ChiCTR2200063219 版本V1.0 版本创建时间2022/09/01 23:49:47 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：

 ChiCTR2200063219 

最近更新日期：

Date of Last Refreshed on：

 2022-09-01 23:49:37 

注册时间：

Date of Registration：

 2022-09-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

改良足背静脉皮瓣与动脉皮瓣修复手外伤的临床疗效比较

Public title：

Comparison of curative effects between modified acrotarsium venous flap and arterial flap in the repair of hand injury

注册题目简写：

English Acronym：

研究课题的正式科学名称：

改良足背静脉皮瓣与动脉皮瓣修复手外伤的临床疗效比较

Scientific title：

Comparison of curative effects between modified acrotarsium venous flap and arterial flap in the repair of hand injury

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：

钟云雪 

研究负责人：

魏在荣 

Applicant：

Zhong Yunxue 

Study leader：

Wei Zairong 

申请注册联系人电话：

Applicant telephone：

 15120310740

研究负责人电话：

Study leader's
telephone：

15208660008

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：

 844564235@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 188116999@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：

遵义医科大学附属医院烧伤整形外科

研究负责人通讯地址：

遵义医科大学附属医院烧伤整形外科

Applicant address：

Department of Burns and Plastic Surgery, Affiliated Hospital of Zunyi Medical University

Study leader's address：

Department of Burns and Plastic Surgery, Affiliated Hospital of Zunyi Medical University

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：

遵义医科大学附属医院

Applicant's institution：

Affiliated Hospital of Zunyi Medical University

研究负责人所在单位：

Affiliation of the Leader：

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：

 KLLY-2021-182

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：

遵义医科大学附属医院生物医学研究伦理委员会

Name of the ethic committee：

Biomedical research ethics committee of the Affiliated Hospital of Zunyi Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-12-31 00:00:00

伦理委员会联系人：

李树飞

Contact Name of the ethic committee：

Li Shufei

伦理委员会联系地址：

遵义医科大学附属医院行政楼3楼

Contact Address of the ethic committee：

3rd floor, administration building, Affiliated Hospital of Zunyi Medical University

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：

遵义医科大学附属医院

Primary sponsor：

Affiliated Hospital of Zunyi Medical University

研究实施负责（组长）单位地址：

贵州省遵义市汇川区大连路149号

Primary sponsor's address：

149 Dalian Road, Huichuan District, Zunyi, Guizhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

贵州

市(区县)：

遵义市

Country：

China

Province：

Guizhou

City：

Zunyi

单位(医院)：

遵义医科大学附属医院

具体地址：

贵州省遵义市汇川区大连路149号

Institution
hospital：

Affiliated Hospital of Zunyi Medical University

Address：

149 Dalian Road, Huichuan District, Zunyi, Guizhou

经费或物资来源：

贵州省科学技术厅项目（2020-5012）；贵州省教科技厅函（2020-39）

Source(s) of funding：

Project of Guizhou Provincial Department of science and Technology (2020-5012); Letter from Guizhou Provincial Department of education, science and Technology (2020-39)

研究疾病：

手部组织缺损  

Target disease：

tissue defect of hand

研究疾病代码：

Target disease code：

研究类型：

预后研究

Study type：

Prognosis study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

病例研究 

Study design：

Case study 

研究目的：

各种外伤导致的组织缺损，特别是手外伤的重建以及修复仍是整形外科医生的关注重点。由于手的功能丰富及特殊的解剖结构往往对我们进行功能及外形的重建带来了极大的阻力。既往流行带蒂皮瓣及动脉皮瓣转移修复手外伤，但其操作难度大，且易出现术区臃肿导致手指功能恢复受限，整形外科医生的目光逐渐被静脉皮瓣所吸引，其操作简便、供区损伤小等优点使静脉皮瓣被应用于临床手外伤的重建与修复当中。 静脉皮瓣是指血液通过静脉管道系统循环的皮瓣（从静脉流入又从静脉流出），而不论其静脉管道内的血液性质及血流方向。随着对静脉皮瓣基础及临床应用增加，特别是对皮瓣成活机理认识加深，成活率、成活后质量明显提高，静脉皮瓣进入修复重建外科医师的视野，成为显微外科领域，尤其是手外科医师所喜爱的一种替代传统皮瓣的理想皮瓣。 近年我科在足背设计了一种顺行的静脉皮瓣，动脉端为足背远端浅筋膜深层大隐静脉、静脉近心端为足背近端浅筋膜浅层静脉，大隐静脉与浅层静脉之间的较粗大、肉眼可见的动脉直接予以结扎；将切取的足背静脉皮瓣的远端大隐静脉同受区动脉相吻合，将浅层静脉分支同受区静脉相吻合，形成“类生理”的顺行静脉皮瓣。该静脉皮瓣仅切取包含浅筋膜浅层静脉的皮肤组织，保留供区皮神经于原位，对供区的损伤小，皮瓣移植后后较少发生水泡、青紫、肿胀等并发症，术后受区和供区的功能恢复良好，临床疗效及随访结果满意。当需要较薄、柔软化及血管化的组织覆盖创面时，该静脉皮瓣可以作为一个不错的选择。但该静脉皮瓣的远期效果、成活机制尚不完全清楚。因此有必要对该静脉皮瓣的临床效果进行进一步观察，并同动脉皮瓣修复的手部组织缺损对比预后情况。  

Objectives of Study：

The reconstruction and repair of tissue defects caused by various defects, especially hand defects, are still the focus of plastic surgeons. Due to the rich functions and special anatomical structure of the hand, it often brings great resistance to our reconstruction of function and shape. In the past, pedicled flap and arterial flap transplant were popular to repair hand defects, but it was difficult to operate, and the operation area was easy to be bloated, resulting in the limited recovery of finger function. The attention of plastic surgeons was gradually attracted by venous flap. Its advantages of simple operation and small damage in donor area made venous flap applied to the reconstruction and repair of clinical hand defects. Venous flap refers to the flap whose blood circulates through the venous pipeline system (flowing in and out of the vein), regardless of the nature and direction of blood flow in the venous pipeline. With the increase of the basic and clinical application of venous flap, especially the deepening understanding of the survival mechanism of flap, the survival rate and the quality after survival are significantly improved. Venous flap has entered the vision of repair and reconstruction surgeons and has become an ideal flap to replace traditional flap in the field of microsurgery, especially surgeons. In recent years, our department has designed an anterograde venous flap on the dorsum of the foot. The arterial end is the deep great saphenous vein of the superficial fascia at the distal end of the dorsum of the foot, the proximal end of the vein is the superficial vein of the superficial fascia at the proximal end of the dorsum of the foot, and the thicker and visible artery between the great saphenous vein and the superficial vein is directly ligated; The distal great saphenous vein of the dorsal pedis vein flap was anastomosed with the recipient artery, and the superficial vein branch was anastomosed with the recipient vein to form a "physiological" anterograde vein flap. The venous flap only cuts the skin tissue containing the superficial fascia and superficial vein, retains the donor cutaneous nerve in situ, and has little damage to the donor area. There are few complications such as blisters, cyanosis and swelling after flap transplantation. The function of the recipient area and donor area recovers well after operation, and the clinical curative effect and follow-up results are satisfactory. When a thin, soft and vascularized tissue is needed to cover the wound, the venous flap can be used as a good choice. However, the long-term effect and survival mechanism of the venous flap are not completely clear. Therefore, it is necessary to further observe the clinical effect of the venous flap and compare the prognosis with the hand tissue defect repaired by the arterial flap.

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所有需要进行游离皮瓣转移修复的手外伤；②无器质性病变；③自愿参与本研究；④病历资料完整。

Inclusion criteria

① All hand injuries requiring free flap transfer; ② No organic lesions; ③ Voluntary participation in this study; ④ The medical records are complete.

排除标准：

①合并重大内科疾病及神经疾病患者；②无法耐受手术者；③无法对治疗进行配合者。

Exclusion criteria：

① Patients with major medical diseases and neurological diseases; ② Those who cannot tolerate the operation; ③ Unable to cooperate with the treatment.

研究实施时间：

Study execute time：

从 From 2022-09-01 00:00:00至 To 2023-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-09-01 00:00:00 至 To 2023-03-31 00:00:00

干预措施：

Interventions：

组别：

静脉皮瓣组

样本量：

 26

Group：

venous flap group

Sample size：

干预措施：

改良足背静脉皮瓣修复手部组织缺损

干预措施代码：

Intervention：

modified acrotarsium venous flap repair the hand tissue defect

Intervention code：

组别：

传统皮瓣组

样本量：

 26

Group：

Traditional flap group

Sample size：

干预措施：

动脉皮瓣修复手外伤创面

干预措施代码：

Intervention：

arterial flap repair the hand injury

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州 

市(区县)：

 遵义 

Country：

China

Province：

Guizhou

City：

Zunyi

单位(医院)：

 遵义医科大学附属医院 

单位级别：

 三甲医院 

Institution
hospital：

Affiliated Hospital of Zunyi Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

皮瓣移植修复后手功能评分

指标类型：

主要指标

Outcome：

Hand function score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

皮瓣移植后并发症

指标类型：

主要指标

Outcome：

Complications

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

供区感觉功能恢复评分

指标类型：

次要指标

Outcome：

the score of recovery of donor sensory function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

受区感觉功能恢复评分

指标类型：

次要指标

Outcome：

the score of recovery of recipient site sensory function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

供区愈合情况

指标类型：

次要指标

Outcome：

The healing condition of donor site

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：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 6 岁 years
最大 Max age 70 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）：

所有患者入院后均告知两种治疗方法的优缺点，若患者同意，将其纳入，始终由同一个试验参与人员使用SPSS20.0软件对其进行随机分组，第一组采用静脉皮瓣转移修复创面，第二组采用传统皮瓣转移修复创面。

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

All patients were informed of the advantages and disadvantages of the two treatment methods after admission. If the patients agreed, they would be included. The same trial participant would always use SPSS20.0 software to randomly group them. The first group used venous flap transfer to repair the wound, an

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：

Blinding：

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）：

待文章发表后通过电话邮箱联系作者

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

Tel. or Email

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：

Excel表，CRF表

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

Exedl Form and Case Record Form

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：

  2022-09-01 23:49:37