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:

惠州海卓科赛医疗有限公司 

Applicant's institution:

Huizhou Hydro Caresys Medical Co., Ltd. 

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:

2018-007-02 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

中山大学附属第一医院临床药品、设备和医疗新技术伦理委员会 

Name of the ethic committee:

Ethics Committee of Clinical Medicine, Equipment and Medical New Technology of the First Affiliated Hospital of Sun Yat-sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-07-03 

伦理委员会联系人:

林颖 

Contact Name of the ethic committee:

Ying Lin 

伦理委员会联系地址:

广东省广州市竹丝岗二马路5号龙珠大厦写字楼1楼110房 

Contact Address of the ethic committee:

Room 110, 1st Floor, Longzhu Building, 5 Second Road, Zhusigang, Guangzhou, Guangdong, 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:

中山大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of Sun Yat-sen University 

研究实施负责(组长)单位地址:

广东省广州市越秀区中山二路58号 

Primary sponsor's address:

58 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

惠州海卓科赛医疗有限公司 

Source(s) of funding:

Huizhou Hydro Caresys Medical Co., Ltd. 

研究疾病:

深二度烧伤 

Target disease:

Deep second- degree burn 

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 

研究目的:

通过前瞻性、多中心、随机、平行对照的非劣效临床试验,评价惠州海卓科赛医疗有限公司生产的CareSYS Ⅰ水动力治疗工作站配套一次性使用清创水刀刀头用于深Ⅱ度烧伤创面清创的有效性及安全性 

Objectives of Study:

The CareSYS I hydrodynamic treatment workstation produced by Huizhou Hydro Caresys Medical Co., Ltd. is used for the one-time use of debridement waterjet cutter head for deep second-degree burns through a prospective, multi-center, randomized, parallel-controlled non-inferior clinical trial. Effectiveness and safety of debridement in burn 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)年龄大于等于18岁,小于等于70岁,性别不限; (2)热液、火焰、电弧、蒸汽等热力导致的深Ⅱ度烧伤创面[5],烧伤创面总面积为2%~50%全身体表面积(TBSA)[5,6]; (3)烧伤创面位于躯干、四肢的非关节功能部位; (4)纳取受试者符合入排标准的100 cm2 ± 10%大小的创面区域为试验窗口区。(对于其余烧伤创面根据研究者判断及患者意愿采用相应方式进行创面处理); (5)能够理解试验内容并自愿同意进行试验者; (6)研究者判定适合行水刀清创的患者。 

Inclusion criteria

(1) Between ages of 18 and 70 years male and female; (2) Deep second- degree burns caused by heat such as hydrothermal fluid, flame, arc, steam, etc. [5], the total area of burn wounds is 2% to 50% of total body surface area (TBSA) [5,6]; (3) Burn wounds are located in the non-articular functional parts of the trunk and limbs; (4) The wound area of 100 cm2 +/-10% that meets the standard of admission is the test window area. (For the remaining burn wounds, according to the judgment of the researcher and the patient's will, the corresponding method is used for wound treatment); (5) Those who are able to understand the test content and voluntarily agree to conduct the test; (6) The investigator determined that the patient was suitable for debridement with a waterjet. 

排除标准:

(1)妊娠及哺乳期妇女; (2)在过去30天内接受过创面外科清创手术者; (3)在过去30天内或预期研究过程中需接受系统性免疫抑制剂治疗(包括糖皮质激素)、细胞毒性药物、抗凝血药物治疗者; (4)目前正在或计划在研究期间参加其他器械或药物临床研究者; (5)伴有造血功能障碍、凝血功能障碍(如血友病)的患者; (6)伴有糖尿病、血管性疾病(包括未行重建的外周血管疾病、血管炎等)、脓皮病或淋巴水肿者; (7)伴有严重的重要脏器急慢性疾病或功能不全者,包括:严重心功能不全(心功能等级Ⅲ级及以上)、严重高血压(血压>160/100 mmHg)、严重心律失常(心率>160次/分)、肝功能异常(丙氨酸氨基转移酶(ALT)>2倍正常值上限、肾功能异常(血肌酐>1.5倍正常值上限)等)或多脏器功能衰竭者; (8)伴有自身免疫性疾病、恶性肿瘤、结核等严重基础性疾病者; (9)获得性免疫缺陷综合征(AIDS)患者或感染人类免疫缺陷病毒(HIV)患者; (10)全身营养状况较差、免疫功能低下者; (11)并发有急性或慢性细菌、病毒或真菌性皮肤病等可能干扰创面愈合者; (12)伴有精神疾病或心理障碍者; (13)既往治疗依从性差者; (14)伴有休克、全身严重感染的患者; (15)化学烧伤[6]或放射性烧伤等特殊原因烧伤[7]的患者; (16)经研究者判定不适合入组的其他情况,如:不能耐受清创术的、随访困难的、合并其他伤口清创影响水刀清创效果的情况等。 

Exclusion criteria:

(1) Pregnant and lactating women; (2) Those who have undergone wound surgery in the past 30 days; (3) Those who require systemic immunosuppressive therapy (including glucocorticoids), cytotoxic drugs, and anticoagulant drugs in the past 30 days or during the expected study period; (4) Those who are currently participating in or planning to participate in other devices or drug clinical investigators during the study period; (5) Patients with hematopoietic dysfunction and coagulopathy (such as hemophilia); (6) Those with diabetes, vascular disease (including peripheral vascular disease, vasculitis, etc.), pyoderma or lymphedema; (7) Those with severe acute organ dysfunction or dysfunction, including: severe cardiac insufficiency (heart function level III and above), severe hypertension (blood pressure > 160/100 mmHg), severe arrhythmia ( Heart rate > 160 beats / min), abnormal liver function (alanine aminotransferase (ALT) >2 times the upper limit of normal value, abnormal renal function (hemoresin > 1.5 times the upper limit of normal), etc.) or multiple organ failure; (8) Those with serious underlying diseases such as autoimmune diseases, malignant tumors, and tuberculosis; (9) Acquired immunodeficiency syndrome (AIDS) patients or patients infected with human immunodeficiency virus (HIV); (10) Those with poor systemic nutritional status and low immune function; (11) concurrent with acute or chronic bacterial, viral or fungal skin diseases that may interfere with wound healing; (12) Those with mental illness or mental disorder; (13) Poor treatment compliance; (14) Patients with shock and severe systemic infection; (15) Patients with chemical burns [6] or burns of special causes such as radioactive burns [7]; (16) Other conditions that are not suitable for enrollment by the investigator, such as: inability to tolerate debridement, difficult follow-up, combined with other wound debridement to affect the debridement effect of waterjet. 

研究实施时间:

Study execute time:

From2018-03-01To 2020-06-30 

干预措施:

Interventions:

组别:

试验组

样本量:

69

Group:

experimental group

Sample size:

干预措施:

CareSYS Ⅰ水动力治疗工作站、一次性使用清创水刀刀头+优拓SSD

干预措施代码:

Intervention:

CareSYS I hydrodynamic treatment workstation, a one-time debridement waterjet cutter +UrgoTul SSD

Intervention code:

组别:

对照组

样本量:

69

Group:

control group

Sample size:

干预措施:

VERSAJET Ⅱ清创水刀系统+优拓SSD

干预措施代码:

Intervention:

VERSAJET II debridement waterjet system+ UrgoTul SSD

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Sun Yat-sen University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广东 

市(区县):

深圳 

Country:

China 

Province:

Guangdong 

City:

Shenzhen 

单位(医院):

深圳市第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shenzhen Second People's Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广东 

市(区县):

佛山 

Country:

China 

Province:

Guangdong 

City:

Foshan 

单位(医院):

佛山市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Foshan First People's Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

山西 

市(区县):

太原 

Country:

China 

Province:

Shanxi 

City:

Taiyuan 

单位(医院):

太原钢铁集团有限公司总医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Sun Yat-sen University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

江苏 

市(区县):

南通 

Country:

China 

Province:

Jiangsu 

City:

Nantong 

单位(医院):

南通大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Nantong University Affiliated Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

坏死组织清除成功率

指标类型:

主要指标 

Outcome:

Necrotic tissue clearance success rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

坏死组织清除率

指标类型:

次要指标 

Outcome:

necrotic tissue clearance rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

清创时间

指标类型:

次要指标 

Outcome:

Debridement time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

创面面积缩小百分比

指标类型:

次要指标 

Outcome:

Percentage reduction of wound area

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

创面感染情况评估

指标类型:

次要指标 

Outcome:

Assessment of 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:

器械操作性能评价

指标类型:

次要指标 

Outcome:

Instrument performance evaluation

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

使用后销毁 

说明

Fate of sample:

Destruction after use 

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 70 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):

随机序列由杭州泰格医药科技有限公司采用统计学软件产生,进行分层随机

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

The random sequence was generated by Hangzhou Taige Pharmaceutical Technology Co., Ltd. using statistical software for stratified randomization.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

根据要求; ResMan

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

On requirements; ResMan

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:

病例记录表

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-12
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