Peripheral Nerve InjuriesNCT03780855
Preliminary Evaluation of the Clinical Safety and Effectiveness of the Bionic Nerve Scaffold
A study testing nerve scaffold in people with Peripheral Nerve Injuries, run by Xijing Hospital at 1 site in China.
Trial summary
The objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels. 10 patients with peripheral sensory nerve defects will be involved and divided into 2 groups: the experimental group is treated with the nerve scaffold… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- nerve scaffold
- 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
- 14 Jun 2017to Dec 2019
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age from 18-50 yeas old, male or female, course of disease is within one year;
- good heart, liver and kidney function;
- with peripheral sensory nerve defects of 1-3 cm in size, and willing to repair it with the nerve scaffold;
- no significant damage existing in the skin and soft tissue in the operative region
- have signed the informed consent form
- good adherence and willing to return for follow-up visits as required.
Who cannot join
- with acute or severe infection
- suffering from serious primary diseases of heart, brain, liver and kidney, blood system, endocrine system and so on, and can not tolerate surgery
- with histories of peripheral vascular disease, immunological disorder chronic alcoholism, and drug abuse and so on
- with family history of genetic
- allergic to collagen and chitosan
- pregnancy and lactating women
- serious damage existing in the skin and soft tissue in the operative region
- bad adherence and can not return for follow-up visits on time as required
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Jing h Huang, MD, 13572066464, huangjh@fmmu.edu.cn
About this study
Official title: Preliminary Evaluation of the Safety and Effectiveness of the Bionic Nerve Scaffold With Longitudinally Oriented Microchannels in Clinical Application
The objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels. 10 patients with peripheral sensory nerve defects will be involved and divided into 2 groups: the experimental group is treated with the nerve scaffold, and the control group without that. Then follow the cases up and draw conclusion according to the results of observation and examination.
Read the detailed description
The objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels developed in the Department of Orthopaedics in Xijing hospital in repairing the peripheral nerve defect. According to the inclusion and exclusion criteria, 10 patients with peripheral sensory nerve defects of 1 to 3 cm in size will be involved. Divided them into 2 groups. The experimental group of 5 cases will be treated with the nerve scaffold, and the control group without that. Then follow the cases up at about 2 weeks, 3 months and 6 months after surgery. Observe the condition of the healing of the local wound and the whole body of the 10 patients. Examine the blood routine and biochemical indexes of the experimental group. Sensory recovery of injured nerves will be tested at about 3 months and 6 months after surgery. Record the results in the case report forms. Analyze the data statistically and draw conclusion.
- Conditions
- Peripheral Nerve Injuries
- Being tested
- nerve scaffold
- Keywords
- scaffold, Peripheral nerve injures, repair, safety, effectiveness
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve scaffoldDevice
It is a new kind of nerve scaffold with the microstructure of longitudinally oriented microchannels. It's made of collagen as the main raw material.
| Study group | Role | What they receive |
|---|---|---|
| nerve scaffold group | Experimental | the experimental group of cases with peripheral sensory nerve injuries will be treated with nerve scaffold. Receives: Device: nerve scaffold |
| non-nerve scaffold group | No intervention | the control group of cases will be treated without nerve scaffold. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observing the condition of the healing of local wound with the naked eye at 2 weeks after operation，including redness, exudation and ulceration.
The condition of the healing of local wound will be observed by the designated doctor with the naked eye to see if there is redness, exudation or ulceration. And then the condition will be recorded.
Measured: 2 weeks after operation
Learning about patients' systemic reactions by asking them at 2 weeks after operation, including fever, nausea, vomiting and skin itching.
The patients will be asked if there is systemic discomfort or any other bad reactions during the 2 weeks, including fever, nausea, vomiting and skin itching. And then the condition will be recorded.
Measured: 2 weeks after operation
Test of white blood cell count at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
Measured: 2 weeks after operation
Test of lymphocyte count at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
Measured: 2 weeks after operation
Test of red blood cell count at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
Measured: 2 weeks after operation
Test of hemoglobin concentration at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
Measured: 2 weeks after operation
Test of platelet count at 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
Measured: 2 weeks after operation
Test of alanine aminotransferase at 2 weeks after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
Measured: 2 weeks after operation
Test of aspartate aminotransferase at 2 weeks after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
Measured: 2 weeks after operation
Test of serum creatinine at 2 weeks after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
Measured: 2 weeks after operation
Test of blood urea nitrogen at 2 weeks after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
Measured: 2 weeks after operation
Test of prothrombin time at 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
Measured: 2 weeks after operation
Test of activated partial thromboplastin time at 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
Measured: 2 weeks after operation
Test of thrombin time at 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
Measured: 2 weeks after operation
Examination of the position sense at 3 months after operation
The position sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is a kind of deep sense.
Measured: 3 months after operation
Examination of the movement sense at 3 months after operation
The movement sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is another kind of deep sense.
Measured: 3 months after operation
Examination of the sense of light touch at 3 months after operation
The sense of light touch of the area innervated by the repaired nerve will be examined by the designated doctor, which is one of the superficial sense categories.
Measured: 3 months after operation
Examination of the sense of pain at 3 months after operation
The sense of pain of the area innervated by the repaired nerve will be examined by the designated doctor, which is another one of the superficial sense categories.
Measured: 3 months after operation
Examination of the sense of temperature at 3 months after operation
The sense of temperature of the area innervated by the repaired nerve will be examined by the designated doctor, which also belongs to the superficial sense categories.
Measured: 3 months after operation
Examination of static two-point discrimination at 3 months after operation
The static two-point discrimination of the area innervated by the repaired nerve will be examined by the designated doctor.
Measured: 3 months after operation
Test of white blood cell count at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
Measured: 3 months after operation
Test of lymphocyte count at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
Measured: 3 months after operation
Test of red blood cell count at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
Measured: 3 months after operation
Test of hemoglobin concentration at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
Measured: 3 months after operation
Test of platelet count at 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
Measured: 3 months after operation
Test of alanine aminotransferase at 3 months after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
Measured: 3 months after operation
Test of aspartate aminotransferase at 3 months after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
Measured: 3 months after operation
Test of serum creatinine at 3 months after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
Measured: 3 months after operation
Test of blood urea nitrogen at 3 months after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
Measured: 3 months after operation
Test of prothrombin time at 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
Measured: 3 months after operation
Test of activated partial thromboplastin time at 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
Measured: 3 months after operation
Test of thrombin time at 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
Measured: 3 months after operation
Examination of the position sense at 6 months after operation
The position sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is a kind of deep sense.
Measured: 6 months after operation
Examination of the movement sense at 6 months after operation
The movement sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is another kind of deep sense.
Measured: 6 months after operation
Examination of the sense of light touch at 6 months after operation
The sense of light touch of the area innervated by the repaired nerve will be examined by the designated doctor, which is one of the superficial sense categories.
Measured: 6 months after operation
Examination of the sense of pain at 6 months after operation
The sense of pain of the area innervated by the repaired nerve will be examined by the designated doctor, which is another one of the superficial sense categories.
Measured: 6 months after operation
Examination of the sense of temperature at 6 months after operation
The sense of temperature of the area innervated by the repaired nerve will be examined by the designated doctor, which also belongs to the superficial sense categories.
Measured: 6 months after operation
Examination of static two-point discrimination at 6 months after operation
The static two-point discrimination of the area innervated by the repaired nerve will be examined by the designated doctor.
Measured: 6 months after operation
Test of white blood cell count at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
Measured: 6 months after operation
Test of lymphocyte count at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
Measured: 6 months after operation
Test of red blood cell count at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
Measured: 6 months after operation
Test of hemoglobin concentration at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
Measured: 6 months after operation
Test of platelet count at 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
Measured: 6 months after operation
Test of alanine aminotransferase at 6 months after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
Measured: 6 months after operation
Test of aspartate aminotransferase at 6 months after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
Measured: 6 months after operation
Test of serum creatinine at 6 months after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
Measured: 6 months after operation
Test of blood urea nitrogen at 6 months after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
Measured: 6 months after operation
Test of prothrombin time at 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
Measured: 6 months after operation
Test of activated partial thromboplastin time at 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
Measured: 6 months after operation
Test of thrombin time at 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
Measured: 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start14 Jun 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhuo j Luo, MD, Study chair, Xijing HospitalRui Cong, MD, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780855
- Sponsor's protocol ID
- KY20172005-1
- Status last verified
- Dec 2017
- First submitted
- 26 Nov 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of the Safety and Effectiveness of the Bionic Nerve Scaffold With Longitudinally Oriented Microchannels in Clinical Application
- ClinicalTrials.gov ID
- NCT03780855
- Acronym / sponsor ID
- KY20172005-1
- Conditions
- Peripheral Nerve Injuries
- Keywords
- scaffold, Peripheral nerve injures, repair, safety, effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 19 Dec 2018 (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 objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels. 10 patients with peripheral sensory nerve defects will be involved and divided into 2 groups: the experimental group is treated with the nerve scaffold, and the control group without that. Then follow the cases up and draw conclusion according to the results of observation and examination.
Detailed description
The objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels developed in the Department of Orthopaedics in Xijing hospital in repairing the peripheral nerve defect. According to the inclusion and exclusion criteria, 10 patients with peripheral sensory nerve defects of 1 to 3 cm in size will be involved. Divided them into 2 groups. The experimental group of 5 cases will be treated with the nerve scaffold, and the control group without that. Then follow the cases up at about 2 weeks, 3 months and 6 months after surgery. Observe the condition of the healing of the local wound and the whole body of the 10 patients. Examine the blood routine and biochemical indexes of the experimental group. Sensory recovery of injured nerves will be tested at about 3 months and 6 months after surgery. Record the results in the case report forms. Analyze the data statistically and draw conclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nerve scaffold group | Experimental | Device: nerve scaffoldthe experimental group of cases with peripheral sensory nerve injuries will be treated with nerve scaffold. |
| non-nerve scaffold group | No intervention | –the control group of cases will be treated without nerve scaffold. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- age from 18-50 yeas old, male or female, course of disease is within one year;
- good heart, liver and kidney function;
- with peripheral sensory nerve defects of 1-3 cm in size, and willing to repair it with the nerve scaffold;
- no significant damage existing in the skin and soft tissue in the operative region
- have signed the informed consent form
Key exclusion criteria (8 listed)
- with acute or severe infection
- suffering from serious primary diseases of heart, brain, liver and kidney, blood system, endocrine system and so on, and can not tolerate surgery
- with histories of peripheral vascular disease, immunological disorder chronic alcoholism, and drug abuse and so on
- with family history of genetic
- allergic to collagen and chitosan
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 |
|---|---|---|
| nerve scaffoldIt is a new kind of nerve scaffold with the microstructure of longitudinally oriented microchannels. It's made of collagen as the main raw material. | Device | nerve scaffold group |
Primary outcome
Observing the condition of the healing of local wound with the naked eye at 2 weeks after operation，including redness, exudation and ulceration.
Time frame: 2 weeks after operation
The condition of the healing of local wound will be observed by the designated doctor with the naked eye to see if there is redness, exudation or ulceration. And then the condition will be recorded.
Learning about patients' systemic reactions by asking them at 2 weeks after operation, including fever, nausea, vomiting and skin itching.
Time frame: 2 weeks after operation
The patients will be asked if there is systemic discomfort or any other bad reactions during the 2 weeks, including fever, nausea, vomiting and skin itching. And then the condition will be recorded.
Test of white blood cell count at 2 weeks after operation
Time frame: 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
Test of lymphocyte count at 2 weeks after operation
Time frame: 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
Test of red blood cell count at 2 weeks after operation
Time frame: 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
Test of hemoglobin concentration at 2 weeks after operation
Time frame: 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
Test of platelet count at 2 weeks after operation
Time frame: 2 weeks after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
Test of alanine aminotransferase at 2 weeks after operation
Time frame: 2 weeks after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
Test of aspartate aminotransferase at 2 weeks after operation
Time frame: 2 weeks after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
Test of serum creatinine at 2 weeks after operation
Time frame: 2 weeks after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
Test of blood urea nitrogen at 2 weeks after operation
Time frame: 2 weeks after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
Test of prothrombin time at 2 weeks after operation
Time frame: 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
Test of activated partial thromboplastin time at 2 weeks after operation
Time frame: 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
Test of thrombin time at 2 weeks after operation
Time frame: 2 weeks after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
Examination of the position sense at 3 months after operation
Time frame: 3 months after operation
The position sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is a kind of deep sense.
Examination of the movement sense at 3 months after operation
Time frame: 3 months after operation
The movement sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is another kind of deep sense.
Examination of the sense of light touch at 3 months after operation
Time frame: 3 months after operation
The sense of light touch of the area innervated by the repaired nerve will be examined by the designated doctor, which is one of the superficial sense categories.
Examination of the sense of pain at 3 months after operation
Time frame: 3 months after operation
The sense of pain of the area innervated by the repaired nerve will be examined by the designated doctor, which is another one of the superficial sense categories.
Examination of the sense of temperature at 3 months after operation
Time frame: 3 months after operation
The sense of temperature of the area innervated by the repaired nerve will be examined by the designated doctor, which also belongs to the superficial sense categories.
Examination of static two-point discrimination at 3 months after operation
Time frame: 3 months after operation
The static two-point discrimination of the area innervated by the repaired nerve will be examined by the designated doctor.
Test of white blood cell count at 3 months after operation
Time frame: 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
Test of lymphocyte count at 3 months after operation
Time frame: 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
Test of red blood cell count at 3 months after operation
Time frame: 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
Test of hemoglobin concentration at 3 months after operation
Time frame: 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
Test of platelet count at 3 months after operation
Time frame: 3 months after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
Test of alanine aminotransferase at 3 months after operation
Time frame: 3 months after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
Test of aspartate aminotransferase at 3 months after operation
Time frame: 3 months after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
Test of serum creatinine at 3 months after operation
Time frame: 3 months after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
Test of blood urea nitrogen at 3 months after operation
Time frame: 3 months after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
Test of prothrombin time at 3 months after operation
Time frame: 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
Test of activated partial thromboplastin time at 3 months after operation
Time frame: 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
Test of thrombin time at 3 months after operation
Time frame: 3 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
Examination of the position sense at 6 months after operation
Time frame: 6 months after operation
The position sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is a kind of deep sense.
Examination of the movement sense at 6 months after operation
Time frame: 6 months after operation
The movement sense of the area innervated by the repaired nerve will be examined by the designated doctor, which is another kind of deep sense.
Examination of the sense of light touch at 6 months after operation
Time frame: 6 months after operation
The sense of light touch of the area innervated by the repaired nerve will be examined by the designated doctor, which is one of the superficial sense categories.
Examination of the sense of pain at 6 months after operation
Time frame: 6 months after operation
The sense of pain of the area innervated by the repaired nerve will be examined by the designated doctor, which is another one of the superficial sense categories.
Examination of the sense of temperature at 6 months after operation
Time frame: 6 months after operation
The sense of temperature of the area innervated by the repaired nerve will be examined by the designated doctor, which also belongs to the superficial sense categories.
Examination of static two-point discrimination at 6 months after operation
Time frame: 6 months after operation
The static two-point discrimination of the area innervated by the repaired nerve will be examined by the designated doctor.
Test of white blood cell count at 6 months after operation
Time frame: 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of white blood cell count will be recorded.
Test of lymphocyte count at 6 months after operation
Time frame: 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of lymphocyte count will be recorded.
Test of red blood cell count at 6 months after operation
Time frame: 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of red blood cell count will be recorded.
Test of hemoglobin concentration at 6 months after operation
Time frame: 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of hemoglobin concentration will be recorded.
Test of platelet count at 6 months after operation
Time frame: 6 months after operation
Blood routine test will be conducted in our hospital. And then the value of platelet count will be recorded.
Test of alanine aminotransferase at 6 months after operation
Time frame: 6 months after operation
Liver function test will be conducted in our hospital. And then the value of alanine aminotransferase will be recorded.
Test of aspartate aminotransferase at 6 months after operation
Time frame: 6 months after operation
Liver function test will be conducted in our hospital. And then the value of aspartate aminotransferase will be recorded.
Test of serum creatinine at 6 months after operation
Time frame: 6 months after operation
Kidney function test will be conducted in our hospital. And then the value of serum creatinine will be recorded.
Test of blood urea nitrogen at 6 months after operation
Time frame: 6 months after operation
Kidney function test will be conducted in our hospital. And then the value of blood urea nitrogen will be recorded.
Test of prothrombin time at 6 months after operation
Time frame: 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of prothrombin time will be recorded.
Test of activated partial thromboplastin time at 6 months after operation
Time frame: 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of activated partial thromboplastin time will be recorded.
Test of thrombin time at 6 months after operation
Time frame: 6 months after operation
Hemagglutination series test will be conducted in our hospital. And then the value of thrombin time will be recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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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.
Zhuo j Luo, MD study chair
Xijing Hospital
Rui Cong, MD study director
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nerve scaffold in people with Peripheral Nerve Injuries, run by Xijing Hospital 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 6 inclusion and 8 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 19 Dec 2018. 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 Jing h Huang, MD (13572066464, huangjh@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observing the condition of the healing of local wound with the naked eye at 2 weeks after operation，including redness, exudation and ulceration. (time frame: 2 weeks after operation). The study lists 50 primary outcomes in all. 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 19 Dec 2018.