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

Primary Purpose

Wound Infection

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
antibacterial bone traction needles
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Wound Infection focused on measuring external fixation, implant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhaoming YeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Antibacterial bone traction needle

bone traction needle

Arm Description

The bone traction needle with an antibacterial coating.

The bone traction needle without an antibacterial coating.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 10, 2023
Last Updated
February 10, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05735470
Brief Title
An Exploratory Clinical Trial to Evaluate the Efficacy and Safety of a Novel Antibacterial Bone Traction Needle
Official Title
An Exploratory Clinical Trial to Evaluate the Efficacy and Safety of a Novel Antibacterial Bone Traction Needle
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
external fixation, implant

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antibacterial bone traction needle
Arm Type
Experimental
Arm Description
The bone traction needle with an antibacterial coating.
Arm Title
bone traction needle
Arm Type
No Intervention
Arm Description
The bone traction needle without an antibacterial coating.
Intervention Type
Device
Intervention Name(s)
antibacterial bone traction needles
Intervention Description
Whether to use bone traction needles containing antibacterial coatings
Primary Outcome Measure Information:
Title
Wound healing grading
Description
The wound healing grading is evaluated by combining the wound healing grading, Sims grading and VAS grading
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoqiang Jin, Doctor
Phone
+8615757172193
Email
jinxq@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wangsiyuan Teng, Doctor
Phone
+8618357162727
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoming Ye, Doctor
Organizational Affiliation
2' affiliated Hospital, Schoolc of Medcine, Zhejiang University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Zhaoming Ye
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaoming Ye, Doctor
Phone
+8613606501549
Email
yezhaominghz@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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