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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05735470
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.7
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Wound Infection	Device: antibacterial bone traction needles	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: An Exploratory Clinical Trial to Evaluate the Efficacy and Safety of a Novel Antibacterial Bone Traction Needle
• Actual Study Start Date: Mar 9, 2022
• Anticipated Primary Completion Date: Mar 30, 2023
• Anticipated Study Completion Date: May 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Wound healing grading [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhaoming Ye	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT05735470
• Other Study ID Numbers: 2021 0873
• First Posted: Feb 21, 2023
• Last Update Posted: Feb 21, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University: external fixation, implant
• Additional relevant MeSH terms: Wound Infection; Anti-Bacterial Agents

Study Results

No Results Posted as of Feb 21, 2023