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

Study Overview
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Brief Summary
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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.

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

Conditions
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Wound Infection

Intervention / Treatment
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* Device: antibacterial bone traction needles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.; The subject understands the significance of this project, voluntarily acts as the subject and signs the informed consent. Exclusion Criteria: The subjects are pregnant or lactating women; Pathological fractures (such as primary or metastatic tumors); The patient is allergic to iodine and its compounds; The patient is allergic to metal implants; Patients with coagulopathy (such as hemophilia, vitamin K deficiency, severe liver disease, etc.); The patient had participated in other clinical trials in the past 3 months; The patient had contraindications to anesthesia and surgery; The patient is currently receiving chemotherapy or radiotherapy, systemic corticosteroid use (continuous use for more than 3 months); 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibacterial bone traction needle<br>The bone traction needle with an antibacterial coating. | Device: antibacterial bone traction needles<br>* Whether to use bone traction needles containing antibacterial coatings<br>|
| No Intervention: bone traction needle<br>The bone traction needle without an antibacterial coating. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing grading | The wound healing grading is evaluated by combining the wound healing grading, Sims grading and VAS grading | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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external fixation, implant