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

Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735470
• Other study ID #: 2021 0873
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiaoqiang Jin, Doctor
• Phone: +8615757172193
• Email: jinxq[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wound Infection

Intervention

Device:
• antibacterial bone traction needles
Whether to use bone traction needles containing antibacterial coatings

Locations

Country	Name	City	State
China	Zhaoming Ye	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing grading	The wound healing grading is evaluated by combining the wound healing grading, Sims grading and VAS grading	3 months