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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country10 target enrollmentMarch 9, 2022

ConditionsWound Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Wound Infection
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment: 10
Locations: 1
Primary Endpoint: Wound healing grading
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 9, 2022

End Date

May 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Sponsor

Eligibility Criteria

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.