An Exploratory Clinical Trial to Evaluate the Efficacy and Safety of a Novel Antibacterial Bone Traction Needle

NCT ID: NCT05735470

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2023-05-30

Brief Summary

The goal of this clinical trial is to test in wound infection. The main question it aims to answer is: Whether this antibacterial bone traction needle is safe and has a good effect on wound infection. Participants will be implanted with an antibacterial bone traction needles and the infection grade of wound after surgery will be observed. If there is a comparison group: Researchers will compare the control group without antibacterial ability to see if the experimental group Can effectively inhibit wound infection.

Conditions

Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Antibacterial bone traction needle

The bone traction needle with an antibacterial coating.

Group Type: EXPERIMENTAL

antibacterial bone traction needles

Intervention Type: DEVICE

Whether to use bone traction needles containing antibacterial coatings

bone traction needle

The bone traction needle without an antibacterial coating.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

antibacterial bone traction needles

Whether to use bone traction needles containing antibacterial coatings

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Limb fractures, infections, defects and deformities caused by various congenital or acquired factors, such as multiple fractures of tibia and fibula, infectious bone defects of tibia, knee varus, horseshoe varus foot, etc.;

2. The subject understands the significance of this project, voluntarily acts as the subject and signs the informed consent.

Exclusion Criteria

1. The subjects are pregnant or lactating women;

2. Pathological fractures (such as primary or metastatic tumors);

3. The patient is allergic to iodine and its compounds;

4. The patient is allergic to metal implants;

5. Patients with coagulopathy (such as hemophilia, vitamin K deficiency, severe liver disease, etc.);

6. The patient had participated in other clinical trials in the past 3 months;

7. The patient had contraindications to anesthesia and surgery;

8. The patient is currently receiving chemotherapy or radiotherapy, systemic corticosteroid use (continuous use for more than 3 months);

9. The patient had poor compliance and was judged by the researchers to be unable to complete the experiment according to the research plan, such as alcohol addiction, drug abuse, schizophrenia, dementia, and did not provide consent for voluntary participation in the clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaoming Ye, Doctor

Role: STUDY_CHAIR

2' affiliated Hospital, Schoolc of Medcine, Zhejiang University, China

Locations

Zhaoming Ye

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoqiang Jin, Doctor

Role: CONTACT

jinxq@zju.edu.cn

+8615757172193

Wangsiyuan Teng, Doctor

Role: CONTACT

+8618357162727

Facility Contacts

Zhaoming Ye, Doctor

Role: primary

yezhaominghz@163.com

+8613606501549

Other Identifiers

2021 0873

Identifier Type: -

Identifier Source: org_study_id