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

Not Applicable

Recruiting

• Conditions: Wound Infection
• Interventions: Device: antibacterial bone traction needles

• Registration Number: NCT05735470
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-09
• Status Verified: 2023-02
• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-02-10
• Last Update Submitted: 2023-02-10
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-03-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibacterial bone traction needle	antibacterial bone traction needles	The bone traction needle with an antibacterial coating.

Primary Outcome Measures

Name	Time	Method
Wound healing grading	3 months	The wound healing grading is evaluated by combining the wound healing grading, Sims grading and VAS grading

Trial Locations

Locations (1)

Zhaoming Ye; 🇨🇳 Hangzhou, Zhejiang, China