Wound InfectionNCT05735470
An Exploratory Clinical Trial to Evaluate the Efficacy and Safety of a Novel Antibacterial Bone Traction Needle
A study testing antibacterial bone traction needles in people with Wound Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Wound Infection
- What is being tested?
- antibacterial bone traction needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Wangsiyuan Teng, Doctor contact
China1 site, 1 recruiting
- Recruiting
Zhaoming Ye
Hangzhou, Zhejiang, 310009
Zhaoming Ye, Doctor, +8613606501549, yezhaominghz@163.com
About this study
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
- Being tested
- antibacterial bone traction needles
- Keywords
- external fixation, implant
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibacterial bone traction needlesDevice
Whether to use bone traction needles containing antibacterial coatings
| Study group | Role | What they receive |
|---|---|---|
| Antibacterial bone traction needle | Experimental | The bone traction needle with an antibacterial coating. Receives: Device: antibacterial bone traction needles |
| bone traction needle | No intervention | The bone traction needle without an antibacterial coating. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing grading
The wound healing grading is evaluated by combining the wound healing grading, Sims grading and VAS grading
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start9 Mar 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaoming Ye, Doctor, Study chair, 2' affiliated Hospital, Schoolc of Medcine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735470
- Sponsor's protocol ID
- 2021 0873
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Trial to Evaluate the Efficacy and Safety of a Novel Antibacterial Bone Traction Needle
- ClinicalTrials.gov ID
- NCT05735470
- Acronym / sponsor ID
- 2021 0873
- Conditions
- Wound Infection
- Keywords
- external fixation, implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibacterial bone traction needle | Experimental | Device: antibacterial bone traction needlesThe bone traction needle with an antibacterial coating. |
| bone traction needle | No intervention | –The bone traction needle without an antibacterial coating. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibacterial bone traction needlesWhether to use bone traction needles containing antibacterial coatings | Device | Antibacterial bone traction needle |
Primary outcome
Wound healing grading
Time frame: 3 months
The wound healing grading is evaluated by combining the wound healing grading, Sims grading and VAS grading
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wangsiyuan Teng, Doctor contact
Zhaoming Ye, Doctor study chair
2' affiliated Hospital, Schoolc of Medcine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antibacterial bone traction needles in people with Wound Infection, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoqiang Jin, Doctor (+8615757172193, jinxq@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing grading (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.