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

February 10, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaoqiang Jin, Doctor
  • Phone Number: +8615757172193
  • Email: jinxq@zju.edu.cn

Study Contact Backup

  • Name: Wangsiyuan Teng, Doctor
  • Phone Number: +8618357162727

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Zhaoming Ye
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Zhaoming Ye, Doctor, 2' affiliated Hospital, Schoolc of Medcine, Zhejiang University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2022

Primary Completion (Anticipated)

March 30, 2023

Study Completion (Anticipated)

May 30, 2023

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Estimate)

February 20, 2023

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021 0873

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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