Wound Infection
Conditions
Keywords
external fixation, implant
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.
Interventions
DEVICEantibacterial bone traction needles
Whether to use bone traction needles containing antibacterial coatings
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing grading | 3 months | The wound healing grading is evaluated by combining the wound healing grading, Sims grading and VAS grading |
Countries
China
Contacts
Primary ContactXiaoqiang Jin, Doctor
Backup ContactWangsiyuan Teng, Doctor
Outcome results
None listed