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

NCT05735470 | Unknown

• 1 other identifier: 2021 0873
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

external fixation, implant

Outcome Measures

Primary Outcomes (1)

• Wound healing grading

  The wound healing grading is evaluated by combining the wound healing grading, Sims grading and VAS grading

  3 months

Study Arms (2)

Antibacterial bone traction needle

EXPERIMENTAL

The bone traction needle with an antibacterial coating.

Device: antibacterial bone traction needles

bone traction needle

NO INTERVENTION

The bone traction needle without an antibacterial coating.

Interventions

antibacterial bone traction needles DEVICE

Whether to use bone traction needles containing antibacterial coatings

Antibacterial bone traction needle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Zhaoming Ye

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Zhaoming Ye, Doctor

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

  STUDY CHAIR

Central Study Contacts

Xiaoqiang Jin, Doctor

CONTACT

+8615757172193; jinxq@zju.edu.cn

Wangsiyuan Teng, Doctor

CONTACT

+8618357162727

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 21, 2023
• Study Start: March 9, 2022
• Primary Completion: March 30, 2023
• Study Completion: May 30, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CN (1)