Clinical trial NCT03780855: Preliminary Evaluation of the Clinical Safety and Effectiveness of the Bionic Nerve Scaffold
Official title: Preliminary Evaluation of the Safety and Effectiveness of the Bionic Nerve Scaffold With Longitudinally Oriented Microchannels in Clinical Application
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Nerve Injuries
Keywords: scaffold
Peripheral nerve injures
repair
safety
effectiveness
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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, 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Observing the condition of the healing of local wound with the naked eye at 2 weeks after operation，including redness, exudation and ulceration.
timeFrame: 2 weeks after operation
measure: Learning about patients' systemic reactions by asking them at 2 weeks after operation, including fever, nausea, vomiting and skin itching.
timeFrame: 2 weeks after operation
measure: Test of white blood cell count at 2 weeks after operation
timeFrame: 2 weeks after operation
measure: Test of lymphocyte count at 2 weeks after operation
timeFrame: 2 weeks after operation
measure: Test of red blood cell count at 2 weeks after operation
timeFrame: 2 weeks after operation
measure: Test of hemoglobin concentration at 2 weeks after operation
timeFrame: 2 weeks after operation
measure: Test of platelet count at 2 weeks after operation
timeFrame: 2 weeks after operation
measure: Test of alanine aminotransferase at 2 weeks after operation
timeFrame: 2 weeks after operation
measure: Test of aspartate aminotransferase at 2 weeks after operation
timeFrame: 2 weeks after operation
measure: Test of serum creatinine at 2 weeks after operation
timeFrame: 2 weeks after operation
measure: Test of blood urea nitrogen at 2 weeks after operation
timeFrame: 2 weeks after operation
measure: Test of prothrombin time at 2 weeks after operation
timeFrame: 2 weeks after operation
measure: Test of activated partial thromboplastin time at 2 weeks after operation
timeFrame: 2 weeks after operation
measure: Test of thrombin time at 2 weeks after operation
timeFrame: 2 weeks after operation
measure: Examination of the position sense at 3 months after operation
timeFrame: 3 months after operation
measure: Examination of the movement sense at 3 months after operation
timeFrame: 3 months after operation
measure: Examination of the sense of light touch at 3 months after operation
timeFrame: 3 months after operation
measure: Examination of the sense of pain at 3 months after operation
timeFrame: 3 months after operation
measure: Examination of the sense of temperature at 3 months after operation
timeFrame: 3 months after operation
measure: Examination of static two-point discrimination at 3 months after operation
timeFrame: 3 months after operation
measure: Test of white blood cell count at 3 months after operation
timeFrame: 3 months after operation
measure: Test of lymphocyte count at 3 months after operation
timeFrame: 3 months after operation
measure: Test of red blood cell count at 3 months after operation
timeFrame: 3 months after operation
measure: Test of hemoglobin concentration at 3 months after operation
timeFrame: 3 months after operation
measure: Test of platelet count at 3 months after operation
timeFrame: 3 months after operation
measure: Test of alanine aminotransferase at 3 months after operation
timeFrame: 3 months after operation
measure: Test of aspartate aminotransferase at 3 months after operation
timeFrame: 3 months after operation
measure: Test of serum creatinine at 3 months after operation
timeFrame: 3 months after operation
measure: Test of blood urea nitrogen at 3 months after operation
timeFrame: 3 months after operation
measure: Test of prothrombin time at 3 months after operation
timeFrame: 3 months after operation
measure: Test of activated partial thromboplastin time at 3 months after operation
timeFrame: 3 months after operation
measure: Test of thrombin time at 3 months after operation
timeFrame: 3 months after operation
measure: Examination of the position sense at 6 months after operation
timeFrame: 6 months after operation
measure: Examination of the movement sense at 6 months after operation
timeFrame: 6 months after operation
measure: Examination of the sense of light touch at 6 months after operation
timeFrame: 6 months after operation
measure: Examination of the sense of pain at 6 months after operation
timeFrame: 6 months after operation
measure: Examination of the sense of temperature at 6 months after operation
timeFrame: 6 months after operation
measure: Examination of static two-point discrimination at 6 months after operation
timeFrame: 6 months after operation
measure: Test of white blood cell count at 6 months after operation
timeFrame: 6 months after operation
measure: Test of lymphocyte count at 6 months after operation
timeFrame: 6 months after operation
measure: Test of red blood cell count at 6 months after operation
timeFrame: 6 months after operation
measure: Test of hemoglobin concentration at 6 months after operation
timeFrame: 6 months after operation
measure: Test of platelet count at 6 months after operation
timeFrame: 6 months after operation
measure: Test of alanine aminotransferase at 6 months after operation
timeFrame: 6 months after operation
measure: Test of aspartate aminotransferase at 6 months after operation
timeFrame: 6 months after operation
measure: Test of serum creatinine at 6 months after operation
timeFrame: 6 months after operation
measure: Test of blood urea nitrogen at 6 months after operation
timeFrame: 6 months after operation
measure: Test of prothrombin time at 6 months after operation
timeFrame: 6 months after operation
measure: Test of activated partial thromboplastin time at 6 months after operation
timeFrame: 6 months after operation
measure: Test of thrombin time at 6 months after operation
timeFrame: 6 months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Zhuo j Luo, MD
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Rui Cong, MD
role: STUDY_DIRECTOR
References: